Chronic Low Back Pain (CLBP)NCT06796023
Comparison Between Lumbar Stabilization Exercises and Lumbar Manipulation on Multifidus Muscle in Chronic Low Back Pain This Study Will Investigate and Compare the Effect of Lumbar Stabilization Exercises and Manipulation on Multifidus Muscle in Chronic Low Back Pain
A study testing Stretching and strengthening exercises for back muscles, Lumbar stabilization Exercises and Lumbar Manipulation in people with Chronic Low Back Pain (CLBP), run by Cairo University.
Trial summary
Histological and morphological changes of multifidus muscle have been reported in lumbar disc herniation (LDH), but there is scarce research comparing the efficacy of different treatment programs that can correct multifidus dysfunction in chronic low back pain (LBP) with LDH. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Stretching and strengthening exercises for back muscles, Lumbar stabilization Exercises and Lumbar Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The selected subjects had chronic LBP with magnetic resonance imaging (MRI) evidence of disc herniation at levels of L4-L5 and/or L5-S1 diagnosed by physician (orthopedist, neurosurgeon).
- A period of continuous complaints of pain for more than 12 weeks.
- All patients reported an average pain level of at least 5 on a scale of 0 to 10.
Who cannot join
- Acute inflammatory diseases of musculoskeletal system.
- Pathology or deformities of hip, knee and ankle joints.
- History of surgical approach to their back or had special pathology or non spinal condition causing referred back symptoms.
- Patient who indicated for surgery to treat lumbar disc herniation (i.e. sever intolerable pain, motor weakness, and cannot control urine and stool).
- Cardiopulmonary diseases which decrease the patient's tolerance and activities.
- Spondylolisthesis.
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- Diabetic neuropathy.
- Osteoporosis.
- A recent history of vestibular disorder or inner ear infection with associated balance and coordination problems.
- A history of cerebral trauma with unresolved neurosensory symptoms or neurological deficits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Lumbar Stabilization Exercises and Lumbar Manipulation on Multifidus Muscle in Chronic Low Back Pain: Randomized Control Trial
Histological and morphological changes of multifidus muscle have been reported in lumbar disc herniation (LDH), but there is scarce research comparing the efficacy of different treatment programs that can correct multifidus dysfunction in chronic low back pain (LBP) with LDH. The purpose: this study will be to investigate and compare the effect of lumbar stabilization exercises and manipulation on multifidus muscle in chronic LBP patients with LDH. Subjects: sixty patients aged ranged from 45 - 65 years suffering from chronic LBP with LDH will be randomly assigned into three groups, each group includes 20 patients. Method: group (A) (control group) will receive general exercises for back muscles, group (B) will receive general exercises and lumbar stabilization exercises, and group (C) will receive general exercises and lumbar manipulation (B and C experimental groups). The outcome measurements pre and post 6 weeks of treatment will be pain intensity by visual analogue scale (VAS), functional disabilities by Oswestry disability index (ODI), lumbar repositioning by Biodex system (LR), cross sectional area (CSA) and the asymmetry of both sides of multifidus muscle at the fourth and fifth lumbar vertebrae by ultrasonography.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Stretching and strengthening exercises for back muscles, Lumbar stabilization Exercises, Lumbar Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching and strengthening exercises for back musclesOther
Stretching and strengthening exercises for back muscles
Lumbar stabilization ExercisesOther
Lumbar stabilization Exercises
Lumbar ManipulationOther
Lumbar Manipulation
| Study group | Role | What they receive |
|---|---|---|
| Stretching and strengthening exercises | Active comparator | Stretching and strengthening exercises for back muscles Receives: Other: Stretching and strengthening exercises for back muscles |
| Lumbar Stabilization | Experimental | Lumbar Stabilization exercises Receives: Other: Stretching and strengthening exercises for back muscles; Other: Lumbar stabilization Exercises |
| Lumbar Manipulation | Experimental | Lumbar Manipulation Receives: Other: Stretching and strengthening exercises for back muscles; Other: Lumbar Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
The patients will asked about the perception of pain using a 10 cm line with 0 (no pain) on one end and 10 (worst pain) on the other end. Patients will be asked to place a mark along the line to dente their level of pain.
Measured: pre and post 6 weeks
functional disabilities by Oswestry disability index
It consists of 10 multiple- choice questions of back pain included disability in daily function and leisure time activities, for each question the patient selects one sentence out of six that best described his disability. For each section of six statements the total score is 5; if the first statement is marked, the score is zero, if the last is marked the score is 5. The final score calculated as follow:
Total score\ (5 x number of questions answered) x 100%. The maximal score is 50 (maximum disability) and the result taken as a percentage from the total score. High score indicate greater disability. Score from 0 to20% indicate minimal disability, score from 20 to 40% indicate moderate disability, score from 40 to 60% indicate sever disability, score from 60 to80% indicate crippled disability, and score from 80 to 100% indicate that the patient confined to bed
Measured: pre and post 6 weeks
lumbar repositioning angle
Biodex system 3 pro Isokinetic dynamometer (Biodex Medical INC., Shirley, New York, USA), equipped with a special forward reclined back attachment, will be used to measure the lumbar repositioning angle of the lumbar region.
- The participant will be positioned in 30° of lumbar flexion for 10 seconds and then instructed to remember the position because he/she will be asked to reproduce this position.
- The participant returns to the neutral position and then will be given the verbal instruction of reproducing the target position as accurately as he/she could.
- The subject will hold the final position for 3 seconds. The test will be repeated 3 times. The mean deviation or absolute error about the 30° target position will be calculated each time.
