- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07694882
Effects of Different Myofascial Release Techniques on Function in Chronic Non-Specific Neck Pain (MFR / CNNP)
Investigation of the Effects of Different Myofascial Release Techniques on Functional Outcomes in Individuals With Chronic Non-Specific Neck Pain
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Setting:
The study will be conducted at Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Healthy Living Center (SAYMER), Orthopedic Rehabilitation Unit, following ethics approval.
Participants and randomization:
Volunteers diagnosed with CNNP by a specialist physician and meeting the eligibility criteria are enrolled after written informed consent. Participants are allocated by simple randomization into three groups: a Conventional Therapy Group, a Manual Myofascial Release Group, and a Self-Myofascial Release Group.
Interventions:
All three groups receive a common base intervention consisting of a hot pack applied to the cervical region and conventional TENS applied to the most painful region (80 Hz frequency, 100 microsecond pulse duration, asymmetric biphasic rectangular waveform, set to a tingling sensation, for 20 minutes), together with a structured standard exercise program. The structured exercise program includes warm-up (cervical mobility, scapular retraction and depression), stretching of the sternocleidomastoid, upper trapezius, levator scapulae, scalenes, pectoralis major and minor, and suboccipital muscles, diaphragmatic breathing, motor control exercises (chin tuck and craniocervical flexion), scapular stabilization (wall slides, wall walk, serratus punch), strengthening of the middle and lower trapezius, and a cool-down.
In addition to the common base intervention, the Manual Myofascial Release Group receives therapist-applied manual myofascial release, including MTrP ischemic compression and along-fiber myofascial release applied to the suboccipital, upper trapezius, levator scapulae, sternocleidomastoid, rhomboid, infraspinatus, and pectoral muscles, with sustained compression (approximately 90 seconds) combined with passive movements.
In addition to the common base intervention, the Self-Myofascial Release Group performs supervised self-applied myofascial release using a duo-ball, massage balls, and a massage stick/cane, targeting the same upper-quarter muscle groups, with sustained compression (approximately 90 seconds) combined with active movements, under physiotherapist supervision.
All interventions are delivered 3 days per week for 6 weeks. Assessments are performed before treatment, immediately after the first session, and after the final session.
Sample size:
The sample size was based on the primary outcome (pain, measured by the Visual Analog Scale), using data from Kim and Lee (2019) as a reference. A medium effect size (0.25), a 5% significance level (alpha = 0.05), and 80% statistical power (1 - beta = 0.80) were assumed. Using G*Power 3.1.9.2 for 3 groups across 3 measurement times, the minimum required total sample was 72 (24 per group). Allowing for possible dropout, the study is planned with 84 participants (28 per group).
Outcome assessment:
The primary outcome is pain intensity assessed with the Visual Analog Scale at rest, during activity, and at night. Secondary outcomes include pressure pain threshold and tolerance (digital algometer), cervical range of motion (digital goniometer), muscle stiffness (indentometer), craniovertebral angle (photogrammetry), cervical proprioception (cervical joint position error test), cervical muscle strength (hand-held dynamometer), cervical and scapular muscle endurance, disability (Neck Disability Index), neck awareness (Fremantle Neck Awareness Questionnaire), multidimensional biopsychosocial status (Bournemouth Neck Pain Questionnaire and BETY-BQ), sleep quality (Pittsburgh Sleep Quality Index), quality of life (SF-36), and kinesiophobia (NeckPix Scale). Assessment and treatment are performed by the same physiotherapist.
This study is being registered to increase transparency, ensure compliance with international standards, and align with the ethics approval process.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Süleyman Güzelşemme, PT, PhD(c)
- Telefonní číslo: +905397892296
- E-mail: suleyman.guzelsemme@gmail.com
Studijní záloha kontaktů
- Jméno: Sevim Öksüz, PT, Assoc. Prof. Dr.
- E-mail: sevim.oksuz@emu.edu.tr
Studijní místa
-
-
Hatay
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Famagusta, Hatay, Kypr, 99628
- Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Healthy Living Center (SAYMER), Orthopedic Rehabilitation Unit
-
Kontakt:
- Sevim Öksüz, PT, Assoc. Prof. Dr.
- E-mail: sevim.oksuz@emu.edu.tr
-
Kontakt:
- Süleyman Güzelşemme, PT, PhD(c)
- Telefonní číslo: +9005397892296
- E-mail: suleyman.guzelsemme@gmail.com
-
Vrchní vyšetřovatel:
- Süleyman Güzelşemme, PT, PhD(c)
-
Dílčí vyšetřovatel:
- Sevim Öksüz, PT, Assoc. Prof. Dr.
-
Dílčí vyšetřovatel:
- Ender Angın, PT, Prof. Dr.
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
Hot pack applied to the cervical region.
Conventional transcutaneous electrical nerve stimulation applied to the most painful region: 80 Hz frequency, 100 microsecond pulse duration, asymmetric biphasic rectangular waveform, set to a tingling sensation, for 20 minutes.
Structured standard exercise program including warm-up, stretching of cervical and shoulder-girdle muscles, diaphragmatic breathing, motor control (chin tuck and craniocervical flexion), scapular stabilization, strengthening of the middle and lower trapezius, and cool-down.
|
|
Experimentální: 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.
|
Hot pack applied to the cervical region.
Conventional transcutaneous electrical nerve stimulation applied to the most painful region: 80 Hz frequency, 100 microsecond pulse duration, asymmetric biphasic rectangular waveform, set to a tingling sensation, for 20 minutes.
Structured standard exercise program including warm-up, stretching of cervical and shoulder-girdle muscles, diaphragmatic breathing, motor control (chin tuck and craniocervical flexion), scapular stabilization, strengthening of the middle and lower trapezius, and cool-down.
Therapist-applied manual myofascial release, including trigger point ischemic compression and along-fiber release to the suboccipital, upper trapezius, levator scapulae, sternocleidomastoid, rhomboid, infraspinatus, and pectoral muscles, with sustained compression of approximately 90 seconds combined with passive movements.
|
|
Experimentální: 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.
|
Hot pack applied to the cervical region.
Conventional transcutaneous electrical nerve stimulation applied to the most painful region: 80 Hz frequency, 100 microsecond pulse duration, asymmetric biphasic rectangular waveform, set to a tingling sensation, for 20 minutes.
Structured standard exercise program including warm-up, stretching of cervical and shoulder-girdle muscles, diaphragmatic breathing, motor control (chin tuck and craniocervical flexion), scapular stabilization, strengthening of the middle and lower trapezius, and cool-down.
Supervised self-applied myofascial release using a duo-ball, massage balls, and a massage stick/cane, targeting the same upper-quarter muscle groups, with sustained compression of approximately 90 seconds combined with active movements.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Pain Intensity (Visual Analog Scale, VAS)
Časové okno: 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.
|
Baseline, immediately after the first session, and after the final session (end of week 6)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pressure Pain Threshold and Tolerance
Časové okno: Baseline, immediately after the first session, and after the final session (end of week 6)
|
Pressure pain threshold and tolerance of the upper-quarter muscles measured with a Wagner Instruments FDIX digital pressure algometer (1 cm2 rubber tip); the mean of three repetitions per point is recorded.
|
Baseline, immediately after the first session, and after the final session (end of week 6)
|
|
Cervical Range of Motion
Časové okno: Baseline, immediately after the first session, and after the final session (end of week 6)
|
Cervical range of motion in flexion, extension, lateral flexion, and rotation measured with a Meloq AB digital goniometer, in degrees; the best of three active repetitions is recorded.
|
Baseline, immediately after the first session, and after the final session (end of week 6)
|
|
Muscle Stiffness
Časové okno: Baseline, immediately after the first session, and after the final session (end of week 6)
|
Myofascial tissue stiffness measured with the IndentoPro digital indentometer, expressed in N/mm; the mean of three repetitions per muscle is recorded.
|
Baseline, immediately after the first session, and after the final session (end of week 6)
|
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Craniovertebral Angle
Časové okno: Baseline and after the final session (end of week 6)
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Craniovertebral angle (forward head posture) assessed by photogrammetry from a right sagittal photograph and analyzed with one software, in degrees; smaller angles indicate more pronounced forward head posture.
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Baseline and after the final session (end of week 6)
|
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Cervical Proprioception (Joint Position Error)
Časové okno: Baseline, immediately after the first session, and after the final session (end of week 6)
|
Cervical proprioception assessed with the Cervical Joint Position Error Test using the AOS PropPoint laser-marker device; joint position error recorded in degrees as the mean of three repetitions per direction.
|
Baseline, immediately after the first session, and after the final session (end of week 6)
|
|
Cervical Muscle Strength
Časové okno: Baseline and after the final session (end of week 6)
|
Isometric strength of the cervical flexor, extensor, and right and left lateral flexor muscles measured with a Lafayette hand-held dynamometer, in kilograms; the highest of three repetitions is recorded.
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Baseline and after the final session (end of week 6)
|
|
Cervical and Scapular Muscle Endurance
Časové okno: Baseline and after the final session (end of week 6)
|
Cervical flexor endurance (head-lift test) and extensor endurance (Biering-Sorensen adapted test with 2 kg load) and scapular muscle endurance (wall-based test monitored with a dynamometer) recorded as holding time in seconds.
|
Baseline and after the final session (end of week 6)
|
|
Disability (Neck Disability Index)
Časové okno: Baseline and after the final session (end of week 6)
|
Neck pain-related disability measured with the Neck Disability Index (Turkish version); total score ranges from 0 to 50, with higher scores indicating greater disability.
|
Baseline and after the final session (end of week 6)
|
|
Neck Awareness (Fremantle Neck Awareness Questionnaire)
Časové okno: Baseline and after the final session (end of week 6)
|
Neck-specific body awareness measured with the Fremantle Neck Awareness Questionnaire (Turkish version), 9 items; total score ranges from 0 to 36, with higher scores indicating reduced neck awareness.
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Baseline and after the final session (end of week 6)
|
|
Multidimensional Neck Pain (Bournemouth Neck Pain Questionnaire)
Časové okno: Baseline and after the final session (end of week 6)
|
Biopsychosocial impact of neck pain measured with the Bournemouth Neck Pain Questionnaire (Turkish version), 7 items; total score ranges from 0 to 70, with higher scores indicating a worse clinical condition.
|
Baseline and after the final session (end of week 6)
|
|
Biopsychosocial Status (BETY-BQ)
Časové okno: Baseline and after the final session (end of week 6)
|
Multidimensional biopsychosocial status measured with the Cognitive Exercise Therapy Approach - Biopsychosocial Questionnaire (BETY-BQ, Turkish version); the total score is used in analyses.
|
Baseline and after the final session (end of week 6)
|
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Sleep Quality (Pittsburgh Sleep Quality Index)
Časové okno: Baseline and after the final session (end of week 6)
|
Sleep quality over the past month measured with the Pittsburgh Sleep Quality Index (Turkish version); total score ranges from 0 to 21, with a score of 5 or above indicating poor sleep quality.
|
Baseline and after the final session (end of week 6)
|
|
Quality of Life (SF-36)
Časové okno: Baseline and after the final session (end of week 6)
|
Health-related quality of life measured with the Short Form-36 (Turkish version) across eight domains, each scored from 0 to 100, with higher scores indicating better health.
|
Baseline and after the final session (end of week 6)
|
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Kinesiophobia (NeckPix Scale)
Časové okno: Baseline and after the final session (end of week 6)
|
Fear of movement during daily activities measured with the NeckPix Scale; total score ranges from 0 to 100, with higher scores indicating greater fear of movement.
|
Baseline and after the final session (end of week 6)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Süleyman Güzelşemme, Eastern Mediterranean University
- Ředitel studie: Sevim Öksüz, PT, Assoc. Prof. Dr., Eastern Mediterranean University
- Ředitel studie: Ender Angın, PT, Prof. Dr., Eastern Mediterranean University
Publikace a užitečné odkazy
Obecné publikace
- GBD 2021 Neck Pain Collaborators. Global, regional, and national burden of neck pain, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2024 Mar;6(3):e142-e155. doi: 10.1016/S2665-9913(23)00321-1.
- Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
- Overmann L, Schleip R, Anheyer D, Michalak J. Effectiveness of myofascial release for adults with chronic neck pain: a meta-analysis. Physiotherapy. 2024 Jun;123:56-68. doi: 10.1016/j.physio.2023.12.002. Epub 2023 Dec 15.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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