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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05617924
Other study ID # SALBP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date January 15, 2023

Study information

Verified date January 2023
Source Afyonkarahisar Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date January 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Intervention

Procedure:
Physical Therapy
Therapy methods using physical agents in treatment

Locations

Country Name City State
Turkey Sevda Adar Afyonkarahisar

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Pain Scale (VAS) 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. 5 minutes
Primary Oswestry Disability Index 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. 20 minutes
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