- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06840795
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
Intervention / Treatment
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
- Name: Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Uskudar University
-
Contact:
- Ömer Şevgi
- Email: omer.sevgin@uskudar.edu.tr
-
-
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.
Sponsor
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.
General Publications
- Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
- Lupowitz L. Vibration Therapy - A Clinical Commentary. Int J Sports Phys Ther. 2022 Aug 1;17(6):984-987. doi: 10.26603/001c.36964. eCollection 2022. No abstract available.
- Li Q, Liu P, Wang Z, Li X. Vibration therapy to improve pain and function in patients with chronic low back pain: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Sep 26;18(1):727. doi: 10.1186/s13018-023-04217-2.
- Leabeater AJ, Clarke AC, James L, Huynh M, Driller M. Under the Gun: Percussive Massage Therapy and Physical and Perceptual Recovery in Active Adults. J Athl Train. 2024 Mar 1;59(3):310-316. doi: 10.4085/1062-6050-0041.23.
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Riphah International UniversityCompletedChronic Neck PainPakistan
Clinical Trials on conventional physiotherapy
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaCompleted
-
Pamukkale UniversityCompletedChronic Low-back PainTurkey
-
Kirsehir Ahi Evran UniversitesiEnrolling by invitation
-
University of LahoreRecruitingHypotonic Cerebral PalsyPakistan
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus
-
Biruni UniversityCompletedPain | Physical Therapy | Nonspecific Chronic Low Back Pain | Manuel TherapyTurkey (Türkiye)
-
International Hellenic UniversityRecruiting
-
Kutahya Health Sciences UniversityRecruitingAnterior Cruciate Ligament InjuriesTurkey
-
Bezmialem Vakif UniversityCompleted