Shoes for self-managing chronic hip Pain: the SCHIPP randomized clinical trial protocol.

BACKGROUND: Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options. Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate 'stable supportive' shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled trial (RCT) aims to determine if stable supportive footwear reduces hip pain during walking compared to flat flexible footwear in people with chronic hip pain consistent with OA. METHODS: This trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures. DISCUSSION: This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.

The Effect of Flat Flexible Versus Stable Supportive Shoes on Knee Osteoarthritis Symptoms : A Randomized Trial.

BACKGROUND: Experts recommend that persons with knee osteoarthritis wear stable supportive shoes; however, evidence suggests that flat flexible shoes may be more beneficial. OBJECTIVE: To compare flat flexible with stable supportive shoes for knee osteoarthritis symptoms. DESIGN: Participant- and assessor-blinded randomized trial. (Prospectively registered with the Australian New Zealand Clinical Trials Registry [ACTRN12617001098325]). SETTING: Community. PARTICIPANTS: 164 patients with moderate to severe symptomatic radiographic medial knee osteoarthritis. INTERVENTION: Flat flexible (n = 82) or stable supportive shoes (n = 82), worn for at least 6 hours a day for 6 months. MEASUREMENTS: Primary outcomes were changes in walking pain (measured by an 11-point numerical rating scale) and physical function (as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale of 0 to 68 points) at 6 months. Secondary outcomes included additional pain and function measures, physical activity, and quality of life. Other measures included adverse events. RESULTS: Of 164 participants recruited, 161 (98%) completed 6-month primary outcomes. No evidence was found that flat flexible shoes were superior to stable supportive shoes in primary outcomes. Evidence did show a between-group difference in change in pain favoring stable supportive shoes (mean difference, 1.1 units [95% CI, 0.5 to 1.8 units]; P = 0.001) but not function (mean difference, 2.3 units [CI, -0.9 to 5.5 units]; P = 0.167). Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, -5.3 units [CI, -10.0 to -0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively). Flat flexible shoes were not superior to stable supportive shoes for any secondary outcome. Fewer participants reported adverse events with stable supportive shoes (n = 12 [15%]) compared with flat flexible shoes (n = 26 [32%]) (risk difference, -0.17 [CI, -0.30 to -0.05]). LIMITATION: No "usual shoes" control group and a select patient subgroup, which may limit generalizability. CONCLUSION: Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.

Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial.

Importance: Most clinical guidelines do not recommend platelet-rich plasma (PRP) for knee osteoarthritis (OA) because of lack of high-quality evidence on efficacy for symptoms and joint structure, but the guidelines emphasize the need for rigorous studies. Despite this, use of PRP in knee OA is increasing. Objective: To evaluate the effects of intra-articular PRP injections on symptoms and joint structure in patients with symptomatic mild to moderate radiographic medial knee OA. Design, Setting, and Participants: This randomized, 2-group, placebo-controlled, participant-, injector-, and assessor-blinded clinical trial enrolled community-based participants (n = 288) aged 50 years or older with symptomatic medial knee OA (Kellgren and Lawrence grade 2 or 3) in Sydney and Melbourne, Australia, from August 24, 2017, to July 5, 2019. The 12-month follow-up was completed on July 22, 2020. Interventions: Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants). Main Outcomes and Measures: The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in medial tibial cartilage volume as assessed by magnetic resonance imaging (MRI). Thirty-one secondary outcomes (25 symptom related and 6 MRI assessed; minimum clinically important difference not known) evaluated pain, function, quality of life, global change, and joint structures at 2-month and/or 12-month follow-up. Results: Among 288 patients who were randomized (mean age, 61.9 [SD, 6.5] years; 169 [59%] women), 269 (93%) completed the trial. In both groups, 140 participants (97%) received all 3 injections. After 12 months, treatment with PRP vs placebo injection resulted in a mean change in knee pain scores of -2.1 vs -1.8 points, respectively (difference, -0.4 [95% CI, -0.9 to 0.2] points; P = .17). The mean change in medial tibial cartilage volume was -1.4% vs -1.2%, respectively (difference, -0.2% [95% CI, -1.9% to 1.5%]; P = .81). Of 31 prespecified secondary outcomes, 29 showed no significant between-group differences. Conclusions and Relevance: Among patients with symptomatic mild to moderate radiographic knee OA, intra-articular injection of PRP, compared with injection of saline placebo, did not result in a significant difference in symptoms or joint structure at 12 months. These findings do not support use of PRP for the management of knee OA. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617000853347.

