Neck PainNCT04831931
The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain
A study testing Exercise Program Applied by Telerehabilitation in people with Neck Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Neck pain is a common musculoskeletal problem occurring as one of the first conditions causing decreased quality of life and disability. An estimated 67.5% of people experience neck pain in their lives (5, 6). When the adult population is considered (15-74 years old), the prevalence ranges from 5.9% to 38.7%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Exercise Program Applied by Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2020to 19 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- voluntary individuals suffering from neck pain for at least 3 months
- over the age of 18
- have a minimum score of 3/10 according to the Numeric Pain Rating Scale
- who fill out the pain preliminary information form, and who will agree to participate in the study through this form.
Who cannot join
- Pregnant women,
- History of malignancy
- Congenital deformities or surgery history in the neck or shoulder area
- perception problems for verbal commands
- not having internet access
- not having equipment to make video calls
Trial locations and contacts
1 site in 1 country.
About this study
Neck pain is a common musculoskeletal problem occurring as one of the first conditions causing decreased quality of life and disability.
An estimated 67.5% of people experience neck pain in their lives (5, 6). When the adult population is considered (15-74 years old), the prevalence ranges from 5.9% to 38.7%.
Read more
Causes of neck pain are largely variable, and include working in unsuitable ergonomic positions, sitting for a long time, and keeping the neck in abnormal physiological position for a long time.
Various factors are effective in the chronic stage of neck pain. Neck pain is associated with decreased strength and endurance of the cervical muscles. It was observed that deep flexor muscles are weak and superficial flexor muscle activity is increased in patients with neck pain; and that exercise is effective in reducing neck pain because strength, endurance, and flexibility can be regained in the structures around the damaged tissue.
There are several approaches that were found to be effective in the treatment of neck pain. These treatment strategies include physical therapy modalities, manual therapy, therapeutic exercise (stretching, strengthening, and endurance exercises) and home exercise programs.
Home exercise programs are used to expand the clinic-based physical therapy approaches to treat neck pain.
It was stated that it is now compulsory to develop new rehabilitation models and practices to cope with global increase in elderly population, limited resources allocated to public health, and changes in population needs. Telerehabilitation is recommended as a solution to provide physical therapy services; however, it was reported in previous studies that more studies are required in this field to accept its effectiveness.
The purpose of the present study is to examine the effects of 4-week exercise protocol established with stretching, strengthening the scapula muscles for the neck and upper body, neck and core stabilization exercises by ensuring the follow-up of the patients with Telerehabilitation Method on patients' neck pain, Daily Life Activities (DLA), and quality of life by comparing its effects with individuals who apply only home program.
- Conditions
- Neck Pain
- Being tested
- Exercise Program Applied by Telerehabilitation
- Keywords
- Neck pain, telerehabilitation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Program Applied by TelerehabilitationOther
Patients will be evaluated 3 times for 4 weeks throughout the study; before the study commences, at the end of 2th and 4th week
Exercises will be planned to last for 15 minutes a day, and will be progressed and changed weekly throughout the study period. To the exercise program; It will be created as a progressive program by including stretching, normal range of motion movements, neck, core and scapular stabilization and strengthening exercises and the same program will be given to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Group | Experimental | Telerehabilitation will be applied in this group, which will last 4 weeks, and include the following processes
* Exercises that will be performed every Monday will be taught and applied face-to-face under the supervision of the therapist with online videoconferencing method. Then, videos of weekly exercises that will be prepared by the therapist will be transmitted online to patients.
* Patients will be asked to perform these exercises 4 days a week in the same week, on Wednesdays, Fridays and Sundays.
* Also, a video call will be made on Fridays to evaluate whether the movements are done effectively and correctly, and questions of patients (if any) will be answered.
* Patients will be informed by the physiotherapist that they should send messages on Wednesdays and Sundays to show that they are doing the exercises.
* The exercise program of new week will be taught every Monday for 4 weeks, the prepared video will be sent, and the program will be advanced and completed. Receives: Other: Exercise Program Applied by Telerehabilitation |
| Exercise Group | Active comparator | Exercise recommendations will be made to this group. Videos and photographs of weekly exercises prepared by the therapist will be sent online to the patient every Monday for 4 weeks, patients will be advised to repeat these exercises 4 days a week. Receives: Other: Exercise Program Applied by Telerehabilitation |
| Control Group | No intervention | No exercise application will be done in this group.Evaluation tests will be applied for 4 weeks only online. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numeric Pain Rating Scale (NPRS) will be used to evaluate pain subjectively. NPRS is used to evaluate pain. The patient is asked to rate the severity of pain over 10, 0 showing no pain, and 10 showing the worst pain score. Validity and validation of the use of NPRS to evaluate chronic pain in the literature with face-to-face and telepresentation methods.
