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Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.

Primary Purpose

Low Back Pain, Low Back Pain, Mechanical, Disc Degeneration

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hot Pack
Manual Traction
Mechanical Traction
Joint Mobilization
TENS
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with discogenic low back pain,
  • Patients of both genders
  • Age ranges from 20 to 60 years
  • NPRS > 5

Exclusion Criteria:

  • Patients with non-mechanical back pain
  • Patients with known metabolic diseases,
  • Osteoporotic patients,
  • Recent history of spinal trauma or surgery,
  • Lumbar myelopathy,
  • Cauda equine syndrome.

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual Traction

Mechanical traction

Arm Description

Moist heat packs & TENS for ten minutes followed by Manual Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient.

Moist heat packs & TENS for ten minutes followed by Mechanical Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.
Oswestry disability index
Changes from base line The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2021
Last Updated
September 17, 2021
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05059249
Brief Title
Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.
Official Title
Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

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
This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Low Back Pain, Mechanical, Disc Degeneration, Disc Prolapse, Disc Prolapse With Radiculopathy, Lumbar Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Traction
Arm Type
Experimental
Arm Description
Moist heat packs & TENS for ten minutes followed by Manual Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient.
Arm Title
Mechanical traction
Arm Type
Experimental
Arm Description
Moist heat packs & TENS for ten minutes followed by Mechanical Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient
Intervention Type
Procedure
Intervention Name(s)
Hot Pack
Intervention Description
Superficial Heating
Intervention Type
Procedure
Intervention Name(s)
Manual Traction
Intervention Description
Manual Traction for 10 minutes
Intervention Type
Procedure
Intervention Name(s)
Mechanical Traction
Intervention Description
Mechanical Traction for 10 minutes
Intervention Type
Procedure
Intervention Name(s)
Joint Mobilization
Intervention Description
3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions
Intervention Type
Procedure
Intervention Name(s)
TENS
Intervention Description
TENS for 10 minutes with hot pack
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.
Time Frame
6 weeks
Title
Oswestry disability index
Description
Changes from base line The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with discogenic low back pain, Patients of both genders Age ranges from 20 to 60 years NPRS > 5 Exclusion Criteria: Patients with non-mechanical back pain Patients with known metabolic diseases, Osteoporotic patients, Recent history of spinal trauma or surgery, Lumbar myelopathy, Cauda equine syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Furqan Yaqoob, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.

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