Cervical Spine DiseaseNCT05098860
Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Degenerative Cervical Diseases
A study testing Home Exercise Program, Manual Therapy Combined with Home Exercise Program and Tele-rehabilitation Assisted Program in people with Cervical Spine Disease and Neck Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to compare the effectiveness of soft tissue, joint mobilization, and tele-rehabilitation within the scope of Manual Therapy to the exercise program. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cervical Spine Disease, Neck Pain
- What is being tested?
- Home Exercise Program, Manual Therapy Combined with Home Exercise Program and Tele-rehabilitation Assisted Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2021to 15 Apr 2023
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 40-65
- Patients diagnosed with cervical degenerative disease
- Patients with neck pain who have had pain for at least three months
- Patients who can participate in the treatment program by following WhatsApp messages with tele-rehabilitation.
Who cannot join
- Patients with an indication for surgery for the cervical region and or a previous history of cervical surgery,
- Currently receiving treatment from another region,
- Having severe neurological loss,
- Having a primary or spinal metastatic malignancy,
- Having a vascular problem in the upper extremity,
- To be diagnosed with advanced osteoporosis,
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- Being pregnant,
- Diagnosis of Diabetes Mellitus,
- Having an Inflammatory Disease (such as rheumatoid arthritis),
- Having a history of trauma,
- Those who have received physical therapy and rehabilitation for the cervical region in the last 6 months will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Education and Research Hospital
Malatya, 44000
About this study
Official title: Comparison of the Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Pain, Anxiety and Quality of Life in Degenerative Cervical Diseases
The study aims to compare the effectiveness of soft tissue, joint mobilization, and tele-rehabilitation within the scope of Manual Therapy to the exercise program.
Read the detailed description
60 subjects with cervical degenerative disease will be included in the study after a voluntary consent form is filled out. Subjects will randomly be divided into 3 groups according to the order.
Group 1:Home Exercise Program: After a general education is given to the patients, an exercise program will be taught. Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks, and fill in follow-up charts. In addition, reminder messages will be sent to these patients once a week by the physiotherapist.
Group 2: Manual Therapy Group: After a general education is given to the patients, the same exercise program will be taught. Soft tissue and joint mobilizations will be applied to the patients in this group within the scope of Manual Therapy (MT). Mobilizations of the cervical vertebrae, scapula, and thoracic vertebrae will be included. MT will be applied to the patients 2 days a week for 8 weeks.
Group 3: Tele-Rehabilitation Group: After general education, treatment will be given in the zoom environment. During the 8 weeks, regularly planned exercises will be done via Zoom for 30-45 minutes 2 days a week, accompanied by a physiotherapist. Patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, mobilization of the thoracic region with a foam roller. Patients will apply those self-mobilization at home in front of the physiotherapist in a visual environment. Patients in this group will regularly do the same home exercises on the other days without tele-rehabilitation.
Measurement and evaluation will be done four times, as pre-treatment, post-treatment (8th week), first follow-up (12 weeks), second follow-up (6th month).
- Conditions
- Cervical Spine Disease, Neck Pain
- Being tested
- Home Exercise Program, Manual Therapy Combined with Home Exercise Program, Tele-rehabilitation Assisted Program
- Keywords
- Pain, Anxiety, Quality of Life, Neck disability
- Medical subject headings
- Neck Pain, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise ProgramOther
Educational training program includes active stretching, strengthening, and stabilization exercises of head and neck muscles as well as relaxation and breathing exercises.
Manual Therapy Combined with Home Exercise ProgramOther
Manual Therapy program includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae.
Tele-rehabilitation Assisted ProgramOther
Tele-rehabilitation assisted program will be given in the on-line environment. Patients will apply active cervical and thoracic region mobilizations called self-mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Program | Active comparator | The home exercise program includes a general educational training program. The program includes active stretching, strengthening, and stabilization exercises of neck muscles, head and neck posture exercises as well as relaxation and diaphragmatic breathing exercises.
Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. Receives: Other: Home Exercise Program |
| Manual Therapy Combined with Home Exercise Program | Active comparator | Manual Therapy includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae. MT will be applied to the patients 2 days a week for 8 weeks.
The home exercise program includes active stretching, strengthening, and stabilization exercises of neck muscles, head and neck posture exercises as well as relaxation and diaphragmatic breathing exercises. Receives: Other: Manual Therapy Combined with Home Exercise Program |
| Tele-rehabilitation Assisted Program | Active comparator | Tele-rehabilitation assisted program will be given in the on-line environment. During 8 weeks, regularly planned exercises will be done via online applications for 30-45 minutes 2 days a week, accompanied by a physiotherapist. These patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, with the assistance of a foam-roller for active mobilization of the thoracic region. Receives: Other: Tele-rehabilitation Assisted Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain at 8 weeks, 12 weeks and 6 months
Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 8 weeks intervention, and at the end of 12 weeks, and 6 months from baseline.
Measured: Baseline, 8 weeks, 12 weeks, 6 months
Change from Baseline in Anxiety at 8 weeks, 12 weeks and 6 months
Anxiety Sensitivity Index-3 will be used to evaluate the anxiety sensitivity of individuals effectively and multidimensionally. The scale is rated in a five-point Likert type and consists of a total of 18 items and is rated as 0 = very little, 4 = very much, and the total scale score ranges from 0 to 72.
Measured: Baseline, 8 weeks, 12 weeks, 6 months
Change from Baseline in Quality of Life at 8 weeks, 12 weeks and 6 months
Nottingham Health Profile will be used to assess health-related quality of life. It is a general quality of life questionnaire that measures the individual's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items and evaluates six dimensions related to health status: Energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). matter). Questions are answered with yes or no. Each section is scored between 0-100. 0 indicates best health, 100 indicates worst health.
Measured: Baseline, 8 weeks, 12 weeks, 6 months
Change from Baseline in Neck Disability at 8 weeks, 12 weeks and 6 months
Neck Disability Index, consists of 10 items. Individuals included in the study will be asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).
Measured: Baseline, 8 weeks, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start29 Oct 2021
- Primary completion15 Jul 2022
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Aygul, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098860
- Sponsor's protocol ID
- KAUMS
- Status last verified
- Dec 2021
- First submitted
- 9 Oct 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Pain, Anxiety and Quality of Life in Degenerative Cervical Diseases
- ClinicalTrials.gov ID
- NCT05098860
- Acronym / sponsor ID
- KAUMS
- Conditions
- Cervical Spine Disease, Neck Pain
- Keywords
- Pain, Anxiety, Quality of Life, Neck disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 28 Oct 2021 (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.
The study aims to compare the effectiveness of soft tissue, joint mobilization, and tele-rehabilitation within the scope of Manual Therapy to the exercise program.
Detailed description
60 subjects with cervical degenerative disease will be included in the study after a voluntary consent form is filled out. Subjects will randomly be divided into 3 groups according to the order.
Group 1:Home Exercise Program: After a general education is given to the patients, an exercise program will be taught. Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks, and fill in follow-up charts. In addition, reminder messages will be sent to these patients once a week by the physiotherapist.
Group 2: Manual Therapy Group: After a general education is given to the patients, the same exercise program will be taught. Soft tissue and joint mobilizations will be applied to the patients in this group within the scope of Manual Therapy (MT). Mobilizations of the cervical vertebrae, scapula, and thoracic vertebrae will be included. MT will be applied to the patients 2 days a week for 8 weeks.
Group 3: Tele-Rehabilitation Group: After general education, treatment will be given in the zoom environment. During the 8 weeks, regularly planned exercises will be done via Zoom for 30-45 minutes 2 days a week, accompanied by a physiotherapist. Patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, mobilization of the thoracic region with a foam roller. Patients will apply those self-mobilization at home in front of the physiotherapist in a visual environment. Patients in this group will regularly do the same home exercises on the other days without tele-rehabilitation.
