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Minimal Clinically Important Change for Pain Intensity and Disability in Patients With Nonspecific Low Back Pain
Abstract
In Brief Study Design. Cohort study. Objective. To estimate the minimal clinically important change (MCIC) on the pain intensity numerical rating scale (PI-NRS) and the Roland Morris Disability Questionnaire (RMQ) in subacute and chronic patients with low back pain (LBP), with and without referred pain to the leg (LP), seen in the routine clinical practice of the Spanish National Health Service. Summary of Background Data. MCIC have been explored in Anglo-Saxon and Northern European LBP patients. No data on the influence of LP on MCIC are available. In Southern European patients, determinants of disability have shown to be different, and MCIC for pain and disability are unknown. Methods. Data from the postmarketing surveillance of 1349 LBP subacute and chronic patients treated in routine clinical practice were used for this study. Three different methods were used to estimate the MCIC over a 12-week period: the mean change score (MCS), the minimal detectable change (MDC), and the optimal cutoff point in receiver operant curves (OCP). Patients' own “global perceived effect” was used as the external criterion. The effect on MCIC of initial scores, duration of pain, and existence of LP were assessed. Results. Different methods led to different MCIC values, with those deriving from OCP being the smallest. Depending on the methods which were used, the MCIC for LBP ranged from 1.5 to 3.2 PI-NRS points in patients with a baseline score below 7 points, and from 2.5 to 4.3 in patients with a baseline score ≥9 points. The MCIC for disability ranged from 2.5 to 6.8 RMQ points in those with baseline scores below 10 points, and from 5.5 to 13.8 inthose baseline scores ≥15 points. These values were similar for patients with LP, and were not influenced by the duration of pain. Conclusion. In subacute and chronic patients, improvements in LBP of ≤1.5 PI-NRS points, or in disability of ≤2.5 RMQ points should be seen as irrelevant. In those patients, MCIC range values are similar in patients with LP, are consistent across different cultural settings and remain stable no matter what the duration of pain is. Data on 1349 subacute and chronic LBP patients seen in routine practice were used to estimate minimal clinically important changes (MCIC) over a 3-month period. Improvements in pain of ≤1.5 PI-NRS points and improvements in disability of ≤2.5 RMQ points should be seen as irrelevant. Ranges of what constitutes a “relevant” (MCIC) change in pain and disability depend on the method that is used to estimate them and the baseline intensity of symptoms. Those values are similar in patients with referred pain and are consistent across different cultural settings. In subacute and chronic patients, MCIC remains stable regardless of the duration of pain.
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“For the numerical pain intensity scale, an improvement of at least 1.5 points (or about 20%) is considered clinically significant [36].”
From EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain (“EFFECT-BACK”): study protocol for a randomized controlled trial (2024) · cites this paper as [36]
In the citing paper
“The minimal clinically important difference for pain has been reported to range from 1.5 to 3.2 points.30 -34”
From Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis (2016) · cites this paper as [30]
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Chiarotto, A., Maxwell, L. J., Ostelo, R., Boers, M., Tugwell, P., & Terwee, C. B. (2018) · Journal of Pain · doi:10.1016/j.jpain.2018.07.009 · Cited by 780
Armijo-Olivo, S., Pitance, L., Singh, V., Neto, F., Thie, N., & Michelotti, A. (2016) · Physical Therapy · doi:10.2522/ptj.20140548 · Cited by 413
Fuentes, J., Armijo-Olivo, S. L., Funabashi, M., Miciak, M., Dick, B. D., Warren, S., Rashiq, S., Magee, D. J., & Gross, D. P. (2013) · Physical Therapy · doi:10.2522/ptj.20130118 · Cited by 314
Olsen, M. F., Bjerre, E. D., Hansen, M. D., Tendal, B., Hilden, J., & Hróbjartsson, A. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.05.007 · Cited by 304
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Self-citation
Metadata
- Authors
- Kovacs, F. M., Abraira, V., Royuela, A., Corcoll, J., Alegre, L., Cano, A., Muriel, A., Zamora, J., Gil del Real, M. T., Gestoso, M., & Mufraggi, N.
- Affiliations
- Fundación Kovacs (ES)
- Hospital Universitario Ramón y Cajal (ES)
- Servei de Salut de les Illes Balears (ES)
- Govern de les Illes Balears (ES)
- Corresponding author
- Kovacs, Francisco M.
- Gestoso, Mario
- Mufraggi, Nicole
- Venue
- Spine
- Published
- 2007-12
- Volume
- 32
- Issue
- 25
- Pages
- 2915-2920
- ISSN
- 0362-2436 (ISSN-L)
- OpenAlex
- W2059808083
- Cited by
- 211
- References
- 20
- Citations by year
- 2026: 15 · 2025: 14 · 2024: 16 · 2023: 9 · 2022: 12 · 2021: 13 · 2020: 5 · 2019: 12 · 2018: 10 · 2017: 8 · 2016: 13 · 2015: 4 · 2014: 11 · 2013: 16 · 2012: 12
- FWCI
- 6.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Spine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- non-specific low back pain, minimal clinically important change, pain intensity, disability, Roland-Morris Disability Questionnaire, numerical rating scale, subacute low back pain, chronic low back pain, minimal detectable change, receiver operating characteristic, global perceived effect, post-marketing surveillance, routine clinical practice, Spanish National Health System, pain duration
- MeSH terms
- Adult, Aged, Chronic Disease, Disability Evaluation, Female, Humans, Male, Middle Aged, Pain Measurement, Patients, Perception, Product Surveillance, Postmarketing, Surveys and Questionnaires, ROC Curve, Severity of Illness Index, Spain, Time Factors, Cohort Studies, Treatment Outcome, Low Back Pain
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