Footwear for osteoarthritis of the lateral knee: protocol for the FOLK randomised controlled trial.

BACKGROUND: Structural features of lateral tibiofemoral (TF) joint osteoarthritis (OA) occur in up to half of all people with knee OA, and co-existing lateral TF OA is associated with worse knee pain in people with mixed compartmental knee OA. Clinical guidelines for management of knee OA advocate advice about appropriate footwear, yet there is no research evaluating which types of footwear are best for managing pain associated with lateral TF OA. Biomechanical evidence suggests that "motion-control" footwear, which possess midsoles that are stiffer medially compared to laterally, may shift load away from the lateral compartment of the knee and thus may reduce knee pain associated with lateral TF OA. The primary aim of this study is to compare the effects of motion-control shoes to neutral shoes on knee pain in people with predominantly lateral TF OA. METHODS: This will be an assessor- and participant-blinded, two-arm, comparative effectiveness randomized controlled trial (RCT) conducted in Melbourne, Australia. We will recruit a minimum of 92 people with painful lateral TF OA from the community. Participants will be randomly allocated to receive either motion-control shoes or neutral shoes and will be instructed to wear their allocated shoes for a minimum of 6 h per day for 6 months. The primary outcome is change in self-reported knee pain on walking, measured using a numerical rating scale, assessed at baseline and 6 months. Secondary outcomes include other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity levels. DISCUSSION: This study will compare the efficacy of motion-control shoes to neutral shoes for people with painful lateral TF OA. Findings will be the first to provide evidence of the effects of footwear on knee pain in this important subgroup of people with knee OA and allow clinicians to provide accurate advice about the most appropriate footwear for managing pain associated with lateral TF OA. TRIAL REGISTRATION: This trial has been prospectively registered by the Australian New Zealand Clinical Trials Registry on 15/11/2018 (reference: ACTRN12618001864213).

Foot orthoses for first metatarsophalangeal joint osteoarthritis: study protocol for the FORT randomised controlled trial.

BACKGROUND: First metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years. Non-drug, non-surgical treatments are recommended by OA clinical guidelines, yet there have only ever been two randomised controlled trials (RCTs) evaluating such strategies in people with first MTP joint OA. Foot orthoses are a common non-drug, non-surgical strategy used by allied health professionals for people with first MTP joint OA, however, it is unknown whether these devices are effective in improving the symptoms associated with the condition. This clinical trial aimed to determine whether contoured foot orthoses lead to greater reductions in first MTP joint pain on walking compared to sham flat insoles in people with first MTP joint OA. METHODS: The FORT trial (Foot ORthoses for big Toe joint osteoarthritis) is a two-arm participant- and assessor-blinded, multi-site RCT conducted in Melbourne, Sydney, Brisbane and the Gold Coast, Australia. We are recruiting 88 community-dwelling people with symptomatic radiographic first MTP joint OA. Following baseline assessment, participants are randomized to receive either: i) contoured foot orthoses; or ii) sham flat insoles following baseline assessment. Participants have two visits with a study podiatrist where they are provided with their allocated insoles, to be worn daily for 12 weeks at all times when wearing shoes. The primary outcome is self-reported first MTP joint pain on walking (numerical rating scale), assessed at baseline and 12 weeks. Secondary outcomes include additional measures of first MTP joint and foot pain, physical function, quality of life, participant-perceived global ratings of change (pain and function), and level of physical activity. DISCUSSION: This study will provide novel evidence about whether contoured foot orthoses improve pain and other symptoms compared to sham insoles in people with first MTP joint OA. Outcomes will help to inform clinical guidelines and practice about the use of foot orthoses for managing symptoms in this under-researched group of people with OA. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry (reference: ACTRN12619000926134 ) on 3/07/2019.

Footwear for self-managing knee osteoarthritis symptoms: protocol for the Footstep randomised controlled trial.

