Intervertebral Disc DisplacementNCT06903000
Effects of IASTM and Vibration Therapy in Cervical Disc Herniation
A study testing a percussion massage gun and specially designed stainless-steel instruments in people with Intervertebral Disc Displacement and Neck Pain, run by Emre DANSUK at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of instrument-assisted soft tissue mobilization (IASTM) and percussion massage therapy on pain, functional status, proprioception, and kinesiophobia in individuals with cervical 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
- Intervertebral Disc Displacement, Neck Pain
- What is being tested?
- a percussion massage gun and specially designed stainless-steel instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have a diagnosis of cervical disc herniation.
- Have a complaint of neck pain lasting at least 3 weeks.
- Have a restriction in cervical range of motion.
Who cannot join
- Have any additional orthopedic or neurological disorders besides cervical problems.
- Have a history of previous trauma to the cervical region.
- Have received physiotherapy within the past 6 months.
- Are unable to tolerate vibration therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functional Status, Proprioception, and Kinesiophobia in Individuals With Cervical Disc Herniation
This study investigates the effects of instrument-assisted soft tissue mobilization (IASTM) and percussion massage therapy on pain, functional status, proprioception, and kinesiophobia in individuals with cervical disc herniation. A total of 66 participants diagnosed with cervical disc herniation will be randomly divided into three groups: vibration therapy, IASTM, and conventional exercise. Each group will receive conventional physiotherapy, while the intervention groups will additionally receive their respective therapies. Outcomes will be measured using the Visual Analog Scale (VAS), Neck Disability Index (NDI), Laser Pointer Joint Position Sense Test, and Tampa Scale for Kinesiophobia (TSK). The aim is to evaluate and compare the effectiveness of both therapies in reducing pain, improving functionality and proprioception, and decreasing fear of movement.
Read the detailed description
Cervical disc herniation is a common musculoskeletal condition that causes significant pain and functional limitations, often affecting individuals in their middle ages and those working in sedentary occupations. This study aims to investigate the therapeutic effects of two modern physical therapy techniques-Instrument-Assisted Soft Tissue Mobilization (IASTM) and percussion-based vibration therapy-on pain, functional capacity, proprioception, and kinesiophobia in individuals with cervical disc herniation.
A total of 66 participants diagnosed with cervical disc herniation will be recruited and randomly assigned to one of three groups: (1) Vibration Therapy Group, (2) IASTM Group, and (3) Conventional Exercise Group. All participants will receive standard physiotherapy, including thermotherapy, TENS, and range of motion exercises. Intervention groups will additionally receive either percussion massage therapy (3 sessions/week for 3 weeks) or IASTM (3 sessions/week for 3 weeks), targeting the cervical and upper back musculature.
Outcome measures will include the Visual Analog Scale (VAS) for pain, the Neck Disability Index (NDI) for functional assessment, a Laser Pointer Joint Position Sense Test for proprioception, and the Tampa Scale for Kinesiophobia (TSK) to assess fear of movement. The study seeks to compare the effectiveness of these approaches in improving clinical outcomes and contributing to evidence-based rehabilitation strategies for individuals with cervical disc pathology.
- Conditions
- Intervertebral Disc Displacement, Neck Pain
- Being tested
- a percussion massage gun, specially designed stainless-steel instruments, Conventional Exercise Group (Control)
- Keywords
- Cervical disc herniation, Neck pain, Instrument-assisted soft tissue mobilization, Vibration therapy, Proprioception, Kinesiophobia, Physiotherapy
- Medical subject headings
- Intervertebral Disc Displacement, Neck Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a percussion massage gunDevice
Participants in this group will receive percussion-based vibration therapy applied using a percussion massage device (Compex Fix 2.0) with a soft head attachment. Therapy will target trapezius, levator scapula, and cervical paravertebral muscles along their origin-insertion lines for 3 minutes per muscle group.
specially designed stainless-steel instrumentsDevice
Participants will receive instrument-assisted soft tissue mobilization applied using specially designed stainless-steel instruments. Techniques (Sweep, Fan, Brush) will be applied to cervical and upper-back musculature (splenius, suboccipital, upper-middle-lower trapezius) and related fascia between C1-T1 vertebrae, parallel to muscle fibers for approximately 6 minutes per session. Each technique will consist of 8-10 repetitions.
Conventional Exercise Group (Control)Other
Participants in this control group will receive conventional physiotherapy treatment alone. The treatment includes heat therapy applied to the cervical region for 20 minutes, TENS application at a frequency of 100 Hz to painful areas, ROM exercises performed in all cervical directions (2 sets of 10 repetitions, 2-second holds at end-range), and isometric strengthening exercises in cervical flexion, extension, and lateral flexion directions (2 sets of 10 repetitions, 6-second holds per repetition). Sessions will take place 4 days per week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vibration Therapy Group | Experimental | Participants in this group will receive percussion-based vibration therapy applied using a percussion massage device (Compex Fix 2.0) with a soft head attachment. Therapy will target trapezius, levator scapula, and cervical paravertebral muscles along their origin-insertion lines for 3 minutes per muscle group. Sessions will be conducted 3 days per week over 3 weeks, alongside conventional physiotherapy, including heat therapy (20 min), Transcutaneous Electrical Nerve Stimulation (TENS - 100 Hz), range-of-motion (ROM) exercises (2 sets of 10 repetitions, 2-second holds at end-range), and isometric strengthening exercises (2 sets of 10 repetitions, 6-second holds per direction). Receives: Device: a percussion massage gun; Other: Conventional Exercise Group (Control) |
| Instrument-Assisted Soft Tissue Mobilization (IASTM) Group | Experimental | Participants will receive instrument-assisted soft tissue mobilization applied using specially designed stainless-steel instruments. Techniques (Sweep, Fan, Brush) will be applied to cervical and upper-back musculature (splenius, suboccipital, upper-middle-lower trapezius) and related fascia between C1-T1 vertebrae, parallel to muscle fibers for approximately 6 minutes per session. Each technique will consist of 8-10 repetitions. Treatments will occur 3 sessions per week for 3 weeks, alongside conventional physiotherapy interventions (heat therapy for 20 minutes, TENS at 100 Hz, ROM exercises, and isometric strengthening exercises as described above). Receives: Device: specially designed stainless-steel instruments; Other: Conventional Exercise Group (Control) |
| Conventional Exercise Group (Control) | Active comparator | Participants in this control group will receive conventional physiotherapy treatment alone. The treatment includes heat therapy applied to the cervical region for 20 minutes, TENS application at a frequency of 100 Hz to painful areas, ROM exercises performed in all cervical directions (2 sets of 10 repetitions, 2-second holds at end-range), and isometric strengthening exercises in cervical flexion, extension, and lateral flexion directions (2 sets of 10 repetitions, 6-second holds per repetition). Sessions will take place 4 days per week for 3 weeks. Receives: Other: Conventional Exercise Group (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Joint Position Sense (Proprioception)
This assessment measures joint position sense-a component of proprioception-which provides information regarding the speed and direction of active and passive movements without visual cues.Participants will be seated at a distance of 100 cm from a target board measuring 90x80 cm. A laser pointer will be secured to the participant's head using a suitable headband. Participants will initially align the laser pointer vertically onto the center (origin) of the target board with their eyes open. They will then flex their head forward and subsequently return to the neutral position, realigning the pointer to the center. Next, participants will repeat the same process with their eyes closed. After performing cervical flexion, they will attempt to return their head to the perceived neutral position without visual assistance. The deviation from the origin will be measured and recorded as an indicator of joint position sense accuracy.
Measured: 3 weeks
Secondary outcomes (3)
Pain Assessment (Visual Analog Scale - VAS)
The Visual Analog Scale (VAS) will be used to evaluate participants' pain intensity. The VAS consists of a horizontal line measuring 10 cm, where '0' represents "no pain" and '10' represents "unbearable pain." Participants will be asked to mark the point that represents their perceived level of pain on this scale. The distance from the starting point (0 cm) to the participant's mark will be measured with a ruler and recorded.
Measured: 3 weeks
Neck Disability Index (NDI)
The Neck Disability Index (NDI) will be used to assess participants' functional limitations related to neck pain. Developed by Vernon and Mior, the NDI is a reliable, valid, and easy-to-administer questionnaire adapted and validated for use in Turkey. It comprises 10 sections evaluating the severity of pain, lifting, reading, headaches, personal care, work activities, concentration, sleep, recreational activities, and driving. Each section offers six responses scored from 0 to 5. A score of 0 indicates no pain or functional limitation, whereas a score of 5 indicates maximum pain and severe limitation in daily activities.
