Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial

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Abstract

Study Design Randomized controlled trial. Background Evidence suggests that multimodal interventions including exercise therapy may be effective for patellofemoral pain (PFP), however no study has investigated the effects of trigger point dry needling (TrP-DN) in people with PFP. Objectives To compare the effects of adding TrP-DN into a manual therapy and exercise program on pain, function, and disability in individuals with PFP. Methods Individuals with PFP (n=60) recruited from a public hospital in Valencia (Spain) were randomly allocated to manual therapy and exercises (n=30) or manual therapy and exercise plus TrP-DN (n=30). Both groups received the same manual therapy and strengthening exercise program for 3 sessions (once a week for 3 weeks). The manual therapy and exercise plus TrP-DN group also received TrP-DN to active TrPs within the vastus medialis and vastus lateralis muscles. The pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS, 0-100 scale) was used as the primary outcome. Secondary outcomes included other subscales of KOOS, the Knee Society Score (KSS), the International Knee Documentation Committee (IKDC), and the numerical pain rate scale (NPRS). Patients were assessed at baseline, 15 days (post-treatment) and 3 months follow-up. Analysis was with mixed ANCOVAs adjusted for baseline scores. Results At 3 months, 58 subjects (97%) completed the follow-up. No significant between-groups differences (all, P>0.391) were observed for any outcome: KOOS-P, mean difference -2.1 (95%CI -4.6, 0.4); IKDC, 2.3 (-0.1, 4.7); knee pain intensity, 0.3 (-0.2, 0.8). Both groups experienced similar moderate-to-large within-group improvements in all outcomes (Standardized Mean Differences of 0.6 to 1.1), however only the KOOS-SP subscale surpassed the pre-specified minimum important change. Conclusions The current clinical trial suggests that the inclusion of 3 sessions of TrP-DN into a manual therapy and exercise program did not result in improved outcomes for pain and disability in individuals with PFP at 3-month follow-up. Level of Evidence Therapy, Level 1b. Prospectively registered July 27, 2015 on www.clinicaltrials.gov (NCT02514005). J Orthop Sports Phys Ther, Epub 13 May 2017. doi:10.2519/jospt.2017.7389.

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Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure.

E M Roos, H. P. Roos, L S Lohmander … (1998)

There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient-centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. In this clinical study, the KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome.

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Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale

John T Farrar, James P Young, Linda LaMoreaux … (2001)

Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.