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability globally, and abnormal knee loading is central to disease pathogenesis. Clinical guidelines recommend clinicians provide advice regarding appropriate footwear for people with knee OA, yet there is little research comparing the effects of different footwear on knee OA symptoms. Research suggests that wearing flat flexible shoes is associated with lower knee joint loads compared to stable supportive shoe styles. This two-arm pragmatic, comparative effectiveness randomised controlled trial will compare the effects of daily use of flat flexible shoes and stable supportive shoes on knee OA clinical outcomes, over 6 months. METHODS: 164 people with symptomatic medial tibiofemoral OA of moderate to severe radiographic severity (Kellgren and Lawrence Grade 3 & 4) will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either i) flat flexible shoes or; ii) stable supportive shoes. Participants will choose two different pairs of shoes from a selection that fulfil the criteria in their allocated shoe class. Limited disclosure will blind participants to group allocation. Participants will be instructed to wear their allocated shoes daily for 6 months (minimum of 6 h/day), after which participants will be reassessed. The primary outcomes are knee pain severity on walking (measured by numerical rating scale) and self-reported physical function (measured by the Western Ontario and McMaster Universities Osteoarthritis Index), assessed at baseline and 6 months. Secondary outcomes include additional measures of knee pain, function, sport and recreation participation and quality-of-life (measured using subscales of the Knee Osteoarthritis Outcome Score), as well as pain at other sites (measured by numerical rating scale), self-reported global ratings of change in pain and physical function (measured by 7-point rating scale), and physical activity levels (measured by Physical Activity Scale for the Elderly). DISCUSSION: This study will determine whether daily wear of flat flexible shoes improves clinical outcomes in the management of knee OA, compared to stable supportive shoes. Findings will assist clinicians in providing evidence-based advice regarding appropriate footwear for people with knee OA to self-manage symptoms. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617001098325 . Registered 28/07/2017.

Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol.

BACKGROUND: Knee osteoarthritis (OA) causes substantial pain, physical dysfunction and impaired quality of life. There is no cure for knee OA, and for some people, the disease may involve progressive symptomatic and structural deterioration over time. Platelet-rich plasma (PRP) is a therapeutic agent that aims to address underlying biological processes responsible for OA pathogenesis. As such, it has the potential to improve both symptoms and joint structure. The aim of this clinical trial is to determine whether a series of injections of PRP into the knee joint will lead to a significantly greater reduction in knee pain, and less loss of medial tibial cartilage volume over 12 months when compared to a series of placebo saline injections in people with knee OA. METHODS: This will be a two-group, superiority, randomised, participant-, interventionist- and assessor-blinded, placebo-controlled trial. Two hundred and eighty-eight participants aged over 50 years with painful knee OA and mild to moderate structural change on x-ray (Kellgren and Lawrence grade 2 and 3) will be randomly allocated to receive either three PRP injections or three normal saline injections into the knee joint at weekly intervals. The primary outcomes will be 12-month change in average overall knee pain severity (numeric rating scale) and medial tibial cartilage volume (magnetic resonance imaging (MRI)). Secondary outcomes include additional measures of knee pain and other symptoms, function in daily living and sport and recreation, quality of life, participant-perceived global ratings of change, and other MRI structural outcomes including meniscal and cartilage morphology, synovitis, effusion, bone marrow lesions and cartilage defects. A range of additional measures will be recorded, and a separate health economic evaluation will be performed. DISCUSSION: The findings from this study will help determine whether PRP improves both clinical and structural knee OA outcomes over 12 months when compared to a series of placebo saline injections. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617000853347 . Prospectively registered 9th of June 2017.

Unloading Shoes for Self-management of Knee Osteoarthritis: A Randomized Trial.

