Chronic Neck PainMFR / CNNPNCT07694882
Effects of Different Myofascial Release Techniques on Function in Chronic Non-Specific Neck Pain
A study testing Hot Pack, Conventional TENS and Structured Exercise Program in people with Chronic Neck Pain and Non-specific Neck Pain, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Neck Pain, Non-specific Neck Pain, Myofascial Trigger Points
- What is being tested?
- Hot Pack, Conventional TENS and Structured Exercise Program
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCyprus
- Study dates
- 14 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sevim Öksüz, PT, Assoc. Prof. Dr. contact
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Healthy Living Center (SAYMER), Orthopedic Rehabilitation Unit
Famagusta, Hatay, 99628
Süleyman Güzelşemme, PT, PhD(c), +9005397892296, suleyman.guzelsemme@gmail.com
Sevim Öksüz, PT, Assoc. Prof. Dr., sevim.oksuz@emu.edu.tr
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Chronic Neck Pain, Non-specific Neck Pain, Myofascial Trigger Points, Myofascial Pain Syndrome - Neck
- Being tested
- Hot Pack, Conventional TENS, Structured Exercise Program, Manual Myofascial Release, Self-Myofascial Release
- Keywords
- chronic non-specific neck pain, myofascial release, manual therapy, trigger points, therapeutic exercise, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot PackOther
Hot pack applied to the cervical region.
Conventional TENSDevice
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 Exercise ProgramBehavioural
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.
Manual Myofascial ReleaseProcedure or surgery
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.
Self-Myofascial ReleaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy Group | Active comparator | Hot pack to the cervical region, conventional TENS, and a structured standard exercise program, delivered 3 days per week for 6 weeks. Receives: Other: Hot Pack; Device: Conventional TENS; Behavioral: Structured Exercise Program |
| Manual Myofascial Release Group | Experimental | Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks. Receives: Other: Hot Pack; Device: Conventional TENS; Behavioral: Structured Exercise Program; Procedure: Manual Myofascial Release |
| Self-Myofascial Release Group | Experimental | 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. Receives: Other: Hot Pack; Device: Conventional TENS; Behavioral: Structured Exercise Program; Behavioral: Self-Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (Visual Analog Scale, VAS)
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.
Measured: Baseline, immediately after the first session, and after the final session (end of week 6)
Secondary outcomes (14)
Pressure Pain Threshold and Tolerance
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.
Measured: Baseline, immediately after the first session, and after the final session (end of week 6)
Cervical Range of Motion
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.
Measured: Baseline, immediately after the first session, and after the final session (end of week 6)
Muscle Stiffness
Myofascial tissue stiffness measured with the IndentoPro digital indentometer, expressed in N/mm; the mean of three repetitions per muscle is recorded.
Measured: Baseline, immediately after the first session, and after the final session (end of week 6)
Craniovertebral Angle
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.
Measured: Baseline and after the final session (end of week 6)
Cervical Proprioception (Joint Position Error)
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.
Measured: Baseline, immediately after the first session, and after the final session (end of week 6)
Cervical Muscle Strength
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.
Measured: Baseline and after the final session (end of week 6)
Cervical and Scapular Muscle Endurance
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.
Measured: Baseline and after the final session (end of week 6)
Disability (Neck Disability Index)
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.
Measured: Baseline and after the final session (end of week 6)
Neck Awareness (Fremantle Neck Awareness Questionnaire)
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.
Measured: Baseline and after the final session (end of week 6)
Multidimensional Neck Pain (Bournemouth Neck Pain Questionnaire)
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.
Measured: Baseline and after the final session (end of week 6)
Biopsychosocial Status (BETY-BQ)
Multidimensional biopsychosocial status measured with the Cognitive Exercise Therapy Approach - Biopsychosocial Questionnaire (BETY-BQ, Turkish version); the total score is used in analyses. It includes 30 items assessed on a 5-point Likert scale (0 to 4). Total scores range from 0 to 120, where higher scores indicate a poorer biopsychosocial status.
Measured: Baseline and after the final session (end of week 6)
Sleep Quality (Pittsburgh Sleep Quality Index)
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.
Measured: Baseline and after the final session (end of week 6)
Quality of Life (SF-36)
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.
Measured: Baseline and after the final session (end of week 6)
Kinesiophobia (NeckPix Scale)
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.
Measured: Baseline and after the final session (end of week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start14 Jul 2026
- Primary completion6 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arm parallel group randomized controlled trial: a Conventional Therapy Group, a Manual Myofascial Release Group, and a Self-Myofascial Release Group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süleyman Güzelşemme, Eastern Mediterranean University
- Investigators
- Süleyman Güzelşemme, Principal investigator, Eastern Mediterranean UniversitySevim Öksüz, PT, Assoc. Prof. Dr., Study director, Eastern Mediterranean UniversityEnder Angın, PT, Prof. Dr., Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694882
- Sponsor's protocol ID
- ETK00-2026-0042
- Acronym
- MFR / CNNP
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. De-identified data may be made available from the corresponding author upon reasonable request, subject to ethics committee approval.
