Abstract
BACKGROUND: Low Back Pain (LBP) is the leading cause of disability worldwide, 90% of which is nonspecific. Manual therapy is one of the recommended treatment modalities. However, reported outcomes may be variable. This review aims to identify their scope in the context of the development of a Core Outcome Set (COS), which is defined as « an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care ». METHODS: A scoping review with risk of bias assessment of randomised controlled trials (RCTs) of manual therapy for nonspecific LBP was conducted using MEDLINE, CENTRAL, PEDro, WebOfScience and ClinicalTrials.gov, from 2010 up to August 2024. Manual therapy was considered the use, alone or in combination, of manipulations (high velocity, low amplitude), mobilisations (low-grade velocity, small-to-large amplitude) or soft tissue relaxation (especially massage, trigger points, muscle contractions). RESULTS: Out of 3929 articles, 147 RCTs and 74 protocols were included. Two main outcomes emerged: pain intensity (assessed by numerical rating scale or visual analogue scale) and disability (mostly assessed by Rolland-Morris Disability Questionnaire or Oswestry Disability Index). Range of motion is the most frequent clinical outcome assessed. Psychological factors such as fear-avoidance beliefs, kinesiophobia and catastrophising, and healthcare consumption, particularly medication, are also frequent. Most of the outcomes were patient-reported outcomes. CONCLUSION: Consistent with a previous COS on nonspecific low back pain, manual therapy appears to address the same outcomes. Clinical trials in manual therapy should focus on using the existing COS by measuring pain intensity using a numerical rating scale, disability using the ODI 2.1a or the 24-item RMDQ, health-related quality of life using the SF-12 or the 10-item PROMIS. Additionally, due to the gap between clinical research and pain experience, trials should consider conducting subgroup analyses to identify effects on outcomes related to gender or age, paying particular attention to health inequalities by carrying out analyses based on socioeconomic status, as these factors are well known to significantly impact pain experience and access to care. REVIEW PROTOCOL: PROSPERO registration CRD42024576475, COMET Database registration 3229.