- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07646379
Effects of Spinal Mobilization With Leg Movement With and Without Neural Flossing Technique in Lumbar Radiculopathy
8. Juni 2026 aktualisiert von: Riphah International University
Effects of Spinal Mobilization With Leg Movement With and Without Neural Flossing Technique on Pain, Disability, and Range of Motion in Patients With Lumbar Radiculopathy
Lumbar radiculopathy is a spinal condition caused by compression or irritation of the lumbar nerve roots, leading to radiating leg pain, sensory changes, and functional disability.
It commonly affects middle-aged and older adults, impairing daily activities and quality of life.
Conservative treatments include medication, physiotherapy, and exercise.
Spinal Mobilization with Leg Movement (SMWLM), a Mulligan technique, uses passive vertebral mobilization with active leg motion to reduce nerve compression and improve mobility.
Neural flossing, or neurodynamic mobilization, enhances nerve mobility by promoting gliding of nerve roots, especially in cases of restricted neural movement.
This study aims to evaluate the effects of spinal mobilization with leg movement (SMWLM) with and without neural flossing technique on pain, disability, and range of motion in patients with lumbar radiculopathy.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This single-blinded randomized clinical trial will be conducted at Noor Al-Shifa Hospital, Lahore, over 10 months following ethical approval.
A total of 36 patients (18 in each group) with lumbar radiculopathy will be recruited by using non-probability convenience sampling.
Group A will receive spinal mobilization with leg movement (SMWLM) with neural flossing technique, while Group B will receive spinal mobilization with leg movement (SMWLM) only.
Each group will undergo treatment 3 times per week for 6 weeks, with each session lasting 45 minutes.
Pre- and post-intervention assessments will include pain (NPRS), SLR range of motion (Goniometer), and disability (Modified Oswestry Disability Index).
Data will be analyzed using SPSS version 26
Studientyp
Interventionell
Einschreibung (Geschätzt)
36
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Samrood Akram, PhD*
- Telefonnummer: 03324806143
- E-Mail: samrood.akram@riphah.edu.pk
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54920
- Physio house (Comprehensive Rehab Center)
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Kontakt:
- Adnan Akram
- Telefonnummer: +92 321 8851888
- E-Mail: dradnan531@gmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
• Patients aged between 30-50 years (9)
- Both male and female genders
- Patient should have lower back pain radiating to one side with numbness, tingling, and muscle weakness (12)
- Positive Lasegue & slump test
Exclusion Criteria:
Any fracture or other injury
- Any systemic illness
- Any inflammatory disease (Rheumatoid arthritis, gout)
- Disc herniation
- Piriformis syndrome
- Lumbar instability
- Scoliosis
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: SMWLM along with neural flossing technique
Spinal Mobilization with Leg Movement (SMWLM) and Neural Flossing are highly effective, conservative physical therapy approaches for managing lumbar radiculopathy (sciatica).
They aim to reduce nerve root compression, disperse neural edema, and restore the healthy gliding of nerves within their surrounding tissues
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The participant will be positioned in side-lying with limb where the pain radiated to on top.
Therapist 1 will stand at the participant's ventral side and apply transverse glide with the thumb on the involved lumbar spinous process.
Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with knee extended, while the glide will be sustained continuously by therapist 1.
The entire motion during mobilization will be maintained pain-free.
The participant will be positioned in side-lying with limb where the pain radiated to on top.
Therapist 1 will stand at the participant's ventral side and apply transverse glide with the thumb on the involved lumbar spinous process.
Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with knee extended, while the glide will be sustained continuously by therapist 1.
The entire motion during mobilization will be maintained pain-free.
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Aktiver Komparator: SMWLM without neural flossing technique
Spinal Mobilization with Leg Movement (SMWLM) is a manual therapy technique developed by Brian Mulligan to treat lumbar radiculopathy.
It combines sustained gliding pressure on the lumbar spine with passive or active straight leg raises to alleviate nerve compression, reduce pain, and restore mobility
|
The participant will be positioned in side-lying with limb where the pain radiated to on top.
Therapist 1 will stand at the participant's ventral side and apply transverse glide with the thumb on the involved lumbar spinous process.
Therapist 2 will then abduct the affected leg by 10° and take the limb gently into hip flexion with knee extended, while the glide will be sustained continuously by therapist 1.
The entire motion during mobilization will be maintained pain-free.
The procedure will be repeated three times as per Mulligans rule of 3, post which the SLR test and NPRS will be re-measured
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Numeric Pain Rating Scale for Pain
Zeitfenster: upto 4 weeks
|
It is a widely used subjective measure for assessing pain intensity, where patients rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
It has high test-retest reliability (ICC = 0.92) and strong construct validity for acute and chronic musculoskeletal conditions
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upto 4 weeks
|
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Goniometer for ROM
Zeitfenster: Upto 4 weeks
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It is a clinical instrument used to measure joint range of motion in degrees, commonly applied in musculoskeletal assessments.
