Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial.

BACKGROUND: Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain. METHODS: Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months. DISCUSSION: Despite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.

Non-drug treatment (excluding surgery) in rheumatoid arthritis: clinical practice guidelines.

OBJECTIVES: Because drugs do not halt joint destruction in rheumatoid arthritis (RA), non-drug treatments are an important adjunct to drug treatment. Establishing rules governing their use is difficult because treatment is multidisciplinary, complex, and difficult to assess. The aims of these guidelines were to (a) establish the indications for physical therapies and for educational, psychological, and other non-drug interventions, (b) address social welfare, occupational, and organizational issues. METHODS: A systematic literature search (MEDLINE, EMBASE, CINAHL, Pascal, Cochrane Library, HTA database) (1985-2006) was completed with information obtained from specialty societies and the grey literature. A review of the studies meeting inclusion criteria, with evidence levels, was used by a multidisciplinary working group (18 experts) to draft guidelines. Consensus was reached when evidence was lacking on key topics. The draft guidelines were scored by 60 peer reviewers, amended when necessary, and then validated by the HAS Board. RESULTS: Of the 1819 articles retrieved, 817 were analysed and 382 cited in the report. Low-power randomized clinical trials constituted the highest level of evidence. Grade B guidelines (intermediate evidence level) concerned aerobic activities, dynamic muscular strengthening, and therapeutic patient education. Grade C (low evidence level) concerned use of rest orthoses or assistive devices, balneotherapy and spa therapy, self-exercise programmes, and conventional physiotherapy. Professional agreement (no scientific evidence) was reached for orthotic insoles and footwear, chiropody care, thermotherapy, acupuncture, psychological support, occupational adjustments, and referral to social workers. CONCLUSION: Aerobic activities, dynamic muscular reinforcement, and therapeutic patient education are valuable in non-drug management of RA.