NCT04581239

Brief Summary

The aim of this study was to find out the effects of active versus passive lower extremity neuralmobilizations combined with lumbar traction and lumbar mobilization in patients with lumbarradiculopathy. The study was conducted in shalamar hospital Lahore and was completed within 6 month of time duration. Sample size of twenty four patient consists of both male and female aged between 45 years to 65 years. Each group contain 12 patients. Group A received active neural mobilizations whereas group B received passive neural mobilization along with lumber traction and mobilization. Patients were re assessed at the end of 6 weeks through SLR , NPRS and ODI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

October 3, 2020

Last Update Submit

October 8, 2020

Conditions

Lumbar Radiculopathy

Keywords

Active Neural MobilizationLumber TractionLumber MobilizationPassive Neural MobilizationLumber Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

    6 week

Secondary Outcomes (2)

  • Straight Leg Raise (SLR)

    6 week

  • Oswestry Disability Index (ODI) questionnaire

    6 week

Study Arms (2)

Active neural mobilization

ACTIVE COMPARATOR

Therapist supervised active neural mobilization of sciatic nerve in lumber radiculopathy patients

Other: Active neural mobilization

passive neural mobilization

EXPERIMENTAL

Therapist done passicive neural mobilization of sciatic nerve in lumber radiculopathy patients

Other: passive neural mobilization

Interventions

Active neural mobilizationOTHER

Active neural mobilization Base line treatment followed heating pad 10 minutes, lumber traction with 50 %of body weight in accordance with tolerance. 15 to 20 Lumber segmental mobilization. Active oscillatory nerve mobilization was given in 3 sets of 10 repetition in each set with 20 sec rest time between set

Active neural mobilization
passive neural mobilizationOTHER

Base line treatment followed heating pad 10 minutes, lumber traction with 50 %of body weight in accordance with tolerance. 15 to 20 Lumber segmental mobilization Passive neural mobilization This oscillatory nerve mobilization was given in 3 sets of 10 repetition in each set with 20 sec rest time between set. Both groups received total 18 session 3 session per week for consecutive 6 weeks

passive neural mobilization

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain radiate from lower lumber area to posterior aspect of leg up to planter surface of toes.
  • Patient with confirmed L4-L5, L5-S1 disc herniation or disc bulge diagnosed by neurophysician.
  • Numeric pain rating scale value is more than 4.
  • Patients having positive compression distraction, Lasegue's sign and lower limb neural tension tests. (LLNTT).Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.

You may not qualify if:

  • Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting
  • blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc)
  • Any systemic disease as diabetes or neurological condition that altered the function of the nervous system
  • Prolong use of steroids.
  • History of any surgery, trauma, or pathology of back, hip, knee, and ankle.
  • Spinal stenosis, Potts disease
  • Taking any treatment or medication except physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar hospital Lahore

Lahore, 54000, Pakistan

Location

Related Publications (14)

  • Masters S, Lind R. Musculoskeletal pain - presentations to general practice. Aust Fam Physician. 2010 Jun;39(6):425-8.

    PMID: 20628683BACKGROUND

  • Satpute K, Hall T, Bisen R, Lokhande P. The Effect of Spinal Mobilization With Leg Movement in Patients With Lumbar Radiculopathy-A Double-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 May;100(5):828-836. doi: 10.1016/j.apmr.2018.11.004. Epub 2018 Dec 3.

    PMID: 30521781BACKGROUND

  • Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008;16(1):8-22. doi: 10.1179/106698108790818594.

    PMID: 19119380BACKGROUND

  • Hahne AJ, Ford JJ, McMeeken JM. Conservative management of lumbar disc herniation with associated radiculopathy: a systematic review. Spine (Phila Pa 1976). 2010 May 15;35(11):E488-504. doi: 10.1097/BRS.0b013e3181cc3f56.

    PMID: 20421859BACKGROUND

  • Harte AA, Baxter GD, Gracey JH. The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord. 2007 Nov 29;8:118. doi: 10.1186/1471-2474-8-118.

    PMID: 18047650BACKGROUND

  • Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.

    PMID: 22851876BACKGROUND

  • Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.

    PMID: 25892373BACKGROUND

  • Kawakami M, Weinstein JN, Spratt KF, Chatani K, Traub RJ, Meller ST, Gebhart GF. Experimental lumbar radiculopathy. Immunohistochemical and quantitative demonstrations of pain induced by lumbar nerve root irritation of the rat. Spine (Phila Pa 1976). 1994 Aug 15;19(16):1780-94. doi: 10.1097/00007632-199408150-00001.

    PMID: 7526474BACKGROUND

  • Kostadinovic S, Milovanovic N, Jovanovic J, Tomasevic-Todorovic S. Efficacy of the lumbar stabilization and thoracic mobilization exercise program on pain intensity and functional disability reduction in chronic low back pain patients with lumbar radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(6):897-907. doi: 10.3233/BMR-201843.

    PMID: 32675390BACKGROUND

  • Winkelstein BA, DeLeo JA. Nerve root injury severity differentially modulates spinal glial activation in a rat lumbar radiculopathy model: considerations for persistent pain. Brain Res. 2002 Nov 29;956(2):294-301. doi: 10.1016/s0006-8993(02)03560-6.

    PMID: 12445698BACKGROUND

  • Kobayashi S, Kokubo Y, Uchida K, Yayama T, Takeno K, Negoro K, Nakajima H, Baba H, Yoshizawa H. Effect of lumbar nerve root compression on primary sensory neurons and their central branches: changes in the nociceptive neuropeptides substance P and somatostatin. Spine (Phila Pa 1976). 2005 Feb 1;30(3):276-82. doi: 10.1097/01.brs.0000152377.72468.f4.

    PMID: 15682006BACKGROUND

  • Leininger B, Bronfort G, Evans R, Reiter T. Spinal manipulation or mobilization for radiculopathy: a systematic review. Phys Med Rehabil Clin N Am. 2011 Feb;22(1):105-25. doi: 10.1016/j.pmr.2010.11.002. Epub 2010 Dec 30.

    PMID: 21292148BACKGROUND

  • Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.

    PMID: 31464753BACKGROUND

  • Han L, Zhao P, Guo W, Wei J, Wang F, Fan Y, Li Y, Min Y. Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015 Mar 27;16:122. doi: 10.1186/s13063-015-0634-0.

    PMID: 25872929BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Binash Afzal, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2020

First Posted

October 9, 2020

Study Start

March 15, 2019

Primary Completion

December 20, 2019

Study Completion

January 30, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)