NCT06707675

Brief Summary

The aim of this study is to examine chronotype preferences in myofascial pain syndrome and to investigate its relationship with pain severity, disability and quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 25, 2024

Last Update Submit

November 27, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • VAS

    The Visual Pain Scale (VAS), which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at 0, and that the most severe pain they have ever felt at 100, and the patient is asked to put a mark on the point corresponding to their pain.

    "Baseline"

  • Pressure Algometry Measurements: (kg/cm2)

    Algometry measurements will be measured with the Baseline Push Pull Force Gauge ® (Fabrication Enterprises, Inc. PO Box 1500, White Plains, New York 10602, USA) algometry device from the painful trigger point area with the patient in a sitting position. Pressure will be applied slowly until the participant first feels pain and responds by saying "stop" and three measurements will be taken with a 30-second interval after each measurement and the average of the three measurements will be recorded as the final value.

    "Baseline"

  • Cervical joint range of motion

    Active passive ROM (flexion, extension, right-left) flexion and rotation) of the cervical joint will be measured.

    "Baseline"

  • Morningness Eveningness Questionnaire

    One of the most widely used tools to assess sleep chronotype preferences. This 19-item screening questionnaire has a rating range of 16 to 86. The scoring results are classified as follows: evening types with scores between 16 and 41, morning types with scores between 59 and 86, and no types with scores between 42 and 58. The Turkish version has been shown to have good validity and reliability

    "Baseline"

Secondary Outcomes (5)

  • Neck Pain Disability Scale

    "Baseline"

  • Pittsburg Sleep Quality Index (PSQI)

    "Baseline"

  • Beck Depression Anxiety Inventory

    "Baseline"

  • The Pain Catastrophizing Scale

    "Baseline"

  • SF-12

    "Baseline"

Study Arms (1)

MPS

Patients aged between 18-65 who applied to the AFSÜ PTR Polyclinic and had complaints of neck and back pain for at least 3 months and were diagnosed with myofascial pain syndrome based on anamnesis and physical examination.

Other: Assessment

Interventions

The patients' demographic information, weight and height measurements, occupational activities and desk work time, daily screen usage time, pain intensity (with VAS), cervical joint range of motion examination, pain threshold (with pressure algometer), functional status (with Neck Pain Disability Scale), sleep quality (with Pittsburgh Sleep Quality Scale), anxiety and depression symptoms (with Beck Depression Inventory), cognitive aspects of pain (with Pain Catastrophizing Scale) will be evaluated. The patients' chronotype preferences will be evaluated with Morningness Eveningness Questionnaire.

MPS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18-65 who applied to Afyonkarahisar Health Sciences University (AFSU) Physical Medicine and Rehabilitation Polyclinic and who have had neck and back pain complaints for at least 3 months were diagnosed with myofascial pain syndrome through anamnesis and physical examination.

You may qualify if:

  • neck-back pain for at least 3 months
  • diagnosis of myofascial pain syndrome by anamnesis and physical examination

You may not qualify if:

  • Cervical Radiculopathy/Myelopathy
  • Recent injection or physical therapy within the last 3 months
  • Neck and shoulder surgery
  • Neurological and inflammatory diseases
  • Pregnancy
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

SEVDA ADAR, Ass. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

December 15, 2024

Primary Completion

May 15, 2025

Study Completion

June 15, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share