Lumbar RadiculopathyNCT06339931
Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.
A study testing SMWLM combined Spinal traction with belt and SMWLM combined spinal traction without belt in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- SMWLM combined Spinal traction with belt and SMWLM combined spinal traction without belt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Nov 2023to 1 Jun 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 16-50 years of both sexes, unilateral radiculopathy in the distribution of specific nerve with positive straight leg raise (SLR).
- Mild to moderate disability and pain on a scale of NPRS < 7, minimum chronicity of 1 month, and maximum 6 months
Who cannot join
- Patients with previous spinal surgery'
- Any bony or soft tissue systemic disease.
- Patients with diagnosed case of co morbidities such as malignancies , RA or fractures that causes bilateral leg pain
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Atta Jaspal Hospital and ortho trauma center
Bhalwal, Punjab Province, 40410
About this study
Official title: Effects of Lumber Spine Mobilization, Leg Movement, and Spinal Traction With and Without Belt in Patients With Lumber Radiculopathy.
Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses.
Read the detailed description
Low back pain (LBP) is one of the primary causes of disability worldwide. Most people-between 50% and 80%-experience LBP at some point in their life. It limits the ability to perform daily activities, such as walking, standing, or lifting objects. It can also lead to decreased mobility, reduced work productivity, and increased healthcare costs. Radiating pain is commonly caused by lumbar intervertebral disk abnormalities, which are linked with nerve root irritation and affect 3% to 10% of people with generalized low back pain. Sciatica, another name for lumbar radiculopathy, is a disorder marked by pain, weakness, numbness, or tingling sensations that radiate down the lower back along a nerve root, frequently into the buttock, thigh, and lower leg. One or more lumbar nerve roots are usually compressed, irritated, or inflamed as a reason.
- Conditions
- Lumbar Radiculopathy
- Being tested
- SMWLM combined Spinal traction with belt, SMWLM combined spinal traction without belt
- Keywords
- Lumber Radiculopathy, Low Back Pain, Quality of Life, Traction
- Medical subject headings
- Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMWLM combined Spinal traction with beltOther
Group A, therapist 1 will stand at the participant's ventral side and apply a transverse glide with the thumb on the involved lumbar spinous process. Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with the knee extended, while the glide will be sustained continuously by Therapist. Wrap the traction belt around both your hips and the proximal aspect of the patient's thighs.Apply traction by leaning backward and shifting your body weight onto your posterior leg.
SMWLM combined spinal traction without beltOther
Group B, therapist 1 will stand at the participant's ventral side and apply a transverse glide with the thumb on the involved lumbar spinous process. Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with the knee extended, while the glide will be sustained continuously by Therapist. Manual traction is applied by placing the patient over a rolled pillow while lying sideways. The roll should be 6-8 inches in diameter and should be placed at the level of the spine where the traction or separation is to occur. Pull the patient's legs toward you as you lean your body backward to apply a traction force.
| Study group | Role | What they receive |
|---|---|---|
| SMWLM combined Spinal traction with belt | Experimental | Group A (Spinal traction with belt plus SMWLM) as per Mulligan rule of three SMWLM on affected lumbar vertebrae. Spinal traction with belt for 10 mins. Receives: Other: SMWLM combined Spinal traction with belt |
| SMWLM combined Spinal traction without belt | Active comparator | Group B (Spinal traction without belt plus SMWLM) as per Mulligan rule of three SMWLM on affected lumbar vertebrae. Manual spinal traction technique without belt. Receives: Other: SMWLM combined spinal traction without belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The NPRS scale will be used to quantify pain intensity levels. The scale ranges from '0' for the least amount of pain ("no pain") to '10' for the most extreme levels of pain ("pain as severe as you can imagine")
Measured: 4 weeks
Inclinometer
Bubble inclinometer for measuring joint range of motion
Measured: 4 weeks
Oswestry Disability Index
Gold standard of low back pain functional outcome tools
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start23 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International 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, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shakil Ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339931
- Sponsor's protocol ID
- REC/RCR &AHS/23/0181
- Status last verified
- Sep 2024
- First submitted
- 25 Mar 2024
- Last updated
- 4 Sep 2024
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumber Spine Mobilization, Leg Movement, and Spinal Traction With and Without Belt in Patients With Lumber Radiculopathy.
