NCT07694882

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 14, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 5, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

chronic non-specific neck painmyofascial releasemanual therapytrigger pointstherapeutic exercisephysiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, immediately after the first session, and after the final session (end of week 6)

Secondary Outcomes (14)

  • 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)

  • +9 more secondary outcomes

Study Arms (3)

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.

Other: Hot PackDevice: Conventional TENSBehavioral: 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.

Other: Hot PackDevice: Conventional TENSBehavioral: Structured Exercise ProgramProcedure: 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.

Other: Hot PackDevice: Conventional TENSBehavioral: Structured Exercise ProgramBehavioral: Self-Myofascial Release

Interventions

Hot pack applied to the cervical region.

Conventional Therapy GroupManual Myofascial Release GroupSelf-Myofascial Release Group

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.

Conventional Therapy GroupManual Myofascial Release GroupSelf-Myofascial Release Group

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.

Conventional Therapy GroupManual Myofascial Release GroupSelf-Myofascial Release Group

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.

Manual Myofascial Release Group

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.

Self-Myofascial Release Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Healthy Living Center (SAYMER), Orthopedic Rehabilitation Unit

Famagusta, Hatay, 99628, Cyprus

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38290198BACKGROUND
  • 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.

    PMID: 29025044BACKGROUND
  • 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.

    PMID: 38383088BACKGROUND

Study Officials

  • Süleyman Güzelşemme

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Sevim Öksüz, PT, Assoc. Prof. Dr.

    Eastern Mediterranean University

    STUDY DIRECTOR
  • Ender Angın, PT, Prof. Dr.

    Eastern Mediterranean University

    STUDY DIRECTOR

Central Study Contacts

Süleyman Güzelşemme, PT, PhD(c)

CONTACT

Sevim Öksüz, PT, Assoc. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three arm parallel group randomized controlled trial: a Conventional Therapy Group, a Manual Myofascial Release Group, and a Self-Myofascial Release Group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator PhD (c)

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start

July 14, 2026

Primary Completion (Estimated)

September 6, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations