Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
FRC exercise
Conventional Exercise
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
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.
Sites / Locations
- King Saud University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FRC group
Conventional treatment
Arm Description
This group will receive FRC exercise.
This group will receive conventional exercise.
Outcomes
Primary Outcome Measures
Passive range of motion (Hip internal rotation)
It will be measured using digital inclinometer
Secondary Outcome Measures
Strength of the hip abductors (gluteus medius)
Strength of the hip abductors will be measured using hand held dynamometer or isokinetic dynamometry,
Pain Intensitiy
Pain intensity will be assessed using visual analog scale (VAS) (0 - 10 cm with 0 indicates no pain and 10 indicates the worst pain).
Functional disability
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.
Full Information
NCT ID
NCT03456050
First Posted
February 26, 2018
Last Updated
February 25, 2019
Sponsor
King Saud University
1. Study Identification
Unique Protocol Identification Number
NCT03456050
Brief Title
Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
Official Title
Effectiveness of a New Therapeutic Technique 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Outcome provider masked about the outcomes
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FRC group
Arm Type
Experimental
Arm Description
This group will receive FRC exercise.
Arm Title
Conventional treatment
Arm Type
Experimental
Arm Description
This group will receive conventional exercise.
Intervention Type
Behavioral
Intervention Name(s)
FRC exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Passive range of motion (Hip internal rotation)
Description
It will be measured using digital inclinometer
Time Frame
Change from baseline passive hip internal range of motion at 8 weeks
Secondary Outcome Measure Information:
Title
Strength of the hip abductors (gluteus medius)
Description
Strength of the hip abductors will be measured using hand held dynamometer or isokinetic dynamometry,
Time Frame
Change from baseline hip abductors strength at 8 weeks
Title
Pain Intensitiy
Description
Pain intensity will be assessed using visual analog scale (VAS) (0 - 10 cm with 0 indicates no pain and 10 indicates the worst pain).
Time Frame
Change from baseline pain intensity at 8 weeks
Title
Functional disability
Description
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.
Time Frame
Change from baseline functional disability at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed alghadir, PHD
Organizational Affiliation
King Saud University
Official's Role
Study Director
Facility Information:
Facility Name
King Saud University
City
Riyad
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be kept secure with principal investigator (Ms. Reem S. Alattallah) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
Learn more about this trial
Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
We'll reach out to this number within 24 hrs