Lumbar Disc HerniationNCT05663437
Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study
A study testing Core stabilization exercises and Core stabilization exercises + neural mobilization technique in people with Lumbar Disc Herniation, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Lumbar disc herniation (LDH) is the most frequent cause of lumbosacral radiculopathy and account for 39% of chronic low back pain cases. In approximately 95% of cases LDH occurs at L4-L5 and L5-S1 levels. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Core stabilization exercises and Core stabilization exercises + neural mobilization technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Oct 2022to 5 Nov 2023
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed and referred females with lumbar disc herniation.
- Have a confirmed L4-S1 lumbar disc herniation through an MRI.
- Postero-lateral Disc herniation of stage I \& II.
- Age group of 30-50 years.
- Low back pain radiating to one leg for more than 3 months.
- Positive SLR test reproducing symptoms between 40°-70°.
Who cannot join
- Spondylolisthesis, spondylitis, and spinal canal stenosis.
- Red flags: spinal tumors, cuada equina syndrome, spinal fractures, osteoporosis, infection.
- Severe vascular disease like DVT.
- Pregnancy and Gynecological problems.
- Psychological disorders affecting subject's ability to follow instructions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow University of Health Sciences
Karachi, Sindh, 74200
Faryah Aslam, DPT, 0321-2318153, fausmanian@gmail.com
Saba A Ali, DPT, MSAPT, 03002886769, saba.aijaz@duhs.edu.pk
About this study
Lumbar disc herniation (LDH) is the most frequent cause of lumbosacral radiculopathy and account for 39% of chronic low back pain cases. In approximately 95% of cases LDH occurs at L4-L5 and L5-S1 levels. Maintaining functional stability of lumbar spine necessitates strengthening of the core muscles that plays a key role in lumbar strengthening, motor control and core stability. Core stability may play a role in passive disc stability, reducing the pressure on disc, relieving nerve impingement and radiating pain. Neural mobilization technique involves manual mobilization or exercise that promotes movement between and around the neural structures.This study is intended to add to the existing literature regarding patients with lumbar radiculopathy due to disc herniation, and to report the effectiveness of core stabilization exercises with and without neural mobilization technique in respective population in reduction of associated symptoms, pain and functional disability, enhancing the quality of life, and restoring a prior functional status and activity potential.
Read the detailed description
An RCT will be conducted on female patients with radiculopathy due to posterolateral disc herniation at L4-S1 levels, visiting Physiotherapy OPD at DUHS Ojha campus. A sample of 70 patients was calculated using PASS v11 software (Microsoft, Redmond, WA, USA). For estimating sample size, pain scores of motor control group (3.4 ±0.9) and motor control+ NDS group (2.5 ±0.8) after 8th session was used from a study conducted earlier. Patients who fulfill the inclusion criteria will be included in the study through convenience sampling, and will be equally allocated either in Core stabilization exercises group A (Control group: n=35) or Core stabilization exercises with Neural mobilization technique group B (Experimental group: n=35). Treatment will be provided on alternate days 3 times a week for 4 consecutive weeks. Patients will be assessed for pain and functional disability prior to the treatment, then at the end of 2nd week and 4th week through 11 points NPRS and Modified Oswestry Disability Questionnaire (MODQ). Data will be entered and analyzed through IBM SPSS version 24 with p-value < 0.05 will be considered as statistically significant.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Core stabilization exercises, Core stabilization exercises + neural mobilization technique
- Keywords
- Lumbar radiculopathy, Disc herniation, Pain intensity, Functional disability, Core stabilization exerices, Neural mobilization technique, Females
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercisesOther
6 core stabilization exercises including: dead bug, side lying, prone, bird dog, bridging, planks (1x10 reps for 15-30 secs each exercise) 3 alternative days a week, for 4 weeks.
Core stabilization exercises + neural mobilization techniqueOther
6 core stabilization exercises including: dead bug, side lying, prone, bird dog, bridging, planks (1x10 reps for 15-30 secs each exercise) 3 alternative days a week, for 4 weeks.
Neural mobilization technique (SLR intervention for first 2 weeks and slider intervention for last 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Core stabilization exercises Receives: Other: Core stabilization exercises |
| Experimental group | Experimental | Core stabilization exercises and Neural mobilization technique Receives: Other: Core stabilization exercises + neural mobilization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numeric Pain Rating Scale (11-point NPRS), a commonly used horizontal line scale with two end points to measure pain intensity. 0 indicates no pain at all, while 10 indicates the worst possible pain experienced.
Measured: Baseline, 2nd week and 4th week (change is being assessed)
Functional disability
Modified Oswestry Disability Questionnaire (MODQ), a self-administered 10 items questionnaire. Items are questions about pain intensity related to activities of daily living. Each section has a score of 0- 5, 5 demonstrating the greatest disability. The percentage of disability is reported by adding scores of all items and multiplying it by 2. Higher score represents higher pain intensity and disability.
