NCT05617924

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

November 8, 2022

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Conventional Physiotherapy

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

Procedure: Physical Therapy

Mechanical Traction

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

Procedure: Physical Therapy

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

Interventions

Therapy methods using physical agents in treatment

Conventional PhysiotherapyMechanical TractionNonsurgical Spinal Decompression

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 20-75 who underwent physical therapy with the diagnosis of Lumbar discopathy in Afyonkarahisar Health Sciences University, Department of Physical Medicine and Rehabilitation Physical Therapy Unit between 01.01.2019-10.11.2022.

You may qualify if:

  • Patients diagnosed with lumbar disc disorders
  • Patients diagnosed with lumbar vertical hernia
  • Aged 20-75 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevda Adar

Afyonkarahisar, 03100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainIntervertebral disc diseaseIntervertebral Disc DisplacementRadiculopathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • SEVDA ADAR

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

December 15, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations