Neck PainNCT04834895
Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain
A study testing mhealth exercise group and brochure exercise group in people with Neck Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives: Increase exercise adherence with mhealth apps. To reduce pain and disability of patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- mhealth exercise group and brochure exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 30 Jul 2021
- 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
- Neck pain that has been going on for at least 3 months
- Participant can use smart phone,
- No problem affecting reading and answering survey questions
Who cannot join
- Presence of visual and auditory problems that may prevent the use of the smartphone application
- Torticollis
- Vertigo
- Pregnancy
- Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
- Dementia
Show all 11Show fewer
- Inflammatory rheumatic disease
- Psychosis and neurological disease diagnosis
- Receiving another treatment or having surgery in 3 months
- Exposure to any neck trauma in the past 6 months
- A past or ongoing cancer history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul
Eda TONGA, eda.tonga@marmara.edu.tr
About this study
In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives:
- Increase exercise adherence with mhealth apps.
- To reduce pain and disability of patients with chronic neck pain.
Read the detailed description
Neck pain is one of the most common musculoskeletal diseases after low back pain in the community. The incidence of neck pain was reported as %37,2. Neck pain can be caused by trauma, poor posture, degenerative diseases, tumors, muscle stress, wiplash injuries, cervical myelopathy, cervical ligamentous instability, fracture, vascular insufficiency or systemic diseases. Neck pain is classified as acute (less than six weeks), subacute (six to twelve weeks) or chronic (lasting more than twelve weeks). While neck pain is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment.
It is emphasized that home exercise programs for neck pain are effective, but exercise adherence is an important factor. Nowadays, with the rapid development of mobile healthcare applications, digital based exercise applications have started to be used in physiotherapy and rehabilitation. Although it has been shown to be useful in studies examining the effectiveness of mHealth applications for different musculoskeletal problems, these studies are quite limited. Several studies have identified the beneficial effects of digital-based exercises, but no clear evidence of superiority over written or oral home exercise programs. In 2019, a mobile exercise application (Neck Exercise) for neck pain patients was developed as a thesis study at Marmara University Health Sciences Institute. The availability of this mobile application is shown on healthy people. However, its efficacy has not been studied in patients with chronic neck pain. This mobile app includes for the neck spinal stabilization , posture, breathing exercises and exercises for scapula circumference. Each exercise is explained with video. In addition, this application gives reminder signals at user-defined time intervals. Participants with chronic neck pain aged between 18-65 years will be included in the study and randomly divided into two groups. One group will be given home exercises via brochure to the other group via mobile application. Participants will be asked to do home exercises 3 days a week for 6 weeks. Pain, disability and exercise adherence of the participants will be evaluated. The Nordic Musculoskeletal Questionnaire, VAS, neck disability index and exercise adherence scale will be used in the evaluation. Our thesis will be the first study examining the effect of a mobile application developed for neck pain on adherence to home exercises. As a result of study, the researchers aim to save paper by prescribing home exercise programs via mobile application and to promote a platform where users can better understand the exercises.
- Conditions
- Neck Pain
- Being tested
- mhealth exercise group, brochure exercise group
- Keywords
- Neck pain, exercise, digital health, mHealth, adherence
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhealth exercise groupOther
Participants were asked to perform 18 exercises specially prepared for neck pain in the M.ü Neck Exercises application according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks
brochure exercise groupOther
Participants were asked to perform 18 exercises specially prepared for neck pain in the brochure according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| mhealth exercise group | Active comparator | home exercise program is given to patients via mobile application Receives: Other: mhealth exercise group |
| brochure exercise group | Experimental | home exercise program is given to patients via brochure Receives: Other: brochure exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Visual Analog Scale (VAS) score at 6 Weeks
VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups.
Measured: Baseline and Week 6
Change from Exercise Adherence Scale Points at 6 Weeks
It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.
Measured: Baseline and Week 6
Secondary outcomes (1)
Change from Neck Pain and Disability Index Points at 6 Weeks
Neck pain and disability balance consist of 20 items. Scoring of each item is done with a 10 cm visual analog scale and scored between 0 and 5 points. The Turkish version study of Biçer et al. Whose reliability and validity has been proven. It was made by (Biçer 2004). The items evaluate the severity of pain and the effect of pain on professional, recreational, social, daily life activities and their relationship with emotional factors. Thus, it measures the effects of neck pain on functionality, quality of life and disability. The total score is the sum of the points in each item and ranges from 0 to 100. The score evaluation was carried out as follows (Buko 2013).
0-4: no problem 5-14: mild severity problem 15-24: moderate severity problem 25-34: severe problem 35 and above: very severe problem
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Feb 2021
- Primary completion20 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Tonga, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834895
- Sponsor's protocol ID
- 09.2019.1056
- Status last verified
- Apr 2021
- First submitted
- 21 Feb 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT04834895
- Acronym / sponsor ID
- 09.2019.1056
- Conditions
- Neck Pain
- Keywords
- Neck pain, exercise, digital health, mHealth, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 8 Apr 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.
In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives:
- Increase exercise adherence with mhealth apps.
- To reduce pain and disability of patients with chronic neck pain.
Detailed description
Neck pain is one of the most common musculoskeletal diseases after low back pain in the community. The incidence of neck pain was reported as %37,2. Neck pain can be caused by trauma, poor posture, degenerative diseases, tumors, muscle stress, wiplash injuries, cervical myelopathy, cervical ligamentous instability, fracture, vascular insufficiency or systemic diseases. Neck pain is classified as acute (less than six weeks), subacute (six to twelve weeks) or chronic (lasting more than twelve weeks). While neck pain is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment.
It is emphasized that home exercise programs for neck pain are effective, but exercise adherence is an important factor. Nowadays, with the rapid development of mobile healthcare applications, digital based exercise applications have started to be used in physiotherapy and rehabilitation. Although it has been shown to be useful in studies examining the effectiveness of mHealth applications for different musculoskeletal problems, these studies are quite limited. Several studies have identified the beneficial effects of digital-based exercises, but no clear evidence of superiority over written or oral home exercise programs. In 2019, a mobile exercise application (Neck Exercise) for neck pain patients was developed as a thesis study at Marmara University Health Sciences Institute. The availability of this mobile application is shown on healthy people. However, its efficacy has not been studied in patients with chronic neck pain. This mobile app includes for the neck spinal stabilization , posture, breathing exercises and exercises for scapula circumference. Each exercise is explained with video. In addition, this application gives reminder signals at user-defined time intervals. Participants with chronic neck pain aged between 18-65 years will be included in the study and randomly divided into two groups. One group will be given home exercises via brochure to the other group via mobile application. Participants will be asked to do home exercises 3 days a week for 6 weeks. Pain, disability and exercise adherence of the participants will be evaluated. The Nordic Musculoskeletal Questionnaire, VAS, neck disability index and exercise adherence scale will be used in the evaluation. Our thesis will be the first study examining the effect of a mobile application developed for neck pain on adherence to home exercises. As a result of study, the researchers aim to save paper by prescribing home exercise programs via mobile application and to promote a platform where users can better understand the exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mhealth exercise group | Active comparator | Other: mhealth exercise grouphome exercise program is given to patients via mobile application |
| brochure exercise group | Experimental | Other: brochure exercise grouphome exercise program is given to patients via brochure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neck pain that has been going on for at least 3 months
- Participant can use smart phone,
- No problem affecting reading and answering survey questions
Key exclusion criteria (11 listed)
- Presence of visual and auditory problems that may prevent the use of the smartphone application
- Torticollis
- Vertigo
- Pregnancy
- Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
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 |
|---|---|---|
| mhealth exercise groupParticipants were asked to perform 18 exercises specially prepared for neck pain in the M.ü Neck Exercises application according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks | Other | mhealth exercise group |
| brochure exercise groupParticipants were asked to perform 18 exercises specially prepared for neck pain in the brochure according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks | Other | brochure exercise group |
Primary outcome
Change from Visual Analog Scale (VAS) score at 6 Weeks
Time frame: Baseline and Week 6
VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups.
Change from Exercise Adherence Scale Points at 6 Weeks
Time frame: Baseline and Week 6
It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.
1 secondary outcome
Change from Neck Pain and Disability Index Points at 6 Weeks
Time frame: Baseline and Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mhealth exercise group and brochure exercise group in people with 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eda TONGA (90 216 330 20 70, eda.tonga@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Visual Analog Scale (VAS) score at 6 Weeks (time frame: Baseline and Week 6). The study lists 2 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 8 Apr 2021.