Neck PainNCT05581186
Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain
A study testing Pulse electromagnetic field therapy and Therapeutic Exercise in people with Neck Pain and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This investigation aims to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on neck pain, cervical range of motion, pressure pain threshold and quality of life in patients with nonspecific chronic neck pain compared to cervical therapeutic exercises. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Neck Pain, Musculoskeletal Diseases, Chronic Neck Pain
- What is being tested?
- Pulse electromagnetic field therapy and Therapeutic Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Sep 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Neck pain for at least 3 months in the 20-55 age range
- Diagnosed with nonspecific chronic neck pain by examination, history and imaging methods
Who cannot join
- Pregnancy
- Inflammatory rheumatologic diseases
- Malignity
- Having a cardiac pacemaker
- Previous surgery related to the cervical spine
- Having bleeding diathesis
Show all 11Show fewer
- Having a body implant with an electronic or battery system
- Neck pain due to neurological and vascular diseases
- Having neurological diseases
- Having received physical therapy and rehabilitation for the cervical area in the last 6 months
- Acute infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Study
This investigation aims to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on neck pain, cervical range of motion, pressure pain threshold and quality of life in patients with nonspecific chronic neck pain compared to cervical therapeutic exercises.
Read the detailed description
Neck pain is a common musculoskeletal complaint in society. It is the most common musculoskeletal problem after low back pain. It may regress spontaneously within a few weeks or may become chronic, as in 30% of patients. When it becomes chronic, it can negatively affect the daily life activities of individuals and lead to functional limitations and inadequacies.
Various approaches exist for neck pain in clinical practice. Among them; education of patients on neck pain, ergonomic arrangements, analgesics, non-steroidal anti-inflammatory drugs, muscle relaxants, exercise, physical therapy agents such as transcutaneous electrical stimulation (TENS), superficial and deep heaters, Pulse Electromagnetic Field Therapy (PEMT) , manipulation, mobilization methods, nerve blockages and surgical intervention.
Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases. This investigation was designed prospective sham controlled randomized study. Participants were randomized into 3 groups: PEMT + therapeutic exercise, sham PEMT + therapeutic exercise, and only therapeutic exercise. As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Neck, SF (Short form) -36 Quality of Life Scale, pressure pain threshold measurement with an algometer, patient global assessment, and physician global assessment will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 6th week controls.
- Being tested
- Pulse electromagnetic field therapy, Sham pulse electromagnetic field therapy, Therapeutic Exercise
- Keywords
- Pulse Electromagnetic Field Therapy, Chronic neck pain, Cervical Disc Disease
- Medical subject headings
- Neck Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse electromagnetic field therapyOther
It was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 25 Hz frequency, 30 Gauss, %35 intensity and for 25 minutes. The treatment period was 5 days a week for 3 weeks, in total. It was applied as 15 sessions.
Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.
Sham pulse electromagnetic field therapyOther
Sham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 15 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device.
Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.
Therapeutic ExerciseOther
Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| PEMT + exercise | Active comparator | A total of 15 sessions of pulse electromagnetic field therapy using an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, Italia),five times a week and once a day for three weeks, were applied to the patients. The patients were then given a daily exercise program once a day by a physiotherapist. Receives: Other: Pulse electromagnetic field therapy |
| Sham PEMT + exercise | Sham comparator | Sham therapy was applied in five sessions a week for three weeks, with a total of 15 sessions, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. Receives: Other: Sham pulse electromagnetic field therapy |
| Exercise only | Other | Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day with the physiotherapist. Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Measured: up to 6th week
Secondary outcomes (6)
Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Measured: up to 6th week
Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks
Cervical flexion, extension ,lateral flexion ,rotations(goniometric measurement results in units of degrees).
Measured: up to 6th week
Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks
The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. Each question measures from 0 to 5, the total score out of 100 is calculated.
Measured: up to 6th week
Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks
The algometer is a useful tool for determining pressure pain threshold measurements. Pressure pain threshold is defined as the minimum force applied to elicit pain. A digital pressure algometer (Baseline, push-pull, force gauce Algometer, USA) will be used for measurements. The most painful point in the cervical region will be determined by sitting all patients in their most comfortable position for measurement. Three measurements will be made at an angle of 90 to this point, repeated at 1-minute intervals, and the average of these three measurements will be taken and this value will be recorded as the mean pressure pain threshold in kg/cm2. During the measurement, the value at the first moment when the patient feels pain will be taken as a basis.
