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Efficacy of Combining Mulligan Spinal Mobilization With Leg Movement and Mechanical Lumbar Traction in Lumbar Radiculopathy

2026년 5월 1일 업데이트: Khyber Medical University Peshawar

Efficacy of Combining Mulligan's Spinal Mobilization With Leg Movement Technique and Mechanical Lumbar Traction Among Patients With Lumbar Radiculopathy: A Randomized Controlled Trial

Lumbar radiculopathy (LR), often caused by disc herniation, results in significant pain, disability, and reduced quality of life. Spinal Mobilization with Leg Movement (SMWLM) is a manual technique that has shown promise, while mechanical lumbar traction is used to reduce nerve compression, though its standalone effectiveness is debated. This randomized controlled trial aims to compare the combined effect of SMWLM plus mechanical lumbar traction against SMWLM alone, both administered with conventional physiotherapy. Outcomes will be assessed over 4 weeks to determine if the combined intervention offers superior pain relief, functional improvement, and range of motion in patients with unilateral L4-L5 or L5-S1 radiculopathy.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Lumbar radiculopathy, commonly arising from disc herniation and nerve root compression, causes disabling leg pain, functional limitations, and reduced quality of life. Manual techniques such as Spinal Mobilization with Leg Movement (SMWLM) have shown promise, while mechanical lumbar traction aims to decrease nerve compression, though its added benefit remains uncertain. This randomized controlled trial will evaluate whether the combination of SMWLM and mechanical lumbar traction, delivered alongside conventional physiotherapy, yields superior clinical outcomes compared to SMWLM and conventional therapy alone. The study will be conducted in Islamabad, Pakistan, enrolling 32 adults aged 20-50 years with unilateral L4-L5 or L5-S1 radiculopathy (confirmed by MRI, symptom duration 4 weeks-6 months, positive Straight Leg Raise below 70°, and pain <7 on the Numeric Pain Rating Scale). Participants will be randomly allocated to either the experimental group (SMWLM + intermittent mechanical lumbar traction at 50% body weight + conventional therapy) or the control group (SMWLM + conventional therapy alone).

The intervention will be applied over four weeks (three sessions weekly for the first two weeks, then two sessions weekly). SMWLM involves a sustained transverse glide to the spinous process of the superior vertebra while the patient actively performs pain-free leg movement. Mechanical traction will be applied intermittently (30-second hold, 10-second rest) for 15 minutes per session. Conventional therapy includes hot pack, TENS, and a standardized exercise program. Primary outcomes include pain intensity (Numeric Pain Rating Scale), hip range of motion during Straight Leg Raise (universal goniometer), and functional disability (Modified Oswestry Low Back Pain Questionnaire) will be measured at baseline, week 2, and week 4. Data will be analyzed using repeated-measures ANOVA and independent t-tests to assess between-group differences. This trial will provide evidence on whether combining mechanical traction with SMWLM enhances pain relief, mobility, and function in lumbar radiculopathy.

연구 유형

중재적

등록 (추정된)

32

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age 20-50 years
  • Male and female participants
  • Unilateral radiculopathy due to L4-L5 or L5-S1 disc bulge, confirmed by clinical examination and MRI
  • Symptom duration of 4 weeks to 6 months
  • Positive Straight Leg Raise (SLR) test on the affected leg (<70° of hip flexion)
  • Pain intensity <7 on the Numeric Pain Rating Scale (NPRS; mild to moderate pain)

Exclusion Criteria:

  • Cognitive impairment, dementia, central cord signs
  • Inflammatory or degenerative spine conditions
  • Spine surgery within the last 6 months
  • Pregnant women in the later half of 2nd trimester or 3rd trimester
  • Muscular involvement (e.g., Deep Gluteal syndrome, Piriformis syndrome)
  • Currently receiving medications or other contemporaneous treatment

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SMWLM + Mechanical Lumbar Traction + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy.
절차: Spinal Mobilization with Leg Movement (SMWLM)
The therapist positions the patient side-lying on the unaffected side with the affected leg slightly abducted. A sustained transverse manual glide is applied to the spinous process of the superior vertebra of the involved lumbar segment (e.g., L4 for an L4-L5 lesion). Simultaneously, the patient actively lifts the leg into hip flexion and knee extension, ensuring the movement remains pain-free. Dosage: 3 sets of 7-10 repetitions per treatment session.
다른 이름들:
  • Mulligan mobilization, SMWLM, spinal mobilization with limb movement
절차: Mechanical Lumbar Traction
Following SMWLM, the patient is placed supine in a Fowler position with hips and knees flexed to 90°, lower legs supported. An intermittent distractive force (up to 50% of body weight) is delivered using an automatic traction device (e.g., PH-T3021). The traction cycle consists of a 30-second hold and a 10-second rest, with a 1-minute ramp-up and ramp-down, for a total of 15 minutes.
다른 이름들:
  • Intermittent lumbar traction, automatic traction therapy
절차: Conventional Physical Therapy

