Investigation of the Effects of Different Myofascial Release Techniques on Functional Outcomes in Individuals With Chronic Non-Specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (Visual Analog Scale, VAS)
研究概览
简要总结
This single-center, three-arm randomized controlled trial compares the effects of different myofascial release techniques, combined with a structured exercise program, on functional outcomes in individuals with chronic non-specific neck pain (CNNP).
Eligible participants (aged 18 to 45 years, neck pain for at least 3 months, pain intensity VAS at least 3, and myofascial trigger points in the upper-quarter muscles) are allocated by simple randomization into three groups:
- Conventional Therapy Group: hot pack, conventional TENS, and a structured exercise program.
- Manual Myofascial Release Group: conventional therapy plus therapist-applied manual myofascial release.
- Self-Myofascial Release Group: conventional therapy plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane.
All interventions are delivered 3 days per week for 6 weeks. The primary outcome is pain intensity. Secondary outcomes include pressure pain threshold and tolerance, cervical range of motion, muscle stiffness, craniovertebral angle, cervical proprioception, muscle strength and endurance, disability, neck awareness, multidimensional biopsychosocial status, sleep quality, quality of life, and kinesiophobia. The aim is to determine whether manual or self-applied myofascial release, added to exercise, produces greater functional improvement in people with chronic non-specific neck pain.
详细描述
Background:
Neck pain is a common public-health problem that reduces individual function and burdens health systems. A large proportion of cases have no identifiable specific pathology and are classified as non-specific. When neck pain persists beyond three months without an explanatory structural or neurological pathology, it is defined as chronic non-specific neck pain (CNNP). CNNP is characterized by functional limitation, muscle dysfunction, reduced cervical range of motion, and increased pain sensitivity. Myofascial pain syndrome and myofascial trigger points (MTrP) in the upper-quarter muscles (such as the trapezius, levator scapulae, sternocleidomastoid, rhomboids, infraspinatus, and pectoral muscles) frequently accompany CNNP and play a dominant pathophysiological role.
Current clinical guidelines prioritize non-pharmacological conservative management, including therapeutic exercise and manual therapy. Myofascial release (MFR) techniques are increasingly used to inactivate MTrP and regulate muscle tone. MFR can be delivered manually by a physiotherapist (manual myofascial release, MMR) or applied by the individual using tools such as foam rollers, balls, and massage sticks (self-myofascial release, SMR). Direct comparisons of MMR and SMR, particularly when combined with a structured exercise program, remain scarce in the literature.
Objective:
To comparatively determine the effectiveness of different myofascial release techniques (manual and self-applied), when combined with a structured exercise program, on functional outcomes in individuals with chronic non-specific neck pain.
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
- Single (Participant)
盲法说明
Participants are not informed that the study has three groups, are unaware of the group allocation and the content of the other groups, and are enrolled so that they do not know one another.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neck pain persisting for at least 3 months and diagnosed as chronic non-specific neck pain by a specialist physician
- •Aged between 18 and 45 years
- •Perceived pain affecting daily living activities (VAS at least 3)
- •Presence of myofascial trigger points in the upper-quarter muscles
排除标准
- •Specific serious cervical spine pathology (radiculopathy, myelopathy, severe nerve root compression, spondylosis, and similar)
- •History of rheumatologic, neurologic, or systemic disease (for example, acute inflammation, multiple sclerosis, Parkinson's disease, rheumatoid arthritis, fibromyalgia, or cancer)
- •History of trauma, fracture, or surgery involving the neck, shoulder, or upper extremity
- •Pregnancy or breastfeeding
- •Any diagnosed psychiatric disorder (for example, major depression or anxiety disorder) or regular use of psychopharmacological medication
- •Use of systemic analgesics, NSAIDs, or muscle relaxants within the last 7 days for pain control
- •Any physiotherapy, manual therapy, or injection treatment to the neck region within the last 3 months
研究组 & 干预措施
Manual Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks.
干预措施: Hot Pack (Other)
Self-Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane, delivered 3 days per week for 6 weeks.
干预措施: Hot Pack (Other)
Self-Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane, delivered 3 days per week for 6 weeks.
干预措施: Self-Myofascial Release (Behavioral)
Conventional Therapy Group
Hot pack to the cervical region, conventional TENS, and a structured standard exercise program, delivered 3 days per week for 6 weeks.
干预措施: Hot Pack (Other)
Conventional Therapy Group
Hot pack to the cervical region, conventional TENS, and a structured standard exercise program, delivered 3 days per week for 6 weeks.
干预措施: Conventional TENS (Device)
Conventional Therapy Group
Hot pack to the cervical region, conventional TENS, and a structured standard exercise program, delivered 3 days per week for 6 weeks.
干预措施: Structured Exercise Program (Behavioral)
Manual Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks.
干预措施: Conventional TENS (Device)
Manual Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks.
干预措施: Structured Exercise Program (Behavioral)
Manual Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks.
干预措施: Manual Myofascial Release (Procedure)
Self-Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane, delivered 3 days per week for 6 weeks.
干预措施: Conventional TENS (Device)
Self-Myofascial Release Group
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane, delivered 3 days per week for 6 weeks.
干预措施: Structured Exercise Program (Behavioral)
结局指标
主要结局
Change in Pain Intensity (Visual Analog Scale, VAS)
时间窗: Baseline, immediately after the first session, and after the final session (end of week 6)
Pain intensity measured on a 10 cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain), assessed at rest, during activity, and at night.
次要结局
- Neck Awareness (Fremantle Neck Awareness Questionnaire)(Baseline and after the final session (end of week 6))
- Multidimensional Neck Pain (Bournemouth Neck Pain Questionnaire)(Baseline and after the final session (end of week 6))
- Sleep Quality (Pittsburgh Sleep Quality Index)(Baseline and after the final session (end of week 6))
- Quality of Life (SF-36)(Baseline and after the final session (end of week 6))
- Kinesiophobia (NeckPix Scale)(Baseline and after the final session (end of week 6))
- Pressure Pain Threshold and Tolerance(Baseline, immediately after the first session, and after the final session (end of week 6))
- Cervical Range of Motion(Baseline, immediately after the first session, and after the final session (end of week 6))
- Muscle Stiffness(Baseline, immediately after the first session, and after the final session (end of week 6))
- Craniovertebral Angle(Baseline and after the final session (end of week 6))
- Cervical Proprioception (Joint Position Error)(Baseline, immediately after the first session, and after the final session (end of week 6))
- Cervical Muscle Strength(Baseline and after the final session (end of week 6))
- Cervical and Scapular Muscle Endurance(Baseline and after the final session (end of week 6))
- Disability (Neck Disability Index)(Baseline and after the final session (end of week 6))
- Biopsychosocial Status (BETY-BQ)(Baseline and after the final session (end of week 6))
研究者
Süleyman Güzelşemme
Principal Investigator PhD (c)
Eastern Mediterranean University