Clinical trial NCT05895630: Online Physical Exercise for Chronic Low Back Pain
Official title: Interactive and Adapted Physical Exercise for the Remote Management of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Physical exercise
Telehealth
Remote interventions
Motivation
Proof-of-concept
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: Université du Québec a Montréal
name: Concordia University, Montreal
name: Université du Québec à Trois-Rivières
name: Institut Universitaire de Gériatrie de Montréal
First posted: 2023-06-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm parallel randomized controlled trial
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from baseline low back pain intensity at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline pain spread at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline stomach pain at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline non-spine pain at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline headache at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline widespread pain at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline opioid use at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline injection use at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Medical interventions: exercise therapy
timeFrame: Baseline
measure: Change from baseline psychological counseling use at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline pain interference with day-to-day activities at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline pain interference with work around home at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline pain interference with ability to participate in social activities at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline pain interference with household chores at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline physical function (household chores) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline physical function (ability to go up and downstairs) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline physical function (ability to go for a walk for at least 15 minutes) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline physical function (ability to run errands and shop) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline feelings of depression (worthlessness) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline feelings of depression (helplessness) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline feelings of depression at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline feelings of depression (hopelessness) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline sleep quality at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline quantity of refreshing sleep at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline extent of problems with sleep at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline difficulty falling asleep at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline absenteeism and compensation benefits (time off work) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline absenteeism and compensation benefits (disability/compensation) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Baseline low back pain-related lawsuits and legal claims
timeFrame: Baseline
measure: Follow-up low back pain-related lawsuits and legal claims
timeFrame: 12 weeks
measure: Change from baseline kinesiophobia at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline catastrophizing at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline substance abuse (item 1) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline substance abuse (item 2) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline cigarette smoking at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Body Mass Index group at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Short Physical Performance Battery (SPPB) test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Timed Up and Go (TUG) test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Unipedal Stance test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Lower Limb Strength test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Lower Limb Strength Takai test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Gait Speed test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline Rapid Assessment of Physical Activity (RAPA) test score at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline International Physical Activity Questionnaire (IPAQ) test score at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Pain intensity before each training session
timeFrame: Assessed before each of the 36 training sessions
measure: Pain intensity after each session
timeFrame: Assessed after each of the 36 training sessions
measure: Pain intensity during the performance of physical tests at baseline
timeFrame: Baseline
measure: Pain intensity during the performance of physical tests at follow-up
timeFrame: 12 weeks
measure: Program adherence
timeFrame: 12 weeks
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Montréal
country: Canada
facility: Centre de recherche de l'Institut universitaire de gériatrie de Montréal
state: Quebec
Study officials:
affiliation: McGill University
name: Mathieu Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states--maybe it is all in their head. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):141-54. doi: 10.1016/j.berh.2011.02.005.
citation: Lauze M, Martel DD, Aubertin-Leheudre M. Feasibility and Effects of a Physical Activity Program Using Gerontechnology in Assisted Living Communities for Older Adults. J Am Med Dir Assoc. 2017 Dec 1;18(12):1069-1075. doi: 10.1016/j.jamda.2017.06.030. Epub 2017 Aug 14.
citation: Martel D, Lauze M, Agnoux A, Fruteau de Laclos L, Daoust R, Emond M, Sirois MJ, Aubertin-Leheudre M. Comparing the effects of a home-based exercise program using a gerontechnology to a community-based group exercise program on functional capacities in older adults after a minor injury. Exp Gerontol. 2018 Jul 15;108:41-47. doi: 10.1016/j.exger.2018.03.016. Epub 2018 Mar 22. No abstract available.
citation: Barbosa Neves B, Franz R, Judges R, Beermann C, Baecker R. Can Digital Technology Enhance Social Connectedness Among Older Adults? A Feasibility Study. J Appl Gerontol. 2019 Jan;38(1):49-72. doi: 10.1177/0733464817741369. Epub 2017 Nov 22.
citation: Angarita-Fonseca A, Page MG, Meloto CB, Gentile EL, Leonard G, Masse-Alarie H, Tufa I, Roy JS, Stone LS, Choiniere M, Fortin M, Roy M, Sean M, Tetreault P, Rainville P, Deslauriers S, Lacasse A; Quebec Back Pain Consortium; Quebec Back Pain Consortium. The Canadian version of the National Institutes of Health minimum dataset for chronic low back pain research: reference values from the Quebec Low Back Pain Study. Pain. 2023 Feb 1;164(2):325-335. doi: 10.1097/j.pain.0000000000002703. Epub 2022 Jun 2.