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Exercise Types for Low Back Pain
N/A
Recruiting
Led By Luciana G Macedo, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 18 to 80 years of age
Back pain being the primary musculoskeletal complaint of the patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 6 and 12 months
Awards & highlights
Study Summary
This trial is testing whether patients with chronic low back pain respond better to two different types of exercise: motor control exercises or graded activity. The results of the study could improve the delivery of exercises for low back pain and lead to better patient outcomes.
Who is the study for?
This trial is for adults aged 18-80 with chronic low back pain lasting more than 3 months, who primarily complain of back pain and can speak English. They should have moderate to severe pain or disability and be suitable for physiotherapy as indicated by the STarT Back Tool.Check my eligibility
What is being tested?
The study compares two exercise treatments for chronic low back pain: graded activity and motor control exercises. It aims to see which exercise works best depending on the patient's characteristics, potentially improving treatment outcomes and reducing healthcare costs.See study design
What are the potential side effects?
Exercise interventions like graded activity or motor control exercises may cause temporary muscle soreness or discomfort, especially when starting a new program or increasing intensity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
My main health issue is back pain.
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I experience moderate to severe pain or disability.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oswestry Disability Index
Secondary outcome measures
EQ-5D-5L
IMPACT of low back pain - PROMIS-9
Pain Numeric Ranting Scale
+1 moreOther outcome measures
Effect Modifier: Coping strategies questionnaire
Effect Modifier: OREBRO LBP screening questionnaire
Effect Modifier: Pain Pressure Threshold Assessment
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Motor Control ExerciseExperimental Treatment1 Intervention
The primary goal of motor control exercises is to retrain optimal control and coordination of the spine. It uses principles of motor learning such as segmentation, simplification and task-specific practice to retrain control of trunk muscles activation, alignment and movement. The first stage of the treatment involves assessment of the postures, movement patterns and muscle activation associated with symptoms and a retraining program designed to improve activity of muscles assessed to have poor control (usually the deep trunk muscles). Participants are taught how to contract these muscles independently. During this stage additional exercises for breathing control, posture of spine and movement are performed. The second stage of the treatment involves the progression of the exercises towards functional activities, firstly using static then dynamic tasks. Education is also included.
Group II: Graded ActivityExperimental Treatment1 Intervention
The primary goal of graded activity is to address individual modifiable contextual factors associated with the pain experience such as self-efficacy, pain-related fear, kinesiophobia and unhelpful beliefs/behaviors about back pain while at the same time addressing physical impairments such as endurance, muscle strength and balance. A primary goal of the program is to increase activity tolerance by performing individualized and submaximal exercises in addition to ignoring illness behaviors and reinforcing well behaviors. 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. Cognitive-behavioral principles are used to help patients overcome the natural anxiety associated with pain and activities.
Find a Location
Who is running the clinical trial?
The University of QueenslandOTHER
140 Previous Clinical Trials
65,802 Total Patients Enrolled
3 Trials studying Low Back Pain
103 Patients Enrolled for Low Back Pain
Laval UniversityOTHER
417 Previous Clinical Trials
171,858 Total Patients Enrolled
4 Trials studying Low Back Pain
10,229 Patients Enrolled for Low Back Pain
University of AlbertaOTHER
888 Previous Clinical Trials
384,544 Total Patients Enrolled
12 Trials studying Low Back Pain
1,266 Patients Enrolled for Low Back Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English and can communicate with my healthcare team.I am between 18 and 80 years old.I have weakness, altered reflexes, or sensation loss due to nerve damage.I have had lower back pain for more than 3 months, with or without leg pain.You have trouble remembering things or understanding instructions, like someone with dementia or Alzheimer's.I have a severe condition like a spinal cord injury that stops me from exercising.My main health issue is back pain.I am classified as moderate or high risk for back pain, suitable for physiotherapy.I experience moderate to severe pain or disability.I might have a serious health issue like an infection, fracture, cancer, or severe arthritis.I am scheduled for or on a wait list for surgery during the trial period.
Research Study Groups:
This trial has the following groups:- Group 1: Motor Control Exercise
- Group 2: Graded Activity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this research?
"Affirmative. According to clinicaltrials.gov, this medical study is actively seeking participants for recruitment as its first posting was on September 15th 2020 and it has been recently updated on April 5th 2022. This trial requires 414 patients from a single site."
Answered by AI
Are there any stipulations for individuals to be accepted into this experiment?
"This medical trial seeks 414 adults aged 18 to 80 who suffer from chronic, non-specific low back pain (lasting longer than 3 months), as indicated by moderate or greater levels of disability on the SF-36 and/or high scores on the STarT Back Tool. Pain in other areas is acceptable so long as it does not eclipse their primary musculoskeletal complaint."
Answered by AI
Can new participants join this trial at the present time?
"This trial, which was initially publicized on September 15th 2020, is actively seeking suitable applicants. The data available on clinicaltrials.gov has been updated as recently as April 5th 2022."
Answered by AI
Is the patient demographic for this study restricted to persons over 30 years of age?
"This trial has a stringent age limit, only admitting patients aged between 18 and 80. Conversely, 11 clinical trials are available for minors whereas 263 studies accept participants over 65 years old."
Answered by AI
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