- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06903000
Effects of IASTM and Vibration Therapy in Cervical Disc Herniation
Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functional Status, Proprioception, and Kinesiophobia in Individuals With Cervical Disc Herniation
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beykoz
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Istanbul, Beykoz, Turkey, 34815
- Emre Dansuk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vibration Therapy Group
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).
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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.
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.
|
|
Experimental: Instrument-Assisted Soft Tissue Mobilization (IASTM) Group
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).
|
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.
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Assessment (Visual Analog Scale - VAS)
Time Frame: 3 weeks
|
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.
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3 weeks
|
|
Neck Disability Index (NDI)
Time Frame: 3 weeks
|
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.
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3 weeks
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Kinesiophobia Assessment (Tampa Scale for Kinesiophobia -TSK)
Time Frame: 3 weeks
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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.
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3 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emre Dansuk, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-1924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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