Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale.
ABSTRACT To determine the minimal clinically important difference (MCID) of changes in chronic musculoskeletal pain intensity that is most closely associated with improvement on the commonly used and validated measure of the patient's global impression of change (PGIC), and to estimate the dependency of the MCID on the baseline pain scores.
This was a prospective cohort study assessing patient's pain intensity by the numerical rating scale (NRS) at baseline and at the 3 month follow-up, and by a PGIC questionnaire. A one unit difference at the lowest end of the PGIC ("slightly better") was used to define MCID as it reflects the minimum and lowest degree of improvement that could be detected. In addition we also calculated the NRS changes best associated with "much better" (two units). In order to characterize the association between specific NRS change scores (raw or percent) and clinically important improvement, the sensitivity and specificity were calculated by the receiver operating characteristic (ROC) method. PGIC was used as an external criterion to distinguish between improved or non-improved patients.
825 patients with chronic musculoskeletal pain (233 with osteoarthritis of the knee, 86 with osteoarthritis of the hip, 133 with osteoarthritis of the hand, 290 with rheumatoid arthritis and 83 with ankylosing spondylitis) were followed up. A consistent relationship between the change in NRS and the PGIC was observed. On average, a reduction of one point or a reduction of 15.0% in the NRS represented a MCID for the patient. A NRS change score of -2.0 and a percent change score of -33.0% were best associated with the concept of "much better" improvement. For this reason these values can be considered as appropriate cut-off points for this measure. The clinically significant changes in pain are non-uniform along the entire NRS. Patients with a high baseline level of pain on the NRS (score of >7 cm), who experienced either a slight improvement or a higher level of response, had absolute raw and percent changes greater that did patients in the lower cohort (score of less than 4 cm).
These results are consistent with the recently published findings generated by different methods and support the use of a "much better" improvement on the pain relief as a clinically important outcome. A further confirmation in other patient populations and different chronic pain syndromes will be needed.
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ABSTRACT: Osteoarthritis (OA) is the fastest growing cause of disability worldwide. Current treatments for OA are severely limited and a large proportion of people with OA live in constant, debilitating pain. There is therefore an urgent need for novel treatments to reduce pain. Synovitis is highly prevalent in OA and is associated with pain. In inflammatory arthritides such as rheumatoid arthritis, methotrexate (MTX) is the gold standard treatment for synovitis and has a well-known, acceptable toxicity profile. We propose that using MTX to treat patients with symptomatic knee OA will be a practical and safe treatment to reduce synovitis and, consequently, pain. Pain Reduction with Oral Methotrexate in knee Osteoarthritis, a pragmatic phase III trial of Treatment Effectiveness (PROMOTE) is an investigator-initiated, multi-centre, randomized, double-blind, pragmatic placebo-controlled trial. A total of 160 participants with symptomatic knee OA will be recruited across primary and secondary care sites in the United Kingdom and randomized on a 1:1 basis to active treatment or placebo, in addition to usual care, for 12 months. As is usual practice for MTX, dosing will be escalated over six weeks to 25 mg (or maximum tolerated dose) weekly for the remainder of the study. The primary endpoint is change in average knee pain during the past week (measured on an 11-point numerical rating scale) between baseline and six months. Secondary endpoints include other self-reported pain, function and quality-of-life measures. A health economics analysis will also be performed. A magnetic resonance imaging substudy will be conducted to provide an explanatory mechanism for associated symptom change by examining whether MTX reduces synovitis and whether this is related to symptom change. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modelling analyses. All analyses will be conducted on an intention-to-treat basis. The PROMOTE trial is designed to examine whether MTX is an effective analgesic treatment for OA. The MRI substudy will address the relationship between synovitis and symptom change. This will potentially provide a much needed new treatment for knee OA. Current Controlled Trials identifier: ISRCTN77854383 (registered: 25 October 2013).Trials 12/2015; 16(1):602. DOI:10.1186/s13063-015-0602-8 · 2.12 Impact Factor
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ABSTRACT: The purpose of this study was to compare manipulative therapy (MT) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability (RASFI) to determine short-term outcomes. This was an assessor-blind, parallel-group randomized comparative trial. Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation. All participants undertook a daily rehabilitation program over the course of the 4-week treatment period. The participants receiving MT had 6 treatments over the same treatment period. The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale, with the secondary outcome measure being joint motion palpation. Data were collected at baseline and during week 5. Missing scores were replaced using a multiple imputation method. Statistical analysis of the data composed of repeated-measures analysis of variance. Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions (P ≤ .006) but not for the Foot and Ankle Disability Index (P = .26). This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone. Copyright © 2014 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.Journal of Manipulative and Physiological Therapeutics 11/2014; DOI:10.1016/j.jmpt.2014.10.001 · 1.25 Impact Factor
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ABSTRACT: Abstract Objective: The aims of this observational, prospective cohort study were to: assess the patients' and therapists' perception of change after physiotherapy in an orthopedic hospital's outpatient clinic; relate these retrospective assessments to a serial assessment of pain; and study the influence of patient characteristics on the perceived change. Methods: 161 patients of the outpatient clinic participated. The main outcome measures were the patient global impression of change (PGIC) and the clinical global impression of change (CGIC) after physiotherapy. The visual analogue scale was used as serial assessment. Results: The PGIC indicated improvement in 128 patients (80%) and the CGIC in 117 patients (73%). The correlation between PGIC and CGIC was good (rS = 0.71, p < 0.001). The perceived change correlated little to baseline pain (PGIC: rS = 0.24, p = 0.004; CGIC: rS = 0.18, p = 0.024) and change in pain due to physiotherapy (PGIC: rS = -0.22, p = 0.004; CGIC: rS = -0.31, p < 0.001). The logistic regression model revealed a significant influence of the patients' education level and the number of problems on the PGIC and the CGIC. Conclusions: The addition of at least one GPC scale might be valuable in evaluating the outcome in physical therapy, which requires little time and thus may be ideal for a clinical setting. Patients' and therapists' perception of change is significantly influenced by the patients' education level and the number of problems, which might be of relevance when choosing adequate treatment strategies.Physiotherapy Theory and Practice 12/2014; DOI:10.3109/09593985.2014.994152