Measured: 3 weeks
Kinesiophobia Assessment (Tampa Scale for Kinesiophobia -TSK)
Participants' kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). This scale, originally developed by Kori et al. in 1990 and validated for use in Turkish, consists of 17 questions designed to measure participants' fear of movement. Responses are scored on a 4-point Likert scale: "strongly disagree" (1), "disagree" (2), "agree" (3), and "strongly agree" (4). Items 4, 8, 12, and 16 are reverse-scored before calculating the total score. Total scores range between 17 and 68, with higher scores indicating a greater degree of kinesiophobia.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start28 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc DisplacementStudies 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emre DANSUK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre DANSUK, Medipol University
- Investigators
- Emre Dansuk, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903000
- Sponsor's protocol ID
- E-10840098-202.3.02-1924
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menek B, Dansuk E, Gorguluer S. Instrument-assisted soft tissue mobilization and percussion massage therapy in cervical disc herniation: a randomized controlled study. J Orthop Surg Res. 2025 Aug 30;20(1):801. doi: 10.1186/s13018-025-06238-5.
PubMed 40886005
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functional Status, Proprioception, and Kinesiophobia in Individuals With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT06903000
- Acronym / sponsor ID
- E-10840098-202.3.02-1924
- Conditions
- Intervertebral Disc Displacement, Neck Pain
- Keywords
- Cervical disc herniation, Neck pain, Instrument-assisted soft tissue mobilization, Vibration therapy, Proprioception, Kinesiophobia, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Emre DANSUKUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 30 Mar 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.
This study investigates the effects of instrument-assisted soft tissue mobilization (IASTM) and percussion massage therapy on pain, functional status, proprioception, and kinesiophobia in individuals with cervical disc herniation. A total of 66 participants diagnosed with cervical disc herniation will be randomly divided into three groups: vibration therapy, IASTM, and conventional exercise. Each group will receive conventional physiotherapy, while the intervention groups will additionally receive their respective therapies. Outcomes will be measured using the Visual Analog Scale (VAS), Neck Disability Index (NDI), Laser Pointer Joint Position Sense Test, and Tampa Scale for Kinesiophobia (TSK). The aim is to evaluate and compare the effectiveness of both therapies in reducing pain, improving functionality and proprioception, and decreasing fear of movement.
Detailed description
Cervical disc herniation is a common musculoskeletal condition that causes significant pain and functional limitations, often affecting individuals in their middle ages and those working in sedentary occupations. This study aims to investigate the therapeutic effects of two modern physical therapy techniques-Instrument-Assisted Soft Tissue Mobilization (IASTM) and percussion-based vibration therapy-on pain, functional capacity, proprioception, and kinesiophobia in individuals with cervical disc herniation.
A total of 66 participants diagnosed with cervical disc herniation will be recruited and randomly assigned to one of three groups: (1) Vibration Therapy Group, (2) IASTM Group, and (3) Conventional Exercise Group. All participants will receive standard physiotherapy, including thermotherapy, TENS, and range of motion exercises. Intervention groups will additionally receive either percussion massage therapy (3 sessions/week for 3 weeks) or IASTM (3 sessions/week for 3 weeks), targeting the cervical and upper back musculature.
Outcome measures will include the Visual Analog Scale (VAS) for pain, the Neck Disability Index (NDI) for functional assessment, a Laser Pointer Joint Position Sense Test for proprioception, and the Tampa Scale for Kinesiophobia (TSK) to assess fear of movement. The study seeks to compare the effectiveness of these approaches in improving clinical outcomes and contributing to evidence-based rehabilitation strategies for individuals with cervical disc pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Vibration Therapy Group | Experimental | Device: a percussion massage gun, Other: Conventional Exercise Group (Control)Participants in this group will receive percussion-based vibration therapy applied using a percussion massage device (Compex Fix 2.0) with a soft head attachment. Therapy will target trapezius, levator scapula, and cervical paravertebral muscles along their origin-insertion lines for 3 minutes per muscle group. Sessions will be conducted 3 days per week over 3 weeks, alongside conventional physiotherapy, including heat therapy (20 min), Transcutaneous Electrical Nerve Stimulation (TENS - 100 Hz), range-of-motion (ROM) exercises (2 sets of 10 repetitions, 2-second holds at end-range), and isometric strengthening exercises (2 sets of 10 repetitions, 6-second holds per direction). |
| Instrument-Assisted Soft Tissue Mobilization (IASTM) Group | Experimental | Device: specially designed stainless-steel instruments, Other: Conventional Exercise Group (Control)Participants will receive instrument-assisted soft tissue mobilization applied using specially designed stainless-steel instruments. Techniques (Sweep, Fan, Brush) will be applied to cervical and upper-back musculature (splenius, suboccipital, upper-middle-lower trapezius) and related fascia between C1-T1 vertebrae, parallel to muscle fibers for approximately 6 minutes per session. Each technique will consist of 8-10 repetitions. Treatments will occur 3 sessions per week for 3 weeks, alongside conventional physiotherapy interventions (heat therapy for 20 minutes, TENS at 100 Hz, ROM exercises, and isometric strengthening exercises as described above). |
| Conventional Exercise Group (Control) | Active comparator | Other: Conventional Exercise Group (Control)Participants in this control group will receive conventional physiotherapy treatment alone. The treatment includes heat therapy applied to the cervical region for 20 minutes, TENS application at a frequency of 100 Hz to painful areas, ROM exercises performed in all cervical directions (2 sets of 10 repetitions, 2-second holds at end-range), and isometric strengthening exercises in cervical flexion, extension, and lateral flexion directions (2 sets of 10 repetitions, 6-second holds per repetition). Sessions will take place 4 days per week for 3 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have a diagnosis of cervical disc herniation.
