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Active, not recruitingNCT06685094Updated Oct 16, 2026

Translation and Validation of the Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life Scales in Albanian

An observational study in Musculoskeletal Pain, Autonomy and Healthy, sponsored by Universidad Católica San Antonio de Murcia. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Universidad Católica San Antonio de Murcia · Observational

Updated Oct 16, 2026Now Active, not recruitingEnrollment updated+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
205
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing.

The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimated through stability and homogeneity assessment

Read the detailed description

The assessment scales of the upper and lower limbs, pain, autonomy and quality of life for use in the Albanian-speaking population are as follow:

  1. Adaptation, validation and test-retest reliability of upper limbs scales as: Disabilities of the arm, shoulder and hand questionnaire (DASH), MAYO Elbow score, oxford Elbow score, patent-rated tennis elbow evaluation, shoulder pain and disability index (SPADI), Simple Shoulder Test (SST) and Upper Limp Functional Index (ULFI).
  2. Adaptation, validation and test-retest reliability of lower limb scales as: Oxford Hip Score, Motricity Index and Trunk Control Test in Albanian language.
  3. Adaptation, validation and test-retest reliability of health scales and autonomy: Pain Disability Index (PDI), Functional Ambulation Category (FAC), Fear-Avoidance Beliefs Questionnaire (FABQ), Graded Chronic Pain Scale (GCPS),Motor Assessment Scale (MAS), Stroke rehabilitation Assessment of movement (STREAM), Hospital Anxiety and Depression Scale (HADS), Headache Impact Test (HIT6), Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS), Instrumental activities of daily living scale (IADL), health status questionnaire (EQ-5D-5L), Social Responsiveness Scale (SRS), short portable mental status questionnaire (SPMSQ), Tampa Skale Kinesiophobia, Ankle--Hindfoot Scale (AOFAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
02

Conditions studied

  • Musculoskeletal Pain
  • Autonomy
  • Healthy
  • Upper Limb Injury
  • Lower Limb Injury
03

In context

Musculoskeletal Pain

515 studies on the registry are indexed under Musculoskeletal Pain; 127 are open to participants now.

This study's enrollment of 205 is above the median of 175 across 136 observational studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 18 are open to participants now.

Browse Universidad Católica San Antonio de Murcia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Albanian patients whom seeking care for articular and muscular pain.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • articular and muscular pain
  • back pain
  • presence of rheumatologic symptoms
  • functional misbalance
  • scoliosis
  • musculoskeletal disorders

Exclusion criteria

Exclusion Criteria:

  • no native albanian language
  • severe trauma to the lumbar spine or hip(s)
  • tumor
  • metabolic disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
205 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Adaptation, validation and test-retest reliability of upper limbs scales

    validation of the scales for the: disabilities of the arm, shoulder and hand questionnaire (DASH), MAYO Elbow score, oxford Elbow score, patent-rated tennis elbow evaluation, shoulder pain and disability index (SPADI), Simple Shoulder Test (SST) and Upper Limp Functional Index (ULFI).

    Time frame: 7 days

  2. Adaptation, validation and test-retest reliability of lower limb scales

    validation of the scales for the: Oxford Hip Score, Motricity Index and Trunk Control Test in Albanian language.

    Time frame: 7 days

  3. Adaptation, validation and test-retest reliability of health scales, depression, anxiety and autonomy

    validation of : Pain Disability Index(PID), Functional Ambulation Category (FAC), Fear-Avoidance Beliefs Questionnaire (FABQ), Graded Chronic Pain Scale (GCPS),Motor Assessment Scale (MAS), Stroke rehabilitation Assessment of movement (STREAM), Hospital Anxiety and Depression Scale (HADS), Headache Impact Test (HIT6), Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS), Instrumental activities of daily living scale (IADL), health status questionnaire (EQ-5D-5L), Social Responsiveness Scale (SRS), short portable mental status questionnaire (SPMSQ), Tampa Skale Kinesiophobia, Ankle--Hindfoot Scale (AOFAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    Time frame: 7 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Jun 2026, 12 months.

Of 51 non-industry observational studies under Musculoskeletal Pain, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's 12 months is below that.

Counting every sponsor, half of 52 studies reached it within 22 months; a quarter within 8 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2024
First posted
Nov 12, 2024
StartActual
Jun 30, 2025
Primary completionActual
Jun 30, 2026
CompletionEst.
Sep 1, 2027
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 16, 2026
Enrollment
300 (estimated)→205 (actual)
Oct 16, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionAdaptation, validation and test-retest reliability of health scales, depression, anxiety and autonomy: how it is measured was reworded
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Recruiting→Active, not recruiting
    Enrollment 300 (estimated)→205 (actual)
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionAdaptation, validation and test-retest reliability of health scales, depression, anxiety and autonomy: how it is measured was reworded
    + 5 other changes: verification date, date precision, description, site details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06685094
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Orges Lena (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Nov 12, 2024
Start date
Jun 30, 2025
Primary completion
Jun 30, 2026
Completion
Sep 1, 2027 (estimated)
Last update
Oct 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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