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

Effects of Manual Lumbar and Prone Traction on Clinical Variables in Patients With Non-specific Low Back Pain: A Randomized Control Study

The study determined the effects of manual Lumbar traction and prone traction on some clinical variables of patients with long standing low back pain.

Study Overview

• Status: Completed
• Conditions: Non-specific Low Back Pain
• Intervention / Treatment: Other: Manual lumbar traction; Other: Prone traction

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Osun
    • Ile Ife, Osun, Nigeria, 220005
      • Obafemi Awolowo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: manual Lumbar Traction; 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	Other: Manual lumbar traction; Patient in the group were treated with manual traction
Experimental: Prone traction; This group consist of patients with non specific chronic low back pain that were put on prone traction.	Other: Prone traction; Patient in the group were placed on prone traction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue scale	It measure pain intensity: 0 which is no pain to 10 which is excruciating pain	Change is being assessed at the Baseline, 3rd week and 6th week of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change is being assessed at the Baseline, 3rd week and 6th week of treatment
Goniometer	It measures spinal flexibility in "degree". The flexibility may start from 0 degree and the maximum depends on the flexibility of each participants	Change is being assessed at the Baseline, 3rd week and 6th week of treatment

Collaborators and Investigators

• Sponsor: Obafemi Awolowo University
• Investigators: Principal Investigator: Adesola O Ojoawo, PhD, Obafemi Awolowo University Ile Ife

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): February 12, 2022

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Low back pain; Disability; Pain Intensity; Manual Lumbar Traction; Prone Traction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Ojo/2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data are kept with the principal investigator. Whosoever is interested can contact him for information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No