NCT06052228

Brief Summary

Pain is one of the main complaints that causes people to apply to health institutions. Pain is seen as a passive warning signal of an underlying disease process; When it becomes chronic, it is considered a disease on its own. Pain that persists longer than the expected recovery time is defined as chronic pain. Pain is associated with a number of psychological, physical, and social factors. Clinical observations report that various psychological problems, especially anxiety, and depression, accompany chronic pain, and the long-term persistence of pain significantly impacts a patient's quality of life. Chronic musculoskeletal pain causes fatigue, sleep disruption, and activity and participation restrictions. Therefore, evaluation of pain originating from the musculoskeletal system and factors that cause and increase pain need to be addressed from a biopsychosocial perspective. Chronic pain is an ideal environment for anxiety to develop. If the person's chronic pain cannot be resolved, anxiety increases and the anxiety becomes excessive, the person may lose the ability to distinguish what is dangerous from what is not, as he cannot evaluate pain-related cues properly. Anxiety and depression scales are often used to assess the long-term psychosocial consequences of chronic musculoskeletal pain. However, these scales are inadequate to explain the relationship between pain and anxiety. The Worry About Pain Questionnaire is a self-report scale of 15 items specifically developed to assess pain-related pressure. To our knowledge, there is no standard, valid, and reliable Turkish questionnaire in the literature that evaluates the pain-related concerns of individuals with musculoskeletal pain and takes into account the cultural differences of Turkish patients. For this reason, our study aims to translate and culturally adapt the Worry About Pain Questionnaire into Turkish in individuals with chronic musculoskeletal pain and to examine the psychometric properties of the Turkish Worry About Pain Questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

September 18, 2023

Last Update Submit

February 20, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Worry About Pain Questionnaire

    The Worry About Pain Questionnaire will be used to evaluate participants' pain-related anxiety levels. Worry About Pain Questionnaire is a Likert-type survey consisting of a total of 15 items. Each question in the survey is scored from 0 (never) to 10 (always). Questions 1, 2, 4, 5, 6, 7, 8, 10, 11, 12 assess the impact of worrying about pain. Questions 3, 9, 13, 14, 15 assess concern about the ability to manage pain.

    4 weeks

  • Fear of Pain Scale III

    Fear of Pain Scale III, which is used to evaluate the participants' fear of pain, consists of a total of 30 items. A Turkish validity and reliability study was conducted by Ünver et al. in 2018.

    4 weeks

  • Short Form McGill Pain Scale

    The McGill Pain Scale Short Form combines the features of the standard McGill Pain Questionnaire and is used to evaluate pain caused by chronic cancer pain, chronic back pain, fibromyalgia syndrome, osteoarthritis pain, neuropathic pain, mastalgia and rheumatoid arthritis. Turkish validity and reliability study was conducted by Yakut et al. in 2007.

    4 weeks

  • Pain Pressure Threshold

    Pressure algometer (dolorimeter) will be used to evaluate sensitivity to pain and determine pressure perception. Pressure algometers have proven useful in assessing fibrositis and hypersensitive points, trigger points, arthritis activation, and visceral pain-pressure sensitivity. For this reason, in our study, the pain pressure threshold will be determined from the trigger points in the upper, middle and lower fibers of the trapezius muscle.

    4 weeks

Secondary Outcomes (5)

  • Beck Depression Inventory,

    4 weeks

  • Beck Anxiety Inventory

    4 weeks

  • Nottingham Health Profile

    4 weeks

  • Pittsburgh Sleep Quality Index

    4 weeks

  • Tampa Kinesiophobia Scale

    4 weeks

Study Arms (1)

Assessment Group

Evaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals.

Other: Assessment Group

Interventions

Evaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals.

Assessment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with Musculoskeletal Pain

You may qualify if:

  • Being able to read and write in Turkish
  • Not having any cognitive impairment
  • Having chronic musculoskeletal pain
  • Being over 18 years of age
  • Being willing and volunteer to work

You may not qualify if:

  • Having a complaint of pain in the musculoskeletal system due to cancer, fracture or surgery within the last 6 months.
  • Having severe cognitive impairment
  • Having a systemic disease such as rheumatoid arthritis, diabetes mellitus
  • Having any neuromuscular disease (such as MS, myopathy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

November 20, 2023

Primary Completion

February 1, 2024

Study Completion

February 20, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations