The Manual Therapy and Strengthening for the Hip (MASH) Trial: Protocol for a Multisite Randomized Trial of a Subgroup of Older Adults With Chronic Back and Hip Pain.

OBJECTIVE: Chronic low back pain (CLBP) is a disabling and costly condition for older adults that is difficult to properly classify and treat. In a cohort study, a subgroup of older adults with CLBP who had elevated hip pain and hip muscle weakness was identified; this subgroup differentiated itself by being at higher risk for future mobility decline. The primary purpose of this clinical trial is to evaluate whether a hip-focused low back pain (LBP) treatment provides better disability and physical performance outcomes for this at-risk group compared with a spine-focused LBP treatment. METHODS: This study is a multisite, single-blinded, randomized controlled, parallel arm, Phase II trial conducted across 3 clinical research sites. A total of 180 people aged between 60 and 85 years with CLBP and hip pain are being recruited. Participants undergo a comprehensive baseline assessment and are randomized into 1 of 2 intervention arms: hip-focused or spine-focused. They are treated twice weekly by a licensed physical therapist for 8 weeks and undergo follow-up assessments at 8 weeks and 6 months after randomization. Primary outcome measures include the Quebec Low Back Disability Scale and the 10-Meter Walk Test, which are measures of self-report and performance-based physical function, respectively. IMPACT: This multicenter, randomized clinical trial will determine whether a hip-focused or spine-focused physical therapist intervention results in improved disability and physical performance for a subgroup of older adults with CLBP and hip pain who are at increased risk of mobility decline. This trial will help further the development of effective interventions for this subgroup of older adults with CLBP.

Dose-Response Relationship Between Neuromuscular Electrical Stimulation and Muscle Function in People With Rheumatoid Arthritis.

BACKGROUND: Neuromuscular electrical stimulation (NMES) is a viable intervention for improving impaired muscle function in individuals with rheumatoid arthritis (RA). However, there is limited evidence about the dose-response relationship between NMES and muscle function in these individuals. OBJECTIVE: The objectives of this study were to investigate the dose-response relationship between NMES and muscle function in individuals with RA and to establish the minimal NMES training intensity for promoting improvements. DESIGN: This study was a secondary analysis of data obtained before and after an NMES intervention in a randomized study. METHODS: The study took place at a research clinic. Only adults diagnosed with RA were included. The intervention consisted of 36 NMES treatment sessions for the quadriceps muscles over 16 weeks. Muscle function was measured before and after the intervention; quadriceps cross-sectional area and muscle quality were assessed using computed tomography, and strength was measured with an isokinetic dynamometer. NMES training intensity was calculated as a percentage by dividing NMES-elicited quadriceps muscle torque by the maximum voluntary isometric contraction. Improvements in muscle function were calculated using paired-sample t tests. The dose-response relationship was determined using curve estimation regression statistics. The minimum NMES training intensity was defined as that sufficient to significantly improve all muscle function measures. RESULTS: Twenty-four people (48 legs) participated (75% women; mean [SD] age = 58 [8] years; mean body mass index = 32 [7] kg/m2). Quadriceps cross-sectional area, muscle quality, and strength improved after the intervention. Associations between NMES training intensity and muscle quality (r2 = 0.20) and strength (r2 = 0.23) were statistically significant, but that between NMES training intensity and muscle cross-sectional area was not (r2 = 0.02). The minimum NMES training intensity necessary to improve all measures of muscle function ranged from 11% to 20% of the maximum voluntary isometric contraction. LIMITATIONS: The relatively small sample size was a limitation. CONCLUSIONS: The minimum NMES training intensity for significant gains in muscle function was ∼15%. Higher NMES intensities may promote better muscle quality and strength in individuals with RA.

Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial.

Importance: Lumbar spinal stenosis (LSS) is the most common reason for spine surgery in older US adults. There is an evidence gap about nonsurgical LSS treatment options. Objective: To explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS. Design, Setting, and Participants: Three-arm randomized clinical trial of 3 years' duration (November 2013 to June 2016). Analysis began in August 2016. All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat. Interventions: Medical care, group exercise, and manual therapy/individualized exercise. Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors in senior community centers. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. Main Outcomes and Measures: Primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes). Results: A total of 259 participants (mean [SD] age, 72.4 [7.8] years; 137 women [52.9%]) were allocated to medical care (88 [34.0%]), group exercise (84 [32.4%]), or manual therapy/individualized exercise (87 [33.6%]). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care (-2.0; 95% CI, -3.6 to -0.4) or group exercise (-2.4; 95% CI, -4.1 to -0.8). Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates. Conclusions and Relevance: A combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity. Trial Registration: ClinicalTrials.gov Identifier: NCT01943435.

Neuromuscular Electrical Stimulation Compared to Volitional Exercise for Improving Muscle Function in Rheumatoid Arthritis: A Randomized Pilot Study.

