VibrationNCT07293676
IASTM and Vibration Effects on Pain, Functionality, and Kinesiophobia in Lumbar Disc Herniation
A study testing Exercise, IASTM and Percussion massage therapy in people with Vibration and Lumbar Disc Herniation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vibration, Lumbar Disc Herniation, Soft Tissue Mobilization
- What is being tested?
- Exercise, IASTM and Percussion massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burak Menek, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, 34820
BURAK MENEK, PhD, +905444761640, bmenek@medipol.edu.tr
About this study
Official title: The Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functionality, and Kinesiophobia in Individuals With Lumbar Disc Herniation
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.
Read the detailed description
The aim of this study is to investigate the effects of Instrument-Assisted Soft Tissue Mobilization and Percussion massage therapy on pain, functionality, and kinesiophobia in individuals with lumbar disc herniation. In addition, participants will be randomly assigned to three groups Conventional Therapy, Percussion Massage Therapy, and IASTM and the study will aim to examine and compare the pre- and post-treatment effects of these three interventions on pain, functionality, and kinesiophobia.
- Conditions
- Vibration, Lumbar Disc Herniation, Soft Tissue Mobilization
- Being tested
- Exercise, IASTM, Percussion massage therapy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
IASTMOther
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 therapyOther
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 group | Role | What they receive |
|---|---|---|
| Conventional exercise group | Active comparator | The exercise program will be performed at home for four weeks, twice daily. Exercise progression will begin with 10 repetitions and will be individualized according to each participant's condition. Exercises that provoke pain will be discontinued as advised. Participants will be provided with an illustrated exercise brochure, and follow-up will be conducted once a week through phone calls.
First, participants will be instructed to lie on their backs on a flat surface with their knees bent, placing approximately a 30 cm elevation (such as two pillows) under the calves to assume a relaxation position and maintain it for 30 seconds. The exercise program will include hip flexor and lumbar extensor stretching, hamstring stretching, bridge exercises, erector spinae strengthening (prone superman), quadruped alternating arm-leg raises, and cat-camel exercises. Receives: Other: Exercise |
| IASTM Group | Experimental | Instrument-assisted soft tissue mobilization treatment will be applied twice per week for a total of eight sessions. The intervention will be performed using stainless-steel tools of various sizes specifically designed for different anatomical regions (Figure 2). Instrument-assisted soft tissue mobilization will be administered to the iliocostalis lumborum, erector spinae, and quadratus lumborum muscles, as well as to the superficial and deep fascia. Before the application, a thin layer of petroleum jelly will be applied to the area to facilitate smooth gliding of the instrument.
The IASTM treatment will be delivered for a total of six minutes, with each technique (sweep, fan, brush, and sweep) being performed for 8-10 repetitions along the affected muscle fibers. Receives: Other: Exercise; Other: IASTM |
| Percussion Massage Therapy Group | Experimental | Vibration massage therapy will be applied twice per week for a total of eight sessions. After positioning the participant in the prone position, the session will begin. For vibration massage, the No. 2 standard ball attachment of the Theragun™ and the Theragun Pro device, which provides 1750 percussions per minute, will be used. The Theragun will be held perpendicular to the muscle at all times, and no additional pressure other than the weight of the device itself will be applied. Throughout the procedure, the massage gun will be kept in continuous contact with the skin, maintaining consistent pressure.
The vibration massage will be administered to the erector spinae and lumbar paravertebral muscle groups. A total of 10 minutes of percussion massage will be applied to the lateral portions of the lower back erector spinae muscles (5 minutes on each side), and the massage gun will be moved in a straight line from the distal to the proximal direction within approximately 30 seconds. Receives: Other: Exercise; Other: Percussion massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: From enrollment to the end of treatment at 4 weeks
Tampa Scale of Kinesiophobia
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.
Measured: From enrollment to the end of treatment at 4 weeks
The Oswestry Disability Index
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start5 Jan 2026
- Primary completion10 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VibrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burak menek, Istanbul Medipol University Hospital
- Investigators
- Burak Menek, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293676
- Sponsor's protocol ID
- E-10840098-202.3.02-1887
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functionality, and Kinesiophobia in Individuals With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07293676
- Acronym / sponsor ID
- E-10840098-202.3.02-1887
- Conditions
- Vibration, Lumbar Disc Herniation, Soft Tissue Mobilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to investigate the effects of Instrument-Assisted Soft Tissue Mobilization and Percussion massage therapy on pain, functionality, and kinesiophobia in individuals with lumbar disc herniation. In addition, participants will be randomly assigned to three groups Conventional Therapy, Percussion Massage Therapy, and IASTM and the study will aim to examine and compare the pre- and post-treatment effects of these three interventions on pain, functionality, and kinesiophobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional exercise group | Active comparator | Other: ExerciseThe exercise program will be performed at home for four weeks, twice daily. Exercise progression will begin with 10 repetitions and will be individualized according to each participant's condition. Exercises that provoke pain will be discontinued as advised. Participants will be provided with an illustrated exercise brochure, and follow-up will be conducted once a week through phone calls. First, participants will be instructed to lie on their backs on a flat surface with their knees bent, placing approximately a 30 cm elevation (such as two pillows) under the calves to assume a relaxation position and maintain it for 30 seconds. The exercise program will include hip flexor and lumbar extensor stretching, hamstring stretching, bridge exercises, erector spinae strengthening (prone superman), quadruped alternating arm-leg raises, and cat-camel exercises. |
| IASTM Group | Experimental | Other: Exercise, Other: IASTMInstrument-assisted soft tissue mobilization treatment will be applied twice per week for a total of eight sessions. The intervention will be performed using stainless-steel tools of various sizes specifically designed for different anatomical regions (Figure 2). Instrument-assisted soft tissue mobilization will be administered to the iliocostalis lumborum, erector spinae, and quadratus lumborum muscles, as well as to the superficial and deep fascia. Before the application, a thin layer of petroleum jelly will be applied to the area to facilitate smooth gliding of the instrument. The IASTM treatment will be delivered for a total of six minutes, with each technique (sweep, fan, brush, and sweep) being performed for 8-10 repetitions along the affected muscle fibers. |
| Percussion Massage Therapy Group | Experimental | Other: Exercise, Other: Percussion massage therapyVibration massage therapy will be applied twice per week for a total of eight sessions. After positioning the participant in the prone position, the session will begin. For vibration massage, the No. 2 standard ball attachment of the Theragun™ and the Theragun Pro device, which provides 1750 percussions per minute, will be used. The Theragun will be held perpendicular to the muscle at all times, and no additional pressure other than the weight of the device itself will be applied. Throughout the procedure, the massage gun will be kept in continuous contact with the skin, maintaining consistent pressure. The vibration massage will be administered to the erector spinae and lumbar paravertebral muscle groups. A total of 10 minutes of percussion massage will be applied to the lateral portions of the lower back erector spinae muscles (5 minutes on each side), and the massage gun will be moved in a straight line from the distal to the proximal direction within approximately 30 seconds. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Conventional exercise group, IASTM Group, Percussion Massage Therapy Group |
| IASTMInstrument-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. | Other | IASTM Group |
| Percussion massage therapyVibration 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. | Other | Percussion Massage Therapy Group |
Primary outcome
Visual Analog Scale
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burak Menek, PhD contact
Burak Menek principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, IASTM and Percussion massage therapy in people with Vibration and Lumbar Disc Herniation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlayda Gundogmus (+90 534 434 99 34, ilayda.gundogmus@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.