- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444125
Two-leg Rotation and Sciatica ((MWM))
Effect of Adding Two Leg-rotation to Standard Physical Therapy in the Treatment of Sciatica Secondary to Lumbar Discogenic Lesions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Among the different causes of low back pain (LBP) is a lesion in the lumbar discs. Narrowing of the disc space and intervertebral foramina, deterioration of disc quality, and protrusion outside its anatomical perimeters can lead to pressure on the surrounding structures and cause radicular pain (Ostelo, 2020). Radicular pain that follows the course of the sciatic nerve or part of it is referred to as sciatica.
Sciatica can be so bothersome secondary to the pain experienced that it can also lead to sensory deficits, tightness in the hamstrings, and limit the person's ability to stand and walk normally, thereby reducing functional ability (Fairag et al., 2022). Emotional disturbances-such as anxiety about moving and depression of varying severity-often occur, especially in people who avoid activities that worsen their pain (Oosterhuis et al., 2019).
Sciatica can be evaluated through several methods. Pain severity is often quantified using instruments such as the visual analog scale (VAS), the numeric pain rating scale (NPRS), and the McGill Pain Questionnaire (Ramasamy et al., 2017). Sciatic nerve mobility is commonly assessed by the straight leg raise (SLR) test, which measures the hip flexion angle (H. M. Hussein et al., 2024). Meanwhile, functional questionnaires determine how sciatic pain affects everyday activities (Machado et al., 2016).
Several therapeutic options are available for treating sciatica and its associated symptoms, including surgical treatment (Machado et al., 2016), medications, physical therapy (Ostelo, 2020), and manual therapies (Kuligowski et al., 2021). Recent studies have highlighted the efficacy of manual therapy in the rehabilitation of subjects with sciatica (Clar et al., 2014). One such manual therapy is the Mulligan Concept, a relatively recent approach developed by pioneer manual therapist Brian Mulligan. Specific Mulligan techniques, such as two-leg rotation, have been described for treating sciatic pain (W Hing et al., 2020).
It has been proposed that the two-leg rotation can enhance vertebral rotation and open the intervertebral foramina, thereby assisting in relieving compressions on the nerve roots caused by prolapsed discs (Pourahmadi et al., 2018).
While the founder of the technique and his fellow students proposed theoretical effects of the two-leg rotation technique, the literature contains almost no research supporting its clinical usefulness. A recent meta-analysis investigated the commonly used Mulligan techniques in the treatment of sciatica and did not include any randomized trials on the two-leg rotation technique. High-quality research studies are needed to establish the clinical effectiveness of two-leg rotation techniques. These studies can help clinical practitioners and manual therapists to determine the appropriate use and expected results of applying the two-leg rotation technique (H. Hussein et al., 2025).
This study aims to investigate the effect of adding a two-leg rotation technique to standard physical therapy on pain, flexibility, function, and sciatica-related bother in patients with discogenic low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hisham Mohamed Hussein, PhD
- Phone Number: +966543704108
- Email: hm.hussein@uoh.edu.sa
Study Locations
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Ha'il Region
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Ha'il, Ha'il Region, Saudi Arabia, 3994
- Recruiting
- University of Hail
-
Contact:
- Hisham Hussein, PhD
- Phone Number: 0543704108
- Email: hm.hussein@uoh.edu.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Both genders.
- Age between 18 and 50
- Have lumbar discogenic lesions.
- Having sciatica symptoms extending down to the knee.
Exclusion Criteria:
- Surgical operation in the lumbar spine
- Severe discogenic lesions with bladder or fecal incontinence or progressive muscular weakness.
- Piriform syndrome.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: standard physical therapy
this group of participants will recieve standard physical therapy care consisted of trans cutanous electrical nerve stimulation + ultrasound+ superficial heat and therapeutic exercises including pelvic tilting exercises
|
Modalities (TENS, US, and superficial heat) All participants received conventional TENS (Chattanooga, Intellect Advanced, USA) with the following parameters: frequency, 100 Hz; pulse duration, 60 ms; amplitude-modulated frequency, 10%; and intensity adjusted to a comfortable tingling sensation. Two electrodes (single channel) were used: the first was placed over the ipsilateral lumbar region, and the second over the popliteal fossa. The duration of the TENS was 20 minutes (Ozen et al., 2023). A ten-minute continuous Ultrasound (US) model (Chattanooga, Intellect Advanced, USA) was applied over the nerve roots. The 5 cm² US head was used, with a frequency of 1 MHz and an intensity of 1.5 W/cm² (Ozen et al., 2023). Exercises in the form of pelvic rocking From the supine position, the participant was asked to bend their hips and knees partially, then arch their lumbar spine, and finally press the bed with their low back. This exercise was performed 10 times per session. |
|
Experimental: 2 leg rotation
this group of participants will recieve the same intervention introduced to the standard physical therapy arm in addition to the 2 leg rotation technique of manual concept.
