NCT03328689

Brief Summary

The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if they occur.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

October 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 25, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

October 23, 2017

Last Update Submit

February 20, 2020

Conditions

Low Back Pain, RecurrentLow Back Pain

Keywords

preventionexerciserandomized controlled trialphysical activity

Outcome Measures

Primary Outcomes (1)

  • Activity limiting flare-up

    * flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15 * activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation. Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above. Flare-up will be collected once a week for 1 year

    12 months

Secondary Outcomes (8)

  • Activity limiting flare-up

    3 and 6 months

  • Personal Impact of low back pain

    3, 6, 12 months

  • Pain intensity _NRS pain

    3, 6, 12 months

  • Disability

    3, 6, 12 months

  • Function

    3, 6, 12 months

  • +3 more secondary outcomes

Study Arms (2)

Physical activity in the community

EXPERIMENTAL

The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..

Other: Physical activity program

Control group standard care

ACTIVE COMPARATOR

Participants from the control group will receive no additional intervention other than being encouraged to continue with their physiotherapists or chiropractor recommendation which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.

Other: Control group standard care

Interventions

Physical activity programOTHER

This arm will begin with PT assessment. Following this, participants will meet with a specialist who will design an individualized physical activity program. Classes will include warm up, 40 minutes of individualized exercises and a cool down that will include back pain specific exercises including core strengthening. The first 4 weeks of exercise will include a 30-minute education program. Education comprise information on back pain, efficient use of the back during daily activities, self-management, self-efficacy and pain neurophysiology. Classes will run for a 12-week period. Participants will be encouraged to attend the exercise facility at least 3 times a week. An activity monitor will be provided to all participants. We will use group classes to facilitate the development of social support.

Physical activity in the community
Control group standard careOTHER

Participants from the control group will receive usual care which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity. Participants in the control group will also receive and activity monitor for collection of physical activity data. This activity monitor may also be used for positive feedback and activity reinforcement

Control group standard care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be included if they meet the following criteria
  • Have been discharged \<3 months from physiotherapy, chiropractic or osteopathic care following a course of treatment for LBP (pain in the area between the 12th rib and buttock crease)
  • Have non-specific LBP which is pain not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture, etc.
  • Non-specific LBP sometimes called mechanical LBP accounts for \~85% of LBP diagnosis.
  • Between 18 and 80 years of age

You may not qualify if:

  • Participants will be excluded if they meet the following criteria:
  • Ongoing high pain intensity, defined as pain intensity of 6 or more on a 0-10 point scale. The cut off of 6/10 is used in the literature to dichotomise low/moderate to high pain intensity.
  • Co-morbidity preventing participation in physical activity evaluated using the Physical Activity Readiness Questionnaire (PAR-Q) from the American College of Sports Medicine guidelines
  • Inadequate English to complete outcome measures
  • Currently participating in an exercise program similar to the one we will evaluate.
  • History of spine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YMCA Hamilton

Hamilton, Ontario, Canada

Location

Related Publications (1)

  • Macedo LG, Richardson J, Battie MC, Hancock M, Kwan M, Hladysh G, Zhuo L. Back to living well: community-based management of low back pain: a feasibility study. Pilot Feasibility Stud. 2021 Jun 24;7(1):134. doi: 10.1186/s40814-021-00863-7.

    PMID: 34167584DERIVED

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Luciana Macedo, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Given that this is an exercise study blinding of participants and those delivering the exercise program will not be possible. Outcome measures will be collected by an investigator not aware of treatment allocation, but most outcome measures will be self-reported and thus, true assessor blinding will no be possible. All statistical analysis will be conducted by a blinded investigator.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 1, 2017

Study Start

November 25, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)