Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

August 5, 2021 updated by: Riphah International University

Effects of Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan
        • Max spine rehab centre, G8 markaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: 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").
6th week
SLR through Inclinometer
Time Frame: 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
6th week
Oswestry Disability Index
Time Frame: 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
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2020

Primary Completion (ACTUAL)

June 15, 2021

Study Completion (ACTUAL)

July 10, 2021

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (ACTUAL)

April 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00856 Iqra Hamid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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