Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effect of a Supervised Exercise Program on Paraspinal Muscle Morphology and Function in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257253
• Other study ID #: CCER19-20-09
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 11, 2022

Study information

• Verified date: March 2023
• Source: Concordia University, Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of a supervised exercise program on paraspinal muscle morphology and function, as well as disability/function in patients with non-specific chronic low back pain. Half of the participants will do a targeted paraspinal muscle exercise program, while the other half will do a general exercise program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 11, 2022
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. chronic nonspecific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain

2. currently seeking care for LBP

3. between 18 and 60 years of age

4. English or French speaker

5. score of "moderate" or "severe" disability on the ODI questionnaire

6. do not currently engage in sports or fitness training specifically for the lower back muscles (3 months prior the beginning of the study).

Exclusion Criteria:

1. evidence of nerve root compression or reflex motor signs deficits (e.g. weakness, reflex changes, or sensory loss with same spinal nerve)

2. previous spinal surgery or vertebral fractures

3. other major lumbar spine structural abnormalities (e.g. spondylolysis, spondylolisthesis, or lumbar scoliosis >10°)

Related Conditions & MeSH terms

• Back Pain
• Diagnostic Imaging
• Exercise Therapy
• Low Back Pain
• Muscle Atrophy
• Muscular Atrophy

Intervention

Other:
• Targeted exercise program
Participants in this experimental intervention group will perform a combination of motor control and isolated lumbar extensor strenghtening exercises. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.
• General exercise program
Participants in this active intervention group will perform a generalized exercise program comprising upper-body and lower-body and hip strengthening exercises, as well as flexibility. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.

Locations

Country	Name	City	State
Canada	PERFORM Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Concordia University, Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in multifidus muscle size (cross-sectional area)	Multifidus muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.	Baseline, 6-week, 12-week
Primary	Change in multifidus muscle fatty infiltration	Multifidus muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.	Baseline, 6-week, 12-week
Secondary	Change in12-item Short Form Health Survey (SF-12)	The 12-item Short Form Health Survey (SF-12) is the condensed form of the previous 36-item Short Form Health Survey and is used to assess health-related quality of life.The 12-item survey consists of 8 domains that assess both physical and mental health composite scores (PCS and MCS). While the SF-12 is weighted and summed to provide an interpretable scale for both the PCS and MCS. The score of the 12 questions can range from 0 (worst level of health) to 100 (highest level of health).	Baseline, 6-week, 12-week, 24-week
Secondary	Change in Oswestry Low Back Pain Disability Index (ODI)	The ODI is used to measure the patient's level of disability in relation to LBP. It is a 10-item scale in which each item is rated from 0-6. Higher scores are indicative of greater disability.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in The International Physical Activity Questionnaire (IPAQ)	The IPAQ is a self-reported log of metabolic equivalent (MET)-minutes per week. The level of physical activity is rated either vigorous, moderate, walking and sitting and must be assigned to the right category. The number of minutes per category is then added up and assessed.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in Tampa Scale of Kinesiophobia (TSK)	The TSK measures pain-related fear in an individual through a 13-item scale. The scores range between 17 and 68 with increasing scores indicating a greater level of kinesiophobia.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in Visual Numerical pain rating scale (NPR)	The NRP for pain is a rating system from 0 to 10 with 0 being no pain and 10 worst pain imaginable.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in The Pain Catastrophizing Scale (PCS)	The PCS is a 13-item questionnaire that assesses the participant's level of catastrophizing. Each item is rated from 0-4 for a possible total of 52. The higher the score, the greater the level of catastrophizing.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in The Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item questionnaire used to assess a patient's level of depression and anxiety. Each item is rated from 0-3 with either depression or anxiety having scores between 0 and 21, with 21 being the highest level possible.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in Insomnia Severity Index (ISI)	The ISI is a 7-item questionnaire used to assess sleep disturbances. Each item is rated from 0 to 4 and the total score is added. The higher the score, the greater the level of sleep disturbances.	Baseline, 6-week, 12-week, 24-week
Secondary	Change in paraspinal muscle size (cross-sectional area)	Paraspinal muscle cross-sectional area measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.	Baseline, 6-week, 12-week
Secondary	Change in paraspinal muscle fatty infiltration	Paraspinal muscle fatty infiltration (composition) measurements will be obtained from magnetic resonance imaging (MRI) from L1 to L5 spinal levels.	Baseline, 6-week, 12-week
Secondary	Change in multifidus muscle function (% thickness change)	Multifidus muscle function, expressed as the % thickness change from a rested to contracted position via contralateral arm lifts will be assessed by ultrasound.	Baseline, 6-week, 12-week
Secondary	Change in lumbar extensor muscle strength	lumbar extensor muscle strength will be assessed using a MedX Lumbar Isokinetic Dynamometer.	Baseline, 6-week, 12-week