Publications
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.
PubMed 38290198Fernandez-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.
PubMed 29025044GBD 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.
PubMed 38383088
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Myofascial Release Techniques on Functional Outcomes in Individuals With Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT07694882
- Acronym / sponsor ID
- MFR / CNNP / ETK00-2026-0042
- Conditions
- Chronic Neck Pain, Non-specific Neck Pain, Myofascial Trigger Points, Myofascial Pain Syndrome - Neck
- Keywords
- chronic non-specific neck pain, myofascial release, manual therapy, trigger points, therapeutic exercise, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 6 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three arm parallel group randomized controlled trial: a Conventional Therapy Group, a Manual Myofascial Release Group, and a Self-Myofascial Release Group.
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy Group | Active comparator | Other: Hot Pack, Device: Conventional TENS, Behavioral: Structured Exercise ProgramHot pack to the cervical region, conventional TENS, and a structured standard exercise program, delivered 3 days per week for 6 weeks. |
| Manual Myofascial Release Group | Experimental | Other: Hot Pack, Device: Conventional TENS, Behavioral: Structured Exercise Program, Procedure: Manual Myofascial ReleaseConventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks. |
| Self-Myofascial Release Group | Experimental | Other: Hot Pack, Device: Conventional TENS, Behavioral: Structured Exercise Program, Behavioral: Self-Myofascial ReleaseConventional 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot PackHot pack applied to the cervical region. | Other | Conventional Therapy Group, Manual Myofascial Release Group, Self-Myofascial Release Group |
| Conventional TENSConventional 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. | Device | Conventional Therapy Group, Manual Myofascial Release Group, Self-Myofascial Release Group |
| Structured Exercise ProgramStructured 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. | Behavioural | Conventional Therapy Group, Manual Myofascial Release Group, Self-Myofascial Release Group |
| Manual Myofascial ReleaseTherapist-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. | Procedure or surgery | Manual Myofascial Release Group |
| Self-Myofascial ReleaseSupervised 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. | Behavioural | Self-Myofascial Release Group |
Primary outcome
Change in Pain Intensity (Visual Analog Scale, VAS)
Time frame: 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.
14 secondary outcomes
Pressure Pain Threshold and Tolerance
Time frame: Baseline, immediately after the first session, and after the final session (end of week 6)
Cervical Range of Motion
Time frame: Baseline, immediately after the first session, and after the final session (end of week 6)
Muscle Stiffness
Time frame: Baseline, immediately after the first session, and after the final session (end of week 6)
Craniovertebral Angle
Time frame: Baseline and after the final session (end of week 6)
Cervical Proprioception (Joint Position Error)
Time frame: Baseline, immediately after the first session, and after the final session (end of week 6)
Cervical Muscle Strength
Time frame: Baseline and after the final session (end of week 6)
Cervical and Scapular Muscle Endurance
Time frame: Baseline and after the final session (end of week 6)
Disability (Neck Disability Index)
Time frame: Baseline and after the final session (end of week 6)
Neck Awareness (Fremantle Neck Awareness Questionnaire)
Time frame: Baseline and after the final session (end of week 6)
Multidimensional Neck Pain (Bournemouth Neck Pain Questionnaire)
Time frame: Baseline and after the final session (end of week 6)
Biopsychosocial Status (BETY-BQ)
Time frame: Baseline and after the final session (end of week 6)
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline and after the final session (end of week 6)
Quality of Life (SF-36)
Time frame: Baseline and after the final session (end of week 6)
Kinesiophobia (NeckPix Scale)
Time frame: Baseline and after the final session (end of week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 38290198Overmann 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.
- Background: PubMed 29025044Fernandez-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.
- Background: PubMed 38383088GBD 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. De-identified data may be made available from the corresponding author upon reasonable request, subject to ethics committee approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevim Öksüz, PT, Assoc. Prof. Dr. contact
Süleyman Güzelşemme principal investigator
Eastern Mediterranean University
Sevim Öksüz, PT, Assoc. Prof. Dr. study director
Eastern Mediterranean University
Ender Angın, PT, Prof. Dr. study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Pack, Conventional TENS and Structured Exercise Program in people with Chronic Neck Pain and Non-specific Neck Pain, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Güzelşemme, PT, PhD(c) (+905397892296, suleyman.guzelsemme@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (Visual Analog Scale, VAS) (time frame: Baseline, immediately after the first session, and after the final session (end of week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694882, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.