Lumbar RadiculopathyNCT06241027
Effects of Myofascial Release and Nerve Flossing Technique on Pain and Disability in Patients With Lumbar Radiculopathy
A study testing Nerve flossing technique and Myofascial release in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Radiculopathy is a clinical condition which involves one or more nerves resulting in impaired function. The site of injury in radiculopathy is at the level of the spinal nerve root. The result is pain known as radicular pain, weakness in limb, numbness, paresthesia and difficulty in controlling specific muscles. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Nerve flossing technique and Myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jul 2023to 12 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 45 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: The age of patients in between 20-45 years old, Patients with low back pain radiating to the lower leg from the last 2 month, patients with positive straight leg raise test.
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Exclusion Criteria: Patients with lumbar spinal fracture, patients having spinal tumor, patients with unhealed wound on the lumbosacral area, patients having peripheral vascular disease, patients who diagnosed with systemic disease such as diabetes mellitus and rheumatoid arthritis.
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Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ripha international university
Lahore, Punjab Province, 5433
Muhammad Aqeel, MSPT(NM), 03037862835, ilyassaqeel@gmail.com
Asrar Yousaf, 030040995505, asrar.yousaf@riphah.edu.pk
About this study
Radiculopathy is a clinical condition which involves one or more nerves resulting in impaired function. The site of injury in radiculopathy is at the level of the spinal nerve root. The result is pain known as radicular pain, weakness in limb, numbness, paresthesia and difficulty in controlling specific muscles. The objective of the study will be to see the effects of myofacsial release and nerve flossing technique on pain and disability in patients with lumbar radiculopathy.
Read the detailed description
This study will be randomized controlled trail. Participants having age in between 20-45 with low back pain radiating to the lower leg from last 2 months will be included in the study while the participants with lumbar spinal fracture, lumbar spinal tumor, peripheral vascular disease and systemic disease will be excluded from the study. Total 36 number of participants will be included in the study by non probability convenient sampling that will be randomly allocated into two groups by lottery method. Group A will receive nerve flossing technique and myofascial release along with conventional treatment while group B will receive nerve flossing technique along with conventional treatment. Nerve flossing technique will be given to patients 3 times per week for 15 minutes per session. Myofascial release technique will be given to the patients 3 times a week for 10 minutes with a total 4 weeks of treatment plan. All the participants will undergo a pre and post treatment test via numeric pain rating scale which will be used for rating pain, SLR, oswestry disability index which will be used for rating the level of disability. The importance of the study is to investigate the effects of these techniques in a controlled research setting will help determine their potential role in personalized treatment plans for patients with lumbar radiculopathy. The data will be analyzed via SPSS version 23.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Nerve flossing technique, Myofascial release
- Keywords
- Lumbar radiculopathy, Myofascial release, Nerve flossing
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve flossing techniqueOther
The nerve flossing technique will be perform actively with the participant sitting on the chair. The participant flexed the knee of the target lower extremity backward beside the chair as far back as possible and flexed the neck at the same time, holding both the flexed knee and neck in thisposition for 5 seconds. The participant in turn extended the neck and knee of the target lower extremity, abducted and flexed the hip until pain will feel and did not push beyond that point. This extended position will be hold for 5 seconds.
Myofascial releaseOther
Myofascial release therapy involved the application of a low load, long duration stretch along the line of maximal fascial restriction. Pressure will be applied directly on the skin toward the direction of restriction until resistance of the tissue barrier will felt, Once found , the collagenous barrier will engaged for 90-120 seconds without sliding over the skin or forcing the tissues until the fascia complex started to yield and a sensation of softening will achieved.This stage will be repeated up to 5 times for new barrier until the sensation of tissue restriction during stretching became weaker.
| Study group | Role | What they receive |
|---|---|---|
| Nerve flossing technique | Experimental | Nerve flossing technique will be repeated 3 times a week for 15 minutes per session include 2 sets of 10 repetitions for 4 weeks Receives: Other: Nerve flossing technique |
| Myofascial release | Experimental | Myofascial release technique will be given to the patients 3 times a week for 10 minutes with a total 4 weeks of treatment plan. Receives: Other: Myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
This scale rates the level of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
Measured: 4 weeks
Secondary outcomes (1)
Straight leg raise test
The Straight Leg Raise (SLR) test is to identify disc pathology or nerve root irritation, as it mechanically stresses lumbosacral nerve roots.
