NCT06903000

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 28, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

March 24, 2025

Last Update Submit

May 31, 2025

Conditions

Keywords

Cervical disc herniationNeck painInstrument-assisted soft tissue mobilizationVibration therapyProprioceptionKinesiophobiaPhysiotherapy

Outcome Measures

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.

    3 weeks

Secondary Outcomes (3)

  • Pain Assessment (Visual Analog Scale - VAS)

    3 weeks

  • Neck Disability Index (NDI)

    3 weeks

  • Kinesiophobia Assessment (Tampa Scale for Kinesiophobia -TSK)

    3 weeks

Study Arms (3)

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).

Device: a percussion massage gunOther: 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).

Device: specially designed stainless-steel instrumentsOther: 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.

Other: Conventional Exercise Group (Control)

Interventions

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.

Vibration Therapy 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.

Instrument-Assisted Soft Tissue Mobilization (IASTM) 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.

Conventional Exercise Group (Control)Instrument-Assisted Soft Tissue Mobilization (IASTM) GroupVibration Therapy Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emre Dansuk

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intervertebral Disc DisplacementNeck PainKinesiophobia

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Emre Dansuk, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

March 28, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations