RecruitingACTRN12621000783820

Smartphone-based exercise intervention for chronic pain: a randomised clinical trial

Efficacy of a smartphone-based exercise therapy intervention on the level of pain, anxiety and depression, sleep and quality of life in patients with chronic pain: a randomised clinical trial


Sponsor

Jose A. Moral-Munoz

Enrollment

300 participants

Start Date

Sep 15, 2021

Study Type

Interventional

Conditions

Summary

Chronic pain (CP) should be understood as a disease in itself, derived from changes in the Central Nervous System, and not as a symptom of another pathology. A multimodal intervention is needed that includes aspects such as physical exercise, diet, social and psychological support. There is evidence that physical exercise has benefits in reducing pain, physical limitations, disability and mental health. The implementation of m-Health technologies constitutes an alternative with proven effects in other patient groups, which improves the therapeutic adherence and autonomy of the patient. Because of this, the development and evaluation of the effectiveness of a m-Health system based on the physical exercise for application in patients with CP respond to a need. Our hypothesis is that a m-health system based on physical exercise recommendations for patients with CP (low back pain, fibromyalgia and diabetic neuropathic pain) will improve pain intensity, presence of anxiety and/or depression, sleep quality and quality of life of this population. Therefore, this project aims to evaluate the effectiveness of a m-health system based on physical exercise recommendations for patients with CP based on its results on pain intensity, presence of anxiety and/or depression, sleep quality and quality of life. The achievement of the present project would serve to analyze the benefits of an exercise program in patients with CP and to identify those patients in whom the benefits would be greater and whose implementation would have greater priority. These results would be part of the future project to develop a multifactorial rehabilitation program based on the biopsychosocial model for patients with non-oncological CP.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic pain — including chronic low back pain, fibromyalgia, and diabetic nerve pain — affects millions of people and is increasingly understood not just as a symptom but as a condition in its own right, involving changes to how the nervous system processes pain signals. Exercise is one of the most effective treatments for chronic pain, but adherence is a major challenge. This trial tests a smartphone-based program that delivers personalised exercise recommendations to patients with chronic pain to see whether it reduces pain intensity, improves mental health, sleep, and quality of life. Participants in the intervention group use the app to follow an individualised exercise plan, while those in the control group receive standard care. The study runs over several weeks and measures pain, anxiety, depression, sleep, and quality of life outcomes. You may be eligible if you have been diagnosed with chronic low back pain, fibromyalgia, or diabetic neuropathic pain, are over 18, own a smartphone with internet access, and are not already doing moderate exercise more than 3 times a week. Note that the study requires ability to understand and write Spanish, as it is based in Spain.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PainReApp Group Individuals of three different chronic pain conditions will be randomly selected: chronic low back pain, fibromyalgia and diabetic neuropathic pain. The intervention group will

PainReApp Group Individuals of three different chronic pain conditions will be randomly selected: chronic low back pain, fibromyalgia and diabetic neuropathic pain. The intervention group will complete a program of exercise guided by a m-health system for 24 weeks. Previously, their doctors determined whether patients would be able to exercise regularly. A program of 60 min, 3 times per week, aimed to improve the general conditioning of the patients will be performed, following the recommendations of the American College of Sports Medicine for patients with chronic pain. The daily session will be divided into the warm-up, aerobic training, strengthening and calm down. - Warm-up: It will consist of 5 min. walking in a way that allows the patient to have a conversation. - Aerobic training: It will consist of 10 to 20 min. walking so the patient can have a conversation, but having to stop and breathe once in a while. - Strengthening: It will be focused on 7 exercises. a) squats, b) stiff-legged deadlifts, c) lateral pull-down, d) reversed flies, e) flies, f) unilateral rows, and g) lateral raise. - Calm down: It will consist of stretching exercises. a) shoulders, b) triceps, c) chest, d) quadriceps, e) hamstrings, and f) back. Patients will have a first face-to-face session in which the use of the smartphone app and the conditioning program will be explained. This session will be performed in the Hospital Universitario Puerta del Mar (Cádiz, Spain). Strengthening exercises will be performed using an elastic band. During the first session, a physiotherapist will explain how to manage the elongation of the elastic band to increase or decrease the resistance intensity. The general recommendation will be 70-80% 1 repetition maximum that allows the patient to perform 8-10 repetitions. These home exercise sessions will be approximately 60 min. depending on the level of the patient. The PainReApp m-health system will provide videos and descriptions of exercises to be performed. The adherence to the intervention will be monitored through the PainReApp application.


Locations(1)

Cádiz, Spain

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ACTRN12621000783820


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