- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752488
The Effect of Telerehabilitation in Patients With Chronic Neck Pain
The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Results and Exercise Adherence in Patients With Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Muğla, Turkey
- Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Telerehabilitation (TR) Group
The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.
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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.
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Active Comparator: Conventional Rehabilitation (CR) Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Short Form-36 (SF-36)
Time Frame: 5 minutes
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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.
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5 minutes
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Visual Analogue Scale (VAS)
Time Frame: 2 minutes
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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
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Neck Disability Index (NDI)
Time Frame: 5 minutes
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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).
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5 minutes
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Tampa Scale for Kinesiophobia
Time Frame: 5 minutes
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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.
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5 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Exercise Adherence Rating Scale (EARS)
Time Frame: 5 minutes
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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.
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5 minutes
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Telemedicine Patient Questionnaire
Time Frame: 5 minutes
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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.
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5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mehmet Özkeskin, PhD, Ege University
- Principal Investigator: İsmet Tümtürk, MSc, Ege University
- Principal Investigator: Cem Yalın Kılınç, Muğla Sıtkı Koçman University
- Study Chair: Fatih Özden, Muğla Sıtkı Koçman University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mugla Training and Research
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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