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CompletedNCT06903000Updated Jun 4, 2025

Effects of IASTM and Vibration Therapy in Cervical Disc Herniation

An interventional study of a percussion massage gun and specially designed stainless-steel instruments in Intervertebral Disc Displacement and Neck Pain, sponsored by Emre DANSUK. Completed at 1 site in Turkey. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Emre DANSUK · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intervertebral Disc Displacement
  • Neck Pain

Keywords

  • Cervical disc herniation
  • Neck pain
  • Instrument-assisted soft tissue mobilization
  • Vibration therapy
  • Proprioception
  • Kinesiophobia
  • Physiotherapy
03

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • 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).

    Device: a percussion massage gun · Other: Conventional Exercise Group (Control)

  • 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).

    Device: specially designed stainless-steel instruments · Other: Conventional Exercise Group (Control)

  • 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.

    Other: Conventional Exercise Group (Control)

Interventions

  • Devicea percussion massage gun

    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.

  • Devicespecially designed stainless-steel instruments

    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.

  • OtherConventional 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 weeks

Secondary outcomes

  1. 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.

    Time frame: 3 weeks

  2. 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.

    Time frame: 3 weeks

  3. 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.

    Time frame: 3 weeks

06

Study locations

1 site
  • Emre Dansuk
    Istanbul, Beykoz 34815, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06903000
Lead sponsor
Emre DANSUK
Responsible party
Emre DANSUK (Principal Investigator, Medipol University) — Sponsor-investigator
First posted
Mar 30, 2025
Start date
Mar 28, 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025
Last update
Jun 4, 2025

Study contacts

Emre Dansuk, PhD
principal investigator · Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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