NCT05496621

Brief Summary

The aim of this study is to investigate the usability of the Turkish version of the Keel Start Tool as a valid and reliable method in groups with 5 different types of musculoskeletal pain (knee, neck, shoulder, back, multiple painful areas). When the literature is examined, Turkish validity has not been made in this area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

February 7, 2022

Last Update Submit

August 10, 2022

Conditions

Keywords

musculoskeletal diseases

Outcome Measures

Primary Outcomes (1)

  • The STarT Back Screening Tool

    The STarT Back Screening Tool is a tool designed by Keele University in 2008 to screen prognosis in patients with low back pain in the initial decision-making process. It consists of 9 items. Subscale scores range from 0 to 5, and patients with 4 or 5 points are classified in the high-risk subgroup. Scores range from 0-9. Patients with a score of 0-3 are classified as a low-risk subgroup and patients with a score of 4-9 are classified as an intermediate-risk subgroup. Cultural adaptation, internal consistency, test repetition and construct validity of the SBST in Turkey were examined in October 2019.

    First week

Secondary Outcomes (3)

  • The Roland-Morris Questionnaire (RMDQ)

    First week

  • Short Form-36 (SF-36)

    First week

  • The Tampa Kinesiophobia Scale

    First week

Study Arms (1)

Musculoskeletal Diseas

EXPERIMENTAL

Questionnaires will be asked for the validity of the Turkish version of the Keel Start Tool.

Other: Questionnaire

Interventions

1st Stage Keele Start MSk tool translated into Turkish and its cultural adaptation, 2nd Stage Statistical analysis of reliability and validity of Turkish Keele start msk tool

Musculoskeletal Diseas

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be 18 years or older.
  • The location of MSC pain must be one of the 5 regions. These 5 regions; knee, shoulder, back, neck, multi-region.
  • Volunteering to participate in the study
  • The patient's pain must be chronic. chronic pain; If there is general agreement on the definition of pain today, the recognition of pain as a disease is controversial. Depending on their duration, different types of pain are now classified as chronic pain, and the generally accepted definition is "pain that continues after a normal recovery period."
  • The patient's Mini mental test score must be 23 and above. The mini mental state examination is scored on a scale of 0-30 with \>25 points interpreted as normal cognitive status.

You may not qualify if:

  • Those with serious pathological symptoms
  • Joint infection
  • Cancer
  • Rheumatoid arthritis
  • Spondyloarthropathy
  • Polymyalgia
  • Inflammatory arthropathy
  • Crystal disease
  • Gout
  • Those with severe and persistent mental health problems
  • Having a diagnosis of dementia
  • Those with a terminal illness diagnosis
  • Those who have recently experienced trauma or bereavement
  • Those who cannot communicate in Turkish
  • Those with neurological problems
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye University

Istanbul, 16360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Burcu Pamukçu

    İstinye University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Our work will be carried out in two stages. 1st stage Keele start msk tool translated into Turkish and its cultural adaptation, 2nd stage statistical analysis of the reliability and validity of the Turkish Keele start msk tool. Permission was obtained from Keele University, the developer of the scale, before starting the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

August 11, 2022

Study Start

February 1, 2019

Primary Completion

May 1, 2019

Study Completion

November 1, 2019

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations