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

1. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Pakistan
    • Capital
      • Islamabad, Capital, Pakistan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SMWLM + Mechanical Lumbar Traction + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM), mechanical lumbar traction, and conventional physiotherapy.
Fremgangsmåte: 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.
Andre navn:
  • Mulligan mobilization, SMWLM, spinal mobilization with limb movement
Fremgangsmåte: 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.
Andre navn:
  • Intermittent lumbar traction, automatic traction therapy
Fremgangsmåte: 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.
Andre navn:
  • Standard physiotherapy, hot pack and TENS, therapeutic exercise
Aktiv komparator: SMWLM + Conventional Therapy
Participants receive Spinal Mobilization with Leg Movement (SMWLM) and conventional physiotherapy without mechanical traction.
Fremgangsmåte: 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.
Andre navn:
  • Mulligan mobilization, SMWLM, spinal mobilization with limb movement
Fremgangsmåte: 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.
Andre navn:
  • Standard physiotherapy, hot pack and TENS, therapeutic exercise

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Intensity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Khyber Medical University Peshawar

Samarbeidspartnere

KMU-Institute of Health Sciences, Islamabad

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2026

Primær fullføring (Antatt)

15. oktober 2026

Studiet fullført (Antatt)

15. november 2026

Datoer for studieregistrering

Først innsendt

1. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KMU/DIR/CTU/2026/03

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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