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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04752488
Other study ID # Mugla Training and Research
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2022
Est. completion date July 29, 2022

Study information

Verified date August 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 29, 2022
Est. primary completion date June 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation (TR)
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.
Conventional Rehabilitation (CR)
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.

Locations

Country Name City State
Turkey Training and Research Hospital Mugla

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
2 minutes
Primary 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). 5 minutes
Primary 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. 5 minutes
Primary 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. 5 minutes
Secondary 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. 5 minutes
Secondary 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. 5 minutes
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