NCT07490366

Brief Summary

This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Another objective of this study was to evaluate and compare the short-term and long-term effectiveness of interfascial block, dry needling, and exercise therapies on pain, disability, and quality of life in patients with myofascial pain syndrome. In this respect, our study is important in terms of its contribution to the literature.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Aug 2025

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

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Study Timeline

Key milestones and dates

Study Progress86%
Aug 2025Oct 2026

Study Start

First participant enrolled

August 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

myofascial painhydrodissectiondry needlingexercise

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale

    0-10 scale. Higher scores represent more severe pain.

    before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

  • Cervical Range of Motion

    Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees.

    before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

  • Neck Disability Index (NDI)

    The Neck Disability Index (NDI) is a widely used self-report questionnaire that measures functional disability associated with neck pain. It consists of 10 items scored from 0 to 5, covering pain intensity and daily activities. Higher scores indicate greater disability. The NDI is commonly used in clinical practice and research to assess baseline status and monitor treatment outcomes.

    before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

  • Pressure Pain Threshold (PPT)

    Pressure Pain Threshold (PPT) is a quantitative measure of pain sensitivity assessed using a pressure algometer. It represents the minimum amount of pressure that evokes pain. PPT is widely used in clinical and research settings to evaluate mechanical pain sensitivity, detect hyperalgesia, and monitor treatment effects. Lower PPT values indicate increased pain sensitivity, while higher values reflect reduced sensitivity.

    before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

Secondary Outcomes (2)

  • 12-Item Short Form Survey (SF-12)

    before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

  • Central Sensitisation Inventory

    before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

Study Arms (3)

Exercise group

EXPERIMENTAL
Other: Exercise

Exercise + Dry Needling Group

EXPERIMENTAL
Other: Dry Needling + Exercise

Exercise + interfascial block group

EXPERIMENTAL
Other: Exercise + interfascial block

Interventions

Cervical range of motion and trapezius fascial stretching exercises

Exercise group

Cervical ROM, fascial stretching exercises for the trapezius muscles, and dry needling of the relevant fascia with Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance.

Exercise + Dry Needling Group

Cervical range of motion (ROM) and trapezius muscles are treated with fascial stretching exercises and ultrasound-guided interfascial injection of 1 cc of 2% lidocaine + 4 cc of 0.9% saline solution.

Exercise + interfascial block group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Myofascial pain in the upper trapezius muscle that has lasted for at least 3 months
  • VAS score of 4 or higher for the current pain
  • Clinically diagnosed with myofascial pain in the trapezius muscle
  • Ages 18 to 55
  • Patients who can follow verbal instructions and have no cognitive deficits

You may not qualify if:

  • Having received interventional injections in the neck and shoulder area within the last 3 months
  • Having received physical therapy within the last 3 months
  • Having received regular nonsteroidal anti-inflammatory and myorelaxant treatment within the last month
  • History of surgery on the affected side (neck or shoulder)
  • Chronic inflammatory disease
  • Acute infection
  • History of malignancy
  • Coagulation disorders
  • Pregnancy
  • Liver and kidney pathologies
  • Drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpaşa Training and Research Hospital

Istanbul, Istanbul, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseDry Needling

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Sibel Süzen Özbayrak

    Haydarpaşa Numune Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Eren Başıbüyük, M.D.

CONTACT

Nilgün Mesci, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

August 1, 2025

Primary Completion

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Safety concerns

Locations