Two-leg Rotation and Sciatica

NCT07444125 | Recruiting

• 1 other identifier: H-2026-039
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

this study including the application of a specific technique of Mulligan mobilization calles 2 leg rotation on patients having lumbar discogenic lesion with sciatica. this technique is designed to address sciatic pain and proposed to reduce sciatica by opening the intervertebral foramnia. However, there is no systematic evedince supporting its clinical effect

Conditions

Sciatica Due to Intervertebral Disc Disorder

Keywords

Sciatica; lumbar disc lesion; Mulligan concept; function; physiotherapy

Outcome Measures

Primary Outcomes (4)

• Pain by the numeric pain rating scale

  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

  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: * Symptoms occur below the gluteal region. Symptoms are familiar to the participant (match their usual pain or discomfort), * Symptoms are elicited during limb elevation (e.g., straight-leg raise). * Symptoms are re-elicited by adding ankle dorsiflexi

  at baseline and after the end of the intervention (after 4 weeks of intervention)

• Function by the Oswestry disability index.

  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

  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).

  at baseline and after the end of the intervention (after 4 weeks of intervention)

Study Arms (2)

standard physical therapy

ACTIVE COMPARATOR

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

Other: standard physical therapy

2 leg rotation

EXPERIMENTAL

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.

Other: standard physical therapy; Other: 2 leg rotation

Interventions

standard physical therapy OTHER

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.

2 leg rotation; standard physical therapy

2 leg rotation OTHER

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).

2 leg rotation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders.
• Age between 18 and 50
• Have lumbar discogenic lesions.
• Having sciatica symptoms extending down to the knee.

You may not qualify if:

• Surgical operation in the lumbar spine
• Severe discogenic lesions with bladder or fecal incontinence or progressive muscular weakness.
• Piriform syndrome.

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

University of Hail

Ha'il, Ha'il Region, 3994, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hisham M Mohamed, PhD

  University of Hail, College of Applied Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham Mohamed Hussein, PhD

CONTACT

+966543704108; hm.hussein@uoh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The allocation process in this study will be conducted randomly and managed by a colleague who is not involved in the study. The assessor and the patients will be blinded throughout the study, while the therapist will be allowed to unmask the allocation process to provide the appropriate treatment. Blindness will be conducted by assigning participants coded numbers, which will be used to identify them throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: double-blind 2 groups pretest-post test randomized controlled trial

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: March 15, 2026
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: it will be avaliable between May 2026 to May 2027

Locations

SA (1)