Measured: pre and post 6 weeks
Cross sectional area of multifidus muscle
Ultrasonography instrument (Phillips HDI 5000) with a frequency 3.5-5 MHz will be used to measure the cross sectional area of multifidus muscles at levels of Lumbar vertebrae (4) and Lumbar vertebrae (5)
Measured: pre and post 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Abutaleb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796023
- Sponsor's protocol ID
- P.T.REC/012/004972
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Lumbar Stabilization Exercises and Lumbar Manipulation on Multifidus Muscle in Chronic Low Back Pain: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06796023
- Acronym / sponsor ID
- P.T.REC/012/004972
- Conditions
- Chronic Low Back Pain (CLBP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
Histological and morphological changes of multifidus muscle have been reported in lumbar disc herniation (LDH), but there is scarce research comparing the efficacy of different treatment programs that can correct multifidus dysfunction in chronic low back pain (LBP) with LDH. The purpose: this study will be to investigate and compare the effect of lumbar stabilization exercises and manipulation on multifidus muscle in chronic LBP patients with LDH. Subjects: sixty patients aged ranged from 45 - 65 years suffering from chronic LBP with LDH will be randomly assigned into three groups, each group includes 20 patients. Method: group (A) (control group) will receive general exercises for back muscles, group (B) will receive general exercises and lumbar stabilization exercises, and group (C) will receive general exercises and lumbar manipulation (B and C experimental groups). The outcome measurements pre and post 6 weeks of treatment will be pain intensity by visual analogue scale (VAS), functional disabilities by Oswestry disability index (ODI), lumbar repositioning by Biodex system (LR), cross sectional area (CSA) and the asymmetry of both sides of multifidus muscle at the fourth and fifth lumbar vertebrae by ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stretching and strengthening exercises | Active comparator | Other: Stretching and strengthening exercises for back musclesStretching and strengthening exercises for back muscles |
| Lumbar Stabilization | Experimental | Other: Stretching and strengthening exercises for back muscles, Other: Lumbar stabilization ExercisesLumbar Stabilization exercises |
| Lumbar Manipulation | Experimental | Other: Stretching and strengthening exercises for back muscles, Other: Lumbar ManipulationLumbar Manipulation |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The selected subjects had chronic LBP with magnetic resonance imaging (MRI) evidence of disc herniation at levels of L4-L5 and/or L5-S1 diagnosed by physician (orthopedist, neurosurgeon).
- A period of continuous complaints of pain for more than 12 weeks.
- All patients reported an average pain level of at least 5 on a scale of 0 to 10.
Key exclusion criteria (10 listed)
- Acute inflammatory diseases of musculoskeletal system.
- Pathology or deformities of hip, knee and ankle joints.
- History of surgical approach to their back or had special pathology or non spinal condition causing referred back symptoms.
- Patient who indicated for surgery to treat lumbar disc herniation (i.e. sever intolerable pain, motor weakness, and cannot control urine and stool).
- Cardiopulmonary diseases which decrease the patient's tolerance and activities.
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 |
|---|---|---|
| Stretching and strengthening exercises for back musclesStretching and strengthening exercises for back muscles | Other | Lumbar Manipulation, Lumbar Stabilization, Stretching and strengthening exercises |
| Lumbar stabilization ExercisesLumbar stabilization Exercises | Other | Lumbar Stabilization |
| Lumbar ManipulationLumbar Manipulation | Other | Lumbar Manipulation |
Primary outcome
visual analogue scale
Time frame: pre and post 6 weeks
The patients will asked about the perception of pain using a 10 cm line with 0 (no pain) on one end and 10 (worst pain) on the other end. Patients will be asked to place a mark along the line to dente their level of pain.
functional disabilities by Oswestry disability index
Time frame: pre and post 6 weeks
It consists of 10 multiple- choice questions of back pain included disability in daily function and leisure time activities, for each question the patient selects one sentence out of six that best described his disability. For each section of six statements the total score is 5; if the first statement is marked, the score is zero, if the last is marked the score is 5. The final score calculated as follow: Total score\ (5 x number of questions answered) x 100%. The maximal score is 50 (maximum disability) and the result taken as a percentage from the total score. High score indicate greater disability. Score from 0 to20% indicate minimal disability, score from 20 to 40% indicate moderate disability, score from 40 to 60% indicate sever disability, score from 60 to80% indicate crippled disability, and score from 80 to 100% indicate that the patient confined to bed
lumbar repositioning angle
Time frame: pre and post 6 weeks
Biodex system 3 pro Isokinetic dynamometer (Biodex Medical INC., Shirley, New York, USA), equipped with a special forward reclined back attachment, will be used to measure the lumbar repositioning angle of the lumbar region. * The participant will be positioned in 30° of lumbar flexion for 10 seconds and then instructed to remember the position because he/she will be asked to reproduce this position. * The participant returns to the neutral position and then will be given the verbal instruction of reproducing the target position as accurately as he/she could. * The subject will hold the final position for 3 seconds. The test will be repeated 3 times. The mean deviation or absolute error about the 30° target position will be calculated each time.
Cross sectional area of multifidus muscle
Time frame: pre and post 6 weeks
Ultrasonography instrument (Phillips HDI 5000) with a frequency 3.5-5 MHz will be used to measure the cross sectional area of multifidus muscles at levels of Lumbar vertebrae (4) and Lumbar vertebrae (5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching and strengthening exercises for back muscles, Lumbar stabilization Exercises and Lumbar Manipulation in people with Chronic Low Back Pain (CLBP), run by Cairo University.
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: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enas Elsayed Dr. Abutaleb, Professor (00201001468054, enas.abutaleb@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: pre and post 6 weeks). The study lists 4 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 28 Jan 2025.