Abstract
BackgroundLow 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.MethodsEligible 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.DiscussionDespite 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 registrationClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.
Highlights
Low back pain is highly prevalent and a major source of disability worldwide
In a study conducted in 2010, it was estimated that the frequency of low back pain was in sixth place out of the 271 conditions studied, with a prevalence of 9.4% and it was the first cause of disability in the world with 58.2 million disabilityadjusted life years (DALYs: number of years lived with a disability) [3]
Number of patients with a clinically relevant change in visual analogue scale (VAS) score for pain, defined by an improvement of at least 30%; cases where patients demonstrate a 30% improvement in VAS scores for pain but require hospitalization for back pain during the study follow-up period will be considered as treatment failuresa
Summary
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. In a study conducted in 2010, it was estimated that the frequency of low back pain was in sixth place out of the 271 conditions studied, with a prevalence of 9.4% and it was the first cause of disability in the world with 58.2 million disabilityadjusted life years (DALYs: number of years lived with a disability) [3]. Opioids have well-documented short-term efficacy, but their long-term efficacy is uncertain, they are sometimes poorly tolerated by older patients, and their long-term use is complicated by addiction in 24% of cases [5, 6]
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