Its reliability has been reported
Measured: 4 weeks
Deep Neck Flexor Endurance Test
Patients are asked to lie on a flat ground in the form of a "hook" during the online video conference. They are then asked to move their jaws closer to their chests in the Chin Tuck Position, raise their heads approximately 2.5 cm, and remain in this position. If patients experience any pain and fatigue or put their heads back on the floor, the test is terminated. The physiotherapist keeps track of the patient during this period. Two measurements are made, and the long-lasting result is recorded. The validity and reliability of the evaluation has been demonstrated by the online video videoconferencing method.
Measured: 4 weeks
Secondary outcomes (2)
Neck Disability Index (NDI)
The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The NDI consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each question has 6 answer options measuring the severity of pain or limitation. Scoring is done between 0 and 5. The highest score is 50, and the minimum score in 0.
According to the total score; 0-4 means no limitation, 5-14 means slight limitation, 15-24 moderate limitation, 25-34 severe limitation, 34 and above completely limitation . The Turkish validity and reliability study of the survey was conducted.
Measured: 4 weeks
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
There are two versions of this scale as the long (WHOQOLS-100) and short (WHOQOLS-27) form. The scale measures the bodily, spiritual, social, and environmental well-being of the individual, and consists of 26 questions. The Turkish version consists of 27 questions. The 27th question is the national question determining the Environmental Area Score. The scale can be applied to non-elderly adults . The field scores are calculated between 4 and 20 because each field refers to the quality of life in the relevant field independently from each other. As the score increases, the quality of life increases. The Turkish validity and reliability study of the scale was conducted .
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Oct 2020
- Primary completion30 Nov 2020
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve özel, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831931
- Sponsor's protocol ID
- C92F2628X5
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makela M, Heliovaara M, Sievers K, Impivaara O, Knekt P, Aromaa A. Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol. 1991 Dec 1;134(11):1356-67. doi: 10.1093/oxfordjournals.aje.a116038.
PubMed 1755449Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
PubMed 15999284Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
PubMed 28807894May S, Gardiner E, Young S, Klaber-Moffett J. Predictor Variables for a Positive Long-Term Functional Outcome in Patients with Acute and Chronic Neck and Back Pain Treated with a McKenzie Approach: A Secondary Analysis. J Man Manip Ther. 2008;16(3):155-60. doi: 10.1179/jmt.2008.16.3.155.
PubMed 19119405Peterson C, Bolton J, Humphreys BK. Predictors of outcome in neck pain patients undergoing chiropractic care: comparison of acute and chronic patients. Chiropr Man Therap. 2012 Aug 24;20(1):27. doi: 10.1186/2045-709X-20-27.
PubMed 22920497Christensen JO, Knardahl S. Time-course of occupational psychological and social factors as predictors of new-onset and persistent neck pain: a three-wave prospective study over 4 years. Pain. 2014 Jul;155(7):1262-1271. doi: 10.1016/j.pain.2014.03.021. Epub 2014 Apr 2.
PubMed 24704365Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
PubMed 17369784Moffett J, McLean S. The role of physiotherapy in the management of non-specific back pain and neck pain. Rheumatology (Oxford). 2006 Apr;45(4):371-8. doi: 10.1093/rheumatology/kei242. Epub 2005 Dec 6.
PubMed 16332949Zronek M, Sanker H, Newcomb J, Donaldson M. The influence of home exercise programs for patients with non-specific or specific neck pain: a systematic review of the literature. J Man Manip Ther. 2016 May;24(2):62-73. doi: 10.1179/2042618613Y.0000000047.
PubMed 27559275Hailey D, Roine R, Ohinmaa A, Dennett L. Evidence of benefit from telerehabilitation in routine care: a systematic review. J Telemed Telecare. 2011;17(6):281-7. doi: 10.1258/jtt.2011.101208. Epub 2011 Aug 15.
PubMed 21844172Rogante M, Grigioni M, Cordella D, Giacomozzi C. Ten years of telerehabilitation: A literature overview of technologies and clinical applications. NeuroRehabilitation. 2010;27(4):287-304. doi: 10.3233/NRE-2010-0612.
