Online Physical Exercise for Chronic Low Back Pain

NCT05895630 | Completed

• 1 other identifier: CLBPEO
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low-back Pain

Keywords

Physical exercise; Telehealth; Remote interventions; Motivation; Proof-of-concept

Outcome Measures

Primary Outcomes (1)

• Change from baseline low back pain intensity at 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).

  Baseline and 12 weeks

Secondary Outcomes (43)

• Change from baseline pain spread at 12 weeks

  Baseline and 12 weeks

• Change from baseline stomach pain at 12 weeks

  Baseline and 12 weeks

• Change from baseline non-spine pain at 12 weeks

  Baseline and 12 weeks

• Change from baseline headache at 12 weeks

  Baseline and 12 weeks

• Change from baseline widespread pain at 12 weeks

  Baseline and 12 weeks

Other Outcomes (5)

• Pain intensity before each training session

  Assessed before each of the 36 training sessions

• Pain intensity after each session

  Assessed after each of the 36 training sessions

• Pain intensity during the performance of physical tests at baseline

  Baseline

Study Arms (3)

Interactive

EXPERIMENTAL

The sessions will be given in groups of 5 to 10 people and will be interactive via Zoom (link will be sent to them by email). They will last 1h30min and will consist of 60min of physical activity, preceded and followed by 15 optional minutes of virtual social interaction with the kinesiologist and the other members of the group. Finally, if the participants are unable to attend the group session, a video of the course given will be available for them to follow afterwards via a website.

Behavioral: Interactive physical exercise

Video

EXPERIMENTAL

The sessions will be done individually without interaction via pre-recorded videos. The videos demonstrate specific classes provided to the patients in this arm by a kinesiologist. Participants will be able to contact the kinesiologist by phone or email to ask questions about the sessions. The sessions will last 1h30min.

Behavioral: Video physical exercise

Control

NO INTERVENTION

The control will be instructed to continue their lifestyle habits throughout the study. These participants will not receive any intervention until their outcome measures at baseline and follow-up are recorded. At this point their participation is completed and they will be offered one of the two physical exercise programs. Therefore, this arm will be acting like a waitlist group.

Interventions

Interactive physical exercise BEHAVIORAL

Interactive remote sessions of physical exercise in groups of 10 patients. The sessions are categorized by level 1, 2 or 3 and the allocation to this level is decided according to a decision tree taking into account the mobility profile (balance and cardiomuscular health). The intervention will last 12 weeks. The sessions will be delivered 3 times per week (Monday, Wednesday, Friday) offering a total of approximately 180 min/week.

Interactive

Video physical exercise BEHAVIORAL

Individual remote sessions of physical exercise based on pre-recorded videos. The video sessions are categorized by level 1, 2 or 3 and the allocation to this level is decided according to a decision tree taking into account the mobility profile (balance and cardiomuscular health). The videos will be delivered 3 times per week (Monday, Wednesday, Friday) offering a total of approximately 180 min/week.

Video

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mathieu Roy: lead
• Université de Montréal: collaborator
• Université du Québec a Montréal: collaborator
• Concordia University, Montreal: collaborator
• Université du Québec à Trois-Rivières: collaborator
• Institut Universitaire de Gériatrie de Montréal: collaborator

Study Sites (2)

McGill University

Montreal, Quebec, H3A 1G1, Canada

Location

Centre de recherche de l'Institut universitaire de gériatrie de Montréal

Montreal, Quebec, Canada

Location

Related Publications (5)

• 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.

  PMID: 22094191 BACKGROUND

• 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.

  PMID: 28818422 BACKGROUND

• 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.

  PMID: 29577975 BACKGROUND

• 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.

  PMID: 29166818 BACKGROUND

• 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.

  PMID: 36638305 BACKGROUND

Related Links

• Fitbit news. The impact of coronavirus on Global activity, March 23, 2020

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mathieu Roy, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed about the comparison arms, or about the specific aims of the study at comparing outcomes from two different types of online interventions. They will also not be made aware of the fact that the waitlist group will be compared to the intervention groups. However, it is not possible to mask completely participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Three-arm parallel randomized controlled trial

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: July 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)