- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07726823
Comparative Effects of Mulligan Bent Leg Raise Versus Spinal Mobilization With Leg Movement in Lumbar Radiculopathy
21. juli 2026 oppdatert av: Riphah International University
Comparative Effects of Mulligan Bent Leg Raise Versus Spinal Mobilization With Leg Movement on Pain, Neural Mobility, Balance and Functional Disability in Lumbar Radiculopathy
Lumbar radiculopathy is a spinal nerve root disorder often caused by lumbar disc herniation or compression, leading to radiating leg pain, restricted movement, and functional difficulties.
This condition significantly disrupts daily activities and overall quality of life.
While medication and exercise are common treatments, manual therapy techniques are gaining recognition for their non-invasive and effective outcomes in relieving symptoms and improving patient function.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This randomized clinical trial will be conducted in Physiotherapy outpatient department of Jinnah Hospital Lahore.
It will include 52 participants, aged 20 to 40 years, meeting clinical criteria for lumbar radiculopathy.
Participants will be selected from an outpatient physiotherapy department and assigned randomly into two equal groups.
Group A will receive the MBLR technique, while Group B will undergo the SMWLM technique.
Both interventions will be applied three times a week for four weeks under standardized protocols.
Key outcome measures include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), neural mobility evaluated through the Straight Leg Raise (SLR) and Slump Test, and functional status measured using the Oswestry Disability Index (ODI), Timed Up and Go (TUG) test, and 5 Repetition Sit-to-Stand test for postural balance.
Assessments will be conducted at baseline, after 2 weeks, at 4 weeks post-intervention, and at 8-week follow-up.
Data analysis will be done by SPSS version 25.
To ensure objectivity, all assessments will be conducted while keeping the patient unaware of their group assignment.
Studietype
Intervensjonell
Registrering (Antatt)
52
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Samrood Akram, PhD*
- Telefonnummer: 03324806143
- E-post: samrood.akram@riphah.edu.pk
Studer Kontakt Backup
- Navn: Amna Zia, PhD*
- Telefonnummer: 03244686993
- E-post: amna.zia@kemu.edu.pk
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
- Femwell Physiocare Woman Rehab clinic
-
Ta kontakt med:
- Arooj Fatima, MS-OMPT
- Telefonnummer: 03270056769
- E-post: draroohfahim@gmail.com
-
-
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 to 40 years (26)
- Diagnosed patient with Unilateral Lumbar Radiculopathy secondary to L4/L5 and L5/S1 lumbar posterolateral disc buldge confirmed on MRI (12)
- Posterolateral Lumbar Radiculopathy
Exclusion Criteria:
• Presence of red flags (e.g., cauda equina syndrome, severe neurological deficits).
- Previous spinal surgery within 1 year.
- Severe osteoporosis or vertebral fractures.
- Pregnant women.
- Systemic inflammatory or autoimmune diseases.
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Mulligan Bent Leg Raise (MBLR)
The Mulligan Bent Leg Raise (BLR) technique is a specialized physical therapy mobilization method used to relieve low back pain, reduce sciatica, and improve hamstring flexibility.
It involves applying gentle, pain-free traction while moving the leg through progressively greater ranges of hip flexion.
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Patient Position - Supine at edge of plinth
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Aktiv komparator: Spinal Mobilization with Leg Movement (SMWLM)
Spinal Mobilization with Leg Movement (SMWLM) is an advanced manual therapy technique developed as part of the Mulligan Concept.
It integrates manual joint mobilization with neurodynamic principles to treat lower back and radiating leg pain, most notably lumbar radiculopathy (sciatica)
|
Patient Position - Side-lying on unaffected side near edge
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
NPRS for pain
Tidsramme: upto 4 weeks
|
Pain intensity will be evaluated using the Numeric Pain Rating Scale, which ranges from 0 indicating "no pain" to 10 representing the "worst possible pain."
It has shown excellent test-retest reliability, with intraclass correlation coefficients (ICC) ranging between 0.95 and 0.98 in individuals with musculoskeletal conditions
|
upto 4 weeks
|
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SLR and Slump test for neural mobility
Tidsramme: Upto 4 weeks
|
To assess neural mobility, the Straight Leg Raise and Slump Tests will be employed.
These are well-established clinical tools for identifying lumbar nerve root irritation.