Measurement and evaluation will be done four times, as pre-treatment, post-treatment (8th week), first follow-up (12 weeks), second follow-up (6th month).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Program | Active comparator | Other: Home Exercise ProgramThe home exercise program includes a general educational training program. The program includes active stretching, strengthening, and stabilization exercises of neck muscles, head and neck posture exercises as well as relaxation and diaphragmatic breathing exercises. Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. |
| Manual Therapy Combined with Home Exercise Program | Active comparator | Other: Manual Therapy Combined with Home Exercise ProgramManual Therapy includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae. MT will be applied to the patients 2 days a week for 8 weeks. The home exercise program includes active stretching, strengthening, and stabilization exercises of neck muscles, head and neck posture exercises as well as relaxation and diaphragmatic breathing exercises. |
| Tele-rehabilitation Assisted Program | Active comparator | Other: Tele-rehabilitation Assisted ProgramTele-rehabilitation assisted program will be given in the on-line environment. During 8 weeks, regularly planned exercises will be done via online applications for 30-45 minutes 2 days a week, accompanied by a physiotherapist. These patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, with the assistance of a foam-roller for active mobilization of the thoracic region. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 40-65
- Patients diagnosed with cervical degenerative disease
- Patients with neck pain who have had pain for at least three months
- Patients who can participate in the treatment program by following WhatsApp messages with tele-rehabilitation.
Key exclusion criteria (11 listed)
- Patients with an indication for surgery for the cervical region and or a previous history of cervical surgery,
- Currently receiving treatment from another region,
- Having severe neurological loss,
- Having a primary or spinal metastatic malignancy,
- Having a vascular problem in the upper extremity,
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 |
|---|---|---|
| Home Exercise ProgramEducational training program includes active stretching, strengthening, and stabilization exercises of head and neck muscles as well as relaxation and breathing exercises. | Other | Home Exercise Program |
| Manual Therapy Combined with Home Exercise ProgramManual Therapy program includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae. | Other | Manual Therapy Combined with Home Exercise Program |
| Tele-rehabilitation Assisted ProgramTele-rehabilitation assisted program will be given in the on-line environment. Patients will apply active cervical and thoracic region mobilizations called self-mobilization. | Other | Tele-rehabilitation Assisted Program |
Primary outcome
Change from Baseline in Pain at 8 weeks, 12 weeks and 6 months
Time frame: Baseline, 8 weeks, 12 weeks, 6 months
Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 8 weeks intervention, and at the end of 12 weeks, and 6 months from baseline.
Change from Baseline in Anxiety at 8 weeks, 12 weeks and 6 months
Time frame: Baseline, 8 weeks, 12 weeks, 6 months
Anxiety Sensitivity Index-3 will be used to evaluate the anxiety sensitivity of individuals effectively and multidimensionally. The scale is rated in a five-point Likert type and consists of a total of 18 items and is rated as 0 = very little, 4 = very much, and the total scale score ranges from 0 to 72.
Change from Baseline in Quality of Life at 8 weeks, 12 weeks and 6 months
Time frame: Baseline, 8 weeks, 12 weeks, 6 months
Nottingham Health Profile will be used to assess health-related quality of life. It is a general quality of life questionnaire that measures the individual's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items and evaluates six dimensions related to health status: Energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). matter). Questions are answered with yes or no. Each section is scored between 0-100. 0 indicates best health, 100 indicates worst health.
Change from Baseline in Neck Disability at 8 weeks, 12 weeks and 6 months
Time frame: Baseline, 8 weeks, 12 weeks, 6 months
Neck Disability Index, consists of 10 items. Individuals included in the study will be asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).
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 2023.
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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.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program, Manual Therapy Combined with Home Exercise Program and Tele-rehabilitation Assisted Program in people with Cervical Spine Disease and Neck Pain, run by Hasan Kalyoncu 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 4 inclusion and 11 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 2023. 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?
Change from Baseline in Pain at 8 weeks, 12 weeks and 6 months (time frame: Baseline, 8 weeks, 12 weeks, 6 months). The study lists 4 primary outcomes in all. 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 2023.