NCT03856333

Brief Summary

The aim of this study was to determine the validity, reliability and sensitivity of the Cognitive Exercise Therapy Approach Scale in patients with neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

February 18, 2019

Last Update Submit

March 8, 2020

Conditions

Keywords

Cognitive Exercise Therapy Approach Scalevalidityreliabilityresponsivenessneck pain

Outcome Measures

Primary Outcomes (1)

  • Cognitive Exercise Therapy Approach Scale (BETY)

    The biopsychosocial process associated with the neck pain will be evaluated by the 'Cognitive Exercise Therapy Approach Scale'. The scale consists of 30 items. The scale was scored using a 5-point Likert system. Every question; No in no time: 0, Yes rarely: 1, Yes sometimes: 2, Yes often: 3, Yes is always scored as 4: and gives a total score of 30 items. High score means low biopsychosocial status assessment is "bad

    Change from the baseline will be assesed at the first week and at the third week.

Secondary Outcomes (5)

  • Neck Disability Index (NDI)

    At the beginning and 2 weeks after the start of treatment

  • Arm, Shoulder and Hand Problems Questionnaire (DASH)

    At the beginning and 2 weeks after the start of treatment

  • Hospital Anxiety and Depression Scale (HADS)

    At the beginning and 2 weeks after the start of treatment

  • Short Form-36 (SF-36)

    At the beginning and 2 weeks after the start of treatment

  • Visual Analogue Scale (VAS)

    At the beginning, and 2 weeks after the start of treatment

Study Arms (1)

traditional treatment

OTHER

30 minutes of conventional TENS, 20 minutes of hotpack, 8 minutes of therapeutic ultrasound and isotonic, isometric, stretching and relaxation exercises 2 weeks, 5 days in a week.

Other: Assigned Interventions

Interventions

exercises, physical agents

traditional treatment

Eligibility Criteria

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

You may qualify if:

  • Individuals aged between 18-65 years
  • Neck pain VAS out of 3 and above which individuals
  • Individuals who have neck pain for more than 3 months

You may not qualify if:

  • Patients with previous neck surgery history
  • Not willing to participate in the study
  • Attract trouble understanding for filling scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özge Şahin

Famagusta, Cyprus

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özge Şahin

    EMU

    PRINCIPAL INVESTIGATOR
  • Sevim Öksüz, PhD

    EMU

    STUDY DIRECTOR
  • Ender Angın, PhD

    EMU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 27, 2019

Study Start

January 31, 2019

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Not ethical

Locations