The SLR test demonstrates strong diagnostic accuracy (~81%) and excellent inter-rater reliability with kappa values above 0.90 and aprox 0.71 for slump test
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Upto 4 weeks
|
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Oswestry Disability Index test for functional outcome
Tidsramme: Upto 4 weeks
|
The ODI will be used to determine the level of functional disability associated with lower back pain.
It includes 10 items that assess various aspects of daily activity.
The tool has proven to be highly reliable (Cronbach's alpha = 0.87) and valid across different patient populations with lumbar spine conditions
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Upto 4 weeks
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Time up and go (TUG) test for functional outcome
Tidsramme: Upto 4 weeks
|
Balance and functional mobility will be measured using the TUG test, which involves timing a patient as they rise from a chair, walk three meters, turn, return, and sit down.
This test is highly reliable (ICC = 0.82 to 0.99) and shows good concurrent validity in both spinal and geriatric populations (34).
The cutoff value for balance and functional mobility TUG test is 7.2 sec
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Upto 4 weeks
|
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Five repetition sit to stand test
Tidsramme: upto 4 weeks
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The 5 Rep Sit-to-Stand Test will be used to assess lower limb strength and functional performance.
The patient gets to their maximum standing position and then sits back down five times as fast as they can without the use of their hands or arms.
It has demonstrated excellent reliability (ICC > 0.90) and shows strong correlation with functional ability (36).
The cutoff value is > 10 sec for 5 rep sitting to standing and standing to sitting transition
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upto 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Amna Zia, PhD, King Edward Medical University
- Hovedetterforsker: Muniba Tahir, Riphah International University, Lahore 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
- George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
- Senol D, Erdem C, Canbolat M, Toy S, Karatas T, Baykara RA, Ozbag D, Akyurek G. Comparison of the effects of conventional physiotherapy and proprioception exercises on pain and ankle proprioception in patients with lumbar radiculopathy. J Back Musculoskelet Rehabil. 2022;35(2):421-428. doi: 10.3233/BMR-200361.
- Ashraf B, Ahmad S, Ashraf K, Kanwal S, Ashraf S, Khan N, et al. Effectiveness of spinal mobilization with leg movement versus McKenzie back extension exercises in lumbar radiculopathy. 2021;15(5):1436-40.
- Fatima A, Mehmood Z, Ahmad SJJoIIMC. Effects of Mulligan Traction Straight Leg Raise Versus Passive Straight Leg Raise in Lumbar Radiculopathy Patients. 2022;17(2):86-90.
- Singh V, Malik MJRJoN. Lumbar radiculopathy managed with spinal mobilization with leg movement: A case study. 2021;20(2):246-9.
- Naidu SP, Srikantaiah S, Boyle RJIJoPT, Research. Immediate Effect of Mulligan's Spinal Mobilization with Limb Movements on Straight Leg Raise Test in Patients with Lumbar Radiculopathy: A Randomized Controlled Trial. 2023;5(1):66-72.
- Singh V, Malik MJAiR. Effect of manual therapy on pain, disability and neural mobility in patients of lumbar prolapsed intervertebral disc: a randomized controlled trial. 2022;36(3):11-8.
- Yasmeen S, Ahmad Z, Ishtiaq NJJRCoRS. The comparative effects of Butler's neural tissue mobilization and Mulligan's Bent leg raise in patients with chronic lumbar radiculopathy. 2022;10(02).
- Lin LH, Lin TY, Chang KV, Wu WT, Ozcakar L. Neural Mobilization for Reducing Pain and Disability in Patients with Lumbar Radiculopathy: A Systematic Review and Meta-Analysis. Life (Basel). 2023 Nov 26;13(12):2255. doi: 10.3390/life13122255.
- Hussein H, Atteya M, Ansari A, Kamel E. A Systematic Review and Meta-Analysis of the Effectiveness of Mulligan Mobilization with Movement on Pain, Range of Motion, Function, and Flexibility in Patients with Sciatica. NeuroRehabilitation. 2025 Mar;56(2):83-96. doi: 10.1177/10538135241301693. Epub 2024 Dec 18.
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)
20. juni 2026
Primær fullføring (Antatt)
20. august 2026
Studiet fullført (Antatt)
20. september 2026
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
21. juli 2026
Først lagt ut (Faktiske)
24. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/RCR&AHS/25/0132 Muniba
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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