Measured: up to 6th week
Change from baseline In the global evaluation of the patient at 3rd and 6th weeks
"Very bad" is written on the end corresponding to the numerical value of "0 cm" and "very good" is written on the end corresponding to the numerical value of "10 cm".
Measured: up to 6th week
Change from baseline In the doctor's global evaluation at 3rd and 6th weeks
"Very bad" is written on the end corresponding to the numerical value of "0 cm" and "very good" is written on the end corresponding to the numerical value of "10 cm".
Measured: up to 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Doğanlar, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581186
- Sponsor's protocol ID
- NECKPEMF2022
- Status last verified
- Sep 2023
- First submitted
- 12 Oct 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
PubMed 19565156Griffiths C, Dziedzic K, Waterfield J, Sim J. Effectiveness of specific neck stabilization exercises or a general neck exercise program for chronic neck disorders: a randomized controlled trial. J Rheumatol. 2009 Feb;36(2):390-7. doi: 10.3899/jrheum.080376.
PubMed 19132780Karakas M, Gok H. Effectiveness of pulsed electromagnetic field therapy on pain, functional status, and quality of life in patients with chronic non-specific neck pain: A prospective, randomized-controlled study. Turk J Phys Med Rehabil. 2020 May 18;66(2):140-146. doi: 10.5606/tftrd.2020.5169. eCollection 2020 Jun.
PubMed 32760890Sutbeyaz ST, Sezer N, Koseoglu BF. The effect of pulsed electromagnetic fields in the treatment of cervical osteoarthritis: a randomized, double-blind, sham-controlled trial. Rheumatol Int. 2006 Feb;26(4):320-4. doi: 10.1007/s00296-005-0600-3. Epub 2005 Jun 29.
PubMed 15986086Hattapoglu E, Batmaz I, Dilek B, Karakoc M, Em S, Cevik R. Efficiency of pulsed electromagnetic fields on pain, disability, anxiety, depression, and quality of life in patients with cervical disc herniation: a randomized controlled study. Turk J Med Sci. 2019 Aug 8;49(4):1095-1101. doi: 10.3906/sag-1901-65.
PubMed 31385489
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulse Electromagnetic Field Therapy (PEMF) in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05581186
- Acronym / sponsor ID
- NECKPEMF2022
- Keywords
- Pulse Electromagnetic Field Therapy, Chronic neck pain, Cervical Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 14 Oct 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 investigation aims to investigate the effectiveness of Pulse Electromagnetic Field Therapy (PEMF) on neck pain, cervical range of motion, pressure pain threshold and quality of life in patients with nonspecific chronic neck pain compared to cervical therapeutic exercises.
Detailed description
Neck pain is a common musculoskeletal complaint in society. It is the most common musculoskeletal problem after low back pain. It may regress spontaneously within a few weeks or may become chronic, as in 30% of patients. When it becomes chronic, it can negatively affect the daily life activities of individuals and lead to functional limitations and inadequacies.
Various approaches exist for neck pain in clinical practice. Among them; education of patients on neck pain, ergonomic arrangements, analgesics, non-steroidal anti-inflammatory drugs, muscle relaxants, exercise, physical therapy agents such as transcutaneous electrical stimulation (TENS), superficial and deep heaters, Pulse Electromagnetic Field Therapy (PEMT) , manipulation, mobilization methods, nerve blockages and surgical intervention.
