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Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Decompression + Hot pack , TENS , Mobilization , Exercise Therapy
Hot pack , TENS, Mobilization, Exercise therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Decompression, radiculopathy, acute, chronic

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • history of radicular pain with straight leg raise (SLR).
  • Patients in the acute phase of (up to 6 weeks) included in group A
  • Patients in chronic phase of (more than 6 weeks) included in group B

Exclusion Criteria:

  • Any systemic soft tissue and bony disease.
  • Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
  • Any recent surgery.
  • Patient with any cervical or thoracic problem.
  • Patients with any other serious pathology/red flags

Sites / Locations

  • DHQ hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Group A

Group B

Group C

Arm Description

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Hot pack , TENS, Mobilization, Exercise therapy

Outcomes

Primary Outcome Measures

Visual Analogue Scale
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured

Secondary Outcome Measures

MODIFIED OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools

Full Information

First Posted
December 16, 2020
Last Updated
March 4, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04674917
Brief Title
Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy
Official Title
Effects of Decompression on Pain, Range of Motion and Function in Patient With Acute vs Chronic Lumbar Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will be done to evaluate the effectiveness of Lumbar Spinal Decompression in patients with acute vs chronic lumbar radiculopathy. Study design will be Randomized control trial and sample size will be 30. Duration of study was of 6 month, convenient sampling was done. Data will be collected from DHQ Daska were randomly allocated in three groups via lottery method, baseline assessment was done. Patients of both gender (male and female) from 18 to 50 years with lumbar radiculopathy diagnosed through X-ray and physical examination will be included. Patients with systemic soft tissue and bony diseases will be excluded. Intervention duration of 4 weeks, 3 sessions in a week. Decompression of lumbar spine will be given once in a week. Whole procedure of treatment program will given to patients and written informed consent will be taken. Basic tools will be Visual analog scale (VAS), SLR, ODI, Inclinometer. Data was analyzed by using SPSS version 21
Detailed Description
Low back pain (LBP) is one of the most common musculoskeletal conditions treated by physical therapists. Although lumbar traction is frequently used by physical therapists in the treatment of patients with LBP. We will use Manual Lumber Spinal Traction on patients with acute vs chronic lumber radiculopathy. The current study will determine the effect of decompression in relieving pain, increase range of motion and improving function in patients of acute and chronic lumbar radiculopathy. Lumbar traction (LT) is routinely used on its own or in conjunction with other treatments for the management of lumbar sciatica. We will use Manual lumbar traction along with hot pack, tens, mobilization and exercise therapy. Intervention duration of 4 weeks, 3 sessions in a week. Decompression of lumbar spine will be given once in a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Decompression, radiculopathy, acute, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Arm Title
Group B
Arm Type
Experimental
Arm Description
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Arm Title
Group C
Arm Type
Other
Arm Description
Hot pack , TENS, Mobilization, Exercise therapy
Intervention Type
Other
Intervention Name(s)
Decompression + Hot pack, TENS, Mobilization, Exercise Therapy
Intervention Description
Group A which includes the acute group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal.. The basic treatments are Hot Pack TENSE Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.
Intervention Type
Other
Intervention Name(s)
Decompression + Hot pack , TENS , Mobilization , Exercise Therapy
Intervention Description
Group B which includes the chronic group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal.. The basic treatments are Hot Pack TENSE Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.
Intervention Type
Other
Intervention Name(s)
Hot pack , TENS, Mobilization, Exercise therapy
Intervention Description
Group C which is our control group to compare it with the groups A and B to study the effects of decompression on lumbar radiculopathy The basic treatments are Hot Pack TENSE Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes The third treatment which is mobilization will be given 1 time on each joint of lumbar spine It is kept in mind that in this group we will not apply the decompression along with the above treatments.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured
Time Frame
4th week
Secondary Outcome Measure Information:
Title
MODIFIED OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Time Frame
4th Week
Other Pre-specified Outcome Measures:
Title
Inclinometer
Description
An inclinometer or clinometer is an instrument used for measuring angles of slope (or tilt), elevation, or depression of an object with respect to gravity's direction.
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of radicular pain with straight leg raise (SLR). Patients in the acute phase of (up to 6 weeks) included in group A Patients in chronic phase of (more than 6 weeks) included in group B Exclusion Criteria: Any systemic soft tissue and bony disease. Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer. Any recent surgery. Patient with any cervical or thoracic problem. Patients with any other serious pathology/red flags
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ hospital
City
Daska
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31456418
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
31078315
Citation
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PubMed Identifier
32246656
Citation
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Citation
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Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy

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