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Recruiting Not applicable

IASTM and Vibration Effects on Pain, Functionality, and Kinesiophobia in Lumbar Disc Herniation

NCT07293676 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-05
Last updated
2026-03-27

Condition(s) studied

VibrationLumbar Disc HerniationSoft Tissue Mobilization

Investigational drug(s) / intervention(s)

ExerciseIASTMPercussion massage therapy

Exercise: The exercise program will be performed at home twice daily for a period of four weeks. Participants will begin with 10 repetitions, and the number of repetitions will be individualized based on each person's clinical condition. They will be advised to discontinue any exercises that cause pain. An illustrated exercise brochure will be provided, and weekly follow-up will be conducted through phone calls to ensure adherence. At the start of the program, participants will be instructed to lie supine on a flat surface, bend their knees, and place approximately 30 cm of support (such as two pillows) under their lower legs to achieve a relaxation position, holding it for 30 seconds. The exercise program will include hip flexor and lumbar extensor stretching, hamstring stretching, bridge exercises, erector spinae strengthening in the prone "superman" position, quadruped alternating arm-leg lifts, and cat-camel exercises.

IASTM: Instrument-assisted soft tissue mobilization will be administered twice a week for a total of eight sessions. The treatment will be performed using stainless steel tools of various sizes specifically designed for different anatomical regions. The intervention will target the iliocostalis lumborum, erector spinae, quadratus lumborum muscles, as well as both the superficial and deep fascia. Before beginning the procedure, a thin layer of petroleum jelly will be applied to the skin to ensure smooth gliding of the instrument. During the treatment, instrument-assisted mobilization will be applied over the muscle fibers using the sweep, fan, brush, and sweep techniques, with each technique performed for 8-10 repetitions. The total duration of the application will be six minutes.

Percussion massage therapy: Vibration massage therapy will be administered twice per week for a total of eight sessions. After positioning the participant in the prone position, the treatment session will begin. The vibration massage will be delivered using the Theragun™ device equipped with the No. 2 standard ball attachment, operating at a frequency of 1750 percussions per minute. The device will be held perpendicular to the muscle throughout the application, and no additional pressure other than the weight of the device itself-will be applied. Continuous contact between the massage gun and the skin will be maintained to ensure consistent pressure. The intervention will target the erector spinae and lumbar paravertebral muscles. A total of 10 minutes of percussion massage will be applied to the lateral portions of the lower back, with 5 minutes administered to each side. During the treatment, the device will be guided in a straight path from the distal toward the proximal region within approximately 30 seconds.

Study summary

The aim of this study is to investigate the effects of Instrument-Assisted Soft Tissue Mobilization and vibration massage therapy on pain, functionality, and kinesiophobia in individuals with lumbar disc herniation.

Eligibility

Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Individuals between 30 and 60 years of age * Individuals diagnosed with lumbar disc herniation at the protrusion level * Individuals with no cognitive, intellectual, or mental impairments and who are able to express themselves * Individuals with a VAS score greater than 5 * Individuals experiencing pain for at least 3 months Exclusion Criteria: * Individuals with a history of lumbar surgery * Individuals who are pregnant * Individuals who have had a spinal tumor or any other malignancy within the past six months * Individuals who have received physiotherapy for low back pain within the last six months * Individuals with orthopedic conditions such as fractures * Individuals diagnosed with neurological, rheumatological, or psychological disorders * Individuals with diagnoses such as infection, spondylosis, spondylolysis, osteoporosis, or ankylosing spondylitis will be excluded from the study.

Primary outcome measure(s)

  • Visual Analog Scale — From enrollment to the end of treatment at 4 weeks
    the Visual Analog Scale (VAS) will be used to assess pain intensity. VAS is a widely used tool in daily clinical practice for evaluating pain, and the average pain score ranges from 0 to 10. The VAS is typically defined as a 10-cm horizontal or vertical line that begins with "no pain" and ends with "unbearable pain." This line may be presented as a simple straight line or divided into equal segments. Participants will be asked to mark a point on the line that corresponds to the intensity of their pain. A score of "0" indicates no pain, scores of 1-4 represent mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 reflect severe pain.
  • Tampa Scale of Kinesiophobia — From enrollment to the end of treatment at 4 weeks
    The Tampa Scale of Kinesiophobia (TSK) will be used to assess kinesiophobia. This scale is commonly applied in individuals with acute and chronic low back pain, fibromyalgia, and musculoskeletal injuries. The TSK is a 17-item questionnaire developed to measure fear of movement and fear of reinjury, particularly in relation to work-related activities and fear-avoidance behaviors. It uses a 4-point Likert scoring system (1 = Strongly disagree, 4 = Strongly agree). The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
  • The Oswestry Disability Index — From enrollment to the end of treatment at 4 weeks
    The Oswestry Disability Index (ODI) will be used to assess functional status. The ODI consists of 10 items scored on a scale from 0 to 5 and evaluates pain and limitations in various daily activities in individuals with low back pain. A score of 5 represents the highest level of disability for each item. The maximum possible score is 100%, indicating complete disability. The total score is interpreted across five categories: 0-20% reflects minimal disability, 21-40% indicates moderate disability, 41-60% represents severe disability, 61-80% corresponds to crippled patients, and 81-100% indicates individuals who are bedbound due to their condition.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medipol University Istanbul Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293676 on ClinicalTrials.gov ↗ ← All trials in Turkey