Qualitative Assessment of Patients Receiving Prolotherapy for Knee Osteoarthritis in a Multimethod Study.

OBJECTIVE: Randomized and open-label studies assessing prolotherapy for knee osteoarthritis have found quantitative improvement on the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC) compared with baseline status and control therapies. This study assessed the qualitative response of participants receiving prolotherapy, an injection-based complementary treatment for symptomatic knee osteoarthritis (OA). DESIGN: Qualitative study using semi-structured in-depth interviews at 52 weeks after enrollment; transcribed responses were discussed by coauthors to identify themes; disagreement was resolved by consensus. SETTING: Outpatient. PARTICIPANTS: Twenty-two participants treated with prolotherapy for symptomatic knee OA who were exited from three randomized and open-label studies. INTERVENTIONS: Intra- and extra-articular hypertonic dextrose injection (prolotherapy). MAIN OUTCOME MEASURES: Patient narrative and composite WOMAC questionnaire (0-100 points) scores. RESULTS: Participants had baseline demographic and knee OA severity similar to those of participants in three prior intervention trials, as well as similar robust follow-up WOMAC score change (19.9 ± 12.6 points), suggesting a representative subsample. Seven themes were identified from participant narratives: (1) improvement in knee-specific quality of life (n = 18), (2) safety and comfort, (3) pretreatment counseling enhanced treatment adherence and optimism, (4) overall positive experience with prolotherapy, (5) limited response to prolotherapy (n = 4), (6) consistency with anecdotal clinical prolotherapy experience; and (7) functional improvement without pain reduction. CONCLUSIONS: Most participants reported substantially improved knee-specific effects, resulting in improved quality of life and activities of daily living; four participants reported minimal or no effect. Clear, complete description of procedural rationale may enhance optimism about and adherence to treatment appointments.

Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes.

OBJECTIVE: Knee osteoarthritis (OA) is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. Recent 52-week randomized controlled and open label studies have reported improvement of knee OA-specific outcomes compared to baseline status, and blinded saline control injections and at-home exercise therapy (p<0.05). However, long term effects of prolotherapy for knee OA are unknown. We therefore assessed long-term effects of prolotherapy on knee pain, function and stiffness among adults with knee OA. DESIGN: Post clinical-trial, open-label follow-up study. SETTING: Outpatient; adults with mild-to-severe knee OA completing a 52-week prolotherapy study were enrolled. INTERVENTION AND OUTCOME MEASURES: Participants received 3-5 monthly interventions and were assessed using the validated Western Ontario McMaster University Osteoarthritis Index, (WOMAC, 0-100 points), at baseline, 12, 26, 52 weeks, and 2.5 years. RESULTS: 65 participants (58±7.4 years old, 38 female) received 4.6±0.69 injection sessions in the initial 17-week treatment period. They reported progressive improvement in WOMAC scores at all time points in excess of minimal clinical important improvement benchmarks during the initial 52-week study period, from 13.8±17.4 points (23.6%) at 12 weeks, to 20.9±2.8 points, (p<0.05; 35.8% improvement) at 2.5±0.6 years (range 1.6-3.5 years) in the current follow-up analysis. Among assessed covariates, none were predictive of improvement in the WOMAC score. CONCLUSIONS: Prolotherapy resulted in safe, significant, progressive improvement of knee pain, function and stiffness scores among most participants through a mean follow-up of 2.5 years and may be an appropriate therapy for patients with knee OA refractory to other conservative care.

Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial.

OBJECTIVES: This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status. DESIGN: This was a prospective three-arm uncontrolled study with 1-year follow-up. SETTING: The setting was outpatient. PARTICIPANTS: The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined). INTERVENTION: The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach. OUTCOME MEASURES: The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction. RESULTS: The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events. CONCLUSIONS: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

Association between disease-specific quality of life and magnetic resonance imaging outcomes in a clinical trial of prolotherapy for knee osteoarthritis.

OBJECTIVE: To assess the relation between knee osteoarthritis (KOA)-specific quality of life (QOL) and intra-articular cartilage volume (CV) in participants treated with prolotherapy. KOA is characterized by CV loss and multifactorial pain. Prolotherapy is an injection therapy reported to improve KOA-related QOL to a greater extent than blinded saline injections and at-home exercise, but its mechanism of action is unclear. DESIGN: Two-arm (prolotherapy, control), partially blinded, controlled trial. SETTING: Outpatient. PARTICIPANTS: Adults with ≥3 months of symptomatic KOA (N=37). INTERVENTIONS: Prolotherapy: 5 monthly injection sessions; CONTROL: blinded saline injections or at-home exercise. MAIN OUTCOME MEASURES: Primary: KOA-specific QOL scores (baseline, 5, 9, 12, 26, and 52wk; Western Ontario and McMaster University Osteoarthritis Index). Secondary: KOA-specific pain, stiffness, function (Western Ontario McMaster University Osteoarthritis Index subscales), and magnetic resonance imaging-assessed CV (baseline, 52wk). RESULTS: Knee-specific QOL improvement among prolotherapy participants exceeded that among controls (17.6±3.2 points vs 8.6±5.0 points; P=.05) at 52 weeks. Both groups lost CV over time (P<.05); no between-group differences were noted (P=.98). While prolotherapy participants lost CV at varying rates, those who lost the least CV ("stable CV") had the greatest improvement in pain scores. Among prolotherapy participants, but not control participants, the change in CV and the change in pain (but not stiffness or function) scores were correlated; each 1% CV loss was associated with 2.7% less improvement in pain score (P<.05). CONCLUSIONS: Prolotherapy resulted in safe, substantial improvement in KOA-specific QOL compared with control over 52 weeks. Among prolotherapy participants, but not controls, magnetic resonance imaging-assessed CV change (CV stability) predicted pain severity score change, suggesting that prolotherapy may have a pain-specific disease-modifying effect. Further research is warranted.

Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

PURPOSE: Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS: Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS: No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS: Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.

Hypertonic dextrose and morrhuate sodium injections (prolotherapy) for lateral epicondylosis (tennis elbow): results of a single-blind, pilot-level, randomized controlled trial.

OBJECTIVE: Chronic lateral epicondylosis is common, debilitating, and often refractory. Prolotherapy (PrT) is an injection therapy for tendinopathy. The efficacy of two PrT solutions for chronic lateral epicondylosis was evaluated. DESIGN: This study is a three-arm randomized controlled trial. Twenty-six adults (32 elbows) with chronic lateral epicondylosis for 3 mos or longer were randomized to ultrasound-guided PrT with dextrose solution, ultrasound-guided PrT with dextrose-morrhuate sodium solution, or watchful waiting ("wait and see"). The primary outcome was the Patient-Rated Tennis Elbow Evaluation (100 points) at 4, 8, and 16 wks (all groups) and at 32 wks (PrT groups). The secondary outcomes included pain-free grip strength and magnetic resonance imaging severity score. RESULTS: The participants receiving PrT with dextrose and PrT with dextrose-morrhuate reported improved Patient-Rated Tennis Elbow Evaluation composite and subscale scores at 4, 8, and/or 16 wks compared with those in the wait-and-see group (P < 0.05). At 16 wks, compared with baseline, the PrT with dextrose and PrT with dextrose-morrhuate groups reported improved composite Patient-Rated Tennis Elbow Evaluation scores by a mean (SE) of 18.7 (9.6; 41.1%) and 17.5 (11.6; 53.5%) points, respectively. The grip strength of the participants receiving PrT with dextrose exceeded that of the PrT with dextrose-morrhuate and the wait and see at 8 and 16 wks (P < 0.05). There were no differences in magnetic resonance imaging scores. Satisfaction was high; there were no adverse events. CONCLUSIONS: PrT resulted in safe, significant improvement of elbow pain and function compared with baseline status and follow-up data and the wait-and-see control group. This pilot study suggests the need for a definitive trial.

Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up.

OBJECTIVE: The objective of this study was to determine whether prolotherapy, an injection-based complementary treatment for chronic musculoskeletal conditions, improves pain, stiffness, and function in adults with symptomatic knee osteoarthritis (KOA) compared to baseline status. DESIGN: This was a prospective, uncontrolled study with 1-year follow-up. SETTING: The study was conducted in an outpatient setting. PARTICIPANTS: Adults with at least 3 months of symptomatic KOA, recruited from clinical and community settings, participated in the study. INTERVENTIONS: Participants received extra-articular injections of 15% dextrose and intra-articular prolotherapy injections of 25% dextrose at 1, 5, and 9 weeks, with as-needed treatments at weeks 13 and 17. OUTCOME MEASURES: Primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). Secondary outcome measure was the validated Knee Pain Scale (KPS). Tertiary outcome measure was procedure-related pain severity and participant satisfaction. RESULTS: Thirty-six (36) participants (60 ± 8.7 years old, 21 female) with moderate-to-severe KOA received an average of 4.3 ± 0.7 prolotherapy injection sessions over a 17-week treatment period and reported progressively improved scores during the 52-week study on WOMAC and KPS measures. Participants reported overall WOMAC score improvement 4 weeks after the first injection session (7.6 ± 2.4 points, 17.2%), and continued to improve through the 52-week follow-up (15.9 ± 2.5 points, p<0.001, 36.1%). KPS scores improved in both injected (p<0.001) and uninjected knees (p<0.05). Prescribed low-dose opioid analgesia effectively treated procedure-related pain. Satisfaction was high and there were no adverse events. Female gender, age 46-65 years old, and body-mass index of 25 kg/m(2) or less were associated with greater improvement on the WOMAC instrument. CONCLUSIONS: In adults with moderate to severe KOA, dextrose prolotherapy may result in safe, significant, sustained improvement of knee pain, function, and stiffness scores. Randomized multidisciplinary effectiveness trials including evaluation of potential disease modification are warranted to further assess the effects of prolotherapy for KOA.

Part-time physicians...prevalent, connected, and satisfied.

OBJECTIVE: The health care workforce is evolving and part-time practice is increasing. The objective of this work is to determine the relationship between part-time status, workplace conditions, and physician outcomes. DESIGN: Minimizing error, maximizing outcome (MEMO) study surveyed generalist physicians and their patients in the upper Midwest and New York City. MEASUREMENTS AND MAIN RESULTS: Physician survey of stress, burnout, job satisfaction, work control, intent to leave, and organizational climate. Patient survey of satisfaction and trust. Responses compared by part-time and full-time physician status; 2-part regression analyses assessed outcomes associated with part-time status. Of 751 physicians contacted, 422 (56%) participated. Eighteen percent reported part-time status (n = 77, 31% of women, 8% of men, p < .001). Part-time physicians reported less burnout (p < .01), higher satisfaction (p < .001), and greater work control (p < .001) than full-time physicians. Intent to leave and assessments of organizational climate were similar between physician groups. A survey of 1,795 patients revealed no significant differences in satisfaction and trust between part-time and full-time physicians. CONCLUSIONS: Part-time is a successful practice style for physicians and their patients. If favorable outcomes influence career choice, an increased demand for part-time practice is likely to occur.