NCT02422459

Brief Summary

The purpose of this study is to determine whether the combination of self-management support, pain science education, and individualized, goal-oriented exercises helps people with chronic pain to increase their function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

April 13, 2015

Last Update Submit

September 13, 2016

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Short-Musculoskeletal Function Assessment - Dysfunction Index

    Measures function

    change in function from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks

Secondary Outcomes (13)

  • Short-Musculoskeletal Function Assessment - Bother Index

    change in bother index from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks

  • Numeric Pain Rating Scale

    change in pain intensity from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks

  • PROMIS Pain Interference Item-Bank - 8 Items

    change in pain interference from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks

  • Numeric Fatigue Rating Scale

    change in fatigue from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks

  • Patient Health Questionnaire - 9

    change in depressive symptoms from baseline at 18 weeks (12 week follow-up) with repeated measures at 0, 7 and 18 weeks

  • +8 more secondary outcomes

Study Arms (2)

COMMENCE

EXPERIMENTAL

ChrOnic pain self-ManageMent support with pain science EducatioN and exerCisE (COMMENCE)

Behavioral: COMMENCE

Wait-list control

NO INTERVENTION

No treatment assigned

Interventions

COMMENCEBEHAVIORAL

ChrOnic pain self-ManageMent support with pain science Education and exerCisE (COMMENCE) consists of two visits with a physiotherapist per week over six weeks. One of the two visits is in a group setting, where the emphasis is on pain neurophysiology education and provision of self-management strategies. The second visit each week is an individualized, one-to-one session in which the focus is on providing support for implementing self-management strategies and developing of an individualized, goal-oriented exercise program.

COMMENCE

Eligibility Criteria

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

You may qualify if:

  • participants will all be adults who have been experiencing non-cancer related pain for at least 12 weeks

You may not qualify if:

  • cancer related pain
  • medical "red flags" suggestive of a non-neuromusculoskeletal etiology of symptoms
  • casted fracture within the last 12 weeks
  • related surgery within the last 26 weeks
  • evidence of upper motor neuron lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woodstock and Area Community Health Centre

Woodstock, Ontario, N4S 3E6, Canada

Location

Related Publications (2)

  • Miller J, MacDermid JC, Walton DM, Richardson J. Chronic Pain Self-Management Support With Pain Science Education and Exercise (COMMENCE) for People With Chronic Pain and Multiple Comorbidities: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 May;101(5):750-761. doi: 10.1016/j.apmr.2019.12.016. Epub 2020 Jan 29.

    PMID: 32004517DERIVED

  • Miller J, MacDermid JC, Walton DM, Richardson J. Chronic pain self-management support with pain science education and exercise (COMMENCE): study protocol for a randomized controlled trial. Trials. 2015 Oct 14;16:462. doi: 10.1186/s13063-015-0994-5.

    PMID: 26466908DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jordan Miller, PhD(c)

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Joy C MacDermid, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 21, 2015

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

CA(1)