NCT04447508

Brief Summary

The study will follow guidelines provided by the ORBIT model for developing behavioural treatments. This model proposes that to optimize an intervention's effectiveness, its development should be undertaken in four phases. Phase 1 (design) and 2a (proof of concept) were completed during the applicant's PhD. The study will complete phase 2b (pilot-feasibility study) of the model with the aim to determine pre-defined feasibility outcomes to inform future progression to phase 3 (efficacy trial) and 4 (effectiveness trials).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Typical duration for not_applicable low-back-pain

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

June 17, 2020

Last Update Submit

September 27, 2021

Conditions

Low Back Pain

Keywords

Pain, behaviour change, exercise

Outcome Measures

Primary Outcomes (5)

  • Eligibility

    Number of eligible participants identified/week

    Through study completion, up to 12 weeks

  • Recruitment

    Percentage of eligible participants recruited/week

    Through study completion, up to 12 weeks

  • Treatment completion

    Percentage of participants that complete at least 3 of 5 motivational interviewing sessions and 5 of the 6 exercise classes

    Through study completion, up to 12 weeks

  • Follow up

    Loss of follow up at 6 weeks post intervention

    Through study completion, up to 12 weeks

  • Completion of outcome measures

    Percentage of participants that complete baseline and follow up measures and complete exercise diary

    Through study completion, up to 12 weeks

Secondary Outcomes (5)

  • Exercise adherence rating scale (EARS)

    Baseline, 6 weeks, 12 weeks

  • Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaire

    Baseline, 6 weeks, 12 weeks

  • Musculoskeletal health (MSK-HQ)

    Baseline, 6 weeks, 12 weeks

  • Health Action Process Approach (HAPA)constructs

    Baseline, 6 weeks, 12 weeks

  • Exercise adherence self report

    Through study completion, up to 12 weeks

Study Arms (2)

Exercise class and motivational interviewing

EXPERIMENTAL

Patients receiving the intervention will be enrolled in an online instructor led group exercise class and five online one on one motivational interviewing sessions.

Behavioral: Participants receive one on one motivational interviewing and participate in a group exercise class virtually.

Usual care

NO INTERVENTION

Participants in the control group will receive an exercise booklet and educated on the benefits of exercise for low back pain. They will be advised to exercise for the duration of the study

Interventions

Participants receive one on one motivational interviewing and participate in a group exercise class virtually.BEHAVIORAL

Participants have one group exercise class over zoom per week and an online one on one motivational interviewing session every second week.

Exercise class and motivational interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (over 18 years old)
  • Low back pain for three months or longer and no current plans for surgical intervention
  • Previously been prescribed exercises by a physiotherapist

You may not qualify if:

  • Plans for long absences during the study period
  • Participating in other studies or interventions targeting exercise or behaviour change during study
  • Recent (2 months) changes to medications
  • Receiving or have received prior psychological interventions for their pain (i.e., cognitive behavioural therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Summers S. Evidence-based practice part 1: pain definitions, pathophysiologic mechanisms, and theories. J Perianesth Nurs. 2000 Oct;15(5):357-65. doi: 10.1053/jpan.2000.18211.

    PMID: 11811340BACKGROUND

  • Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

    PMID: 3461421BACKGROUND

  • Briggs AM, Woolf AD, Dreinhofer K, Homb N, Hoy DG, Kopansky-Giles D, Akesson K, March L. Reducing the global burden of musculoskeletal conditions. Bull World Health Organ. 2018 May 1;96(5):366-368. doi: 10.2471/BLT.17.204891. Epub 2018 Apr 12. No abstract available.

    PMID: 29875522BACKGROUND

  • Gomes T, Mamdani MM, Dhalla IA, Cornish S, Paterson JM, Juurlink DN. The burden of premature opioid-related mortality. Addiction. 2014 Sep;109(9):1482-8. doi: 10.1111/add.12598. Epub 2014 Jul 7.

    PMID: 25041316BACKGROUND

  • Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.

    PMID: 28436583BACKGROUND

  • Meade LB, Bearne LM, Sweeney LH, Alageel SH, Godfrey EL. Behaviour change techniques associated with adherence to prescribed exercise in patients with persistent musculoskeletal pain: Systematic review. Br J Health Psychol. 2019 Feb;24(1):10-30. doi: 10.1111/bjhp.12324. Epub 2018 Jun 17.

    PMID: 29911311BACKGROUND

  • Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.

    PMID: 25642841BACKGROUND

  • Kok G, Gottlieb NH, Peters GJ, Mullen PD, Parcel GS, Ruiter RA, Fernandez ME, Markham C, Bartholomew LK. A taxonomy of behaviour change methods: an Intervention Mapping approach. Health Psychol Rev. 2016 Sep;10(3):297-312. doi: 10.1080/17437199.2015.1077155. Epub 2015 Oct 15.

    PMID: 26262912BACKGROUND

  • Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.

    PMID: 17716083BACKGROUND

MeSH Terms

Conditions

Low Back PainPainMotor Activity

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator,Postdoctoral Research Fellow

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 25, 2020

Study Start

November 1, 2021

Primary Completion

April 1, 2022

Study Completion

September 1, 2023

Last Updated

September 28, 2021

Record last verified: 2021-09