Cervical Disc HerniationNCT05501184
SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
A study testing Synchronous Exercise Program and Asynchronous Exercise Program in people with Cervical Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- Synchronous Exercise Program and Asynchronous Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
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.
- Conditions
- Cervical Disc Herniation
- Being tested
- Synchronous Exercise Program, Asynchronous Exercise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous Exercise ProgramOther
The exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Asynchronous Exercise ProgramOther
The exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Telerehabilitation Group | Experimental | 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. Receives: Other: Synchronous Exercise Program |
| Asynchronous Telerehabilitation Group | Active comparator | 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. Receives: Other: Asynchronous Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (4)
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
Measured: 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.
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.
Measured: 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.
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.
Measured: The cervical mobility was measured at baseline and at the end of treatment in the 8th week.
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.
Measured: The quality of life was measured at baseline and at the end of treatment in the 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Feb 2022
- Primary completion15 Jul 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Timurtas, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501184
- Sponsor's protocol ID
- 26.05.2022/67
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
- ClinicalTrials.gov ID
- NCT05501184
- Acronym / sponsor ID
- 26.05.2022/67
- Conditions
- Cervical Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telerehabilitation Group | Experimental | Other: Synchronous Exercise ProgramThe 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. |
| Asynchronous Telerehabilitation Group | Active comparator | Other: Asynchronous Exercise ProgramThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronous Exercise ProgramThe exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression. | Other | Synchronous Telerehabilitation Group |
| Asynchronous Exercise ProgramThe exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression. | Other | Asynchronous Telerehabilitation Group |
Primary outcome
Numerical Pain Rating Scale (NPRS)
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.
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.
4 secondary outcomes
Neck Disability Index (NDI)
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.
Tampa Scale of Kinesiophobia (TSK)
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.
Cervical Mobility
Time frame: The cervical mobility was measured at baseline and at the end of treatment in the 8th week.
Short Form-36 (SF-36)
Time frame: The quality of life was measured at baseline and at the end of treatment in the 8th week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous Exercise Program and Asynchronous Exercise Program in people with Cervical Disc Herniation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.