BACKGROUND: Appropriate footwear is recommended for self-management of knee osteoarthritis. Shoes that reduce harmful knee loads are available, but symptomatic effects are uncertain. OBJECTIVE: To evaluate the efficacy of unloading shoes in alleviating knee osteoarthritis symptoms. DESIGN: Participant- and assessor-blinded comparative effectiveness randomized, controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12613000851763). SETTING: Community. PARTICIPANTS: 164 persons with medial knee osteoarthritis. INTERVENTION: Walking shoes with triple-density, variable-stiffness midsoles and mild lateral-wedge insoles designed to unload the medial knee and worn daily (intervention) versus conventional walking shoes (comparator). MEASUREMENTS: Primary outcomes were pain with walking (assessed on a numerical rating scale [NRS]) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) at 6 months. Secondary outcomes were knee pain and stiffness (WOMAC), average pain (NRS), intermittent and constant knee pain (Intermittent and Constant Osteoarthritis Pain questionnaire), quality of life (Assessment of Quality of Life instrument), physical activity (Physical Activity Scale for the Elderly), and global change in pain and function (Likert scales). RESULTS: A total of 160 participants (98%) completed primary outcome measures at 6 months. Changes in pain (mean difference, 0.0 units [95% CI, -0.9 to 0.8 unit]) and function (mean difference, 0.3 unit [CI, -3.2 to 3.7 units]) did not differ between groups at 6 months, with both groups showing clinically relevant improvements in function and the intervention group showing clinically relevant improvements in pain. There were no differences in secondary outcomes. Pain was globally improved in 54% of participants, and function was globally improved in 44% to 48%. Unloading shoes were not associated with increased probability of improvement (odds ratios, 0.99 [CI, 0.53 to 1.86] for pain and 0.85 [CI, 0.45 to 1.61] for function). LIMITATION: Effects on joint structure were not evaluated. CONCLUSION: Shoes with modified midsoles to unload the medial knee conferred no additional benefit over conventional walking shoes. Both improved pain and function by clinically relevant amounts. PRIMARY FUNDING SOURCE: Australian National Health and Medical Research Council.

Knee muscle strength after recent partial meniscectomy does not relate to 2-year change in knee adduction moment.

BACKGROUND: Knee muscle weakness and a greater external knee adduction moment are suggested risk factors for medial tibiofemoral knee osteoarthritis. Knee muscle weakness and a greater knee adduction moment may be related to each other, are potentially modifiable, and have been observed after arthroscopic partial meniscectomy. QUESTIONS/PURPOSES: The aim of this exploratory study was to determine if knee muscle weakness 3 months after arthroscopic partial meniscectomy (baseline) is associated with an increase in external knee adduction parameters during the subsequent 2 years. METHODS: Eighty-two participants undergoing medial arthroscopic partial meniscectomy were assessed at baseline, and 66 participants who were reassessed 2 years later were included in our study. Isokinetic muscle strength and external adduction moment parameters (peak and impulse) during normal and fast walking were measured at baseline and followup. Multiple linear regression models were used to examine the association between baseline muscle strength and 2-year change in adduction moment parameters. A post hoc power calculation showed we had 80% power to detect a correlation of 0.31 between baseline muscle strength and change in the external knee adduction, with an alpha error of 0.05 and two-sided significance. RESULTS: Maximal isokinetic muscle strength 3 months after arthroscopic partial meniscectomy was not associated with change in adduction moment parameters (p value range from 0.12 to 0.96). CONCLUSIONS: No evidence was found to suggest that improving maximal knee muscle strength after a recent arthroscopic partial meniscectomy would reduce change in knee adduction moment observed during the subsequent 2 years. As muscle function is modifiable, future investigation of other aspects of muscle function that may relate to change in knee adduction moment is warranted.

Unloading shoes for osteoarthritis of the knee: protocol for the SHARK randomised controlled trial.

BACKGROUND: Knee osteoarthritis (OA) is a common and disabling condition. Abnormalities in knee loading play an important role in disease pathogenesis, yet there are few non-surgical treatments for knee OA capable of reducing knee load. This two-arm randomised controlled trial is investigating the efficacy of specially-designed unloading shoes for the treatment of symptoms in people with knee OA. METHODS/DESIGN: 164 people with symptomatic medial tibiofemoral joint OA will be recruited from the community and randomly allocated to receive either unloading shoes or control shoes. Unloading shoes have a specially-designed triple-density midsole where the medial side is softer than normal and the lateral side harder as well as a lateral wedge between the sole and sock-liner. Control shoes are standard athletic shoes and do not contain these features. Participants will be blinded to shoe allocation and will be instructed to wear the shoes as much as possible every day for 6 months, for a minimum of 4 hours per day. The primary outcomes are knee pain (numerical rating scale) and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index) measured at baseline and 6 months. Secondary outcomes include additional measures of knee pain, knee stiffness, participant global ratings of change in symptoms, quality-of-life and physical activity. CONCLUSIONS: The findings from this study will help determine whether specially-designed unloading shoes are efficacious in the management of knee OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12613000851763.

Acupuncture for chronic knee pain: a randomized clinical trial.

IMPORTANCE: There is debate about benefits of acupuncture for knee pain. OBJECTIVE: To determine the efficacy of laser and needle acupuncture for chronic knee pain. DESIGN, SETTING, AND PARTICIPANTS: Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists. INTERVENTIONS: No acupuncture (control group, n = 71) and needle (n = 70), laser (n = 71), and sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial. MAIN OUTCOMES AND MEASURES: Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data. RESULTS: At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events. CONCLUSIONS AND RELEVANCE: In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12609001001280.

The relationship between patellofemoral and tibiofemoral morphology and gait biomechanics following arthroscopic partial medial meniscectomy.

PURPOSE: To examine the relationship between tibiofemoral and patellofemoral joint articular cartilage and subchondral bone in the medial and gait biomechanics following partial medial meniscectomy. METHODS: For this cross-sectional study, 122 patients aged 30-55 years, without evidence of knee osteoarthritis at arthroscopic partial medial meniscectomy, underwent gait analysis and MRI on the operated knee once for each sub-cohort of 3 months, 2 years, or 4 years post-surgery. Cartilage volume, cartilage defects, and bone size were assessed from the MRI using validated methods. The 1st peak in the knee adduction moment, knee adduction moment impulse, 1st peak in the knee flexion moment, knee extension range of motion, and the heel strike transient from the vertical ground reaction force trace were identified from the gait data. RESULTS: Increased knee stance phase range of motion was associated with decreased patella cartilage volume (B = -17.9 (95% CI -35.4, -0.4) p = 0.045) while knee adduction moment impulse was associated with increased medial tibial plateau area (B = 7.7 (95% CI 0.9, 13.3) p = 0.025). A number of other variables approached significance. CONCLUSIONS: Knee joint biomechanics exhibited by persons who had undergone arthroscopic partial meniscectomy gait may go some way to explaining the morphological degeneration observed at the patellofemoral and tibiofemoral compartments of the knee as patients progress from surgery. LEVEL OF EVIDENCE: III.

Sexual activity satisfaction in symptomatic hip osteoarthritis patients: A cross-sectional, national web-based study.

AIM: Despite high-interest rates in sex in people with hip osteoarthritis (OA), clinicians tend not to address sexual issues, especially in older adults. The objective of this study is to evaluate sexual activity and factors associated with sexual activity satisfaction in people with symptomatic hip OA. METHODS: A cross-sectional study was conducted among 252 participants with symptomatic hip OA in Australia. Quality of sex life was assessed using the online composite of sexual activities and positions questionnaires. A Poisson model with robust variance was used to calculate the prevalence ratio (PR). Factors that showed a univariate association with sexual satisfaction were then included in a multivariable model. PR with corresponding 95% confidence intervals (CI) are reported. RESULTS: Among the 282 participants registered on the study website, 252 met the inclusion criteria, and 60.3% (152/252) completed the sexual activity questionnaires. Hip OA interfered with sexual activity in 70.0% of the participants. High confidence in completing sexual activity (PR: 0.53, 95% CI: 0.36 to 0.77) was associated with an increased prevalence ratio of sexual satisfaction. High anxiety, depression or stress during sexual activity (PR: 1.33, 95% CI: 1.10 to 1.60) was associated with an increased prevalence ratio of sexual dissatisfaction after adjusting for hip pain level and perceived partner's orgasm. CONCLUSION: Although a large proportion of people with hip OA remain sexually active, a substantial proportion of persons are dissatisfied with their sexual activity. Hip OA interfered with sexual activity in most participants. Psychological factors were found to be associated with sexual activity satisfaction.

Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design.

BACKGROUND: Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain. METHODS/DESIGN: Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group) and received no acupuncture treatment. The other three were treatment groups: i) laser acupuncture, ii) sham laser or, iii) needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8-12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS) and self-reported physical function measured by the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale) and physical function (NRS). Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 months. DISCUSSION: The findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12609001001280.

Effect of functional weightbearing versus non-weightbearing quadriceps strengthening exercise on contact force in varus-malaligned medial knee osteoarthritis: A secondary analysis of a randomized controlled trial.