PubMed 21160118Galea MD. Telemedicine in Rehabilitation. Phys Med Rehabil Clin N Am. 2019 May;30(2):473-483. doi: 10.1016/j.pmr.2018.12.002. Epub 2019 Mar 5.
PubMed 30954160Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
PubMed 3785962Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PubMed 21621130Mani S, Sharma S, Singh DK. Concurrent validity and reliability of telerehabilitation-based physiotherapy assessment of cervical spine in adults with non-specific neck pain. J Telemed Telecare. 2021 Feb;27(2):88-97. doi: 10.1177/1357633X19861802. Epub 2019 Jul 4.
PubMed 31272309
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Exercise Program Applied by Telerehabilitation Method in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04831931
- Acronym / sponsor ID
- C92F2628X5
- Conditions
- Neck Pain
- Keywords
- Neck pain, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 5 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.
Neck pain is a common musculoskeletal problem occurring as one of the first conditions causing decreased quality of life and disability.
An estimated 67.5% of people experience neck pain in their lives (5, 6). When the adult population is considered (15-74 years old), the prevalence ranges from 5.9% to 38.7%.
Causes of neck pain are largely variable, and include working in unsuitable ergonomic positions, sitting for a long time, and keeping the neck in abnormal physiological position for a long time.
Various factors are effective in the chronic stage of neck pain. Neck pain is associated with decreased strength and endurance of the cervical muscles. It was observed that deep flexor muscles are weak and superficial flexor muscle activity is increased in patients with neck pain; and that exercise is effective in reducing neck pain because strength, endurance, and flexibility can be regained in the structures around the damaged tissue.
There are several approaches that were found to be effective in the treatment of neck pain. These treatment strategies include physical therapy modalities, manual therapy, therapeutic exercise (stretching, strengthening, and endurance exercises) and home exercise programs.
Home exercise programs are used to expand the clinic-based physical therapy approaches to treat neck pain.
It was stated that it is now compulsory to develop new rehabilitation models and practices to cope with global increase in elderly population, limited resources allocated to public health, and changes in population needs. Telerehabilitation is recommended as a solution to provide physical therapy services; however, it was reported in previous studies that more studies are required in this field to accept its effectiveness.
The purpose of the present study is to examine the effects of 4-week exercise protocol established with stretching, strengthening the scapula muscles for the neck and upper body, neck and core stabilization exercises by ensuring the follow-up of the patients with Telerehabilitation Method on patients' neck pain, Daily Life Activities (DLA), and quality of life by comparing its effects with individuals who apply only home program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Group | Experimental | Other: Exercise Program Applied by TelerehabilitationTelerehabilitation will be applied in this group, which will last 4 weeks, and include the following processes * Exercises that will be performed every Monday will be taught and applied face-to-face under the supervision of the therapist with online videoconferencing method. Then, videos of weekly exercises that will be prepared by the therapist will be transmitted online to patients. * Patients will be asked to perform these exercises 4 days a week in the same week, on Wednesdays, Fridays and Sundays. * Also, a video call will be made on Fridays to evaluate whether the movements are done effectively and correctly, and questions of patients (if any) will be answered. * Patients will be informed by the physiotherapist that they should send messages on Wednesdays and Sundays to show that they are doing the exercises. * The exercise program of new week will be taught every Monday for 4 weeks, the prepared video will be sent, and the program will be advanced and completed. |
| Exercise Group | Active comparator | Other: Exercise Program Applied by TelerehabilitationExercise recommendations will be made to this group. Videos and photographs of weekly exercises prepared by the therapist will be sent online to the patient every Monday for 4 weeks, patients will be advised to repeat these exercises 4 days a week. |
| Control Group | No intervention | –No exercise application will be done in this group.Evaluation tests will be applied for 4 weeks only online. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- voluntary individuals suffering from neck pain for at least 3 months
- over the age of 18
- have a minimum score of 3/10 according to the Numeric Pain Rating Scale
- who fill out the pain preliminary information form, and who will agree to participate in the study through this form.
