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Effects of Manual Lumbar and Prone Traction in Patients With Low Back Pain (L&PtracinLBP)

Primary Purpose

Non-specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Manual lumbar traction
Prone traction
Sponsored by
Obafemi Awolowo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain focused on measuring Manual Lumbar Traction, Prone Traction, Pain Intensity, Low back pain, Disability

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants diagnosed with Non-Specific Low Back Pain of not less than 3 months duration who were referred by a physician.
  • Participants between the ages of 40 years and older.

Exclusion Criteria:

  • Low back pain patients with specific pathology, such as systemic inflammatory diseases, pregnancy, fractures of the spine, tumors, infections.
  • Participants with pathology affecting the trunk or upper and lower extremities

Sites / Locations

  • Obafemi Awolowo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

manual Lumbar Traction

Prone traction

Arm Description

The subjects consist of 25 patients with chronic low back pain. They underwent a manual lumbar traction with Physiotherapist pulling the patients while lying prone on a couch

This group consist of patients with non specific chronic low back pain that were put on prone traction.

Outcomes

Primary Outcome Measures

Visual Analogue scale
It measure pain intensity: 0 which is no pain to 10 which is excruciating pain

Secondary Outcome Measures

Roland Morris low back pain Disability questionnaire
It measures the disability of the patients from 0, no disability to 24 which is the greatest disability
Goniometer
It measures spinal flexibility in "degree". The flexibility may start from 0 degree and the maximum depends on the flexibility of each participants

Full Information

First Posted
August 23, 2022
Last Updated
August 25, 2022
Sponsor
Obafemi Awolowo University
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1. Study Identification

Unique Protocol Identification Number
NCT05518552
Brief Title
Effects of Manual Lumbar and Prone Traction in Patients With Low Back Pain
Acronym
L&PtracinLBP
Official Title
Effects of Manual Lumbar and Prone Traction on Clinical Variables in Patients With Non-specific Low Back Pain: A Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
February 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo 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 determined the effects of manual Lumbar traction and prone traction on some clinical variables of patients with long standing low back pain.
Detailed Description
Traction therapy has been used in the management of low back pain (LBP) especially None Specific Low Back Pain. There are several recommendations on how lumbar traction should be performed, but the type of technique to be applied differs among the sources. Prone traction adapted from inversion therapy which is a form of gravitational traction has been reported to be effective in ameliorating disabilities of patients with low back pain as well reduce pain intensity. Manual lumbar traction is performed by the therapist, pulling at the patient's ankles and has been reported to be effective in relieving pain and reducing disability of patient with None Specific Low Back Pain (NSLBP). Documented evidences on the efficacy of traction in non-specific low back pain are still inconclusive. While manual lumbar traction seems more commonly used, probably owing to its positional advantage, its relative effectiveness compared with manual prone traction is still unknown, hence this study. Therefore, the aim of this study was to examine the efficacy of manual lumbar traction and prone traction on pain intensity, disability, spinal range of motion and quality of life in patients with None Specific Low Back Pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
Keywords
Manual Lumbar Traction, Prone Traction, Pain Intensity, Low back pain, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The group underwent manual lumbar traction with the patient lying prone on a couch using a manual technique by pulling from the ankles of the patient. Manual traction was performed by the therapist, pulling at the patient's ankles.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manual Lumbar Traction
Arm Type
Experimental
Arm Description
The subjects consist of 25 patients with chronic low back pain. They underwent a manual lumbar traction with Physiotherapist pulling the patients while lying prone on a couch
Arm Title
Prone traction
Arm Type
Experimental
Arm Description
This group consist of patients with non specific chronic low back pain that were put on prone traction.
Intervention Type
Other
Intervention Name(s)
Manual lumbar traction
Intervention Description
Patient in the group were treated with manual traction
Intervention Type
Other
Intervention Name(s)
Prone traction
Intervention Description
Patient in the group were placed on prone traction
Primary Outcome Measure Information:
Title
Visual Analogue scale
Description
It measure pain intensity: 0 which is no pain to 10 which is excruciating pain
Time Frame
Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Secondary Outcome Measure Information:
Title
Roland Morris low back pain Disability questionnaire
Description
It measures the disability of the patients from 0, no disability to 24 which is the greatest disability
Time Frame
Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Title
Goniometer
Description
It measures spinal flexibility in "degree". The flexibility may start from 0 degree and the maximum depends on the flexibility of each participants
Time Frame
Change is being assessed at the Baseline, 3rd week and 6th week of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with Non-Specific Low Back Pain of not less than 3 months duration who were referred by a physician. Participants between the ages of 40 years and older. Exclusion Criteria: Low back pain patients with specific pathology, such as systemic inflammatory diseases, pregnancy, fractures of the spine, tumors, infections. Participants with pathology affecting the trunk or upper and lower extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adesola O Ojoawo, PhD
Organizational Affiliation
Obafemi Awolowo University Ile Ife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obafemi Awolowo University
City
Ile Ife
State/Province
Osun
ZIP/Postal Code
220005
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data are kept with the principal investigator. Whosoever is interested can contact him for information
Citations:
PubMed Identifier
15066687
Citation
Ostelo RW, de Vet HC, Knol DL, van den Brandt PA. 24-item Roland-Morris Disability Questionnaire was preferred out of six functional status questionnaires for post-lumbar disc surgery. J Clin Epidemiol. 2004 Mar;57(3):268-76. doi: 10.1016/j.jclinepi.2003.09.005.
Results Reference
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PubMed Identifier
12384756
Citation
Ozaktay AC, Cavanaugh JM, Asik I, DeLeo JA, Weinstein JN. Dorsal root sensitivity to interleukin-1 beta, interleukin-6 and tumor necrosis factor in rats. Eur Spine J. 2002 Oct;11(5):467-75. doi: 10.1007/s00586-002-0430-x. Epub 2002 Jun 4.
Results Reference
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Effects of Manual Lumbar and Prone Traction in Patients With Low Back Pain

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