- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617924
Efficacy of Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
Comparison of the Efficacy of Conventional Physiotherapy, Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Afyonkarahisar, Turkey, 03100
- Recruiting
- Sevda Adar
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Conventional Physiotherapy
Treatment method using physical agents such as analgesic currents and superficial-deep heaters
|
Therapy methods using physical agents in treatment
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Mechanical Traction
It is a stretching process for the spine with a weight and pulling system for the spine.
|
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.
|
Therapy methods using physical agents in treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Pain Scale (VAS)
Time Frame: 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.
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5 minutes
|
Oswestry Disability Index
Time Frame: 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.
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20 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SALBP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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