Effectiveness of A Telehealth Postural Awareness Program Combined With Exercise In People With Neck Pain

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

A postural awareness program with exercises

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, neck, telehealth, awareness, posture, exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

being aged 18 years or over,
volunteering to take part in the study,
being a student of online education,
without a history of any neurological or orthopedic problem,
with resting neck pain (as measured by the VAS) lasting ≤30 days
that is aggravated by movement without extending distal to the shoulders.

Exclusion Criteria:

rheumatological diseases, malignity or structural deformities,
previous surgical intervention related to the neck region,
severe pain (more than 7 in 0 to 10 VAS)

Sites / Locations

Tezel Yıldırım Şahan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Postural Awareness Program with Exercises in people with neck pain

Arm Description

Postural education, bad posture, good posture, awareness, their effects in daily life

Outcomes

Primary Outcome Measures

Neck pain

Visual Analog Scale- The evaluations of this study was performed at beginning and end of study. Neck pain was determined with Visual Analog Scale with 0 indicating "no pain", 10 indicating "the most severe pain

Secondary Outcome Measures

Neck Disability

Neck Disability Index-The Neck Disability Index consists of 10 items: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. Individuals included in the study were asked to rate each title between 0 (no disability) and 5 (complete disability). The total score ranges between 0 (no disability) and 50 (complete disability)

Leisure Time Management

Leisure Time Management- This scale consists of four sub-dimensions and 15 items. These sub-dimensions were investigated as "evaluation", "programming", "leisure attitude", "goal setting and method". The answer codes of each item vary between 1 and 5 as a Likert type.

Exercise Stage of Change

Exercise Stage of Change Scale-The "Exercise Behavior Change Steps Questionnaire" aims to determine the individual's exercise behavior steps. The four items in the questionnaire, in which the participants' wishes for exercise are tried to be determined, are answered as yes/no. Individuals' intention to exercise and their habits of participating in exercise are divided into five different exercise behavior steps according to their responses to the items: Pre-tendency, Tendency, Preparation, Movement and Continuity.

Full Information

NCT ID

NCT05509491

First Posted

August 18, 2022

Last Updated

August 19, 2022

Sponsor

Hacettepe University

Collaborators

Saglik Bilimleri Universitesi

1. Study Identification

Unique Protocol Identification Number

NCT05509491

Brief Title

Effectiveness of A Telehealth Postural Awareness Program Combined With Exercise In People With Neck Pain

Official Title

Postural Awareness Program With Exercises In Patients With Neck Pain

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

February 5, 2022 (Actual)

Primary Completion Date

April 10, 2022 (Actual)

Study Completion Date

May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

Collaborators

Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

People with neck pain often experience pain, neck disability, and poor quality of life. Postural-based awareness programs are evidence-based interventions for postural problems and neck pain disorders. This study aims to determine the effectiveness of a telehealth physiotherapist-delivered postural awareness program combined with exercise in people with neck pain. Pain, neck disability, leisure time management, and exercise stage of change were evaluated.

Detailed Description

Pain with visual analog scale, neck disability with Neck Disability Index, Leisure time management with Leisure Time Management Scale, and exercise stage of change with exercise Stage of change Scale were determined. The authors aim to find out if there are any changes before and after the program on the pain, neck disability, and evaluation subscale of the leisure time management scale, and exercise stage of change of participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

neck pain, neck, telehealth, awareness, posture, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

12-week physiotherapist delivered a postural awareness program with exercises

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Postural Awareness Program with Exercises in people with neck pain

Arm Type

Experimental

Arm Description

Postural education, bad posture, good posture, awareness, their effects in daily life

Intervention Type

Behavioral

Intervention Name(s)

A postural awareness program with exercises

Intervention Description

A program about postural awareness, bad posture, good posture and their effects on daily life

Primary Outcome Measure Information:

Title

Neck pain

Description

Visual Analog Scale- The evaluations of this study was performed at beginning and end of study. Neck pain was determined with Visual Analog Scale with 0 indicating "no pain", 10 indicating "the most severe pain

Time Frame

5 minute

Secondary Outcome Measure Information:

Title

Neck Disability

Description

Neck Disability Index-The Neck Disability Index consists of 10 items: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. Individuals included in the study were asked to rate each title between 0 (no disability) and 5 (complete disability). The total score ranges between 0 (no disability) and 50 (complete disability)

Time Frame

10 minute

Title

Leisure Time Management

Description

Leisure Time Management- This scale consists of four sub-dimensions and 15 items. These sub-dimensions were investigated as "evaluation", "programming", "leisure attitude", "goal setting and method". The answer codes of each item vary between 1 and 5 as a Likert type.

Time Frame

10 minute

Title

Exercise Stage of Change

Description

Exercise Stage of Change Scale-The "Exercise Behavior Change Steps Questionnaire" aims to determine the individual's exercise behavior steps. The four items in the questionnaire, in which the participants' wishes for exercise are tried to be determined, are answered as yes/no. Individuals' intention to exercise and their habits of participating in exercise are divided into five different exercise behavior steps according to their responses to the items: Pre-tendency, Tendency, Preparation, Movement and Continuity.

Time Frame

10 minute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: being aged 18 years or over, volunteering to take part in the study, being a student of online education, without a history of any neurological or orthopedic problem, with resting neck pain (as measured by the VAS) lasting ≤30 days that is aggravated by movement without extending distal to the shoulders. Exclusion Criteria: rheumatological diseases, malignity or structural deformities, previous surgical intervention related to the neck region, severe pain (more than 7 in 0 to 10 VAS)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tezel Y Şahan, pHD

Organizational Affiliation

University of Health science

Official's Role

Study Chair

Facility Information:

Facility Name

Tezel Yıldırım Şahan

City

Ankara

ZIP/Postal Code

06018

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

The authors decided that if a researcher want ıpd than they will send them with e mail

Citations:

PubMed Identifier

35907828

Citation

Bennell KL, Jones SE, Hinman RS, McManus F, Lamb KE, Quicke JG, Sumithran P, Prendergast J, George ES, Holden MA, Foster NE, Allison K. Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 30;23(1):733. doi: 10.1186/s12891-022-05685-z.

Results Reference

background

PubMed Identifier

32826008

Citation

Alfawaz S, Lohman E, Alameri M, Daher N, Jaber H. Effect of adding stretching to standardized procedures on cervical range of motion, pain, and disability in patients with non-specific mechanical neck pain: A randomized clinical trial. J Bodyw Mov Ther. 2020 Jul;24(3):50-58. doi: 10.1016/j.jbmt.2020.02.020. Epub 2020 Feb 22.

Results Reference

background

PubMed Identifier

33831805

Citation

Toprak Celenay S, Mete O, Sari A, Ozer Kaya D. A comparison of kinesio taping and classical massage in addition to cervical stabilization exercise in patients with chronic neck pain. Complement Ther Clin Pract. 2021 May;43:101381. doi: 10.1016/j.ctcp.2021.101381. Epub 2021 Apr 2.

Results Reference

background

PubMed Identifier

28146026

Citation

Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.

Results Reference

background

Neck Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial