Association Between Disease-Specific Quality of Life and Magnetic Resonance Imaging Outcomes in a Clinical Trial of Prolotherapy for Knee Osteoarthritis
University of Wisconsin School of Medicine and Public Health, Department of Family Medicine, Madison WI 53715. Electronic address: . Archives of physical medicine and rehabilitation
(Impact Factor: 2.57).
07/2013; 94(11). DOI: 10.1016/j.apmr.2013.06.025
To assess the relationship 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 compared to blinded saline injections and at-home exercise but the mechanism of action is unknown.
Two-arm (Prolotherapy, Control), partially blinded, controlled trial.
Outpatient. Participants: 37 adults with ≥3 months of symptomatic KOA.
Prolotherapy: 5 monthly injection sessions; Control: blinded saline injections or at-home exercise.
Primary: KOA-specific QoL scores (baseline, 5, 9, 12, 26, 52 weeks; Western Ontario McMaster University Osteoarthritis Index, WOMAC). Secondary: KOA-specific pain, stiffness, function (WOMAC subscales), magnetic resonance imaging (MRI)-assessed CV (baseline, 52 weeks).
Knee-specific QoL improvement among Prolotherapy participants exceeded that of Controls (17.6±3.2 versus 8.6±5.0 points, p=0.05) at 52 weeks. Both groups lost CV over time (p<0.05); no between-group differences were noted (p=0.98). 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, 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<0.05).
Prolotherapy resulted in safe, substantial improvement in KOA-specific QoL compared to Control over 52-weeks. Among prolotherapy participants, but not Controls, MRI-assessed CV change (CV stability) predicted pain severity score change, suggesting prolotherapy may have pain-specific disease-modifying effect. Further research is warranted.
Available from: Fariba Eslamian
- "Although cartilage volume increases after each prolotherapy session and will remain increased for a time, it decreases over time, which has a significant correlation with the pain subscales of the WOMAC score [Rabago et al. 2013a]. Therefore, it is possible that with longer follow up, we would observe similar improvements to those reported by others. "
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ABSTRACT: Prolotherapy is an injection-based complementary treatment, which has shown promising results in the treatment of different musculoskeletal disorders. The aim of this study was to determine the therapeutic efficacy of dextrose prolotherapy on pain, range of motion, and function in patients with knee osteoarthritis (OA).
In this single-arm prospective study, participants with symptomatic moderate knee osteoarthritis underwent prolotherapy with intra-articular injection of 20% dextrose water at baseline, and at 4 weeks and 8 weeks later. Patients were followed for 24 weeks. Pain severity at rest and activity, according to the visual analog scale (VAS), articular range of motion (ROM), and Western Ontario and McMaster Universities arthritis index (WOMAC) scores were measured at baseline, 4, 8, and 24 weeks later.
A total of 24 female patients (average age: 58.37 ± 11.8 years old) received 3-monthly injection therapies. Before the treatment, the mean articular range of motion was 105.41 ± 11.22°. Mean VAS scale at rest and activity was 8.83 ± 1.37 and 9.37 ± 1.31, respectively. At the end of week 24, knee ROM increased by 8°. Pain severity in rest and activity decreased to 4.87 ± 1.39, 45.86%, and 44.23%, respectively (p < 0.001). Total WOMAC score and its subcategories showed a continuous improvement trend in all the evaluation sessions, so that at the end of the study, the total score decreased by 30.5 ± 14.27 points (49.58%) (p < 0.001). Improvements of all parameters were considerable until week 8, and were maintained throughout the study period.
Prolotherapy with three intra-articular injections of hypertonic dextrose given 4 weeks apart for selected patients with knee OA, resulted in significant improvement of validated pain, ROM, and WOMAC-based function scores, when baseline levels were compared at 24 weeks. Further studies with randomized controlled trials involving a comparison group are suggested to confirm these findings.
Therapeutic advances in musculoskeletal disease 03/2015; 7(2). DOI:10.1177/1759720X14566618
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ABSTRACT: 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.
Post clinical-trial, open-label follow-up study.
Outpatient; adults with mild-to-severe knee OA completing a 52-week prolotherapy study were enrolled.
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.
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.
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.
Copyright © 2015 Elsevier Ltd. All rights reserved.
Complementary Therapies in Medicine 04/2015; 23(3). DOI:10.1016/j.ctim.2015.04.003 · 1.55 Impact Factor
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ABSTRACT: Capsaicin specifically activates, and then gradually exhausts, the transient receptor potential vanilloid type 1 (TRPV-1) receptor, a key receptor in neuropathic pain. Activation of the TRPV-1 receptor is accompanied by burning pain. A natural substance or medication that can reduce the burning pain resultant from capsaicin application may have therapeutic potential in neuropathic pain.
To assess the pain relieving effects of a mannitol-containing cream in a capsaicin-based pain model.
Randomized, placebo-controlled, double-blind clinical trial.
Outpatient pain clinic.
Twenty five adults with pain-free lips.
Capsaicin .075% cream was applied to both halves of each participant's upper lip, inducing pain via stimulation of the transient receptor potential vanilloid one (TRPV1, capsaicin) receptor, then removed after five minutes, or when participants reported a burning pain of 8/10, whichever came first. A cream containing mannitol and the same cream without mannitol (control) were then immediately applied, one on each side of the lip, in an allocation-masked manner.
Participants self-recorded a numerical rating scale (NRS, 0-10) pain score for each side of the lip per minute for 10 minutes. A t-test was performed to evaluate the pain-score change from baseline between each side of the lip at each recording. Area under the curve (AUC) analysis was used to determine the overall difference between groups.
Participants reached a capsaicin-induced pain level of 7.8±1.0 points in 3.3±1.6 minutes that was equal on both sides of the lip. Both groups reported progressive diminution of pain over the 10-minute study period. However, participants reported significantly reduced pain scores on the mannitol cream half-lip compared to control at 3 through 10 minutes (p<.05), and in AUC analysis (p<.001).
Mannitol cream reduced self-reported pain scores in a capsaicin pain model more rapidly than a control cream, potentially via a TRPV1 receptor effect.
Copyright © 2015 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.
PM&R 05/2015; DOI:10.1016/j.pmrj.2015.05.002 · 1.53 Impact Factor
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