NCT05518552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 23, 2022

Last Update Submit

August 25, 2022

Conditions

Keywords

Manual Lumbar TractionProne TractionPain IntensityLow back painDisability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Roland Morris low back pain Disability questionnaire

    Change is being assessed at the Baseline, 3rd week and 6th week of treatment

  • Goniometer

    Change is being assessed at the Baseline, 3rd week and 6th week of treatment

Study Arms (2)

manual Lumbar Traction

EXPERIMENTAL

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

Prone traction

EXPERIMENTAL

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

Other: Prone traction

Interventions

Patient in the group were treated with manual traction

manual Lumbar Traction

Patient in the group were placed on prone traction

Prone traction

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obafemi Awolowo University

Ile-Ife, Osun State, 220005, Nigeria

Location

Related Publications (2)

  • 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.

    PMID: 15066687BACKGROUND
  • 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.

    PMID: 12384756BACKGROUND

MeSH Terms

Conditions

PainLow Back Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Officials

  • Adesola O Ojoawo, PhD

    Obafemi Awolowo University Ile Ife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 26, 2022

Study Start

January 25, 2019

Primary Completion

December 18, 2019

Study Completion

February 12, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

The data are kept with the principal investigator. Whosoever is interested can contact him for information

Locations