Back to Living Well: Implementation of a Community-based Program for Low Back Pain

NCT05929846 | Active Not Recruiting DMC

• 1 other identifier: 15354
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is usually a long-term condition with episodes of improvement, remission, and recurrence. There is evidence that long term exercise combined with education and self-management is effective at reducing the negative consequences of LBP. However, problems with uptake and long-term adherence to such programs are often reported in the literature. Using best available evidence, the implementation of the BackToLivingWell (BLW) will be evaluated, a community-based online or in-person program for the prevention long term disability due to LBP through exercise and self management.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Roland Morris Disability Questionnaire

  RMDQ is for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. The score ranges from 0 (no disability) to 24 (maximum disability).

  12-months

Secondary Outcomes (17)

• Pain NRS

  Baseline, 3 months, 6 months & 12 months

• Self Report Flare

  Once a week for 12 months (week 0-week 52)

• Activity Limitation

  Once a week for 12 months (week 0-week 52)

• EQ-5D-5L

  Once a week for 12 months (week 0-week 52)

• TAMPA Scale of Kinesiophobia

  Baseline, 3 months, 6 months & 12 months

Other Outcomes (1)

• Long term physical activity

  12 months after baseline

Study Arms (2)

In-Person

Participants will be assessed by a LiveWell specialist to assess functional goals and baseline capacity and design an individualized program. LiveWell specialist may also refer participants for an assessment with a physiotherapist based on a pre-defined criteria including redflag for serious conditions. Participants will engage in a 12-week program consisting of 45 minute sessions 3 times a week. Day 1 will include individualized program at the fitness center, Day 2 will include a group class exercises ending with mindfulness activities, action planning and education. Day 3 will consist of an independent day when participants can attend other classes at the YMCA or repeat the fitness center. In addition, there will be 12 virtual videos of education on self-management that will be discussed during the group activity day (Day 2) .

Other: Back to Living Well Program

e-Health

Participants will be assessed by a LiveWell specialist to assess functional goals and baseline capacity and provide recommendation on exercise modifications and the program. LiveWell specialist may also refer participants for an assessment with a physiotherapist based on a pre-defined criteria including redflag for serious conditions. Participants will engage in a 12-week program consisting of 45 minute sessions 3 times a week. They will be provided with 3 exercise videos (including 3 levels of exercises per video) and will also have access to the on-demand YMCA platform for additional videos. In addition, there will be 12 virtual videos of education on self-management that will be discussed during follow-up phone calls. Participants will also be provided with an action planning document to complete at home. All online participants will have a phone call with the LiveWell specialist at 3 and 7 weeks to discuss the program, action planning and the education materials.

Other: Back to Living Well Program

Interventions

Back to Living Well Program OTHER

The Back to Living Well program (BLW), a sustainable community-based program for persons with persistent mild to moderate LBP. The goal of the intervention is to provide an opportunity for community dwelling persons with persistent mild to moderate LBP to learn how to safely engage in exercise and become active self-managers. The 12-week program will engage participants in weekly exercise sessions, education and self management sessions, and encourage independent exercise at least 1x per week. All participants will be encouraged to complete an action plan and watch online education videos weekly.

In-Person; e-Health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be individuals from the community suffering from LBP. We will recruit participants that have demonstrated interested on the Back to Living Well program and have reached out to the YMCA to learn more about the program and to register. Participants will be referred to the study by the YMCA at the time that they decide to enroll in the program in one of the YMCA available locations ( YMCA location in Downtown Hamilton, Les Chater, Ron Edwards, Laurier Brantford or Flamborough ) .

You may qualify if:

• Currently starting or enrolled in the Back to Living Well program at a YMCA in Downtown Hamilton, Les Chater, Ron Edwards, Laurier Brantford or Flamborough
• Have non-specific LBP
• History of persistent LBP for 3 or more months that is mild, moderate, or severe
• If moderate levels of pain or less (pain \<6) they must have a history of flares or at least one flare within the previous year, if pain \>=6, flare is not necessary.
• years old or older

You may not qualify if:

• Co-morbidity preventing participation in exercise based on screening using the Physical Activity Readiness Questionnaire and later not cleared by their family physician
• Inadequate English to complete questionnaires and interviews
• Participants who are currently seeking care for LBP

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Related Publications (1)

• Macedo L, Di Pelino S, Santos VS, Richardson J, MacDermid J, Hancock M, Battie MC, Saragiotto BT, Hayden JA, Rushton A, Packham T, Freman M, Bray S, Griffin M, Hladysh G, Miller P, Attwell S. Implementation of back to living well, a community-based program for the tertiary prevention of low back pain: a study protocol. BMC Musculoskelet Disord. 2024 Jul 27;25(1):593. doi: 10.1186/s12891-024-07712-7.

  PMID: 39068385 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciana Macedo, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Julie Richardson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Joy MacDermid, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Mark Hancock, PhD

  Macquarie University

  PRINCIPAL INVESTIGATOR

• Michele Crites Battie

  Western University

  PRINCIPAL INVESTIGATOR

• Bruno Saragiotto, PhD

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

• Jill Hayden, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Alison Rushton, EdD

  Western University

  PRINCIPAL INVESTIGATOR

• Tara Packham, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Steven Bray, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Meridith Griffin, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Diego Silva, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 3, 2023
• Study Start: June 10, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CA (1)