Which Exercise for Low Back Pain: A Validation Study

NCT03327753 | Completed

• 1 other identifier: WhichEx2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Dr. Macedo and others involved in the proposed research recently conducted a study that investigated whether simple clinical characteristics could identify patients who benefit more from either motor control exercises or graded activity. Results were statistically significant and clinically relevant demonstrating that a simple questionnaire could help aid the selection of the most appropriate exercise therapy for each individual patient. Therefore, we aim to conduct a randomized controlled trial following a similar approach to the original study to validate in a different sample the results of the effect modification analysis.

Conditions

Chronic Low Back Pain; Non Specific Low Back Pain

Keywords

exercise; mobility; physiotherapy; validation

Outcome Measures

Primary Outcomes (1)

• Patient Specific Functional Scale

  This scale evaluates patient's self function on a scale from 0-10.

  12 months

Secondary Outcomes (4)

• Patient Specific Functional Scale

  2 and 6 month

• Roland Morris Disability Questionnaire

  2, 6 and 12 months

• Numeric Rating Scale- pain

  2, 6 and 12 months

• SF-36

  2, 6 and 12 months

Other Outcomes (4)

• Effect Modifier - OREBRO

  baseline

• Effect modifier _ Lumbar instability

  baseline

• Effect modifier _ Kinesiophobia

  baseline

Study Arms (2)

Motor control exercises

EXPERIMENTAL

A primary goal of the motor control exercise program is to regain control and coordination of the spine and pelvis using principles of motor learning such as segmentation and simplification. The whole intervention is based on assessment of the individual patient's motor control impairments and the patient's individual treatment goals (set collaboratively with the therapist).

Behavioral: Motor control exercises

Graded activity

EXPERIMENTAL

A primary goal of the graded activity program is to increase activity tolerance by performing individualized and submaximal exercises in addition to ignoring illness behaviors and reinforcing well behaviors. The intervention uses cognitive behavioral approaches to deal with fear of movement and self efficacy.

Behavioral: Graded activity

Interventions

Motor control exercises BEHAVIORAL

The first stage of the treatment involves assessment of symptoms and implementation of a retraining program designed to improve activity of muscles assessed to have poor control and reducing activity of any muscle identified to be overactive. Participants are taught how to contract these muscles independently from the superficial trunk muscles and progress until the patient are able to maintain isolated contractions of the target muscles. During this stage exercises for breathing control, posture of spine and lower limb and movement are performed. The second stage of the treatment involved the progression of the exercises towards more functional activities. Throughout this process the recruitment of the trunk muscles, posture, movement pattern and breathing are assessed and corrected.

Motor control exercises

Graded activity BEHAVIORAL

The program is based on activities that each patient identify as problematic and that they cannot perform or have difficulty performing because of their back pain. The activities in the program are progressed in a time-contingent manner from the baseline assessed ability to a target goal set jointly by patient and therapist. Patients receive daily quotas and are instructed to only perform the agreed amount, even when they feel they are capable of doing more. Cognitive-behavioural principles are used to help patients overcome the natural anxiety associated with pain and activities. Physiotherapists use positive reinforcement, explain pain mechanisms and addressed negative behaviours and pain-related anxiety. A plan for managing relapses is developed between therapists and patients.

Graded activity

Eligibility Criteria

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

Sponsors & Collaborators

• McMaster University: lead
• University of Alberta: collaborator
• Macquarie University, Australia: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized into one of two groups, both of which are exercises considered part of standard care.

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 31, 2017
• Study Start: January 10, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)