Effect of Vibration Massager Therapy on Non-Specific Low Back Pain

February 26, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

Effect of Vibration Massager Therapy on Non-Specific Low Back Pain: A Randomized Controlled Trial

The main purpose of this study was to examine the effects of vibratory massage therapy on individuals with non-specific low back pain.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will be conducted using a randomized controlled design. Volunteers between the ages of 18-65 with non-specific low back pain will be included in the study. Inclusion criteria are that participants do not have structural pathologies and agree to participate in the study voluntarily. Exclusion criteria include spinal deformities and exercise intolerance. Participants will be randomly divided into two groups. Individuals in the first group will receive vibratory massage therapy, while the second group will be evaluated with standard treatment methods as a control. Both groups will receive treatment 3 times a week for 8 weeks. Participants' quality of life, pain levels, range of motion, and muscle activity will be evaluated before and after treatment. Data will be collected using tools such as SF-36, Oswestry Low Back Pain Index, and VAS (Visual Analog Scale).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having back pain for the last 3 months VAS >4
  • Between 18-65 years of age.
  • Volunteers for the study.
  • Not having undergone surgical intervention in the last 6 months
  • Individuals with structural amoli (e.g. spinal deformity).
  • Having chronic bone disease

Exclusion Criteria:

  • Not being able to cooperate
  • Presence of psychological problems
  • Use of sleeping pills,
  • Presence of neurological and orthopedic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
conventional physiotherapy
Conventional physiotherapy methods will be applied. Pain relief, electrotherapy, hot applications, ultrasound etc.
Experimental: vibration
vibration massage therapy in addition to conventional physiotherapy
Conventional physiotherapy methods will be applied. Pain relief, electrotherapy, hot applications, ultrasound etc.
The device-assisted massage therapy will be applied by the physiotherapist with its gun-shaped form that massages through vibration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 14 weeks
It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.
14 weeks
Pittsburgh Sleep Quality Index
Time Frame: 14 weeks
The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month. There are seven components in Pittsburg Sleep Quality Index. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ainaz Vahedi, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

April 20, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Uskudar20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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