BACKGROUND: Knee osteoarthritis progression may be related to altered knee loads, particularly in those with varus malalignment. Using randomized controlled trial data, this secondary analysis of complete datasets (n = 67) compared the effects of a functional weightbearing (WB) and non-weightbearing quadriceps strengthening exercise (NWB) program on measures of medial tibiofemoral joint contact force (MTCF) during walking. METHODS: Participants aged ≥50 years and with medial knee osteoarthritis and varus malalignment were randomly allocated to a 12-week, home-based, physiotherapist-prescribed exercise program comprised of WB exercises (n = 31), or NWB exercise (n = 36). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from six lower-limb muscles were acquired during walking at baseline and at 12-weeks follow-up. An electromyogram-informed neuromusculoskeletal model estimated bodyweight (BW) normalized MTCF (peak and impulse), including external and muscular contributions to MTCF. RESULTS: There was no between-group difference in the change in peak MTCF (-0.02 [-0.12, 0.09] BW) or MTCF impulse (-0.01 [-0.06, 0.03] BW·s). There was a between-group difference in the muscle contribution to peak MTCF (-0.08 [-0.15, -0.00] BW) and MTCF impulse (-0.04 [-0.08, -0.00] BW·s), whereby the muscle contribution reduced more in the NWB group over time compared to the WB group. There was also a between group-difference in the external contribution to peak MTCF (0.09 [0.01, 0.18] BW), but this reduced more in the WB group than in the NWB group. CONCLUSIONS: Our findings suggest no difference in MTCF between the two exercise programs, but differences in the contribution to MTCF between the two exercise programs were observed in those with medial knee osteoarthritis and varus malalignment.

Effect of motion control versus neutral walking footwear on pain associated with lateral tibiofemoral joint osteoarthritis: a comparative effectiveness randomised clinical trial.

OBJECTIVES: To determine if motion control walking shoes are superior to neutral walking shoes in reducing knee pain on walking in people with lateral knee osteoarthritis (OA). DESIGN: Participant-blinded and assessor-blinded, comparative effectiveness, superiority randomised controlled trial. SETTING: Melbourne, Australia. PARTICIPANTS: People with symptomatic radiographic lateral tibiofemoral OA from the community and our volunteer database. INTERVENTION: Participants were randomised to receive either motion control or neutral shoes and advised to wear them >6 hours/day over 6 months. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was change in average knee pain on walking over the previous week (11-point Numeric Rating Scale (NRS), 0-10) at 6 months. The secondary outcomes included other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity. RESULTS: We planned to recruit 110 participants (55 per arm) but ceased recruitment at 40 (n=18 motion control shoes, n=22 neutral shoes) due to COVID-19-related impacts. All 40 participants completed 6-month outcomes. There was no evidence that motion control shoes were superior to neutral shoes for the primary outcome of pain (mean between-group difference 0.4 NRS units, 95% CI -1.0 to 1.7) nor for any secondary outcome. The number of participants experiencing any adverse events was similar between groups (motion control shoes: n=5, 28%; neutral shoes: n=4, 18.2%) and were minor. CONCLUSIONS: Motion control shoes were not superior to neutral shoes in improving knee pain on walking in symptomatic radiographic lateral tibiofemoral joint OA. Further research is needed to identify effective treatments in this important but under-researched knee OA subgroup. TRIAL REGISTRATION NUMBER: ACTRN12618001864213.

Podiatry Intervention Versus Usual General Practitioner Care for Symptomatic Radiographic Osteoarthritis of the First Metatarsophalangeal Joint: A Randomized Clinical Feasibility Study.

OBJECTIVE: To determine the feasibility of a clinical trial comparing a podiatry intervention to usual general practitioner (GP) care for people with first metatarsophalangeal (MTP) joint osteoarthritis (OA). METHODS: A 2-arm, participant- and assessor-blinded, randomized feasibility study was conducted over 12 weeks. Participants were age >40 years and had pain and radiographic OA in the first MTP joint. Participants in the podiatry group had 3 visits and received foot orthoses, exercise, manual therapy, and advice. Participants in the GP group had 1 visit and received medication advice/prescription and the same advice as the podiatry group. Primary outcomes were measures of feasibility (recruitment, attendance, and retention rates; percentage of prescribed exercise sessions completed; orthoses wear hours/day; treatment fidelity). Secondary outcomes included self-reported pain, function, satisfaction, adherence, adverse events, and dropouts. RESULTS: A total of 236 people were screened, and 30 (13%) were included. All except 1 participant in the podiatry group attended the required clinical visits, and retention rates were 93% (podiatry group) and 80% (GP group). Participants completed 66% of the exercise sessions and wore orthoses for an average of 6.3 hours/day. Adherence to medication use was 5.3 on an 11-point numeric rating scale. Both treatment approaches improved pain and function by clinically important differences at 12 weeks. CONCLUSION: A clinical trial comparing a podiatry intervention to usual GP care for people with first MTP joint OA is feasible. Given the improvements in pain and function observed, a larger appropriately powered clinical trial is warranted to evaluate the superiority of one treatment approach over the other.