Measured: Baseline, 2nd week and 4th week (change is being assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start6 Oct 2022
- Primary completion5 Oct 2023 (estimated)
- Study completion5 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faryah Aslam, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663437
- Sponsor's protocol ID
- IRB-2696
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- 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 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study
- ClinicalTrials.gov ID
- NCT05663437
- Acronym / sponsor ID
- IRB-2696
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar radiculopathy, Disc herniation, Pain intensity, Functional disability, Core stabilization exerices, Neural mobilization technique, Females
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 5 Oct 2023 (estimated)
- Study completion
- 5 Nov 2023 (estimated)
- First posted
- 23 Dec 2022 (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.
Lumbar disc herniation (LDH) is the most frequent cause of lumbosacral radiculopathy and account for 39% of chronic low back pain cases. In approximately 95% of cases LDH occurs at L4-L5 and L5-S1 levels. Maintaining functional stability of lumbar spine necessitates strengthening of the core muscles that plays a key role in lumbar strengthening, motor control and core stability. Core stability may play a role in passive disc stability, reducing the pressure on disc, relieving nerve impingement and radiating pain. Neural mobilization technique involves manual mobilization or exercise that promotes movement between and around the neural structures.This study is intended to add to the existing literature regarding patients with lumbar radiculopathy due to disc herniation, and to report the effectiveness of core stabilization exercises with and without neural mobilization technique in respective population in reduction of associated symptoms, pain and functional disability, enhancing the quality of life, and restoring a prior functional status and activity potential.
Detailed description
An RCT will be conducted on female patients with radiculopathy due to posterolateral disc herniation at L4-S1 levels, visiting Physiotherapy OPD at DUHS Ojha campus. A sample of 70 patients was calculated using PASS v11 software (Microsoft, Redmond, WA, USA). For estimating sample size, pain scores of motor control group (3.4 ±0.9) and motor control+ NDS group (2.5 ±0.8) after 8th session was used from a study conducted earlier. Patients who fulfill the inclusion criteria will be included in the study through convenience sampling, and will be equally allocated either in Core stabilization exercises group A (Control group: n=35) or Core stabilization exercises with Neural mobilization technique group B (Experimental group: n=35). Treatment will be provided on alternate days 3 times a week for 4 consecutive weeks. Patients will be assessed for pain and functional disability prior to the treatment, then at the end of 2nd week and 4th week through 11 points NPRS and Modified Oswestry Disability Questionnaire (MODQ). Data will be entered and analyzed through IBM SPSS version 24 with p-value < 0.05 will be considered as statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Core stabilization exercisesCore stabilization exercises |
| Experimental group | Experimental | Other: Core stabilization exercises + neural mobilization techniqueCore stabilization exercises and Neural mobilization technique |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed and referred females with lumbar disc herniation.
- Have a confirmed L4-S1 lumbar disc herniation through an MRI.
- Postero-lateral Disc herniation of stage I \& II.
- Age group of 30-50 years.
- Low back pain radiating to one leg for more than 3 months.
Key exclusion criteria (5 listed)
- Spondylolisthesis, spondylitis, and spinal canal stenosis.
- Red flags: spinal tumors, cuada equina syndrome, spinal fractures, osteoporosis, infection.
- Severe vascular disease like DVT.
- Pregnancy and Gynecological problems.
- Psychological disorders affecting subject's ability to follow instructions.
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 |
|---|---|---|
| Core stabilization exercises6 core stabilization exercises including: dead bug, side lying, prone, bird dog, bridging, planks (1x10 reps for 15-30 secs each exercise) 3 alternative days a week, for 4 weeks. | Other | Control group |
| Core stabilization exercises + neural mobilization technique6 core stabilization exercises including: dead bug, side lying, prone, bird dog, bridging, planks (1x10 reps for 15-30 secs each exercise) 3 alternative days a week, for 4 weeks. Neural mobilization technique (SLR intervention for first 2 weeks and slider intervention for last 2 weeks). | Other | Experimental group |
Primary outcome
Pain intensity
Time frame: Baseline, 2nd week and 4th week (change is being assessed)
Numeric Pain Rating Scale (11-point NPRS), a commonly used horizontal line scale with two end points to measure pain intensity. 0 indicates no pain at all, while 10 indicates the worst possible pain experienced.
Functional disability
Time frame: Baseline, 2nd week and 4th week (change is being assessed)
Modified Oswestry Disability Questionnaire (MODQ), a self-administered 10 items questionnaire. Items are questions about pain intensity related to activities of daily living. Each section has a score of 0- 5, 5 demonstrating the greatest disability. The percentage of disability is reported by adding scores of all items and multiplying it by 2. Higher score represents higher pain intensity and disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercises and Core stabilization exercises + neural mobilization technique in people with Lumbar Disc Herniation, run by Dow University of Health Sciences at 1 site 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 6 inclusion and 5 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 30 Dec 2022. 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 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?
Contact Faryah Aslam, DPT (0321-2318153, fausmanian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, 2nd week and 4th week (change is being assessed)). The study lists 2 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 30 Dec 2022.