- Have a complaint of neck pain lasting at least 3 weeks.
- Have a restriction in cervical range of motion.
Key exclusion criteria (4 listed)
- Have any additional orthopedic or neurological disorders besides cervical problems.
- Have a history of previous trauma to the cervical region.
- Have received physiotherapy within the past 6 months.
- Are unable to tolerate vibration therapy.
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 |
|---|---|---|
| a percussion massage gunParticipants in this group will receive percussion-based vibration therapy applied using a percussion massage device (Compex Fix 2.0) with a soft head attachment. Therapy will target trapezius, levator scapula, and cervical paravertebral muscles along their origin-insertion lines for 3 minutes per muscle group. | Device | Vibration Therapy Group |
| specially designed stainless-steel instrumentsParticipants will receive instrument-assisted soft tissue mobilization applied using specially designed stainless-steel instruments. Techniques (Sweep, Fan, Brush) will be applied to cervical and upper-back musculature (splenius, suboccipital, upper-middle-lower trapezius) and related fascia between C1-T1 vertebrae, parallel to muscle fibers for approximately 6 minutes per session. Each technique will consist of 8-10 repetitions. | Device | Instrument-Assisted Soft Tissue Mobilization (IASTM) Group |
| Conventional Exercise Group (Control)Participants in this control group will receive conventional physiotherapy treatment alone. The treatment includes heat therapy applied to the cervical region for 20 minutes, TENS application at a frequency of 100 Hz to painful areas, ROM exercises performed in all cervical directions (2 sets of 10 repetitions, 2-second holds at end-range), and isometric strengthening exercises in cervical flexion, extension, and lateral flexion directions (2 sets of 10 repetitions, 6-second holds per repetition). Sessions will take place 4 days per week for 3 weeks. | Other | Conventional Exercise Group (Control), Instrument-Assisted Soft Tissue Mobilization (IASTM) Group, Vibration Therapy Group |
Primary outcome
Assessment of Joint Position Sense (Proprioception)
Time frame: 3 weeks
This assessment measures joint position sense-a component of proprioception-which provides information regarding the speed and direction of active and passive movements without visual cues.Participants will be seated at a distance of 100 cm from a target board measuring 90x80 cm. A laser pointer will be secured to the participant's head using a suitable headband. Participants will initially align the laser pointer vertically onto the center (origin) of the target board with their eyes open. They will then flex their head forward and subsequently return to the neutral position, realigning the pointer to the center. Next, participants will repeat the same process with their eyes closed. After performing cervical flexion, they will attempt to return their head to the perceived neutral position without visual assistance. The deviation from the origin will be measured and recorded as an indicator of joint position sense accuracy.
3 secondary outcomes
Pain Assessment (Visual Analog Scale - VAS)
Time frame: 3 weeks
Neck Disability Index (NDI)
Time frame: 3 weeks
Kinesiophobia Assessment (Tampa Scale for Kinesiophobia -TSK)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 40886005Menek B, Dansuk E, Gorguluer S. Instrument-assisted soft tissue mobilization and percussion massage therapy in cervical disc herniation: a randomized controlled study. J Orthop Surg Res. 2025 Aug 30;20(1):801. doi: 10.1186/s13018-025-06238-5.
- 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. This study is not recruiting at the moment.
Emre Dansuk, PhD principal investigator
Medipol 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 a percussion massage gun and specially designed stainless-steel instruments in people with Intervertebral Disc Displacement and Neck Pain, run by Emre DANSUK 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Joint Position Sense (Proprioception) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903000, which also lists 1 linked publication.
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 4 Jun 2025.