Smartphone-based exercise intervention for chronic pain: PainReApp randomized clinical trial protocol.

Aim To evaluate the effectiveness of PainReApp, an mHealth system, based on physical exercise recommendations for patients with chronic pain (low back pain, fibromyalgia and diabetic neuropathic pain) based on pain intensity, quality of life, anxiety and/or depression, and sleep quality. Design Single-blinded randomized controlled trial. Methods One hundred patients from three different chronic conditions (low back pain, fibromyalgia and neuropathic diabetic pain) will be recruited and randomized into two groups to receive the intervention with a physical activity program guided by the PainReApp system (experimental group) or with the program information in paper format (control group). All patients will attend a first face-to-face session in which the smartphone application usage (experimental group) and exercise execution will be explained (both groups). Data will be collected at baseline, 4, 12 and 24 weeks. Nevertheless, the users of the application will have a daily registry of the exercise performed and the self-perceived difficulty. The primary outcomes of the trial will be the intensity of pain and quality of life. Anxiety and/or depression and sleep quality will be also assessed to evaluate the influence of the physical activity at multiple levels. Discussion Physical exercise is becoming one of the leading evidence-based interventions to treat chronic pain. It needs to be adapted to the necessities of each pain condition. One of the major problems is the low adherence to the proposed program. New strategies that empower the patients, such as the m-Health, are reliable and useful tools to ease this end. Impact To the best of our knowledge, this is the first long-term randomized controlled trial researching the impact of an m-health system on chronic pain from different origin. The intervention is based on international physical exercise recommendations and can be performed without specific material, allowing the home-based practice. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12621000783820).