It demonstrates excellent intra-rater (ICC = 0.95) and inter-rater reliability (ICC = 0.89), with strong validity when compared with digital motion analysis tools
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Upto 4 weeks
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Modfied Oswestry Disability Index for disability
Zeitfenster: Upto 4 weeks
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It is a self-reported questionnaire used to assess disability due to low back pain, covering aspects such as pain, mobility, and daily activities.
It is a highly valid tool (construct validity r = 0.75) with excellent reliability (Cronbach's alpha = 0.90, ICC = 0.91), making it one of the most commonly used functional outcome measures in spine-related research
|
Upto 4 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Rahat Afzal, MS-OMPT, Governement Teaching Hospital Shahdara Lahore.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Hanif A. Effects of non-surgical decompression therapy in addition to routine physical therapy on pain, range of motion, endurance, functional disability and quality of life versus routine physical therapy alone in patients with lumbar radiculopathy; a randomized controlled trial. BMC Musculoskelet Disord. 2022 Mar 16;23(1):255. doi: 10.1186/s12891-022-05196-x.
- Soar H, Comer C, Wilby MJ, Baranidharan G. Lumbar radicular pain. BJA Educ. 2022 Sep;22(9):343-349. doi: 10.1016/j.bjae.2022.05.003. Epub 2022 Aug 1. No abstract available.
- Ali MS, Kelini KIS, Elsayed M, Galal DOSM, Abdul-Rahman RS. Prevalence of lumbosacral radiculopathy among physiotherapists of pediatric rehabilitation. Revista iberoamericana de psicología del ejercicio y el deporte. 2024;19(2):184-8.
- Bateman EA, Fortin CD, Guo M. Musculoskeletal mimics of lumbosacral radiculopathy. Muscle Nerve. 2025 May;71(5):816-832. doi: 10.1002/mus.28106. Epub 2024 May 10.
- Pinto MV, Ng PS, Laughlin RS, Thapa P, Aragon Pinto C, Shelly S, Shouman K, Dyck PJ, Dyck PJB. Risk factors for lumbosacral radiculoplexus neuropathy. Muscle Nerve. 2022 May;65(5):593-598. doi: 10.1002/mus.27484. Epub 2022 Jan 22.
- Hincapie CA, Kroismayr D, Hofstetter L, Kurmann A, Cancelliere C, Raja Rampersaud Y, Boyle E, Tomlinson GA, Jadad AR, Hartvigsen J, Cote P, Cassidy JD. Incidence of and risk factors for lumbar disc herniation with radiculopathy in adults: a systematic review. Eur Spine J. 2025 Jan;34(1):263-294. doi: 10.1007/s00586-024-08528-8. Epub 2024 Oct 25.
- Price MR, Mead KE, Cowell DM, Troutner AM, Barton TE, Walters SA, Daniels CJ. Medication recommendations for treatment of lumbosacral radiculopathy: A systematic review of clinical practice guidelines. PM R. 2024 Oct;16(10):1128-1142. doi: 10.1002/pmrj.13142. Epub 2024 Apr 17.
- Wang S, Hebert JJ, Abraham E, Vandewint A, Bigney E, Richardson E, El-Mughayyar D, Attabib N, Wedderkopp N, Kingwell S, Soroceanu A, Weber MH, Hall H, Finkelstein J, Bailey CS, Thomas K, Nataraj A, Paquet J, Johnson MG, Fisher C, Rampersaud YR, Dea N, Small C, Manson N. Postoperative recovery patterns following discectomy surgery in patients with lumbar radiculopathy. Sci Rep. 2022 Jul 1;12(1):11146. doi: 10.1038/s41598-022-15169-8.
- Kim SJ, Jang HY, Lee S-M. Effects of spinal mobilization with leg movement and neural mobilization on pain, mobility, and psychosocial functioning of patients with lumbar disc herniation: A randomized controlled study. Physical Therapy Rehabilitation Science. 2023;12(2):92-104.
- Rakesh R. Effectiveness of Mckenzie Exercises Versus Neural Flossing Technique in Patients with Lumbar Radiculopathy. Indian Journal of Physiotherapy & Occupational Therapy. 2024;18.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
30. Mai 2026
Primärer Abschluss (Geschätzt)
30. Juli 2026
Studienabschluss (Geschätzt)
30. August 2026
Studienanmeldedaten
Zuerst eingereicht
8. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2026
Zuerst gepostet (Tatsächlich)
12. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- REC/RCR&AHS/25/0124 Ruhma
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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