- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05698069
Turkish Version of Pain Modulation Index
January 16, 2023 updated by: Ece Cinar, Ege University
Reliability and Validity of the Turkish Version of the Pain Modulation Index
In order to assess the validity and reliability of the Turkish version of Pain Modulation Index, 125 volunteers with chronic pain were enrolled in the study.
Test and re-test method was used to assess reliability and correlation analyses with Pain Detect, visual analog scale pain and central sensitization inventory scores were used to assess validity of the questionnaire.
Turkish version of the Pain Modulation Index was found to be a valid and reliable tool for evaluating chronic pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pain Modulation Index is a questionnaire that was developed in English for the assessment of chronic pain for qualities consistent with central sensitization.
The English version of the questionnaire was translated into Turkish by two physicians than back translated into English by two separate bilingual translators.
Initially 10 volunteers were asked to answer this first version of the questionnaire and report any difficulties in understanding the items.
Their feedback was used to give the questionnaire its final shape.
For the validation stage, patients that were diagnosed as having chronic non-cancer pain with more than 3 months duration were enrolled into the study.
They answered the questions twice, 15 days apart.
In addition to the Turkish version of the Pain Modulation Index, on the first visit, they were also asked to answer Pain Detect and Central Sensitization Inventory.
Their answers were analysed to assess the validity and reliability of the Turkish version of Pain Modulation Index.
Study Type
Observational
Enrollment (Actual)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Izmir
-
Bornova, Izmir, Turkey, 355100
- Ege University Hospital, Department of Physical and rehabilitation medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who had non-cancer pain for more than 3 months duration.
Description
Inclusion Criteria:
- presence of chronic non-cancer pain of more than 3 months duration
Exclusion Criteria:
- Illiteracy
- Refusal to take part in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with chronic pain
Patients with non-cancer pain of more than 3 months duration.
|
A 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes.
A questionnaire that was validated for the assessment of neuropathic pain
A questionnaire developed for the detection of central sensitization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliability of the Turkish version of pain modulation index
Time Frame: 15 days
|
Internal consistency was evaluated by test retest method and calculating the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency
|
15 days
|
|
Validity of the Turkish version of Pain Modulation Index
Time Frame: 1 day
|
Index scores were analysed for their correlation with Pain Detect and Central Sensitization Inventory scores.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simin Hepguler, Prof, Ege University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
January 5, 2023
Study Registration Dates
First Submitted
January 16, 2023
First Submitted That Met QC Criteria
January 16, 2023
First Posted (Estimate)
January 26, 2023
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 16, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-7T/44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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