- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907356
Effect of Sciatic Nerve Slider Technique in Different Positions in Low Back Pain Patients
Comparison of Sciatic Nerve Slider Technique in Different Positions in Patients With Low Back Pain Associated With Sciatica: Randomized Control Trial
Study Overview
Status
Conditions
Detailed Description
Low back pain (LBP) is one of the most common musculoskeletal disorders, accounting for a significant portion of disability. It's a severe healthcare burden that has large societal costs, according to estimates, LBP can affect anywhere between 22% and 65% of people within a year. Additionally, back pain-related absences from work result in prolonged periods of sick leave, which has an adverse effect on workplace productivity.
Sciatica is the name given to a collection of symptoms caused by compression and irritation of the sciatic nerve, including pain, numbness, muscular weakness, and difficulty moving or controlling the legs. The lower back, buttocks, and multiple dermatomes of the leg and foot are typically where symptoms appear. Sciatica can be caused by a disc bulge or herniation, lumbar canal stenosis, spondylolisthesis, trauma, piriformis syndrome, or spinal tumors. It affects women more than men and people who lead sedentary lifestyles more than active ones. It might arise quickly or gradually with physical activity, and it is usually unilateral.
The slider and tensioner are two distinct types of neural mobilization procedures. There are clinical improvements and positive therapeutic benefits after treatment with different neural mobilization techniques, but the slider technique is safer, involves less stretching and strain of the nerves, and has a more significant effect than the tensioner technique.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Bank
-
Hebron, West Bank, Palestinian Territory, occupied
- Princess Alia Governmental Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age range between 40 - 65 years,
- Both genders,
- Diagnosed by magnetic resonance imaging to confirm disc lesion,
- LBP with radicular pain for more than 12 weeks up to 1 year with no acute episodes in the last 4 weeks, and a numeric pain rating score (NPRS) greater than 4/10.
- Positive SLR test with reproduction of neurological symptoms.
Exclusion Criteria:
- Sciatica due to other pathologies (e.g. lumbar canal stenosis or piriformis syndrome),
- Having any physiotherapy before 6 months.
- History of spinal surgery
- Vertebral fracture or trauma,
- Negative SLR test,
- pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
Conventional physiotherapy alone
|
The patient will receive conventional physiotherapy, which includes: a moist hot pack, TENS, and back strengthening exercises (as a home program).
|
|
Experimental: Study Group One
sciatic nerve slider technique in a slump lying position in combination with Conventional physiotherapy
|
The patient will receive conventional physiotherapy, which includes: a moist hot pack, TENS, and back strengthening exercises (as a home program).
The patient will be sitting at the edge of the couch with the posterior aspect of the knee at the edge, the thighs parallel to each other, and flexion at the thoracic and lumbar spines (slouch position).
The therapist will be standing at the bedside of the patient with a proximal arm over the patient's shoulder and one hand guiding the neck movements of the patient and the other hand guiding the knee movements, passively performing cervical neck flexion with knee flexion (stretching the nerve proximally and relaxing at the distal end) and then moving into cervical extension with knee extension.
Provide five sets in every session: the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions; and the fifth: 30 repetitions.
The end position is held for 5 seconds, and the rest between sets is 1-2 minutes
|
|
Experimental: Study Group Two
sciatic nerve slider technique in a supine position in combination with Conventional physiotherapy
|
The patient will receive conventional physiotherapy, which includes: a moist hot pack, TENS, and back strengthening exercises (as a home program).
.The patient will be in a supine position.
The therapist will hold the patient's limb passively and then move the hip into flexion with the ankle in plantar flexion and the knee in extension, stretching the nerve at the hip and relaxing at the ankle, Then reversing the movement with the hip into extension, maintaining the knee in extension and the ankle in dorsiflexion, relaxing the nerve at the hip and stretching at the ankle.
Provide five sets in every session; the first: 10 repetitions, the second: 15 repetitions, the third: 20 repetitions, the fourth: 25 repetitions, and the fifth: 30 repetitions.
The end position is held for 5 seconds, and the rest between sets is 1-2 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4 weeks
|
A numeric pain rating scale (NPRS) will be used to evaluate pain intensity.
The scale has a length of 10 cm and a range of 0-10, Here, a score of zero (zero) denotes the absence of pain, a score of one to three (1-3) denotes mild pain, a score of three to five (moderate pain), and a score of six to ten (severe pain)
|
4 weeks
|
|
Oswestry Disability Index (ODI)
Time Frame: 4 weeks
|
The disability caused by low back pain will be measured via the Arabic version of the Oswestry Disability Index.
The patient will fill out the questionnaire in about 5 minutes, and then the therapist will score it in about 1 minute.
The patient marks the most relevant answer for each question as accurately as they can.
The scoring system employs a numerical scale from 0 to 5, with the first possible answer being 0 and the last possible answer being 5.
The maximum possible score for each section is 5.
All the scores will be added together and divided by the total number of possible points to calculate the total score
|
4 weeks
|
|
Modified Schober test
Time Frame: 4 weeks
|
Lumbar flexion flexibility will be measured by the modified Schober test.
The patient will be standing, and the examiner will mark the L5 spinous process by drawing a horizontal line across the patient's back.
A second line is marked 10 cm above the first line.
The patient is then instructed to flex forward as if attempting to touch his/her toes, and the examiner remeasures the distance between two lines with the patient fully flexed.
The difference between the measurements in the erect and flexion positions indicates the outcome of the lumbar flexion.
|
4 weeks
|
|
Hand-held dynamometry
Time Frame: 4 weeks
|
The hand-held dynamometer has good to excellent reliability and validity for most measures of muscle strength, it portable device that is an appropriate and convenient method to assess lower limb muscle strength.
to Assessment of isometric muscle strength and power will be performed with the participants in three positions (seated, supine, and prone); hip flexors, knee extensors, and knee flexors were assessed in a seated position; ankle plantar flexors, ankle dorsiflexors, hip abductors, and hip adductors in a supine position; hip extensors in a prone position
|
4 weeks
|
|
Flexible ruler
Time Frame: 4 weeks
|
The lumbar lordosis will be measured by a flexible ruler.
It is commonly used to measure the degree of spinal curvature of the lumbar lordosis in the sagittal plane.
It is a safe, easy-to-use, and inexpensive tool.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beliz Belgen Kaygisiz, PT, PhD, European University of Lefke
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- BAYEK022.06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Ache Laboratorios Farmaceuticos S.A.Unknown
Clinical Trials on Conventional physiotherapy
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaCompleted
-
Pamukkale UniversityCompletedChronic Low-back PainTurkey
-
Kirsehir Ahi Evran UniversitesiEnrolling by invitation
-
University of LahoreRecruitingHypotonic Cerebral PalsyPakistan
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus
-
Biruni UniversityCompletedPain | Physical Therapy | Nonspecific Chronic Low Back Pain | Manuel TherapyTurkey (Türkiye)
-
International Hellenic UniversityRecruiting
-
Kutahya Health Sciences UniversityRecruitingAnterior Cruciate Ligament InjuriesTurkey
-
Bezmialem Vakif UniversityCompleted