About this trial
The goal of this clinical trial is to evaluate whether a wearable biofeedback smartbelt system can improve pain and disability in adults with chronic lower back pain. The intervention combines a wearable belt that measures muscle activity with a mobile application that provides real-time feedback during exercise.
The main questions it aims to answer are:
* Does the MMG-biofeedback system improve disability, as measured by the Oswestry Disability Index (ODI), compared to standard care alone over an 8-week period? * Does the system reduce perceived pain levels and improve exercise adherence in individuals with lower back pain over an 8-week period?
Researchers will compare participants receiving the MMG-biofeedback belt alongside standard care to those receiving standard care alone to determine whether the addition of real-time muscle activation feedback leads to improved outcomes.
Participants will:
* Be randomly assigned to either the intervention group (biofeedback system + standard care) or control group (standard care only) * Complete an 8-week home-based exercise programme, all participants are asked to complete the programme at least 5 times a week * Use the wearable belt and mobile application during exercise sessions (intervention group only) * Receive a booklet with the exercise programme and video links (control group only) * Complete questionnaires on pain, disability, and usability at baseline and after 8 weeks, and at a 3-month follow-up * Have their exercise adherence and engagement monitored throughout the study
The study includes an initial pilot phase to assess feasibility, followed by a larger randomised controlled phase to evaluate early clinical effectiveness.
Eligibility criteria
Qualifiers
Over the age of 18
Non-specific LBP for at least 6 weeks in the past 12 months
Pain 4/10 on a visual analogue scale or more or Oswestry Disability Index over 20%
Disqualifiers
History of malignancy with new onset back pain suggestive of recurrence.
Unexplained weight loss, fever, or systemic symptoms.
Recent significant trauma (e.g., fall from height, road traffic accident).
Suspected or confirmed spinal infection (e.g., discitis, osteomyelitis).
Trial design
Treatments tested in this trial
- MMG-biofeedback belt
Treatment groups
Sponsors and collaborators
Imperial College London
Lead sponsor
Surrey Physio
Collaborator