NCT06293001

Brief Summary

Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement. Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied. The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

February 19, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

QuestionnaireShoulder painValidityReliabilityCross-cultural adaptation

Outcome Measures

Primary Outcomes (1)

  • Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale)

    A score of 0 represents the best score and a score of 10 represents the worst score and indicates worsening of the symptom.

    10 minutes

Study Arms (1)

Patients with shoulder pain

Patients with shoulder pain, pain for at least three months and aged between 18 and 64 years, and for the re-test only participants with unchanged health status were included in the study. Patients with rheumatological, neurological or musculoskeletal diseases, invasive intervention in the last 3 months, active infection, history of cancer, post-traumatic condition requiring surgery were excluded.

Other: No intervention

Interventions

No intervention

Patients with shoulder pain

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with shoulder pain were included in the study. Patients with shoulder pain, pain for at least three months and aged between 18 and 64 years, and for the re-test only participants with unchanged health status were included in the study. Patients with rheumatological, neurological or musculoskeletal diseases, invasive intervention in the last 3 months, active infection, history of cancer, post-traumatic condition requiring surgery were excluded.

You may qualify if:

  • Patients with shoulder pain who have had pain for at least three months The ages between of 18 and 64.

You may not qualify if:

  • Rheumatological, neurological or musculoskeletal diseases, Non-invasive interventions performed in the last 3 months, Active infections, History of cancer, Conditions requiring post-traumatic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Turgut

Ankara, 06300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Turgut, Ass. Prof.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Elif TURGUT

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 5, 2024

Study Start

November 28, 2023

Primary Completion

April 26, 2024

Study Completion

June 30, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations