Chronic Neck PainNCT04752488
The Effect of Telerehabilitation in Patients With Chronic Neck Pain
A study testing Telerehabilitation (TR) and Conventional Rehabilitation (CR) in people with Chronic Neck Pain, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Telerehabilitation (TR) and Conventional Rehabilitation (CR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2022to 29 Jul 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
- Patients between the ages of 18 - 65
- Patients who have suffered from neck pain for at least 3 months
- Signing the consent form
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Results and Exercise Adherence in Patients With Chronic Neck Pain
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.
Read the detailed 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Telerehabilitation (TR), Conventional Rehabilitation (CR)
- Keywords
- Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation (TR)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation (TR) Group | Experimental | The TR group will be followed up through the video-based exercise software within the 8-week home exercise program. Receives: Other: Telerehabilitation (TR) |
| Conventional Rehabilitation (CR) Group | Active comparator | 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. Receives: Other: Conventional Rehabilitation (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
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).
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Secondary outcomes (2)
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 Mar 2022
- Primary completion20 Jun 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih ÖZDEN, Marmara University
- Investigators
- Mehmet Özkeskin, PhD, Study director, Ege Universityİsmet Tümtürk, MSc, Principal investigator, Ege UniversityCem Yalın Kılınç, Principal investigator, Muğla Sıtkı Koçman UniversityFatih Özden, Study chair, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752488
- Sponsor's protocol ID
- Mugla Training and Research
- Status last verified
- Aug 2022
- First submitted
- 10 Feb 2021
- Last updated
- 16 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Results and Exercise Adherence in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04752488
- Acronym / sponsor ID
- Mugla Training and Research
- Conditions
- Chronic Neck Pain
- Keywords
- Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 12 Feb 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.
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.
Detailed 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.
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 |
|---|---|---|
| Telerehabilitation (TR) Group | Experimental | Other: Telerehabilitation (TR)The TR group will be followed up through the video-based exercise software within the 8-week home exercise program. |
| Conventional Rehabilitation (CR) Group | Active comparator | Other: Conventional Rehabilitation (CR)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18 - 65
- Patients who have suffered from neck pain for at least 3 months
- Signing the consent form
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| 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. | Other | Telerehabilitation (TR) Group |
| 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. | Other | Conventional Rehabilitation (CR) Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 2 minutes
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.
Neck Disability Index (NDI)
Time frame: 5 minutes
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).
Short Form-36 (SF-36)
Time frame: 5 minutes
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.
Tampa Scale for Kinesiophobia
Time frame: 5 minutes
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.
2 secondary outcomes
Exercise Adherence Rating Scale (EARS)
Time frame: 5 minutes
Telemedicine Patient Questionnaire
Time frame: 5 minutes
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 16 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Neck Pain
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
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.
Mehmet Özkeskin, PhD study director
Ege University
İsmet Tümtürk, MSc principal investigator
Ege University
Cem Yalın Kılınç principal investigator
Muğla Sıtkı Koçman 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 Telerehabilitation (TR) and Conventional Rehabilitation (CR) in people with Chronic Neck Pain, 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 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 16 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?
Visual Analogue Scale (VAS) (time frame: 2 minutes). 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 16 Aug 2022.