Is Heel Height Associated with Pain Exacerbations in Hip Osteoarthritis Patients?-Results from a Case-Crossover Study.

The etiology of osteoarthritis (OA) pain exacerbations is not well understood. The purpose of this study is to evaluate the association of heel height and duration of wearing shoes with higher heels with pain exacerbations in people with hip OA. Eligible participants with symptomatic hip OA were instructed to complete online questionnaires every 10 days over a 90-day follow-up period. They were required to complete the questionnaire whenever they were experiencing hip pain exacerbation. Of 252 participants recruited, 137 (54.4%) contributed both case and control period data, and were included in the analysis. Wearing shoes with a heel height ≥ 2.5 cm during the past 24 h was associated with lower odds of pain exacerbations (OR: 0.54, 95% CI: 0.30 to 0.99). A longer duration (>6 h) of wearing shoes with heel height ≥ 2.5 cm was also associated with a lower risk of hip pain exacerbations (p for linear trend = 0.003). Wearing shoes with heel height ≥ 2.5 cm and longer duration in the past 24 h may be protective against hip pain exacerbations in people with symptomatic hip OA. Given the observational study nature, it would be prudent for this to be replicated in an independent data set.

Hip joint kinematics and segment coordination variability according to pain and structural disease severity in hip osteoarthritis.

This study aimed to evaluate hip joint kinematic variability and segment coordination variability during walking according to pain and radiographic disease severity in people with hip osteoarthritis. Fifty-five participants with hip osteoarthritis had pain severity assessed during walking using an item on the Western Ontario and McMasters Universities Osteoarthritis Index (no pain = 10; mild pain = 28; moderate pain = 17). Radiographic disease severity was graded by Kellgren and Lawrence scale (KL2 = 29; KL3 = 21; KL4 = 5). Hip kinematics variability was estimated as the curve coefficient of variation. Vector coding was used to calculate coordination variability for select joint couplings. One-way analysis of variances with planned adjusted post hoc comparisons were used to compare hip kinematics variability and coordination variability of select segment couplings (pelvis sagittal vs thigh sagittal; pelvis frontal vs thigh frontal; pelvis transverse vs thigh transverse; thigh sagittal vs shank sagittal; thigh frontal vs shank sagittal; thigh transverse vs shank sagittal) according to pain and radiographic disease severity. No main effect of pain severity was observed for sagittal or transverse plane hip kinematic variability (P ≥ .266), and although there was a main effect for frontal plane hip kinematic variability (P = .035), there were no significant differences when comparing between levels of pain severity (P > .006). There was no main effect of radiographic disease severity on hip kinematic variability in the sagittal (P = .539) or frontal (P = .307) plane. No significant differences in coordination of variability of segment couplings were observed (all P ≥ .229). Movement variability as assessed in this study did not differ according to pain severity during walking or radiographic disease severity.

Frontal plane hip joint loading according to pain severity in people with hip osteoarthritis.

The primary objective was to examine the hip adduction moment during walking in people with hip osteoarthritis (OA) according to pain severity. Sixty-eight participants with unilateral symptomatic hip OA were included. Pain during walking was assessed on a 5-point Likert item within the Western Ontario and McMaster Universities Index (no pain = 12; mild pain n = 37; moderate pain n = 19). Measures of the external hip adduction moment (peaks, Nm/BW × BH (%) and impulse, Nm.s/BW × BH (%)) were determined. Other measures included frontal plane hip, pelvis and trunk kinematics, walking speed and peak isometric hip abductor strength. Variables were compared according to pain severity using linear models and biomechanical variables were examined. Participants with moderate pain had a significantly higher second peak hip adduction moment and impulse compared to those with less pain. There was no difference in any measure of hip adduction moment between those with mild pain and no pain. There were no differences in kinematics across pain severity categories. Participants with moderate pain had a significantly slower walking speed compared to participants with mild and no pain. Participants with moderate pain had weaker peak isometric hip abductor strength compared to those with mild pain and no pain. The hip adduction moment during walking, hip abduction strength and walking speed differs according to pain severity during walking in people with hip OA. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1637-1644, 2018.