OBJECTIVE: The aim of this study was to compare the feasibility and effectiveness of neuromuscular electrical stimulation (NMES) with that of high-intensity volitional resistance training for improving muscle structure and function and physical function in patients with rheumatoid arthritis (RA). We also compared pre-intervention and post-intervention values of myocyte characteristics. METHODS: In this 2-group, single-blind, randomized pilot study, adult patients with RA were assigned to 36 sessions of NMES (n = 31 patients) or volitional training (n = 28 patients) over 16 weeks. Outcome measures included muscle structure and function (quadriceps muscle area, density, and strength), physical function (performance-based and patient-reported), feasibility (increased pain, increased disease activity, attrition, and adherence), and myocyte characteristics (area, proportion of type I or II muscle fibers, and intramyocellular lipid content). Analysis of covariance was used to compare groups. RESULTS: The intervention intensity in the NMES group was less than half that in the volitional exercise group (31% versus 77% of maximum effort). Both groups experienced significant improvements in muscle structure and function (P < 0.001 to 0.019). Improvements in muscle characteristics and physical function were not different between groups. Exercise did not result in serious adverse events or increases in pain and disease activity. Attrition was 29% in the NMES group and 7% in the volitional exercise group. CONCLUSION: Both NMES and high-intensity volitional resistance training can be used as effective approaches to improving muscle structure and function in patients with RA. NMES may be a viable alternative for improving muscle function in patients in whom high-intensity resistance exercise may not be tolerated or is contraindicated, but attrition must be considered when using this approach.

Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial.

BACKGROUND: Lumbar spinal stenosis is the most common reason for spinal surgery in older adults. Previous studies have shown that surgery is effective for severe cases of stenosis, but many patients with mild to moderate symptoms are not surgical candidates. These patients and their providers are seeking effective non-surgical treatment methods to manage their symptoms; yet there is a paucity of comparative effectiveness research in this area. This knowledge gap has hindered the development of clinical practice guidelines for non-surgical treatment approaches for lumbar spinal stenosis. METHODS/DESIGN: This study is a prospective randomized controlled clinical trial that will be conducted from November 2013 through October 2016. The sample will consist of 180 older adults (>60 years) who have both an anatomic diagnosis of stenosis confirmed by diagnostic imaging, and signs/symptoms consistent with a clinical diagnosis of lumbar spinal stenosis confirmed by clinical examination. Eligible subjects will be randomized into one of three pragmatic treatment groups: 1) usual medical care; 2) individualized manual therapy and rehabilitative exercise; or 3) community-based group exercise. All subjects will be treated for a 6-week course of care. The primary subjective outcome is the Swiss Spinal Stenosis Questionnaire, a self-reported measure of pain/function. The primary objective outcome is the Self-Paced Walking Test, a measure of walking capacity. The secondary objective outcome will be a measurement of physical activity during activities of daily living, using the SenseWear Armband, a portable device to be worn on the upper arm for one week. The primary analysis will use linear mixed models to compare the main effects of each treatment group on the changes in each outcome measure. Secondary analyses will include a responder analysis by group and an exploratory analysis of potential baseline predictors of treatment outcome. DISCUSSION: Our study should provide evidence that helps to inform patients and providers about the clinical benefits of three non-surgical approaches to the management of lumbar spinal stenosis symptoms. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01943435.

Neuromuscular electrical stimulation and volitional exercise for individuals with rheumatoid arthritis: a multiple-patient case report.

BACKGROUND AND PURPOSE: Muscle atrophy is common in patients with rheumatoid arthritis (RA). Although neuromuscular electrical stimulation (NMES) is a viable treatment for muscle atrophy, there is no evidence about the use of NMES in patients with RA. The purposes of this multiple-patient case report are: (1) to describe the use of NMES applied to the quadriceps femoris muscles in conjunction with an exercise program in patients with RA; (2) to report on patient tolerance and changes in lean muscle mass, quadriceps femoris muscle strength (force-producing capacity), and physical function; and (3) to explore how changes in muscle mass relate to changes in quadriceps femoris muscle strength, measures of physical function, and patient adherence. CASE DESCRIPTION: Seven patients with RA (median age=61 years, range=39-80 years) underwent 16 weeks of NMES and volitional exercises. Lean muscle mass and strength of the quadriceps femoris muscle and physical function were measured before and after treatment. OUTCOMES: One patient did not tolerate the NMES treatment, and 2 patients did not complete at least half of the proposed treatment. Patients who completed the NMES and volitional exercise program increased their lean muscle mass, muscle strength, and physical function. DISCUSSION: Because of the small sample, whether NMES combined with exercises is better than exercise alone or NMES alone could not be determined. However, the outcomes from this multiple-patient case report indicate that NMES is a viable treatment option to address muscle atrophy and weakness in patients with RA. Strategies to increase tolerance and adherence to NMES are warranted.

Immediate improvements in side-to-side weight bearing and iliac crest symmetry after manipulation in patients with low back pain.

BACKGROUND: Although there is good evidence that spinal manipulation is an effective treatment to improve pain and function for patients with low back pain (LBP), there is little evidence to support the mechanism by which manipulation works. OBJECTIVES: To determine if iliac crest (IC) and weight-bearing (WB) symmetry improve after spinal manipulation and to determine if improvements in IC and WB symmetry are associated with improvements in pain and function in patients with low back pain. DESIGN: Single group, within-subjects, repeated measures design. METHOD: Thirty consecutive patients (mean age = 40+/-13) who came to a spine specialty center for treatment of acute or chronic LBP and who would be receiving spinal manipulation participated in the study (14 male patients). Patients completed a series of self-report measures of pain and function and received a standardized physical examination, including the assessment of IC and WB symmetry. Patients received a standardized manipulative intervention, and immediate and 3- to 4-day follow-up examinations were performed by a blinded examiner. Paired t tests were performed to determine within-group changes, and Pearson product moment correlation coefficients were calculated to determine the relationship between improvements in IC and WB symmetry and improvements in pain and function. To control for the potential that an association between changes in IC and/or WB symmetry and changes in pain and function could be confounded by the baseline outcome measure, simultaneous linear regression was performed on any significant correlation. Partial F tests were used to determine if the additional explained variability was significant. RESULTS: Patients with LBP demonstrated significant improvements in IC and WB symmetry after manipulation (P<.001). Improvements in WB symmetry were associated with improvements in the patients' self-reported levels of pain 3 to 4 days after manipulation (r=.5, P=.007). Based on the significant association between improvements in WB symmetry and improvements in pain, the final pain score was regressed on the change in WB symmetry, after controlling for the baseline level of pain. The addition of the change in WB symmetry explained a 10% additional increase in variability in the patient's level of pain at the 3- to 4-day follow-up (P =.01). No relationship was found between improvements in IC and WB symmetry and improvements in function as determined by the Oswestry Disability Questionnaire 3 to 4 days after manipulation. CONCLUSION: IC and WB symmetry improved immediately after spinal manipulation. Improvements in WB symmetry were related to improvements in the patients' self-reported levels of pain, even after controlling for the baseline level of pain. Improvements in IC and WB symmetry were not related to changes in function. The results of this study provide initial data to elucidate how manipulation may work to improve pain and function in patients with LBP.

A modified neuromuscular electrical stimulation protocol for quadriceps strength training following anterior cruciate ligament reconstruction.

STUDY DESIGN: Randomized clinical trial, single-masked. OBJECTIVES: To determine the effectiveness of using a modified neuromuscular electrical stimulation (NMES) training program as an adjunct treatment for improving quadriceps strength and physical function in rehabilitation following anterior cruciate ligament reconstruction (ACLR). BACKGROUND: NMES training for quadriceps strengthening has previously been shown to be an effective adjunct treatment following ACLR when performed against isometric resistance using a dynamometer with the knee positioned in flexion. We developed a modified version of published NMES protocol because some patients have difficulty tolerating the existing protocol and many clinics may not have instrumented dynamometers. There is a need to determine the effectiveness of this modified protocol. METHODS AND MEASURES: Forty-three subjects who had undergone ACLR were randomly assigned to either a group that received (NMES group) or did not receive (comparison group) the NMES treatment in conjunction with their rehabilitation. Group means for quadriceps strength and self-reported measures of knee function were compared after 12 and 16 weeks of rehabilitation. The proportion of subjects in each group achieving clinical criteria to initiate ambulation without crutches, treadmill running, and agility training at selected times during rehabilitation were also compared. RESULTS: The NMES group demonstrated moderately greater quadriceps strength at 12 weeks (effect size, 0.48), and moderately higher levels of self-reported knee function at both 12 (effect size, 0.72) and 16 (effect size, 0.65) weeks of rehabilitation compared to the comparison group. A greater proportion of subjects in the NMES group achieved clinical criteria for advancing to agility training at 16 weeks. CONCLUSIONS: The modified NMES quadriceps training protocol can be a useful adjunct to ACLR rehabilitation programs, but the treatment effect is smaller than what has been reported in previous studies.

Reliability of measuring iliac crest level in the standing and sitting position using a new measurement device.

BACKGROUND: To date, the reliability studies of iliac crest (IC) level used nominal scales and presented conflicting results. To perform the IC level measurement, we propose the use of a measurement device that is composed of an inclinometer mounted on a crest level tester that measures IC level in degrees. OBJECTIVES: To determine the interrater reliability of measuring iliac crest level in the standing and sitting position using an experimental device and to assess the precision of the measurements taken with the experimental device. METHOD: Forty individuals (mean age 40 +/- 12 years) referred to physical therapy for treatment of low back pain (LBP) participated in the study (16 male participants). Six examiners performed the measurements. Three of the 6 examiners performed the measurements on each individual. Each examiner independently performed the measurement of IC level in standing and in sitting using the measurement device. RESULTS: Intraclass correlation coefficients, [formula (1,1)] for measurement of IC level in standing and sitting, were 0.80 (95% CI = 0.7-0.9) and 0.73 (95% CI = 0.6-0.8), respectively. Standard errors of measurement for IC level in standing and sitting were 0.91 and 0.86 degrees, respectively. CONCLUSION: The use of a measurement device resulted in good reliability of IC level measurement in degrees in standing and moderate reliability of IC level in sitting position. This finding is relevant to plan future studies that will investigate if changes in IC level may be associated with outcomes of pain and function in patients with low back or pelvic dysfunctions.