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Completed

NCT Number: NCT06840795

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

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Volt Therapy Health Medical and Consulting Ltd.

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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)

Treatment and study plan

Conventional Physiotherapy

Other

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

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.

Primary outcomes

  1. Oswestry Low Back Pain Disability Questionnaire

    Time frame: Baseline and 8 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.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: Baseline and 8 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.

  2. Visual Analog Scale

    Time frame: Baseline and 8 weeks

    1=no pain, 10=worst pain

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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