- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458399
Effect of Sciatic Nerve Neurodynamic Sliding on Pain, Disability, and Balance in Patients With Lumbar Radiculopathy
Effect of Sciatic Nerve Neurodynamic Sliding Technique on Pain, Disability, and Balance in Patients With Lumbar Radiculopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Radicular pain in lumbar radiculopathy is a mixture of nociceptive and neuropathic component. Several conservative treatments are available to treat lumbar radiculopathy: moderate evidence (Level B) of effectiveness for the conservative treatment: patient education and self-management, McKenzie method, mobilization and manipulation, exercise therapy, traction (short-term outcomes), neural mobilization, and epidural injections. Two interventions were identified to have weak evidence of effectiveness (Level C): traction for long-term outcomes and dry needling. Three interventions were identified to have conflicting or no evidence (Level D) of effectiveness: electro-diagnostic-based management, laser and ultrasound, and electrotherapy. The efficacy of individual treatment is controversial; a multimodal approach is recommended because it is more effective. However, little high-quality evidence supports the use of conservative treatment.
As well as being amongst the manual therapy techniques recommended to improve patients' pain and disability, neural mobilization (NM) has also been advocated as an analgesic treatment option. NMs are techniques that involve a specific sequence of joint movements to mobilize the involved peripheral nerve in order to enhance nerve gliding and reduce the neural mechanosensitivity.
This study will provide further insight into the efficacy of sciatic nerve neurodynamic Slider technique in reducing pain, improving functional outcomes, and balance, offering a cost-effective management strategy for affected individuals.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdelrahman El-Sayed, Master
- Phone Number: 01091843750
- Email: Tahaabdelrahman07@gmail.com
Study Contact Backup
- Name: Hoda Zayed, PHD
- Phone Number: 01111052808
- Email: hoda.zayed@cu.edu.eg
Study Locations
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Suez, Egypt
- Abdelrahman Taha El-sayed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic unilateral lumbar painful radiculopathy (duration ranged from 3 to 18 months).
- During the evaluation session, repeated lumbar movements did not improve or worsen lower extremity symptoms.
- Positive straight leg raise (SLR) response. A positive SLR test was defined as the presence of both of these findings: (1) the test reproduced the patient's symptoms and (2) the symptoms decreased with the ankle plantar flexion component of the test.
- Unilateral Pain radiating below the knee, with leg pain equal to or more severe than the accompanying back pain.
- The presence of paresthesia such as pins and needles or numbness in the affected limb, along with neurological deficits-whether motor, sensory, or reflex-that corresponded to the dermatome or myotome of the affected nerve root.
Exclusion Criteria:
- Systemic diseases such as autoimmune and metabolic diseases.
- Previous Lumbar Spine surgery.
- Lumbar spine stenosis.
- Spinal deformity.
- Spinal fracture.
- Bilateral lower extremity symptoms.
- Steroid injection or use of anti-inflammatory medications within two to four weeks prior to study commencement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Selected conventional physical therapy program group
The participants will receive selected conventional physical therapy program, 3 sessions per week for six weeks.
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The program will include: 1- Transcutaneous electrical nerve stimulation (TENS) will be applied at Lumbosacral area, with pulse frequency of 100 Hz for 15 minutes. 2) Manual therapy intervention: Myofascial release will be performed on low back muscles and gluteus, piriformis, hamstring, and calf of the affected lower extremity applied for 20 minutes. Following side posture positional distraction, the wedge pillow will be removed and the patient is maintained in the same position. The physical therapist performed passive spinal rotation mobilization. Finally, high-velocity low-amplitude (HVLA) manipulation will be applied from the same position. 3) Core stability exercises: They are consisted of of side plank on knee or ankle on both sides, and clamshell exercise. The clamshell exercise consists of three sets of ten repetitions. Side plank will be performed three times in a static manner for 10-20 seconds or up to patient failure. |
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Experimental: Sciatic nerve slider mobilization group
The participants will receive sciatic nerve slider mobilization in addition to selected conventional physical therapy program, 3 sessions per week for six weeks.
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The program will include: 1- Transcutaneous electrical nerve stimulation (TENS) will be applied at Lumbosacral area, with pulse frequency of 100 Hz for 15 minutes. 2) Manual therapy intervention: Myofascial release will be performed on low back muscles and gluteus, piriformis, hamstring, and calf of the affected lower extremity applied for 20 minutes. Following side posture positional distraction, the wedge pillow will be removed and the patient is maintained in the same position. The physical therapist performed passive spinal rotation mobilization. Finally, high-velocity low-amplitude (HVLA) manipulation will be applied from the same position. 3) Core stability exercises: They are consisted of of side plank on knee or ankle on both sides, and clamshell exercise. The clamshell exercise consists of three sets of ten repetitions. Side plank will be performed three times in a static manner for 10-20 seconds or up to patient failure.
Mobilization will be applied from supine position, alternating hip flexion with knee extension and dorsiflexion, and knee flexion with plantar flexion, performed three times for 1 minute straight leg raising technique rhythmically
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain pressure threshold
Time Frame: 6 weeks
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It will be assessed by pressure pain algometer to measure this tenderness to palpation. An electronic digital algometer (Biotronik Care, Mars OneSKU: SF1005, India). Manual palpation with mild pressure will be utilized from supine to the common peroneal nerve, which passes behind the head of the fibula and runs around the neck of the fibula; from prone to the sciatic nerve at the midpoint of a line from the ischial tuberosity to the greater trochanter of the femur; and the tibial nerve, which bisects the popliteal fossa at the midpoint of the popliteal crease. Positive reporting consists of pain or discomfort on the symptomatic side, as well as greater pain or discomfort on the symptomatic side than on the asymptomatic side. Three measurements will be performed at each test site, with a 10-second pause between each. The average of the three measurements will be calculated. |
6 weeks
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Functional Disability
Time Frame: 6 weeks
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The Roland-Morris Disability Questionnaire will be used to assess functional disability.
It includes 24 items with face validity to describe patients with low back pain.
The Roland-Morris Disability Questionnaire has excellent psychometrics, is simple to administer, and has been found to be effective in therapy research studies.
Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.
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6 weeks
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Balance Evaluation
Time Frame: 6 weeks
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It will be assessed by the Berg Balance Scale (BBS) is an objective measure of static and dynamic balance abilities.
The scale consists of 14 functional tasks commonly performed in everyday life.
Scoring uses a five-point ordinal scale, with scores ranging from 0 to 4. Maximum score of 56 points is possible.
Lower scores indicate poor balance.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ebtesam Fahmy, Professor, Cairo university
- Study Chair: Rasha El-Rewainy, Professor, Cairo university
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006269
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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