- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456050
Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
February 25, 2019 updated by: Reem S. Alattallah, King Saud University
Effectiveness of a New Therapeutic Technique 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
The aims of this study are to examine the effectiveness of functional range conditioning in patients with chronic non-specific low back pain in terms of improving hip internal rotation and strength of the hip abductors, and reducing pain and disability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It will be a single blind two-arm randomized controlled trial.
Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain will be invited to participate in this study.
Subjects who will fulfill the study's criteria and who are willing to participate in this study will be asked to sign an informed consent form.
The primary outcome will be the active and passive range of motion (ROM) of the hip internal rotators and it will be measured using digital inclinometer.
The secondary outcomes in this study will be the maximum torque of the hip abductors (gluteus medius), concentric at a constant, low-speed, and high-speed.
The peak torque and strength will be measured using isokinetic dynamometry, pain intensity will be assessed using a visual analog scale and disability will be assessed using Oswestry disability index.
All participants will have their information taken by the principal investigator.
Subsequently, participants will randomly be assigned to either the FRC group or the conventional treatment group by the principal investigator.
Concealed randomization will be performed by means of a computer-generated table of random numbers.
Outcomes will be measured at baseline, week 4 and week 8 for all participants in both groups by an assistant researcher.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Riyad, Saudi Arabia
- King Saud University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain
Exclusion Criteria:
- Hip, spine and knee pathology.
- Hip and knee replacement.
- Surgery and fracture within the last 6 months.
- Cancer.
- Pregnant women.
- Any medical condition that precluded safe participation in exercise programs such as significant cardiac, pulmonary, neurological disease or mental disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FRC group
This group will receive FRC exercise.
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The program will consist of hip joint controlled articular rotations (CARs) in standing position for 3 - 5 repetitions.
Then, the participant will sit on the floor in what is called 90/90 position which is sitting in hip and flexion in 90 degrees for both the lead (front) and trail (side) leg.
The participant will perform a Progressive and regressive angular isometric loadings (PAILs and RAILs) for the trail leg to increase the range of internal rotation, the contraction will be performed three times and the holding of the position will be for two minutes.
After expanding the range, the participant will perform Progressive and regressive angular loadings (PALs and RALs) isometric contractions in form of a passive range hold for internal rotation and abduction, for 3 - 5 times.
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Experimental: Conventional treatment
This group will receive conventional exercise.
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The conventional training program in this study will be the routine training for increasing the hip rotation.
By screening the scientific literature, the conventional training found to consists of static stretching and strengthening using body weight and/or a band and the time of holding a stretch is about 30 seconds.
For that the flexibility exercise will consist of progressive stretching from a prone position (leg fall in a stretch), the participant will perform 3 - 5 repetitions with 30 seconds hold or as tolerated.
The strengthening exercise consists of hip abduction (hip opening) using a band or ankle weight from side lying for 10 - 12 repetitions 3 times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Passive range of motion (Hip internal rotation)
Time Frame: Change from baseline passive hip internal range of motion at 8 weeks
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It will be measured using digital inclinometer
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Change from baseline passive hip internal range of motion at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength of the hip abductors (gluteus medius)
Time Frame: Change from baseline hip abductors strength at 8 weeks
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Strength of the hip abductors will be measured using hand held dynamometer or isokinetic dynamometry,
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Change from baseline hip abductors strength at 8 weeks
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Pain Intensitiy
Time Frame: Change from baseline pain intensity at 8 weeks
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Pain intensity will be assessed using visual analog scale (VAS) (0 - 10 cm with 0 indicates no pain and 10 indicates the worst pain).
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Change from baseline pain intensity at 8 weeks
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Functional disability
Time Frame: Change from baseline functional disability at 8 weeks
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Functional disability will be assessed using Oswestry disability index.
Each item in the questionnaire is scored on a 0-5 scale with zero indicating the least amount of disability and the 5 indicating most severe disability.The scores for total items answered are summed, and multiplied by two to get the index (range 0 to 100).
Zero indicates no disability and 100 indicates maximum possible disability.
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Change from baseline functional disability at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ahmed alghadir, PHD, King Saud University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
March 6, 2018
First Posted (Actual)
March 7, 2018
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMS 028-3839
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data will be kept secure with principal investigator (Ms.
Reem S. Alattallah) and sub-investigator (Dr.
Ahmad Alghadir) due to confidentiality issues
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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