Chronic PainNCT05698069
Turkish Version of Pain Modulation Index
An observational study of Chronic Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain Modulation Index, Pain Detect and Central sensitization inventory
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 5 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had non-cancer pain for more than 3 months duration.
Who may be able to join
- presence of chronic non-cancer pain of more than 3 months duration
Who cannot join
- Illiteracy
- Refusal to take part in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Hospital, Department of Physical and rehabilitation medicine
Bornova, İzmir, 355100
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Pain Modulation Index, Pain Detect, Central sensitization inventory
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Modulation IndexDiagnostic test
A 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes.
Pain DetectOther
A questionnaire that was validated for the assessment of neuropathic pain
Central sensitization inventoryOther
A questionnaire developed for the detection of central sensitization.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic pain | Patients with non-cancer pain of more than 3 months duration. Receives: Diagnostic Test: Pain Modulation Index; Other: Pain Detect; Other: Central sensitization inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the Turkish version of pain modulation index
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
Measured: 15 days
Validity of the Turkish version of Pain Modulation Index
Index scores were analysed for their correlation with Pain Detect and Central Sensitization Inventory scores.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2022
- Primary completion1 Sep 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Cinar, Ege University
- Investigators
- Simin Hepguler, Prof, Principal investigator, Ege University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698069
- Sponsor's protocol ID
- 21-7T/44
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Austin PD, Asghari A, Costa DSJ, Siddall PJ. The development of a novel questionnaire assessing alterations in central pain processing in people with and without chronic pain. Scand J Pain. 2020 Apr 28;20(2):407-417. doi: 10.1515/sjpain-2019-0087.
PubMed 31785195
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Pain Modulation Index
- ClinicalTrials.gov ID
- NCT05698069
- Acronym / sponsor ID
- 21-7T/44
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic pain | – | Diagnostic Test: Pain Modulation Index, Other: Pain Detect, Other: Central sensitization inventoryPatients with non-cancer pain of more than 3 months duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had non-cancer pain for more than 3 months duration.
Key inclusion criteria (1 listed)
- presence of chronic non-cancer pain of more than 3 months duration
Key exclusion criteria (2 listed)
- Illiteracy
- Refusal to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Modulation IndexA 18 item questionnaire assessing patients' pain characteristics for the detection of disordered pain modulation processes. | Diagnostic test | Patients with chronic pain |
| Pain DetectA questionnaire that was validated for the assessment of neuropathic pain | Other | Patients with chronic pain |
| Central sensitization inventoryA questionnaire developed for the detection of central sensitization. | Other | Patients with chronic pain |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 31785195Austin PD, Asghari A, Costa DSJ, Siddall PJ. The development of a novel questionnaire assessing alterations in central pain processing in people with and without chronic pain. Scand J Pain. 2020 Apr 28;20(2):407-417. doi: 10.1515/sjpain-2019-0087.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
RecruitingObservational study
Different Treatments in Chronic Pain Patients.
Chronic Pain, Nociplastic Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simin Hepguler, Prof principal investigator
Ege University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the Turkish version of pain modulation index (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.