NCT07413770

Brief Summary

The aim of this study is to evaluate the effects of classical massage on pain, muscle sensitivity, muscle activity, functional status, and quality of life in individuals with myofascial pain syndrome, and to compare the effectiveness of classical massage applied alone versus in combination with a conventional physiotherapy program.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

February 17, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

February 8, 2026

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    The primary outcome of this study is pain intensity, will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.

    6 weeks

Secondary Outcomes (4)

  • Pressure Pain Threshold-Algometer

    6 weeks

  • Muscle Activity

    6 weeks

  • Functional Status (Neck Disability Index)

    6 weeks

  • Quality of Life (SF-12)

    6 weeks

Study Arms (3)

Conventional Physiotherapy

EXPERIMENTAL
Other: Conventional treatment

Therapeutic massage

EXPERIMENTAL
Other: Therapeutic Massage

Combined treatment

EXPERIMENTAL
Other: combined treatment

Interventions

Participants inthis group will receive a conventional physiotherapy program consisting of moist heat application for 15 minutes, pain-limited static stretching of the upper trapezius muscle (30-second stretch with 10-second rest, repeated five times), electrotherapy modalities (TENS, ultrasound, and infrared therapy), and postural education with a home exercise program for approximately 10 minutes.

Conventional Physiotherapy

Participants in this group will receive a 20-minute therapeutic massage intervention identical in technique and sequence to the massage component applied in combined group, targeting the neck and upper back muscles using Swedish massage techniques, without additional conventional physiotherapy modalities.

Therapeutic massage

Participants in this group will receive a combined intervention consisting of a conventional physiotherapy program together with a 20-minute therapeutic massage applied to the neck and upper back muscles (erector spinae, upper and middle trapezius, and levator scapulae), delivered according to Swedish massage principles, including effleurage, kneading, and deep friction techniques targeting active trigger points.

Combined treatment

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of myofascial pain syndrome confirmed by a physical medicine and rehabilitation physician, according to the criteria of Travell and Simons (1992)
  • Male or female participants aged 30-50 years
  • Presence of at least one active trigger point in the upper trapezius muscle confirmed by palpation
  • Pain radiating to the neck and upper extremity persisting for at least 3 months
  • Pain intensity of ≥4/10 on the Visual Analog Scale (VAS)
  • Functional impairment indicated by a Neck Disability Index (NDI) score ≥10/50 (≥20%)
  • Written informed consent

You may not qualify if:

  • Presence of diagnosed systemic musculoskeletal or rheumatologic disorders (e.g., fibromyalgia, rheumatoid arthritis)
  • Signs or symptoms of neuropathic pain or cervical radiculopathy
  • Conditions contraindicating massage therapy (e.g., skin infection, open wounds, bleeding disorders, active inflammation)
  • Receipt of manual therapy, massage, dry needling, injections, or similar treatments targeting the affected region within the preceding 1 month
  • Pregnancy or breastfeeding
  • History of acute trauma, fracture, or surgical intervention involving the neck or shoulder region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

MassageCombined Modality Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Begüm Kara Kaya, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 17, 2026

Study Start

January 12, 2026

Primary Completion

February 20, 2026

Study Completion

March 3, 2026

Last Updated

February 17, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations