Myofascial Pain Dysfunction SyndromeNDINCT06833359
Validity, Reliability of Neck Disability Index in Albanian
An observational study of Myofascial Pain Dysfunction Syndrome and Trigger Point Pain, Myofascial, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
To translate and validate the Cervical Disability Index (NDI) into Albanian for use in the Albanian-speaking population Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Dysfunction Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- Observation
- How many people
- 582 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2025to 14 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults with cervical pain
Who may be able to join
- Myofascial syndrome
- Headache
- muscular pain
- articular pain
- arthirtis
Who cannot join
- contraindications to manual therapy
- severe trauma
- tumor
- metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation, Translation, and Cross-cultural Validation of the Cervical Disability Index (NDI) for Use in the Albanian-speaking Population
To translate and validate the Cervical Disability Index (NDI) into Albanian for use in the Albanian-speaking population
Read the detailed description
The cross-cultural adaptation will be carried out according to the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.
Psychometric properties will be assessed by administering the questionnaire to approximately 400 participants. Reliability will be estimated by assessing stability and homogeneity.
- Being tested
- Observation
- Keywords
- Validity, cross-cultural adaptation, Albanian Neck Disability index, Translation
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The Cervical Disability Index will be taught individually online through the Google questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Albanian Neck Disability Index
An online questionnaire used to assess the impact of neck pain on patients' activities of daily living and quality of life which consists of 10 items, each addressing a specific dimension of functionality or symptoms related to neck disorders.Each item includes five response options ranging from 0 to 5 points, where 0 indicates the absence of problems or limitations and 5 represents the maximum inability or restriction to perform the evaluated activity. The total score is calculated by adding the values of the 10 items, with a maximum of 50 points.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start16 Feb 2025
- Primary completion25 Feb 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Dysfunction SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasemin Todri, Universidad Católica San Antonio de Murcia
- Investigators
- Jasemin Todri, Principal investigator, UCAM Universidad Catolica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833359
- Sponsor's protocol ID
- 208/9
- Acronym
- NDI
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation, Translation, and Cross-cultural Validation of the Cervical Disability Index (NDI) for Use in the Albanian-speaking Population
- ClinicalTrials.gov ID
- NCT06833359
- Acronym / sponsor ID
- NDI / 208/9
- Keywords
- Validity, cross-cultural adaptation, Albanian Neck Disability index, Translation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 18 Feb 2025 (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.
To translate and validate the Cervical Disability Index (NDI) into Albanian for use in the Albanian-speaking population
Detailed description
The cross-cultural adaptation will be carried out according to the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.
Psychometric properties will be assessed by administering the questionnaire to approximately 400 participants. Reliability will be estimated by assessing stability and homogeneity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults with cervical pain
Key inclusion criteria (5 listed)
- Myofascial syndrome
- Headache
- muscular pain
- articular pain
- arthirtis
Key exclusion criteria (4 listed)
- contraindications to manual therapy
- severe trauma
- tumor
- metabolic disease
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 |
|---|---|---|
| ObservationThe Cervical Disability Index will be taught individually online through the Google questionnaire. | Other | – |
Primary outcome
Albanian Neck Disability Index
Time frame: 7 days
An online questionnaire used to assess the impact of neck pain on patients' activities of daily living and quality of life which consists of 10 items, each addressing a specific dimension of functionality or symptoms related to neck disorders.Each item includes five response options ranging from 0 to 5 points, where 0 indicates the absence of problems or limitations and 5 represents the maximum inability or restriction to perform the evaluated activity. The total score is calculated by adding the values of the 10 items, with a maximum of 50 points.
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 18 Apr 2025.
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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.
Jasemin Todri principal investigator
UCAM Universidad Catolica San Antonio de Murcia
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 Myofascial Pain Dysfunction Syndrome and Trigger Point Pain, Myofascial, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 5 inclusion and 4 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 18 Apr 2025. 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 Spain. 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?
Albanian Neck Disability Index (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.