Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04852900
Collaborator
(none)
45
1
3
8.8
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Decompression with 30%
  • Other: Decompression with 40%
  • Other: Decompression with 50%
N/A

Detailed Description

Decompression therapy differs from traction-based therapy in that the traction applied to the spine in decompression therapy is typically alternated between lower and higher levels of tension for predetermined periods of time. In either therapy, spinal tension is maintained for the period's typically extending 30-minutes or longer. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy
Actual Study Start Date :
Oct 14, 2020
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jul 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Decompression with 30%

Decompression with 30% and mobilization

Other: Decompression with 30%
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

Experimental: Decompression with 40%

Decompression with 40% and mobilization

Other: Decompression with 40%
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

Experimental: Decompression with 50%

Decompression with 50% and mobilization

Other: Decompression with 50%
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

Outcome Measures

Primary Outcome Measures

  1. Numeric Pain Rating Scale [6th week]

    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").

  2. SLR through Inclinometer [6th week]

    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

  3. Oswestry Disability Index [6th week]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Severe paraspinal Muscle Spasm

  • Acute prolapse intervertebral disc

  • Bilateral Positive SLR

  • Osteoporotic

  • H/O Spinal Fracture

Contacts and Locations

Locations

Site City State Country Postal Code
1 Max spine rehab centre, G8 markaz Islamabad Punjab Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Nazish Rafique, MSPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04852900
Other Study ID Numbers:
  • REC/00856 Iqra Hamid
First Posted:
Apr 21, 2021
Last Update Posted:
Aug 6, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2021