All participants receive a standardized conventional therapy program consisting of:

  • Moist hot pack on the lumbar region for 10 minutes.
  • Transcutaneous electrical nerve stimulation (TENS) with 50-100 ms pulse width for 10 minutes, electrodes placed over the lumbar spine and affected lower limb.
  • Supervised therapeutic exercises: heel sitting (lumbar flexion), drawing-in maneuver, bridging, and pelvic tilting (2 sets of 5-7 repetitions per session).
  • Home exercise program: same exercises performed daily, 3 sets of 10 repetitions, with progression as tolerated.
다른 이름들:
  • Standard physiotherapy, hot pack and TENS, therapeutic exercise
활성 비교기: SMWLM + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction.
절차: Spinal Mobilization with Leg Movement (SMWLM)
The therapist positions the patient side-lying on the unaffected side with the affected leg slightly abducted. A sustained transverse manual glide is applied to the spinous process of the superior vertebra of the involved lumbar segment (e.g., L4 for an L4-L5 lesion). Simultaneously, the patient actively lifts the leg into hip flexion and knee extension, ensuring the movement remains pain-free. Dosage: 3 sets of 7-10 repetitions per treatment session.
다른 이름들:
  • Mulligan mobilization, SMWLM, spinal mobilization with limb movement
절차: Conventional Physical Therapy

All participants receive a standardized conventional therapy program consisting of:

  • Moist hot pack on the lumbar region for 10 minutes.
  • Transcutaneous electrical nerve stimulation (TENS) with 50-100 ms pulse width for 10 minutes, electrodes placed over the lumbar spine and affected lower limb.
  • Supervised therapeutic exercises: heel sitting (lumbar flexion), drawing-in maneuver, bridging, and pelvic tilting (2 sets of 5-7 repetitions per session).
  • Home exercise program: same exercises performed daily, 3 sets of 10 repetitions, with progression as tolerated.
다른 이름들:
  • Standard physiotherapy, hot pack and TENS, therapeutic exercise

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain Intensity
기간: Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
The average pain intensity (Numerical Pain Rating Scale) over the previous 24 hours is rated on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). The patient is asked to provide current, best, and worst pain ratings; the mean of the three ratings will be used.
Baseline, Week 2 (mid-intervention), Week 4 (post-intervention)
Functional Disability
기간: Baseline, Week 2, Week 4
Modified Oswestry Low Back Pain Questionnaire (MOLBPQ) is a validated 10-item questionnaire measuring how much low back pain has affected daily activities (e.g., walking, sitting, lifting, sleeping). Each item scores 0-5; total sum is expressed as a percentage (0-50). Higher scores indicate greater disability.
Baseline, Week 2, Week 4
Hip Range of Motion
기간: Baseline, Week 2, Week 4
Straight Leg Raise (SLR) Test is a pain-free hip flexion angle (in degrees) measured with a universal goniometer during the passive straight leg raise test. The examiner stops the movement at the point where the patient first reports concordant radicular pain or tightness. Standardized goniometer placement relative to the femur ensures consistency.
Baseline, Week 2, Week 4

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Khyber Medical University Peshawar

협력자

KMU-Institute of Health Sciences, Islamabad

수사관

  • 수석 연구원: Muhammad Haris, DPT, Institute of Health Science, Khyber Medical University Islamabad
  • 수석 연구원: Dr Muhammad Mustafa, MSPT, Institute of Health Science, Khyber Medical University Islamabad
  • 수석 연구원: Kinza Afzal, DPT, Hamdard University Islamabad Campus

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 1일

기본 완료 (추정된)

2026년 10월 15일

연구 완료 (추정된)

2026년 11월 15일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 1일

처음 게시됨 (실제)

2026년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 1일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KMU/DIR/CTU/2026/03

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data (IPD) that underlie the results reported in published articles will be shared. This includes the demographic data, baseline characteristics, and all primary outcome measures (NPRS pain scores, Straight Leg Raise goniometry angles, and Modified Oswestry Disability scores) at the three assessment time points. The shared data will be accompanied by a data dictionary explaining all variable names and values.

IPD 공유 기간

Data will become available beginning 6 months after publication of the primary results and will remain available for 2 years.

IPD 공유 액세스 기준

Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator, Dr. Muhammad Haris, at drm.harispt@gmail.com. To gain access, data requestors must sign a data access agreement that includes commitments to use the data only for the specified research purpose, to maintain appropriate data security, and not to attempt to re-identify participants. A review of the proposal by the study team is required prior to approval.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

요추 신경근병증에 대한 임상 시험

Spinal Mobilization with Leg Movement (SMWLM)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Netherlands

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다