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临床试验/NCT06903000
NCT06903000已完成不适用

Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functional Status, Proprioception, and Kinesiophobia in Individuals With Cervical Disc Herniation

Emre DANSUK1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
Assessment of Joint Position Sense (Proprioception)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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).

干预措施: a percussion massage gun (Device)

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).

干预措施: Conventional Exercise Group (Control) (Other)

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).

干预措施: Conventional Exercise Group (Control) (Other)

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).

干预措施: specially designed stainless-steel instruments (Device)

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.

干预措施: Conventional Exercise Group (Control) (Other)

结局指标

主要结局

Assessment of Joint Position Sense (Proprioception)

时间窗: 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.

次要结局

  • Pain Assessment (Visual Analog Scale - VAS)(3 weeks)
  • Neck Disability Index (NDI)(3 weeks)
  • Kinesiophobia Assessment (Tampa Scale for Kinesiophobia -TSK)(3 weeks)

研究者

发起方
Emre DANSUK
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emre DANSUK

Principal Investigator

Medipol University

研究点 (1)

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