Chronic Low Back PainNCT03456050
Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
A study testing FRC exercise and Conventional Exercise in people with Chronic Low Back Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- FRC exercise and Conventional Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Mar 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- FRC exercise, Conventional Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRC exerciseBehavioural
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.
Conventional ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FRC group | Experimental | This group will receive FRC exercise. Receives: Behavioral: FRC exercise |
| Conventional treatment | Experimental | This group will receive conventional exercise. Receives: Behavioral: Conventional Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive range of motion (Hip internal rotation)
It will be measured using digital inclinometer
Measured: Change from baseline passive hip internal range of motion at 8 weeks
Secondary outcomes (3)
Strength of the hip abductors (gluteus medius)
Strength of the hip abductors will be measured using hand held dynamometer or isokinetic dynamometry,
Measured: Change from baseline hip abductors strength at 8 weeks
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).
Measured: Change from baseline pain intensity at 8 weeks
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.
Measured: Change from baseline functional disability at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start15 Mar 2018
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem S. Alattallah, King Saud University
- Investigators
- ahmed alghadir, PHD, Study director, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456050
- Sponsor's protocol ID
- CAMS 028-3839
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept secure with principal investigator (Ms. Reem S. Alattallah) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a New Therapeutic Technique 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT03456050
- Acronym / sponsor ID
- CAMS 028-3839
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRC group | Experimental | Behavioral: FRC exerciseThis group will receive FRC exercise. |
| Conventional treatment | Experimental | Behavioral: Conventional ExerciseThis group will receive conventional exercise. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain
Key exclusion criteria (6 listed)
- Hip, spine and knee pathology.
- Hip and knee replacement.
- Surgery and fracture within the last 6 months.
- Cancer.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRC exerciseThe 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. | Behavioural | FRC group |
| Conventional ExerciseThe 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. | Behavioural | Conventional treatment |
Primary outcome
Passive range of motion (Hip internal rotation)
Time frame: Change from baseline passive hip internal range of motion at 8 weeks
It will be measured using digital inclinometer
3 secondary outcomes
Strength of the hip abductors (gluteus medius)
Time frame: Change from baseline hip abductors strength at 8 weeks
Pain Intensitiy
Time frame: Change from baseline pain intensity at 8 weeks
Functional disability
Time frame: Change from baseline functional disability at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No. Data will be kept secure with principal investigator (Ms. Reem S. Alattallah) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed alghadir, PHD study director
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRC exercise and Conventional Exercise in people with Chronic Low Back Pain, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive range of motion (Hip internal rotation) (time frame: Change from baseline passive hip internal range of motion at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.