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The Effect of Telerehabilitation in Patients With Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation (TR)
Conventional Rehabilitation (CR)
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Telerehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between the ages of 18 - 65
  • Patients who have suffered from neck pain for at least 3 months
  • Signing the consent form

Exclusion Criteria:

  • Situations that prevent the evaluation or communication with the individual
  • Illiterate individuals
  • Individuals who have undergone an operation due to neck pain problem, diagnosed with a tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome
  • Conditions in which specific pathological condition is proven such as malignant condition, fracture, systemic rheumatoid disease
  • Orthopedic and neurological problems that prevent evaluation and/or treatment
  • Complaints of pain and numbness spreading to the upper extremities
  • Individuals with a diagnosed psychiatric disease
  • Individuals who have received physiotherapy in the last 6 months
  • Individuals using another treatment method during the study
  • Individuals with musculoskeletal pain in any other part of the body during work
  • Pregnant participants

Sites / Locations

  • Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation (TR) Group

Conventional Rehabilitation (CR) Group

Arm Description

The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.

The CR group will be trained face-to-face with conventional methods before the 8-week home exercise program, and an exercise program will be prescribed with a visual information form.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
The patients will be asked to mark their pain feelings for rest and activity on a 10 cm numerical line (0: no pain, 10: unbearable pain). It is planned to use numerical VAS in our study. The cut-off values for chronic musculoskeletal pain will be classified as the severity of pain according to VAS as follows: <3.4 centimeters: mild pain, 3.5-7.4 centimeters: moderate pain, > 7.5 centimeters: severe pain.
Neck Disability Index (NDI)
NDI consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, study, driving, sleeping, and recreation. For each item included in the study; 0 indicates "no disability" and 5 represents "complete disability" Participants will be asked to give points between these scores. The total score ranges between 0 (no disability) and 50 (complete disability).
Short Form-36 (SF-36)
SF-36 consists of thirty-six items. These provide measurements of eight dimensions. Subscales evaluate health between 0-100 points; '0' indicates poor health, '100' indicates good health.
Tampa Scale for Kinesiophobia
The scale is a 17-item. A 4-point Likert scoring (1= strongly disagree, 4= totally agree) is used in the scale. The participant gets a total score between 17-68. The high score obtained by the participant indicates that the kinesiophobia is also high.

Secondary Outcome Measures

Exercise Adherence Rating Scale (EARS)
EARS provides a measurement of commitment to home exercise. This may facilitate the evaluation of interventions that promote self-management, for the treatment of chronic conditions.
Telemedicine Patient Questionnaire
Telemedicine Patient Questionnaire evaluates the usability and satisfaction of the patients. The total score is scored between 17 and 85. Higher scores indicate expectation, satisfaction and usability.

Full Information

First Posted
February 10, 2021
Last Updated
August 12, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04752488
Brief Title
The Effect of Telerehabilitation in Patients With Chronic Neck Pain
Official Title
The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Results and Exercise Adherence in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Telerehabilitation offers more efficient follow-up of patients during their home exercise period as a cost-effective and effective treatment model. This study was planned to examine the effectiveness of telerehabilitation in patients with chronic neck pain. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.
Detailed Description
With telerehabilitation, patients can easily adapt to home exercise programs and be monitored remotely. In this way, it will be ensured that individuals can apply their exercises at an optimum level in non-clinical settings and to prevent exercise application errors that occur due to the learning effect frequently observed in conventional methods. Exercise is considered a central element in physical therapy and rehabilitation management in patients with chronic neck pain. However, studies have found that improvements after physical therapy and rehabilitation are not preserved in the long term, and recurrence of chronic low back pain is common. With a more cost-effective treatment model, "telerehabilitation", it is aimed that patients can be followed more efficiently during their home exercise period. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation (TR) Group
Arm Type
Experimental
Arm Description
The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.
Arm Title
Conventional Rehabilitation (CR) Group
Arm Type
Active Comparator
Arm Description
The CR group will be trained face-to-face with conventional methods before the 8-week home exercise program, and an exercise program will be prescribed with a visual information form.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation (TR)
Intervention Description
The home exercise program will be educated to the patient on the first day. Exercises for isometric and isotonic strengthening, stretching, and stabilization of the neck muscles will be given. Exercises will be presented to the patients in audio-video format and detailed instructions with explanations. The exercise protocol will also be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation (CR)
Intervention Description
The home exercise program will be educated to the patient on the first day. Isometric and isotonic strengthening, stretching and stabilization exercises for the neck muscles will be given. Exercise information form including explanation and picture of the exercises will be given to the patients. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
The patients will be asked to mark their pain feelings for rest and activity on a 10 cm numerical line (0: no pain, 10: unbearable pain). It is planned to use numerical VAS in our study. The cut-off values for chronic musculoskeletal pain will be classified as the severity of pain according to VAS as follows: <3.4 centimeters: mild pain, 3.5-7.4 centimeters: moderate pain, > 7.5 centimeters: severe pain.
Time Frame
2 minutes
Title
Neck Disability Index (NDI)
Description
NDI consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, study, driving, sleeping, and recreation. For each item included in the study; 0 indicates "no disability" and 5 represents "complete disability" Participants will be asked to give points between these scores. The total score ranges between 0 (no disability) and 50 (complete disability).
Time Frame
5 minutes
Title
Short Form-36 (SF-36)
Description
SF-36 consists of thirty-six items. These provide measurements of eight dimensions. Subscales evaluate health between 0-100 points; '0' indicates poor health, '100' indicates good health.
Time Frame
5 minutes
Title
Tampa Scale for Kinesiophobia
Description
The scale is a 17-item. A 4-point Likert scoring (1= strongly disagree, 4= totally agree) is used in the scale. The participant gets a total score between 17-68. The high score obtained by the participant indicates that the kinesiophobia is also high.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Exercise Adherence Rating Scale (EARS)
Description
EARS provides a measurement of commitment to home exercise. This may facilitate the evaluation of interventions that promote self-management, for the treatment of chronic conditions.
Time Frame
5 minutes
Title
Telemedicine Patient Questionnaire
Description
Telemedicine Patient Questionnaire evaluates the usability and satisfaction of the patients. The total score is scored between 17 and 85. Higher scores indicate expectation, satisfaction and usability.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 18 - 65 Patients who have suffered from neck pain for at least 3 months Signing the consent form Exclusion Criteria: Situations that prevent the evaluation or communication with the individual Illiterate individuals Individuals who have undergone an operation due to neck pain problem, diagnosed with a tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome Conditions in which specific pathological condition is proven such as malignant condition, fracture, systemic rheumatoid disease Orthopedic and neurological problems that prevent evaluation and/or treatment Complaints of pain and numbness spreading to the upper extremities Individuals with a diagnosed psychiatric disease Individuals who have received physiotherapy in the last 6 months Individuals using another treatment method during the study Individuals with musculoskeletal pain in any other part of the body during work Pregnant participants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Özkeskin, PhD
Organizational Affiliation
Ege University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cem Yalın Kılınç
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Özden
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Chair
Facility Information:
Facility Name
Training and Research Hospital
City
Muğla
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Telerehabilitation in Patients With Chronic Neck Pain

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