An interventional study of Hot Pack and Conventional TENS in Chronic Neck Pain, Non-specific Neck Pain and Myofascial Trigger Points, sponsored by Eastern Mediterranean University. Recruiting at 1 site in Cyprus. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Treatment
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:
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.
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.
339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.
This study's planned enrollment of 84 is above the median of 50 across 307 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Hot pack to the cervical region, conventional TENS, and a structured standard exercise program, delivered 3 days per week for 6 weeks.
Other: Hot Pack · Device: Conventional TENS · Behavioral: Structured Exercise Program
Conventional therapy (hot pack, conventional TENS, and structured exercise program) plus therapist-applied manual myofascial release, delivered 3 days per week for 6 weeks.
Other: Hot Pack · Device: Conventional TENS · Behavioral: Structured Exercise Program · Procedure: Manual Myofascial Release
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.
Other: Hot Pack · Device: Conventional TENS · Behavioral: Structured Exercise Program · Behavioral: Self-Myofascial Release
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.
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.
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.
Time frame: Baseline, immediately after the first session, and after the final session (end of week 6)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after the final session (end of week 6)
Plan to share: 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.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2026, 1 month after the start.
Of 202 non-industry interventional studies with no phase under Myofascial Pain Syndromes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's planned 1 month is below that.
Counting every sponsor, half of 204 studies reached it within 5 months; a quarter within 2 and three quarters within 13.
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