Back to resultsSYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
Primary Purpose
Cervical Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Synchronous Exercise Program
Asynchronous Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- Participants between the ages of 18-65,
- Who had access to the internet and smartphone,
- Had the ability to conduct video calls were included in the study.
Exclusion Criteria:
- Participants were excluded if they had COVID-19,
- Had surgery in the last 6 months,
- Received physiotherapy treatment.
- Had a condition that prevented them from exercising.
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Synchronous Telerehabilitation Group
Asynchronous Telerehabilitation Group
Arm Description
The exercise program was applied to groups that include three participants of the synchronous group 3 days per week by video conference method on an online platform (Zoom) with the supervision of a physiotherapist. The time of the group session was organized according to the availability of participants in that group and the physiotherapist using shared calendar availability (Doodle). The physiotherapist sent a reminder to participants one hour prior to each session including the video conference meeting link. Each exercise session lasted approximately 40 minutes. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist demonstrated the exercises as needed, supervised the group by giving real-time feedback, and progressed the exercise program according to the needs of each group.
The exercise program was prescribed and followed up 3 days per week via the mobile application (FizyoTr). A notification was sent to participants' phones via mobile application prior to each session and attendance to the exercise program was recorded. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist progressed the exercise program according to the assessment at 4 weeks and the needs of each participant.
Outcomes
Primary Outcome Measures
Numerical Pain Rating Scale (NPRS)
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Secondary Outcome Measures
Neck Disability Index (NDI)
The participants' level of disability related to neck pain was evaluated using NDI. The NDI consists of 10 questions scored between 0 to 5 to measure disability related to limitation or pain (12). Questions include neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and leisure activities. The scores range from 0 to 50 with higher scores indicating a more severe disability. The Turkish version of NDI has been shown to be valid and reliable in patients with neck pain
Tampa Scale of Kinesiophobia (TSK)
The TSK is a scale developed by Vlaeyen et al. consisting of 17 questions that assess kinesiophobia. For each question, a 4-point Likert scoring (1 = strongly disagree, 4 = completely agree) is used. After reversing items 4, 8, 12, and 16, a total score is calculated. The total score ranges from 17-68. A higher score indicates a higher level of kinesiophobia. The Turkish version of TSK has been shown to be valid and reliable.
Cervical Mobility
The range of neck extension, flexion, and right and left lateral flexion were measured using a universal goniometer. For flexion and extension measurement, the participant sat on the side of the physiotherapist. The pivot point of the goniometer was placed at the acromion. The fixed arm of the goniometer was parallel to the ground. The measuring arm followed the midline of the ear. While measuring flexion, the participant was asked to try to touch his/her chin to the chest and for extension, to move his/her face parallel to the ceiling. For lateral flexion, pivot point of the goniometer was placed on the spinal ridge of C7. The fixed arm of the goniometer was kept parallel to the ground. The measuring arm followed the spinal projections of the vertebrae. The participant was asked to move his/her ear towards the shoulder.
Short Form-36 (SF-36)
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning (19). The Turkish version of the SF-36 has been shown to have validity and reliability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05501184
Brief Title
SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
Official Title
COMPARISON OF SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
August 11, 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
This was a randomized controlled trial conducted to examine the changes in the pain, physical function, quality of life, and kinesiophobia of participants with non-specific neck pain in Marmara University Physiotherapy and Rehabilitation Department. This study was approved by the Clinical Studies Ethics Committee of Marmara University Faculty of Health Sciences in January 2022 and was carried out in accordance with the Declaration of Helsinki. The participants were informed about the study and their consent was obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation
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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synchronous Telerehabilitation Group
Arm Type
Experimental
Arm Description
The exercise program was applied to groups that include three participants of the synchronous group 3 days per week by video conference method on an online platform (Zoom) with the supervision of a physiotherapist. The time of the group session was organized according to the availability of participants in that group and the physiotherapist using shared calendar availability (Doodle). The physiotherapist sent a reminder to participants one hour prior to each session including the video conference meeting link. Each exercise session lasted approximately 40 minutes. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist demonstrated the exercises as needed, supervised the group by giving real-time feedback, and progressed the exercise program according to the needs of each group.
Arm Title
Asynchronous Telerehabilitation Group
Arm Type
Active Comparator
Arm Description
The exercise program was prescribed and followed up 3 days per week via the mobile application (FizyoTr). A notification was sent to participants' phones via mobile application prior to each session and attendance to the exercise program was recorded. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist progressed the exercise program according to the assessment at 4 weeks and the needs of each participant.
Intervention Type
Other
Intervention Name(s)
Synchronous Exercise Program
Intervention Description
The exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Intervention Type
Other
Intervention Name(s)
Asynchronous Exercise Program
Intervention Description
The exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.
Time Frame
The pain was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
The participants' level of disability related to neck pain was evaluated using NDI. The NDI consists of 10 questions scored between 0 to 5 to measure disability related to limitation or pain (12). Questions include neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and leisure activities. The scores range from 0 to 50 with higher scores indicating a more severe disability. The Turkish version of NDI has been shown to be valid and reliable in patients with neck pain
Time Frame
The disability was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.
Title
Tampa Scale of Kinesiophobia (TSK)
Description
The TSK is a scale developed by Vlaeyen et al. consisting of 17 questions that assess kinesiophobia. For each question, a 4-point Likert scoring (1 = strongly disagree, 4 = completely agree) is used. After reversing items 4, 8, 12, and 16, a total score is calculated. The total score ranges from 17-68. A higher score indicates a higher level of kinesiophobia. The Turkish version of TSK has been shown to be valid and reliable.
Time Frame
The kinesiophobia was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.
Title
Cervical Mobility
Description
The range of neck extension, flexion, and right and left lateral flexion were measured using a universal goniometer. For flexion and extension measurement, the participant sat on the side of the physiotherapist. The pivot point of the goniometer was placed at the acromion. The fixed arm of the goniometer was parallel to the ground. The measuring arm followed the midline of the ear. While measuring flexion, the participant was asked to try to touch his/her chin to the chest and for extension, to move his/her face parallel to the ceiling. For lateral flexion, pivot point of the goniometer was placed on the spinal ridge of C7. The fixed arm of the goniometer was kept parallel to the ground. The measuring arm followed the spinal projections of the vertebrae. The participant was asked to move his/her ear towards the shoulder.
Time Frame
The cervical mobility was measured at baseline and at the end of treatment in the 8th week.
Title
Short Form-36 (SF-36)
Description
The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning (19). The Turkish version of the SF-36 has been shown to have validity and reliability.
Time Frame
The quality of life was measured at baseline and at the end of treatment in the 8th week.
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:
Participants between the ages of 18-65,
Who had access to the internet and smartphone,
Had the ability to conduct video calls were included in the study.
Exclusion Criteria:
Participants were excluded if they had COVID-19,
Had surgery in the last 6 months,
Received physiotherapy treatment.
Had a condition that prevented them from exercising.
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
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