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Traction in Vertical Sitting Position Versus Supine Lying Position in Patients of Chronic Radicular Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traction
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, Chronic pain, Traction

Eligibility Criteria

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

Inclusion Criteria: Both genders have an age range between 20-50 years. Chronicity of radicular low back pain for at least 3 months Capable of attending physiotherapy sessions regularly (5 times a week for 12 weeks) Exclusion Criteria: Patients with indications of spinal cord involvement (For instance; Urine or Fecal incontinency, Lack of sensation, or Limb paralysis Pregnant females will not be included. Patients with a background of spinal trauma Patients presenting a history of systemic disease

Sites / Locations

  • Al-Barkat Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group-A (Vertical sitting traction)

Group-B (supine lying traction)

Arm Description

This session will be followed by the application of the continuous mechanical traction in the vertical sitting position with a belt around the chest. A total of 30 minutes session per day with 5 sessions per week for 12 weeks will be provided to the participants in this group

Following the conventional treatment, continuous mechanical traction will be applied in the supine lying position with a traction force equal to 50% of the total body weight. A total of 20 minutes session per day with 5 sessions per week will be provided to the participants in group B.

Outcomes

Primary Outcome Measures

Oswestry Disability Index
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. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures
Numeric Pain Rating Scale
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05794347
Brief Title
Traction in Vertical Sitting Position Versus Supine Lying Position in Patients of Chronic Radicular Low Back Pain
Official Title
Effects of Vertical Sitting Versus Supine Lying Traction on Pain, Range of Motion and Function in Patients With Chronic Radicular Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 25, 2023 (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
No

5. Study Description

Brief Summary
The primary objective of the study is to determine the effects of vertical sitting versus supine lying traction on pain, range of motion, and function in patients with chronic radicular low back pain (CRLBP). CRLBP is one of the major types of lower back pain and causes significant disability and reduction in quality of life in the human population. The study will be a randomized controlled trial and the study setting will be Al-Barkat Hospital Gojra . A total of 30 participants will be selected randomly employing a non-probability convenient sampling technique. Two experimental groups will be made. Group A will be given vertical traction in a sitting position and Group B will be given traction in supine lying. Both groups will receive baseline physiotherapy treatment which includes Hot-pack, TENS, and ultrasound. The Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI) will be used as outcome-measuring tools for pain intensity and functional disability respectively. An inclinometer will be used to measure ROM. Measures will be taken at (0, 4th, 8th, and 12th week). Data will be analyzed by using parametric/non-parametric tests after assessing the normality. SPSS version 28.
Detailed Description
CRLBP of the lumbosacral region is a disorder that is closely linked with socioeconomic consequences. The incidence of lower back pain among workers is approximately 13%. Out of which, CRLBP is responsible for 11%. In the lumbosacral region, radicular pain has an occurrence rate of 10 % to 25%. Key interventions by physical therapists involve pain relieving modalities, stretching, muscle conditioning, lumbar traction, and awareness about correct postures that lead to useful exercises. As the reason behind the radicular low back pain is the spinal nerve compression due to the spinal canal impingement, the lumbar traction lightens the pain through vertebral separation producing decompression on the pressed nerve. Radicular low back pain shows diverse symptoms, it can be self-limiting, staying only for a short interval with no aftereffects, or can be a key concern behind long-term disability and work loss. The narrative on the effectiveness of vertical traction as a component of physical therapy modalities is contradictory. Despite the fact that lumbar traction has been preferred over other methods for the treatment of lumbar disk disorders, it is usually not advised in the treatment of acute low back pain because of the efficiency of more active treatment options. The aim of the study is to determine the effects of vertical sitting versus supine lying traction on pain, range of motion, and function in patients with radicular low back pain. This study may help physiotherapists to have an estimate of the best possible position for applying traction in patients with radicular low back pain. The conclusion of this study might provide therapists with an optimum traction treatment protocol for CRLBP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, Chronic pain, Traction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-A (Vertical sitting traction)
Arm Type
Experimental
Arm Description
This session will be followed by the application of the continuous mechanical traction in the vertical sitting position with a belt around the chest. A total of 30 minutes session per day with 5 sessions per week for 12 weeks will be provided to the participants in this group
Arm Title
Group-B (supine lying traction)
Arm Type
Active Comparator
Arm Description
Following the conventional treatment, continuous mechanical traction will be applied in the supine lying position with a traction force equal to 50% of the total body weight. A total of 20 minutes session per day with 5 sessions per week will be provided to the participants in group B.
Intervention Type
Other
Intervention Name(s)
Traction
Intervention Description
Continuous mechanical traction will be applied to the lumbar area in 2 different positions.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
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. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures
Time Frame
follow up at 12th week
Title
Numeric Pain Rating Scale
Description
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.
Time Frame
follow up at 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders have an age range between 20-50 years. Chronicity of radicular low back pain for at least 3 months Capable of attending physiotherapy sessions regularly (5 times a week for 12 weeks) Exclusion Criteria: Patients with indications of spinal cord involvement (For instance; Urine or Fecal incontinency, Lack of sensation, or Limb paralysis Pregnant females will not be included. Patients with a background of spinal trauma Patients presenting a history of systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
uneeb ur Rehman, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Barkat Hospital
City
Gojra
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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10626315
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Results Reference
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Results Reference
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Traction in Vertical Sitting Position Versus Supine Lying Position in Patients of Chronic Radicular Low Back Pain

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