Efficacy of Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain

Sponsor
Afyonkarahisar Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT05617924
Collaborator
(none)
160
1
1
157.1

Study Details

Study Description

Brief Summary

Motorized traction and non-surgical spinal decompression treatments are relatively new treatments for which there is insufficient evidence in the literature. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Physical Therapy

Detailed Description

Low back pain is one of the leading causes of disability worldwide. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greater risk for low back pain. Anatomical structures that potentially nociceptive contributors to low back pain are intervertebral discs, facet joints, and vertebral end plates. It has been determined that nonsurgical treatments are clinically effective in reducing pain and functional improvement in patients with lumbar disc herniation. However, the level of evidence has generally not been highly evaluated, which can be attributed to the paucity of well designed randomized controlled trials. Despite moderate evidence, exercise and traction are recommended. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.

01.01.2019-10.11.2022. Investigators planned to examine the records of patients aged 20-75 years who underwent physical therapy with the diagnosis of lumbar discopathy in AFSU FTR Department Physical Therapy Unit. Investigators planned to examine the routine anamnesis examination, treatment card and control evaluation records of the patients made in the FTR outpatient clinic from the automation system of their hospital.

Study Design

Study Type:
Observational
Actual Enrollment :
160 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Comparison of the Efficacy of Conventional Physiotherapy, Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
Actual Study Start Date :
Dec 15, 2022
Actual Primary Completion Date :
Jan 15, 2023
Actual Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Conventional Physiotherapy

Treatment method using physical agents such as analgesic currents and superficial-deep heaters

Procedure: Physical Therapy
Therapy methods using physical agents in treatment

Mechanical Traction

It is a stretching process for the spine with a weight and pulling system for the spine.

Procedure: Physical Therapy
Therapy methods using physical agents in treatment

Nonsurgical Spinal Decompression

Non-surgical spinal decompression is a technique that uses a precision computerized mechanism and opens spinal nerve roots through segmental distraction.

Procedure: Physical Therapy
Therapy methods using physical agents in treatment

Outcome Measures

Primary Outcome Measures

  1. Visual Pain Scale (VAS) [5 minutes]

    Visual Pain Scale (VAS), which is easy to understand, apply and interpret, provides valid and reliable data in a short time, is the most used method in clinics. With a visual linear scale of 100 mm, the patient is told that there is no pain at the 0 point, and the most severe pain ever felt in life at the 100 point, and the patient is asked to put a mark on the point corresponding to his or her pain.

  2. Oswestry Disability Index [20 minutes]

    The Oswestry Disability Index was first described in 1980. The questionnaire consists of 10 items addressing different aspects of the function. Each item was scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage. Turkish validity and reliability have been demonstrated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients diagnosed with lumbar disc disorders

  • Patients diagnosed with lumbar vertical hernia

  • Aged 20-75 years

Exclusion Criteria:
  • Patients treated for acute low back pain

  • Patients with a history of lumbar surgery

  • Patients with Spondylolisthesis or Spinal Stenosis

  • Those with inflammatory rheumatic diseases (Ankylosing spondylitis, spondylarthropathy etc.)

  • Patients with sequestered hernia

  • Patients with insufficient data in the records

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sevda Adar Afyonkarahisar Turkey 03100

Sponsors and Collaborators

  • Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: SEVDA ADAR, Afyonkarahisar Health Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sevda Adar, assistant professor, Afyonkarahisar Health Sciences University
ClinicalTrials.gov Identifier:
NCT05617924
Other Study ID Numbers:
  • SALBP
First Posted:
Nov 16, 2022
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2023