Lumbar RadiculopathyNCT05955781
Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy
A study testing Spinal Mobilization With Leg Movement, Spinal Mobilization and Conventional treatment in people with Lumbar Radiculopathy, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group A will be recieving spinal mobilzation with leg movement along with TENS \& hot pack.whie group B will be given only spinal… 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?
- Spinal Mobilization With Leg Movement, Spinal Mobilization and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 10 Feb 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
- Patients diagnosed with lumbar Radiculopathy with unilateral radiating leg pain.
- Both Genders with Age between 20 to 50 Years.
- Patient willing to participate and complete their follow-ups.
- Pain from (0-35 degrees) in Straight Leg Raise(Dural Pain).
- Positive neurodynamic test i.e. SLR test(35-70 degrees),which indicate sciatica)
- Pain more 3-5 or More on NPRS.
Who cannot join
- Spinal stenosis.
- Cauda equina syndrome.
- Patients having Somatic referred pain.
- Specific diseases of spine like ankylosing spondylitis, ,vertebral collapse, Rheumatoid arthritis, and Spondylolisthesis.
- Tb spine, intermittent claudication,diabetic neuropathy.
- Recent infection.
Show all 9Show fewer
- Mental retardation.
- Previous spinal Surgery.
- Pelvis Fracture.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group A will be recieving spinal mobilzation with leg movement along with TENS \& hot pack.whie group B will be given only spinal mobilization with TENS \& hot pack.before and after the introduction of interventions pain,disabaility,speed of gait,cadence and SLR will be checked before and after the treatment
Read the detailed description
Lumbar Radiculopathy is a medical condition that occurs when one or more nerve roots in the spinal cord are compressed or damaged, leading to pain, weakness, numbness or tingling sensations in the affected area of the body. This condition can be caused by herniated discs, spinal stenosis, Degenerative disc disease, tumors and infections.This study will be a Randomized Control Trial.The study will be conducted in district Swabi. We will recruit the data from NCS University Rehabilitation Centre Swabi.oswestry disbaility index will be given at the start of study and NPRS to check their pain and disbaility levels.SMWLM will be given to experimental group.Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.The patient receives a set of three repetitions, then three sets of six repetitions, with a 30-second break in between each set of treatments. In this session, a progression was also provided as free SLR overpressure. A total of 6 sessions will be given thrice a week on alternate days for 2 consecutive weeks. The treatment will be given with 5 repetitions of SMWLM and 10 repetitions of spinal mobilization with three sets of transverse glide. Total time duration of the treatment will be around 25-35 minutes§ Pre assessment will be conducted at baseline followed by intervention for 3 days per week for 6 consecutive weeks.Final assessment will be conducted at the end of 6 weeks of intervention
- Conditions
- Lumbar Radiculopathy
- Being tested
- Spinal Mobilization With Leg Movement, Spinal Mobilization, Conventional treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mobilization With Leg MovementProcedure or surgery
spinal mobilization with leg movement is the intervention given to experimental group. This technique involves applying pressure to the relevant spinous process while the patient moves their limb through the previously restricted range of motion. It is assumed that the restriction of movement is due to a spinal issue but it does not always indicate nerve damage as spinal movement is necessary for limb movement beyond a certain point. The goal is to address any spinal mechanical limitations and there may also be potential effects on the nerves.
Spinal MobilizationProcedure or surgery
The patients will be given Spinal mobilization transverse glide(kaltenborn glide) on the effected spinous process. The total time duration will be 25-30 minutes.
Conventional treatmentProcedure or surgery
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Spinal Mobilization with Leg Movement (SMWLM) will be given as intervention to experimental group. Participants will be given Hot pack for 15 minutes, TENS for 10 minutes. Receives: Procedure: Spinal Mobilization With Leg Movement; Procedure: Conventional treatment |
| Group B | Active comparator | The patients will be given Spinal mobilization (transverse glide) on the effected spinous process. The total time duration will be 25-30 minutes. Participants will be given Hot pack for 15 minutes, TENS for 10 minutes. Receives: Procedure: Spinal Mobilization; Procedure: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain
Measured: 2 weeks
Secondary outcomes (3)
Straight leg raise
Goniometer is a manual scale use for measuring the range of motion of a joint. In this scale degree varies from 0-360 angle
Measured: 2 weeks
Lumbar Disability
Lumbar disability will be measured using Oswestry Disability Index which is a valid and reliable tool consisting of 10 items from which patient gets to choose according to their level of function
Measured: 2 weeks
Cadence
10 METER WALK TEST: Initial 2 meters of the gait and final 2 meters of the gait will be for acceleration and deceleration. And the patient is then asking to walk and will assess the cadence and speed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start15 Feb 2023
- Primary completion20 Sep 2023 (estimated)
- Study completion10 Feb 2024 (estimated)
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 Foundation University IslamabadThe 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
- Model description
- Prallel Group Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955781
- Sponsor's protocol ID
- FUI/CTR/2023/13
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Spinal Mobilization With Leg Movement on Pain And Disability in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT05955781
- Acronym / sponsor ID
- FUI/CTR/2023/13
- Conditions
- Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 21 Jul 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.
This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group A will be recieving spinal mobilzation with leg movement along with TENS \& hot pack.whie group B will be given only spinal mobilization with TENS \& hot pack.before and after the introduction of interventions pain,disabaility,speed of gait,cadence and SLR will be checked before and after the treatment
Detailed description
Lumbar Radiculopathy is a medical condition that occurs when one or more nerve roots in the spinal cord are compressed or damaged, leading to pain, weakness, numbness or tingling sensations in the affected area of the body. This condition can be caused by herniated discs, spinal stenosis, Degenerative disc disease, tumors and infections.This study will be a Randomized Control Trial.The study will be conducted in district Swabi. We will recruit the data from NCS University Rehabilitation Centre Swabi.oswestry disbaility index will be given at the start of study and NPRS to check their pain and disbaility levels.SMWLM will be given to experimental group.Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.The patient receives a set of three repetitions, then three sets of six repetitions, with a 30-second break in between each set of treatments. In this session, a progression was also provided as free SLR overpressure. A total of 6 sessions will be given thrice a week on alternate days for 2 consecutive weeks. The treatment will be given with 5 repetitions of SMWLM and 10 repetitions of spinal mobilization with three sets of transverse glide. Total time duration of the treatment will be around 25-35 minutes§ Pre assessment will be conducted at baseline followed by intervention for 3 days per week for 6 consecutive weeks.Final assessment will be conducted at the end of 6 weeks of intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prallel Group Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Spinal Mobilization With Leg Movement, Procedure: Conventional treatmentSpinal Mobilization with Leg Movement (SMWLM) will be given as intervention to experimental group. Participants will be given Hot pack for 15 minutes, TENS for 10 minutes. |
| Group B | Active comparator | Procedure: Spinal Mobilization, Procedure: Conventional treatmentThe patients will be given Spinal mobilization (transverse glide) on the effected spinous process. The total time duration will be 25-30 minutes. Participants will be given Hot pack for 15 minutes, TENS for 10 minutes. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed with lumbar Radiculopathy with unilateral radiating leg pain.
- Both Genders with Age between 20 to 50 Years.
- Patient willing to participate and complete their follow-ups.
- Pain from (0-35 degrees) in Straight Leg Raise(Dural Pain).
- Positive neurodynamic test i.e. SLR test(35-70 degrees),which indicate sciatica)
Key exclusion criteria (9 listed)
- Spinal stenosis.
- Cauda equina syndrome.
- Patients having Somatic referred pain.
- Specific diseases of spine like ankylosing spondylitis, ,vertebral collapse, Rheumatoid arthritis, and Spondylolisthesis.
- Tb spine, intermittent claudication,diabetic neuropathy.
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 |
|---|---|---|
| Spinal Mobilization With Leg Movementspinal mobilization with leg movement is the intervention given to experimental group. This technique involves applying pressure to the relevant spinous process while the patient moves their limb through the previously restricted range of motion. It is assumed that the restriction of movement is due to a spinal issue but it does not always indicate nerve damage as spinal movement is necessary for limb movement beyond a certain point. The goal is to address any spinal mechanical limitations and there may also be potential effects on the nerves. | Procedure or surgery | Group A |
| Spinal MobilizationThe patients will be given Spinal mobilization transverse glide(kaltenborn glide) on the effected spinous process. The total time duration will be 25-30 minutes. | Procedure or surgery | Group B |
| Conventional treatmentParticipants will be given Hot pack for 15 minutes, TENS for 10 minutes | Procedure or surgery | Group A, Group B |
Primary outcome
pain severity
Time frame: 2 weeks
Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain
3 secondary outcomes
Straight leg raise
Time frame: 2 weeks
Lumbar Disability
Time frame: 2 weeks
Cadence
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Mobilization With Leg Movement, Spinal Mobilization and Conventional treatment in people with Lumbar Radiculopathy, run by Foundation University Islamabad 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 9 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 21 Jul 2023. 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?
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?
pain severity (time frame: 2 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 21 Jul 2023.