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Clinical Trials/NCT05895630
NCT05895630
Completed
N/A

Interactive and Adapted Physical Exercise for the Remote Management of Chronic Low Back Pain

Mathieu Roy2 sites in 1 country57 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Low-back Pain
Sponsor
Mathieu Roy
Enrollment
57
Locations
2
Primary Endpoint
Change from baseline low back pain intensity at 12 weeks
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to evaluate the effects of technology-based interventions, specifically web-based platforms, on outcomes of patients with chronic low back pain. The objectives are to develop and evaluate the feasibility and effectiveness of these interventions, and to examine factors such as age and gender on implementation and adherence. It consists of an interventional proof-of-concept pilot study with 45 participants randomly divided into 3 groups: an interactive physical activity group, a pre-recorded video physical activity group, and a control group. Assessments will be conducted at weeks 0 and 12 to measure pain intensity with the Canadian adaptation of the National Institutes of Health minimal dataset for chronic low back pain.

Detailed Description

Technology-based interventions, specifically web-based platforms, have been used during the pandemic and, to a lower extent, prior to it, to maintain and improve physical and mental health while avoiding physical contact and therefore, risk of contagion, but also facilitating access to services such as psychotherapy or rehabilitation. Specifically, remote interventions have shown to be effective in the management of symptoms of people with chronic musculoskeletal pain, including chronic low back pain (CLBP). The objectives are to develop and evaluate the feasibility and effectiveness of these interventions, and to examine factors such as age and gender on implementation and adherence, as well as to validate the effectiveness of the interventions in improving CLBP outcomes and compare the effects of two different modalities of remote intervention (interactive and pre-recorded videos) against a waitlist control group. The study is an interventional proof-of-concept pilot study. Participants will be 45 people with CLBP aged 18 to 80 years who are able to consent, have no contraindication to physical activity, and can communicate, read, and understand French. Participants will be randomly divided into 3 groups: an interactive physical activity group, a video physical activity group, and a control group. Recruitment will be done from participant pools of the Quebec Pain Research Network, the Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal (CRIUGM), the Association Québécoise de la Douleur Chronique, and former participants of the laboratory's research projects. The intervention will last 12 weeks and consist of 3 physical activity sessions per week for the intervention groups. The interactive group sessions will be live via Zoom and the video sessions will consist of be pre-recorded videos. The control group will be instructed to continue their lifestyle habits throughout the study. Assessments will be conducted at weeks 0 and 12 via videoconference, telephone or lime-survey format to measure physical health, mental health, lifestyle, and quality of life. It will also evaluate the feasibility and adherence of the interactive or video technology. The study will also take into account age, gender and baseline pain intensity as potential confounding factors, by introducing them as covariates. We will use ANOVAs to compare the effects of the intervention on the variables of interest between groups. The primary variable will be pain intensity from the National Institutes of Health minimum dataset for chronic low back pain. Other variables form this dataset will be explored as secondary outcomes, along with variables related to physical performance. The study aims to recruit 60 participants, with a 25% dropout rate, to have a sample size of 45 participants completing the project in order to detect a small effect size.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Mathieu Roy

Assistant Professor

McGill University

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of chronic low back pain, lasting for more than 6 months
  • To have an internet connection and access to a computer with webcam or tablet
  • To be able to follow a physical activity program

Exclusion Criteria

  • Being under 18 years of age or over 80 years of age
  • A history of psychiatric or neurological illness
  • Presentation of neuropathic signs (radiating pain that spreads to the knee and leg (http://www.physio-pedia.com/Red_Flags_in_Spinal_Conditions)

Outcomes

Primary Outcomes

Change from baseline low back pain intensity at 12 weeks

Time Frame: Baseline and 12 weeks

Pain intensity perceived on average for the previous 7 days, reported in an 11-point numerical rating scale from 0 (no pain) to 10 (maximum imaginable pain).

Secondary Outcomes

  • Change from baseline headache at 12 weeks(Baseline and 12 weeks)
  • Change from baseline non-spine pain at 12 weeks(Baseline and 12 weeks)
  • Change from baseline widespread pain at 12 weeks(Baseline and 12 weeks)
  • Change from baseline pain spread at 12 weeks(Baseline and 12 weeks)
  • Change from baseline opioid use at 12 weeks(Baseline and 12 weeks)
  • Change from baseline stomach pain at 12 weeks(Baseline and 12 weeks)
  • Change from baseline injection use at 12 weeks(Baseline and 12 weeks)
  • Change from baseline psychological counseling use at 12 weeks(Baseline and 12 weeks)
  • Medical interventions: exercise therapy(Baseline)
  • Change from baseline pain interference with day-to-day activities at 12 weeks(Baseline and 12 weeks)
  • Change from baseline pain interference with work around home at 12 weeks(Baseline and 12 weeks)
  • Change from baseline pain interference with ability to participate in social activities at 12 weeks(Baseline and 12 weeks)
  • Change from baseline pain interference with household chores at 12 weeks(Baseline and 12 weeks)
  • Change from baseline physical function (household chores) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline physical function (ability to go up and downstairs) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline physical function (ability to go for a walk for at least 15 minutes) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline physical function (ability to run errands and shop) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline feelings of depression (worthlessness) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline feelings of depression (helplessness) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline feelings of depression at 12 weeks(Baseline and 12 weeks)
  • Change from baseline sleep quality at 12 weeks(Baseline and 12 weeks)
  • Follow-up low back pain-related lawsuits and legal claims(12 weeks)
  • Change from baseline Lower Limb Strength test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Rapid Assessment of Physical Activity (RAPA) test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline catastrophizing at 12 weeks(Baseline and 12 weeks)
  • Change from baseline cigarette smoking at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Timed Up and Go (TUG) test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline feelings of depression (hopelessness) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline quantity of refreshing sleep at 12 weeks(Baseline and 12 weeks)
  • Change from baseline extent of problems with sleep at 12 weeks(Baseline and 12 weeks)
  • Change from baseline absenteeism and compensation benefits (time off work) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline absenteeism and compensation benefits (disability/compensation) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline substance abuse (item 1) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Short Physical Performance Battery (SPPB) test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline difficulty falling asleep at 12 weeks(Baseline and 12 weeks)
  • Baseline low back pain-related lawsuits and legal claims(Baseline)
  • Change from baseline kinesiophobia at 12 weeks(Baseline and 12 weeks)
  • Change from baseline substance abuse (item 2) at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Body Mass Index group at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Unipedal Stance test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Lower Limb Strength Takai test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline Gait Speed test score at 12 weeks(Baseline and 12 weeks)
  • Change from baseline International Physical Activity Questionnaire (IPAQ) test score at 12 weeks(Baseline and 12 weeks)

Study Sites (2)

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