Key exclusion criteria (6 listed)
- Pregnant women,
- History of malignancy
- Congenital deformities or surgery history in the neck or shoulder area
- perception problems for verbal commands
- not having internet access
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 |
|---|---|---|
| Exercise Program Applied by TelerehabilitationPatients will be evaluated 3 times for 4 weeks throughout the study; before the study commences, at the end of 2th and 4th week Exercises will be planned to last for 15 minutes a day, and will be progressed and changed weekly throughout the study period. To the exercise program; It will be created as a progressive program by including stretching, normal range of motion movements, neck, core and scapular stabilization and strengthening exercises and the same program will be given to both groups. | Other | Exercise Group, Supervised Exercise Group |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
Numeric Pain Rating Scale (NPRS) will be used to evaluate pain subjectively. NPRS is used to evaluate pain. The patient is asked to rate the severity of pain over 10, 0 showing no pain, and 10 showing the worst pain score. Validity and validation of the use of NPRS to evaluate chronic pain in the literature with face-to-face and telepresentation methods. Its reliability has been reported
Deep Neck Flexor Endurance Test
Time frame: 4 weeks
Patients are asked to lie on a flat ground in the form of a "hook" during the online video conference. They are then asked to move their jaws closer to their chests in the Chin Tuck Position, raise their heads approximately 2.5 cm, and remain in this position. If patients experience any pain and fatigue or put their heads back on the floor, the test is terminated. The physiotherapist keeps track of the patient during this period. Two measurements are made, and the long-lasting result is recorded. The validity and reliability of the evaluation has been demonstrated by the online video videoconferencing method.
2 secondary outcomes
Neck Disability Index (NDI)
Time frame: 4 weeks
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
Time frame: 4 weeks
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 5 Apr 2021.
- Background: PubMed 1755449Makela M, Heliovaara M, Sievers K, Impivaara O, Knekt P, Aromaa A. Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol. 1991 Dec 1;134(11):1356-67. doi: 10.1093/oxfordjournals.aje.a116038.
- Background: PubMed 15999284Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- Background: PubMed 28807894Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- Background: PubMed 19119405May S, Gardiner E, Young S, Klaber-Moffett J. Predictor Variables for a Positive Long-Term Functional Outcome in Patients with Acute and Chronic Neck and Back Pain Treated with a McKenzie Approach: A Secondary Analysis. J Man Manip Ther. 2008;16(3):155-60. doi: 10.1179/jmt.2008.16.3.155.
- Background: PubMed 22920497Peterson C, Bolton J, Humphreys BK. Predictors of outcome in neck pain patients undergoing chiropractic care: comparison of acute and chronic patients. Chiropr Man Therap. 2012 Aug 24;20(1):27. doi: 10.1186/2045-709X-20-27.
- Background: PubMed 24704365Christensen JO, Knardahl S. Time-course of occupational psychological and social factors as predictors of new-onset and persistent neck pain: a three-wave prospective study over 4 years. Pain. 2014 Jul;155(7):1262-1271. doi: 10.1016/j.pain.2014.03.021. Epub 2014 Apr 2.
- Background: PubMed 17369784Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
- Background: PubMed 16332949Moffett J, McLean S. The role of physiotherapy in the management of non-specific back pain and neck pain. Rheumatology (Oxford). 2006 Apr;45(4):371-8. doi: 10.1093/rheumatology/kei242. Epub 2005 Dec 6.
- Background: PubMed 27559275Zronek M, Sanker H, Newcomb J, Donaldson M. The influence of home exercise programs for patients with non-specific or specific neck pain: a systematic review of the literature. J Man Manip Ther. 2016 May;24(2):62-73. doi: 10.1179/2042618613Y.0000000047.
- Background: PubMed 21844172Hailey D, Roine R, Ohinmaa A, Dennett L. Evidence of benefit from telerehabilitation in routine care: a systematic review. J Telemed Telecare. 2011;17(6):281-7. doi: 10.1258/jtt.2011.101208. Epub 2011 Aug 15.
- Background: PubMed 21160118Rogante M, Grigioni M, Cordella D, Giacomozzi C. Ten years of telerehabilitation: A literature overview of technologies and clinical applications. NeuroRehabilitation. 2010;27(4):287-304. doi: 10.3233/NRE-2010-0612.
- Background: PubMed 30954160Galea MD. Telemedicine in Rehabilitation. Phys Med Rehabil Clin N Am. 2019 May;30(2):473-483. doi: 10.1016/j.pmr.2018.12.002. Epub 2019 Mar 5.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain
Not yet recruiting
Effect of Excercises on Pain , Disability and Craniovertebral Angle in Patients With Forward Head Posture.
Farward Head Posture
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
RecruitingObservational study
Upper Extremity Exercise Capacity in Chronic Non-specific Neck Pain
Neck Pain
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
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 Exercise Program Applied by Telerehabilitation in people with Neck Pain, run by Medipol 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 6 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 5 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?
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?
Numeric Pain Rating Scale (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT04831931, which also lists 22 linked publications.
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 5 Apr 2021.