- ClinicalTrials.gov ID
- NCT06339931
- Acronym / sponsor ID
- REC/RCR &AHS/23/0181
- Conditions
- Lumbar Radiculopathy
- Keywords
- Lumber Radiculopathy, Low Back Pain, Quality of Life, Traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 1 Apr 2024 (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.
Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses.
Detailed description
Low back pain (LBP) is one of the primary causes of disability worldwide. Most people-between 50% and 80%-experience LBP at some point in their life. It limits the ability to perform daily activities, such as walking, standing, or lifting objects. It can also lead to decreased mobility, reduced work productivity, and increased healthcare costs. Radiating pain is commonly caused by lumbar intervertebral disk abnormalities, which are linked with nerve root irritation and affect 3% to 10% of people with generalized low back pain. Sciatica, another name for lumbar radiculopathy, is a disorder marked by pain, weakness, numbness, or tingling sensations that radiate down the lower back along a nerve root, frequently into the buttock, thigh, and lower leg. One or more lumbar nerve roots are usually compressed, irritated, or inflamed as a reason.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMWLM combined Spinal traction with belt | Experimental | Other: SMWLM combined Spinal traction with beltGroup A (Spinal traction with belt plus SMWLM) as per Mulligan rule of three SMWLM on affected lumbar vertebrae. Spinal traction with belt for 10 mins. |
| SMWLM combined Spinal traction without belt | Active comparator | Other: SMWLM combined spinal traction without beltGroup B (Spinal traction without belt plus SMWLM) as per Mulligan rule of three SMWLM on affected lumbar vertebrae. Manual spinal traction technique without belt. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age of 16-50 years of both sexes, unilateral radiculopathy in the distribution of specific nerve with positive straight leg raise (SLR).
- Mild to moderate disability and pain on a scale of NPRS < 7, minimum chronicity of 1 month, and maximum 6 months
Key exclusion criteria (3 listed)
- Patients with previous spinal surgery'
- Any bony or soft tissue systemic disease.
- Patients with diagnosed case of co morbidities such as malignancies , RA or fractures that causes bilateral leg pain
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 |
|---|---|---|
| SMWLM combined Spinal traction with beltGroup A, therapist 1 will stand at the participant's ventral side and apply a transverse glide with the thumb on the involved lumbar spinous process. Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with the knee extended, while the glide will be sustained continuously by Therapist. Wrap the traction belt around both your hips and the proximal aspect of the patient's thighs.Apply traction by leaning backward and shifting your body weight onto your posterior leg. | Other | SMWLM combined Spinal traction with belt |
| SMWLM combined spinal traction without beltGroup B, therapist 1 will stand at the participant's ventral side and apply a transverse glide with the thumb on the involved lumbar spinous process. Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with the knee extended, while the glide will be sustained continuously by Therapist. Manual traction is applied by placing the patient over a rolled pillow while lying sideways. The roll should be 6-8 inches in diameter and should be placed at the level of the spine where the traction or separation is to occur. Pull the patient's legs toward you as you lean your body backward to apply a traction force. | Other | SMWLM combined Spinal traction without belt |
Primary outcome
Numeric pain rating scale
Time frame: 4 weeks
The NPRS scale will be used to quantify pain intensity levels. The scale ranges from '0' for the least amount of pain ("no pain") to '10' for the most extreme levels of pain ("pain as severe as you can imagine")
Inclinometer
Time frame: 4 weeks
Bubble inclinometer for measuring joint range of motion
Oswestry Disability Index
Time frame: 4 weeks
Gold standard of low back pain functional outcome tools
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 4 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Lumbar Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root 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.
Shakil Ur Rehman principal investigator
Riphah International 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 SMWLM combined Spinal traction with belt and SMWLM combined spinal traction without belt in people with Lumbar Radiculopathy, run by Riphah International University 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 2 inclusion and 3 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 4 Sep 2024. 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?
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?
Numeric pain rating scale (time frame: 4 weeks). The study lists 3 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 4 Sep 2024.