NCT04852900

Brief Summary

This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

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

October 14, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

April 20, 2021

Last Update Submit

August 5, 2021

Conditions

Lumbar Radiculopathy

Keywords

PainRadiculopathyLumbarDecompression

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni-dimensional measure of pain intensity in adults(21). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    6th week

  • SLR through Inclinometer

    The Straight Leg Raise (SLR) test is a neurodynamic test. Neurodynamic tests check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression. These tests, along with relevant history and decreased range of motion, are considered by some to be the most important physical signs of disc herniation, regardless of the degree of disc injury. SLR is a neural tension test that can be used to rule in or out neural tissue involvement as a result of a space occupying lesion, often a lumbar disc herniation. It is one of the most common neurological tests of the lower limb

    6th week

  • Oswestry Disability Index

    Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Most effective for persistent severe disability while the Roland-Morris is better for mild to moderate disability. Questionnaire examines perceived level of disability in 10 everyday activities of daily living

    6th week

Study Arms (3)

Decompression with 30%

EXPERIMENTAL

Decompression with 30% and mobilization

Other: Decompression with 30%

Decompression with 40%

EXPERIMENTAL

Decompression with 40% and mobilization

Other: Decompression with 40%

Decompression with 50%

EXPERIMENTAL

Decompression with 50% and mobilization

Other: Decompression with 50%

Interventions

Decompression with 30%OTHER

* Hot Pack for 10 mins Soft Tissue Mobilization * Muscle Strengthening * Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Decompression with 30%
Decompression with 40%OTHER

* Hot Pack for 10 mins Soft Tissue Mobilization * Muscle Strengthening * Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Decompression with 40%
Decompression with 50%OTHER

* Hot Pack for 10 mins Soft Tissue Mobilization * Muscle Strengthening * Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

Decompression with 50%

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Genders
  • Age between 30 to 50 years
  • Unilateral Radiculopathy
  • Limited SLR (Less than 60 degree)
  • Pain on Numeric Pain Rating Scale \< 7
  • BMI ≤ 30

You may not qualify if:

  • Severe paraspinal Muscle Spasm
  • Acute prolapse intervertebral disc
  • Bilateral Positive SLR
  • Osteoporotic
  • H/O Spinal Fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max spine rehab centre, G8 markaz

Islamabad, Punjab Province, Pakistan

Location

Related Publications (8)

  • Alexander CE, Weisbrod LJ, Varacallo MA. Lumbosacral Radiculopathy. 2024 Feb 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430837/

    PMID: 28613587BACKGROUND

  • Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.

    PMID: 31788391BACKGROUND

  • Chen BL, Guo JB, Zhang HW, Zhang YJ, Zhu Y, Zhang J, Hu HY, Zheng YL, Wang XQ. Surgical versus non-operative treatment for lumbar disc herniation: a systematic review and meta-analysis. Clin Rehabil. 2018 Feb;32(2):146-160. doi: 10.1177/0269215517719952. Epub 2017 Jul 17.

    PMID: 28715939BACKGROUND

  • Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, Park KB, Shin BC, Lee MS, Ha IH. Long-Term Course of Alternative and Integrative Therapy for Lumbar Disc Herniation and Risk Factors for Surgery: A Prospective Observational 5-Year Follow-Up Study. Spine (Phila Pa 1976). 2016 Aug 15;41(16):E955-E963. doi: 10.1097/BRS.0000000000001494.

    PMID: 26882505BACKGROUND

  • Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.

    PMID: 22543563BACKGROUND

  • Abdurrahman G, Şener Ü, Karabacak H, Kağan Ü. Kadın ve erkek genç erişkinler arasında fiziksel aktivite ve yaşam kalitesi farklılıklarının araştırılması. Kocatepe Tıp Dergisi. 2011;12(3):145-50.

    BACKGROUND

  • Demirel A, Yorubulut M, Ergun N. Regression of lumbar disc herniation by physiotherapy. Does non-surgical spinal decompression therapy make a difference? Double-blind randomized controlled trial. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1015-1022. doi: 10.3233/BMR-169581.

    PMID: 28505956BACKGROUND

  • Oh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.

    BACKGROUND

MeSH Terms

Conditions

RadiculopathyPain

Interventions

Decompression

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Officials

  • Nazish Rafique, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 21, 2021

Study Start

October 14, 2020

Primary Completion

June 15, 2021

Study Completion

July 10, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)