- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07646379
Effects of Spinal Mobilization With Leg Movement With and Without Neural Flossing Technique in Lumbar Radiculopathy
8 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Beräknad)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Samrood Akram, PhD*
- Telefonnummer: 03324806143
- E-post: samrood.akram@riphah.edu.pk
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54920
- Physio house (Comprehensive Rehab Center)
-
Kontakt:
- Adnan Akram
- Telefonnummer: +92 321 8851888
- E-post: dradnan531@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
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.
|
|
Aktiv 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numeric Pain Rating Scale for Pain
Tidsram: 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
|
upto 4 weeks
|
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Goniometer for ROM
Tidsram: Upto 4 weeks
|
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
Tidsram: Upto 4 weeks
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Rahat Afzal, MS-OMPT, Governement Teaching Hospital Shahdara Lahore.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 maj 2026
Primärt slutförande (Beräknad)
30 juli 2026
Avslutad studie (Beräknad)
30 augusti 2026
Studieregistreringsdatum
Först inskickad
8 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2026
Senast verifierad
1 juni 2026
Mer information
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