Magnetotherapy is a treatment method based on magnetic field interaction. As a result of pulsed or alternating electromagnetic fields, an electrical current occurs in the tissues. Pulse magnetotherapy has three physical mechanisms known to be effective in living tissue: Magnetic induction, magneto-mechanical effects, and electronic interactions. Effects of magnetic field application are vasodilation, analgesic effect, anti-inflammatory effect, acceleration of healing, antiedematous effect. Magnetotherapy increases the oxygen release of erythrocytes and provides oxygenation of the tissues. This causes a decrease in toxins in the damaged area, an increase in vital nutrients and endorphins. With this physiological change, magnetic energy decreases the pain receptor sensitivity that sends a message to the brain. With this treatment method, pain reduction is achieved, while joint mobility increases. This investigation was designed prospective sham controlled randomized study. Participants were randomized into 3 groups: PEMT + therapeutic exercise, sham PEMT + therapeutic exercise, and only therapeutic exercise. As evaluation parameters, cervical range of motion, Visual Pain Scale (VAS) Neck, Visual Pain Scale (VAS) Neck, SF (Short form) -36 Quality of Life Scale, pressure pain threshold measurement with an algometer, patient global assessment, and physician global assessment will be evaluated with.It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the end of the treatment and at the 6th week controls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEMT + exercise | Active comparator | Other: Pulse electromagnetic field therapyA total of 15 sessions of pulse electromagnetic field therapy using an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, Italia),five times a week and once a day for three weeks, were applied to the patients. The patients were then given a daily exercise program once a day by a physiotherapist. |
| Sham PEMT + exercise | Sham comparator | Other: Sham pulse electromagnetic field therapySham therapy was applied in five sessions a week for three weeks, with a total of 15 sessions, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. |
| Exercise only | Other | Other: Therapeutic ExerciseExercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day with the physiotherapist. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Neck pain for at least 3 months in the 20-55 age range
- Diagnosed with nonspecific chronic neck pain by examination, history and imaging methods
Key exclusion criteria (11 listed)
- Pregnancy
- Inflammatory rheumatologic diseases
- Malignity
- Having a cardiac pacemaker
- Previous surgery related to the cervical spine
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 |
|---|---|---|
| Pulse electromagnetic field therapyIt was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 25 Hz frequency, 30 Gauss, %35 intensity and for 25 minutes. The treatment period was 5 days a week for 3 weeks, in total. It was applied as 15 sessions. Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions. | Other | PEMT + exercise |
| Sham pulse electromagnetic field therapySham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 15 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device. Therapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions. | Other | Sham PEMT + exercise |
| Therapeutic ExerciseTherapeutic Exercise As a therapeutic exercise program (neck stability exercises); active cervical ROM, cervical isometric and progressive (selfexercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises. It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions. | Other | Exercise only |
Primary outcome
Change from baseline visual analog scale (VAS) neck and arm pain at 3rd and 6th week
Time frame: up to 6th week
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
6 secondary outcomes
Change from baseline quality of life (short form 36 (SF-36)) at 3rd and 6th weeks
Time frame: up to 6th week
Change from baseline range of motion of cervical spine measurements with goniometer at 3rd and 6th weeks
Time frame: up to 6th week
Change from baseline Neck Dısabılıty Index (NDI) at 3rd and 6th weeks
Time frame: up to 6th week
Change from baseline Pressure pain threshold measurement with an algometer at 3rd and 6th weeks
Time frame: up to 6th week
Change from baseline In the global evaluation of the patient at 3rd and 6th weeks
Time frame: up to 6th week
Change from baseline In the doctor's global evaluation at 3rd and 6th weeks
Time frame: up to 6th 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 21 Sep 2023.
- Background: PubMed 19565156Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
- Background: PubMed 19132780Griffiths C, Dziedzic K, Waterfield J, Sim J. Effectiveness of specific neck stabilization exercises or a general neck exercise program for chronic neck disorders: a randomized controlled trial. J Rheumatol. 2009 Feb;36(2):390-7. doi: 10.3899/jrheum.080376.
- Background: PubMed 32760890Karakas M, Gok H. Effectiveness of pulsed electromagnetic field therapy on pain, functional status, and quality of life in patients with chronic non-specific neck pain: A prospective, randomized-controlled study. Turk J Phys Med Rehabil. 2020 May 18;66(2):140-146. doi: 10.5606/tftrd.2020.5169. eCollection 2020 Jun.
- Background: PubMed 15986086Sutbeyaz ST, Sezer N, Koseoglu BF. The effect of pulsed electromagnetic fields in the treatment of cervical osteoarthritis: a randomized, double-blind, sham-controlled trial. Rheumatol Int. 2006 Feb;26(4):320-4. doi: 10.1007/s00296-005-0600-3. Epub 2005 Jun 29.
- Background: PubMed 31385489Hattapoglu E, Batmaz I, Dilek B, Karakoc M, Em S, Cevik R. Efficiency of pulsed electromagnetic fields on pain, disability, anxiety, depression, and quality of life in patients with cervical disc herniation: a randomized controlled study. Turk J Med Sci. 2019 Aug 8;49(4):1095-1101. doi: 10.3906/sag-1901-65.
- 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 Pulse electromagnetic field therapy and Therapeutic Exercise in people with Neck Pain and Musculoskeletal Diseases, run by Afyonkarahisar Health Sciences 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 2 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 21 Sep 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. Some participants in this study may receive a placebo. 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 visual analog scale (VAS) neck and arm pain at 3rd and 6th week (time frame: up to 6th week). 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 NCT05581186, which also lists 5 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 21 Sep 2023.