Low Back Pain, MechanicalNCT05691907
Directional Preference Exercises in Comparison to Motor Control Exercises in Mechanical Low Back Pain
A study testing THE therapy and Directional Preference Exercises in people with Low Back Pain, Mechanical, run by Foundation University Islamabad at 2 sites in Pakistan.
Trial summary
The purpose of this study is to determine the effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- THE therapy and Directional Preference Exercises
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Feb 2023to 1 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both male \& Female patients
- Age group 20-60 Years
- Diagnosed with mechanical low back pain having pain aggravation in flexion bias
Who cannot join
- Lumbar stenosis
- Cauda Equina
- Spondylolisthesis
- Ankylosing Spondylitis
- Scoliosis
- Leg Length Discrepancy
Show all 10Show fewer
- Muscular Dystrophy
- Low back pain from non-musculoskeletal causes
- Fracture or traumatic low back pain
- Any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Foundation University
Islamabad
Kulsum International Hospital
Islamabad
About this study
Official title: Effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain
The purpose of this study is to determine the effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain
- Conditions
- Low Back Pain, Mechanical
- Being tested
- THE therapy, Directional Preference Exercises, Motor Control Exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THE therapyDevice
THE therapy consisting of:
- Heating Pad
- Interferential Therapy
Directional Preference ExercisesProcedure or surgery
Directional Preference Exercises consisting of Mckenzie's extension protocol
Motor Control ExercisesProcedure or surgery
Motor Control Exercises consisting of External limb loading extension protocol
| Study group | Role | What they receive |
|---|---|---|
| Directional Preference Exercises | Experimental | Directional Preference Exercises will be provided, also known as Mckenzie's extension exercises Receives: Device: THE therapy; Procedure: Directional Preference Exercises |
| Motor Control Exercises | Experimental | Motor Control Exercises consisting of extension bias external limb loading protocol. Receives: Device: THE therapy; Procedure: Motor Control Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back Pain
Pain will be measured using Numeric Pain Rating Scale, on a scale of 1 to 10. higher scores represent poorer outcome.
Measured: 2 week
Disability
Disability will be measured using Roland Morris Disability Questionnaire. Higher scores represent poorer outcome.
Measured: 2 week
Range of Motion
Range of Motion will be measured using inclinometer. Higher scores represent better outcome.
Measured: 2 week
Sleep Quality
Sleep Quality will be measured using Pittsburg Sleep Quality Index. Higher scores represent poorer outcome.
Measured: 2 week
Postural Stability Index
Postural Stability Index will be measured using Biodex Balance System. Higher scores represent poorer outcome.
Measured: 2 week
Real time Physical Activity
Real time Physical Activity will be measured using wearable sensor technology. Higher scores represent better outcome.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, PhD*, Principal investigator, FUI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691907
- Sponsor's protocol ID
- FUI/CTR/2023/2
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05691907
- Acronym / sponsor ID
- FUI/CTR/2023/2
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Jan 2023 (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 purpose of this study is to determine the effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Directional Preference Exercises | Experimental | Device: THE therapy, Procedure: Directional Preference ExercisesDirectional Preference Exercises will be provided, also known as Mckenzie's extension exercises |
| Motor Control Exercises | Experimental | Device: THE therapy, Procedure: Motor Control ExercisesMotor Control Exercises consisting of extension bias external limb loading protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Both male \& Female patients
- Age group 20-60 Years
- Diagnosed with mechanical low back pain having pain aggravation in flexion bias
Key exclusion criteria (10 listed)
- Lumbar stenosis
- Cauda Equina
- Spondylolisthesis
- Ankylosing Spondylitis
- Scoliosis
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 |
|---|---|---|
| THE therapyTHE therapy consisting of: * Heating Pad * Interferential Therapy | Device | Directional Preference Exercises, Motor Control Exercises |
| Directional Preference ExercisesDirectional Preference Exercises consisting of Mckenzie's extension protocol | Procedure or surgery | Directional Preference Exercises |
| Motor Control ExercisesMotor Control Exercises consisting of External limb loading extension protocol | Procedure or surgery | Motor Control Exercises |
Primary outcome
Back Pain
Time frame: 2 week
Pain will be measured using Numeric Pain Rating Scale, on a scale of 1 to 10. higher scores represent poorer outcome.
Disability
Time frame: 2 week
Disability will be measured using Roland Morris Disability Questionnaire. Higher scores represent poorer outcome.
Range of Motion
Time frame: 2 week
Range of Motion will be measured using inclinometer. Higher scores represent better outcome.
Sleep Quality
Time frame: 2 week
Sleep Quality will be measured using Pittsburg Sleep Quality Index. Higher scores represent poorer outcome.
Postural Stability Index
Time frame: 2 week
Postural Stability Index will be measured using Biodex Balance System. Higher scores represent poorer outcome.
Real time Physical Activity
Time frame: 2 week
Real time Physical Activity will be measured using wearable sensor technology. Higher scores represent better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain, Mechanical
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability by Numerical Pain Rating Scale and Modified Oswestry Disability Index Respectively.
Chronic Non Specific Mechanical Low Back Pain
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
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.
Muhammad Osama, PhD* principal investigator
FUI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THE therapy and Directional Preference Exercises in people with Low Back Pain, Mechanical, run by Foundation University Islamabad at 2 sites in Pakistan.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Results are not available in the source record.
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?
Back Pain (time frame: 2 week). The study lists 6 primary outcomes in all. 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 20 Jan 2023.