|
Modalities (TENS, US, and superficial heat) All participants received conventional TENS (Chattanooga, Intellect Advanced, USA) with the following parameters: frequency, 100 Hz; pulse duration, 60 ms; amplitude-modulated frequency, 10%; and intensity adjusted to a comfortable tingling sensation. Two electrodes (single channel) were used: the first was placed over the ipsilateral lumbar region, and the second over the popliteal fossa. The duration of the TENS was 20 minutes (Ozen et al., 2023). A ten-minute continuous Ultrasound (US) model (Chattanooga, Intellect Advanced, USA) was applied over the nerve roots. The 5 cm² US head was used, with a frequency of 1 MHz and an intensity of 1.5 W/cm² (Ozen et al., 2023). Exercises in the form of pelvic rocking From the supine position, the participant was asked to bend their hips and knees partially, then arch their lumbar spine, and finally press the bed with their low back. This exercise was performed 10 times per session.
The patient lies in a crook lying.
Both hips are flexed to beyond 90° with knees bent.
The therapist supports the pelvis/legs.
The knees are brought to the side, limiting the SLR, while rotating the pelvis and trunk as far as possible without pain.
The therapist was allowed to change the hip / lumbar position (flexion/extension) if pain is provoked.
Sustain for 20 seconds and return to the start position painlessly.
Reassess SLR in supine (Wayne Hing et al., 2020).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain by the numeric pain rating scale
Time Frame: at baseline and after the end of intervention (after 4 weeks of intervention)
|
The Numeric Pain Rating Scale (NPRS) is a unidimensional 0-to-10 measure, where 0 denotes "no pain" and 10 signifies "worst imaginable pain."
Participants indicated their current pain intensity by choosing the number that best reflected their experience (H.
Hussein, Atteya, et al., 2024).
Previous investigations have confirmed the NPRS's strong psychometric properties, reporting validity and reliability coefficients of 0.941 and 0.95, respectively (Alghadir et al., 2018).
|
at baseline and after the end of intervention (after 4 weeks of intervention)
|
|
Flexibility measured by the passive straight leg raise test
Time Frame: at baseline and after the end of the intervention (after 4 weeks of intervention)
|
The passive straight leg raise (SLR) test was performed with the participant supine. The assessor passively elevated the symptomatic lower limb in the sagittal plane until the participant experienced their typical symptoms or hamstring tightness limited further motion. Upon symptom onset, the assessor documented the type, severity, location, and whether the symptoms matched the participant's usual pain. Then, the assessor lowered the limb slightly until the symptoms subsided. Next, passive ankle dorsiflexion and active neck flexion were applied to determine if symptoms could be reproduced. The interpretation is deemed positive when all of the following criteria are satisfied:
|
at baseline and after the end of the intervention (after 4 weeks of intervention)
|
|
Function by the Oswestry disability index.
Time Frame: at baseline and after the end of the intervention (after 4 weeks of intervention)
|
A validated Arabic version of the Oswestry Disability Index (ODI) was used to assess function. This scale consisted of ten sections, each describing a different domain of function. Each one of these sections contains six phrases, which are scored from 0 to 5. The maximum score is 100, which indicates the worst functional ability, while lower scores indicate better function. Each participant was instructed to choose the most appropriate statement from each section of the ODI. The values of all statements chosen by the participants were added, and the total score was then used for analysis (Hussien et al., 2017). |
at baseline and after the end of the intervention (after 4 weeks of intervention)
|
|
Sciatica bothersomeness and frequency by Sciatica bothersomeness and frequency scale
Time Frame: at baseline and after the end of the intervention (after 4 weeks of intervention)
|
The Sciatica Frequency Index asks patients to indicate how often they experience each of the symptoms covered by the Sciatica Bothersomeness Index (SBI).
In fact, the concept of "bothersomeness" has become a common way to quantify symptoms in sciatica and low back pain.
For this reason, we selected the SBI as the best tool for capturing patients' own perceptions of their sciatica symptoms in the current study.
The Sciatica Bothersomeness Index employs a uniform format to assess four key complaints: leg pain, numbness or tingling in the leg, foot, or groin, weakness in the leg or foot, and back or leg pain when sitting.
Patients rated the severity of each symptom, and the ratings were summed to produce a total SBI score.
The index has been featured in multiple investigations, and three of its items have been incorporated into the North American Spine Society's outcome instrument (Grøvle et al., 2010).
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at baseline and after the end of the intervention (after 4 weeks of intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hisham M Mohamed, PhD, University of Hail, College of Applied Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
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
- H-2026-039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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