NCT07410221

Brief Summary

Background This study aimed to evaluate the additive effect of Pain Neuroscience Education (PNE), which addresses the biopsychosocial and neurophysiological foundations of pain, on conventional physiotherapy in myofascial pain syndrome (MPS). Methods Forty individuals with MPS aged between 18-50 years participated in the study. The participants were divided into two groups as study group (n=20) and control group (n=20). The control group received a conventional physiotherapy and rehabilitation program three times a week 6 weeks. In the Study group, PNE was given once a week for 6 weeks in addition to the conventional physiotherapy and rehabilitation programme. Short Form Mc-Gill Pain Questionnaire (SF-MPQ), Algometer, Pain Catastrophising Scale (PCS), Tampa Scale of Kinesiophobia (TSK) and Depression-Anxiety-Stress Scale (DASS), Pittsburg Sleep Quality Index (PSQI) and Myotonometry were used in the evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

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

June 10, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 21, 2026

Last Update Submit

February 7, 2026

Conditions

Keywords

Pain ManagementKinesiophobiaMyofascial Pain SyndromesNeuroscience Pain EducationPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (2)

  • Short Form Mc-Gill Pain Questionnaire (SF-MPQ)

    Because pain is a multidimensional experience involving sensory and emotional components and is often difficult to describe, standardized pain assessment tools are essential in clinical practice. Due to the length and time required to complete the McGill Pain Questionnaire, pain was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), developed by Melzack in 1987. The SF-MPQ consists of three sections. The first section includes 15 pain descriptors (11 sensory and 4 affective), each scored from 0 (none) to 3 (severe), providing total, sensory, and affective pain scores. The second section assesses overall pain intensity using a Likert-type scale ranging from 0 (no pain) to 5 (unbearable pain). The third section evaluates current pain intensity using a 10 cm Visual Analog Scale, scored from 0 (no pain) to 10 (severe pain).

    Baseline and end of Week 6

  • Pressure Pain Threshold Assessment

    Pressure pain threshold is explained as the minimum amount of pressure measured at the first moment when the applied pressure sensation turns into pain. BASELINE® (USA) brand algometer, which can measure the pressure pain thresholds of trigger points, was used in the study. The pressure value is obtained by pressing a dynamic metal piston with a round disc with a surface area of 1 cm² at its tip to the relevant area. In our study, the pressure pain threshold of the sternocleidomastoid (SCM), upper trapezius (UT), levator scapula (LS), pectoralis major (PM) muscles, which are specified as overstrained muscle groups in the definition of 'Upper Cross Syndrome'

    Baseline and end of Week 6

Secondary Outcomes (5)

  • Pain Catastrophising Scale (PCS)

    Baseline and end of Week 6

  • Tampa Scale of Kinesiophobia (TSK)

    Baseline and end of Week 6

  • Depression Anxiety Stress Scale (DASS)

    Baseline and end of Week 6

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline and end of Week 6

  • Myotonometric Evaluation

    Baseline and end of Week 6

Study Arms (2)

Study Gruop

EXPERIMENTAL
Other: Conventional physiotherapyOther: ExerciseOther: Pain neuroscience education (PNE)

Control group

ACTIVE COMPARATOR
Other: Conventional physiotherapyOther: Exercise

Interventions

Transcutaneous electrical nerve stimulation (TENS); The negative electrode was placed on the trigger point and the positive electrode was placed on the insertion of the acromial tendon of the trapezius muscle. Conventional type TENS with a frequency of 50-100 Hz and a current duration of 100 μsec was applied for 20 minutes by adjusting the current intensity to the value that the patient could tolerate. US; Chattanooga® (Mexico) with 1.5 Watt/ cm² current intensity, 1 MHz frequency and continuous mode was applied to the right and left sides for 4 minutes each. It was performed by drawing circles on the trigger point and surrounding tissues with the US probe. HP; was applied for 20 minutes to the area covering the muscle with trigger point and surrounding tissues

Control groupStudy Gruop

An exercise programme consisting of stretching exercises for tense muscles which are effective in the formation of Myofascial Pain Syndrome (MPS) and trunk stabilisation exercises to provide deep postural muscle activation was applied. Abdominal hallowing exercise, shoulder bridge exercise, swimming exercise and stretching exercises were performed as 10 repetitions. In addition, scapular stabilisation exercises were also included in the programme because myofascial pain often leads to immobilisation. The 6-week exercise programme was planned to be progressively revised every 2 weeks. In this case, other extremities were included, new exercises were added, and progressive difficulty level was provided with the help of a medicine ball or resistance band. Patients were asked to perform this exercise programme, which was applied in the clinic, at home once a day for 10 repetitions. Whether the exercises were performed regularly at home was followed up with verbal feedback

Control groupStudy Gruop

Pain Neuroscience Education (PNE) was delivered to the study group through individual, face-to-face sessions focusing on pain neurophysiology. The content was based on the book Explain Pain and supported by a PowerPoint presentation incorporating metaphors, examples, and visual materials to enhance comprehension. Considering reduced attention span in individuals with chronic pain, PNE was provided once weekly for 6 weeks, with each session lasting approximately 15 minutes, resulting in a total duration of 90 minutes. Conventional physiotherapy interventions were initiated immediately after each PNE session. Patients were encouraged to ask questions during treatment to reinforce the educational content through their own pain experiences and to promote active engagement in subsequent sessions.

Study Gruop

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of myofascial pain syndrome by a physician
  • Presence of a taut band detected by palpation
  • Referred pain elicited by compression of trigger points
  • Local twitch response induced by transverse palpation of the taut band
  • Age between 18-65 years
  • Voluntary patients with symptoms lasting at least 6 months

You may not qualify if:

  • Skin lesions or history of head trauma preventing study participation
  • Ongoing or previous cancer treatment
  • Uncontrolled hypertension or diabetes mellitus
  • History of fracture involving the upper extremities or cervical region
  • History of trauma or surgery in the cervical or upper extremity region
  • Known rheumatological disease
  • Receipt of physical therapy within the last 6 months
  • Presence of other cervical pathologies causing neck or back pain apart from MPS
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye Üniversitesi

Istanbul, Merkez, 08100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesAgnosiaKinesiophobia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Lecturer

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 13, 2026

Study Start

June 10, 2022

Primary Completion

July 1, 2023

Study Completion

July 10, 2023

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.

Locations