NCT06840795

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2025

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

February 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

February 17, 2025

Last Update Submit

September 3, 2026

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Oswestry Low Back Pain Disability Questionnaire

    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.

    Baseline and 8 weeks

Secondary Outcomes (2)

  • Pittsburgh Sleep Quality Index

    Baseline and 8 weeks

  • Visual Analog Scale

    Baseline and 8 weeks

Study Arms (2)

CPT alone

ACTIVE COMPARATOR

conventional physiotherapy

Other: conventional physiotherapy

PVT + CPT

EXPERIMENTAL

vibration massage therapy in addition to conventional physiotherapy

Other: conventional physiotherapyOther: State the device (Theragun PRO Plus)

Interventions

conventional physiotherapyOTHER

Conventional physiotherapy methods will be applied. Pain relief, electrotherapy, hot applications, ultrasound etc.

CPT alonePVT + CPT
State the device (Theragun PRO Plus)OTHER

30-40 Hz, 10 min per session, and the treated regions; for CPT, hot pack 20 min + TENS 20 min + ultrasound \~8 min + supervised exercise. Must match the manuscript exactly.

PVT + CPT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Structural spinal pathology or deformity.
  • Recent spinal surgery.
  • Chronic bone disease.
  • Neurological or orthopedic disorders that could interfere with the assessments or treatment program.
  • Use of hypnotic medication.
  • Psychological or cognitive conditions that could prevent informed participation or completion of the assessments.
  • Inability to cooperate with the study procedures.
  • The diagnosis of CNLBP and the absence of suspected serious spinal pathology were determined based on: (Medical history ,Clinical examination ,Available medical records)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Volt Therapy Health Medical and Consulting Ltd.

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 36237646BACKGROUND

  • 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.

    PMID: 37752526BACKGROUND

  • 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.

    PMID: 37248364BACKGROUND

  • 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.

    PMID: 33239942BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ainaz Vahedi

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 21, 2025

Study Start

March 1, 2025

Primary Completion

May 10, 2025

Study Completion

February 15, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)