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 posted5 Feb 2024
- Study start17 Jul 2023
- Primary completion12 Feb 2024 (estimated)
- Study completion12 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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asrar Yousaf, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241027
- Sponsor's protocol ID
- REC/RCR & AHS/23/0234
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release and Nerve Flossing Technique on Pain and Disability in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT06241027
- Acronym / sponsor ID
- REC/RCR & AHS/23/0234
- Conditions
- Lumbar Radiculopathy
- Keywords
- Lumbar radiculopathy, Myofascial release, Nerve flossing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 12 Feb 2024 (estimated)
- Study completion
- 12 Feb 2024 (estimated)
- First posted
- 5 Feb 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.
Radiculopathy is a clinical condition which involves one or more nerves resulting in impaired function. The site of injury in radiculopathy is at the level of the spinal nerve root. The result is pain known as radicular pain, weakness in limb, numbness, paresthesia and difficulty in controlling specific muscles. The objective of the study will be to see the effects of myofacsial release and nerve flossing technique on pain and disability in patients with lumbar radiculopathy.
Detailed description
This study will be randomized controlled trail. Participants having age in between 20-45 with low back pain radiating to the lower leg from last 2 months will be included in the study while the participants with lumbar spinal fracture, lumbar spinal tumor, peripheral vascular disease and systemic disease will be excluded from the study. Total 36 number of participants will be included in the study by non probability convenient sampling that will be randomly allocated into two groups by lottery method. Group A will receive nerve flossing technique and myofascial release along with conventional treatment while group B will receive nerve flossing technique along with conventional treatment. Nerve flossing technique will be given to patients 3 times per week for 15 minutes per session. Myofascial release technique will be given to the patients 3 times a week for 10 minutes with a total 4 weeks of treatment plan. All the participants will undergo a pre and post treatment test via numeric pain rating scale which will be used for rating pain, SLR, oswestry disability index which will be used for rating the level of disability. The importance of the study is to investigate the effects of these techniques in a controlled research setting will help determine their potential role in personalized treatment plans for patients with lumbar radiculopathy. The data will be analyzed via SPSS version 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve flossing technique | Experimental | Other: Nerve flossing techniqueNerve flossing technique will be repeated 3 times a week for 15 minutes per session include 2 sets of 10 repetitions for 4 weeks |
| Myofascial release | Experimental | Other: Myofascial releaseMyofascial release technique will be given to the patients 3 times a week for 10 minutes with a total 4 weeks of treatment plan. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Nerve flossing techniqueThe nerve flossing technique will be perform actively with the participant sitting on the chair. The participant flexed the knee of the target lower extremity backward beside the chair as far back as possible and flexed the neck at the same time, holding both the flexed knee and neck in thisposition for 5 seconds. The participant in turn extended the neck and knee of the target lower extremity, abducted and flexed the hip until pain will feel and did not push beyond that point. This extended position will be hold for 5 seconds. | Other | Nerve flossing technique |
| Myofascial releaseMyofascial release therapy involved the application of a low load, long duration stretch along the line of maximal fascial restriction. Pressure will be applied directly on the skin toward the direction of restriction until resistance of the tissue barrier will felt, Once found , the collagenous barrier will engaged for 90-120 seconds without sliding over the skin or forcing the tissues until the fascia complex started to yield and a sensation of softening will achieved.This stage will be repeated up to 5 times for new barrier until the sensation of tissue restriction during stretching became weaker. | Other | Myofascial release |
Primary outcome
Numeric pain rating scale
Time frame: 4 weeks
This scale rates the level of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
1 secondary outcome
Straight leg raise test
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Lumbar Radiculopathy
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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.
Muhammad Asrar Yousaf, Phd 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 Nerve flossing technique and Myofascial release 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?
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 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Aqeel, MSPT(NM) (03037862835, ilyassaqeel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 4 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 5 Feb 2024.