Chronic PainNCT04265248
Evaluation of the Effects of Virtual Reality in Patients With Chronic Neck Pain
A study testing Virtual Reality Headset and Exercise in people with Chronic Pain and Pain, Neck, run by Josue Fernandez Carnero at 2 sites in Spain.
Trial summary
The main objective of this research is to assess the effectiveness of virtual reality as a treatment to reduce pain and disability in patients with chronic neck pain compared to a regular exercise program for the neck. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Pain, Neck
- What is being tested?
- Virtual Reality Headset and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2020to 30 Jul 2020
- 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
- Idiopathic chronic neck pain.
- Understands and accept the informed consent form.
- Meets the age limits criteria.
Who cannot join
- Patients under 18 or over 65 years old.
- Pregnancy.
- Specific neck pain due to metastases, neoplasms, infectious or inflammatory. processes, fractures, or traumatic history of cervical injury.
- Positive neurological signs or evidence of spinal cord compression (abnormal diffuse sensitivity, hyperreflexia or diffuse weakness).
- Cervical osteoarthritis.
- Polyarthrosis.
Show all 11Show fewer
- Neck Pain associated with vertigo (vestibular involvement).
- Neck Pain associated with whiplash injuries.
- Previous cervical surgeries.
- Headaches before cervicalgia without cervical origin.
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
CEU San Pablo
Madrid, Madrid, Montepríncipe, 28668
About this study
Official title: Effectiveness of Cervical Exercises Using Virtual Reality Headsets on Pain and Disability in Patients With Chronic Neck Pain
The main objective of this research is to assess the effectiveness of virtual reality as a treatment to reduce pain and disability in patients with chronic neck pain compared to a regular exercise program for the neck.
Read the detailed description
Chronic neck pain is one of the most common causes of pain and disability. Its prevalence is approximately 15% in adults and it is one of the main causes of medical leave and the increase of drug consumption. Recent research has found that neck pain is a common pathology among the population. Among the variables associated with neck pain, besides rheumatology, include genetic, psychopathological variables (such as depression, anxiety, coping skills, somatization), sleep disorders, smoking and a sedentary lifestyle, among others. All those variables alter the nervous system in a proprioceptive level, so that deep and superficial flexor, as well as the rest of the muscles, they do not receive correct information that prevents them from processing properly the obtained information. Therefore, alterations also occur at central nervous system levels as in the processing of pain and its control by inhibitory descending systems.
One of the most effective treatments for this pathology is active exercise. The main objective is the activation and strengthening of the deep flexor muscles by craniocervical flexion. It is also important to re-educate all the movements performed with the neck; extension, rotation and inclination are essential movements that also require good initial control of deep flexor muscles and its dynamism is essential to interact with our surroundings.
The action observation which consists of observing an action carried out by another person is based on the ability of the nervous system to assimilate the images seen and process them until they reach the motor cortex, and thanks to the mirror neurons, the painful pattern decreases until it disappears. Thus, visualising a painful situation provokes and evokes in the brain, a painful experience, even when this is not actually happening. Therefore, it has been proved that it can produce changes in the motor cortex since the observation reinforces the cortical representation of the action, thus achieving an improvement in strength and functionality in patients with chronic pain.
Taking all this into account, in this study the investigators propose the idea of working with virtual reality headset in patients with chronic neck pain. This treatment offers great visual, auditory and vestibular feedback that makes it an attractive and stimulating exercise for the patient. It has the ability to individualize treatments and patient needs. These virtual environments can graduate and increase the complexity of the task while decreasing the help and feedback provided by the therapist. The goal of a virtual reality based treatment is to make patients more participatory in their real environments as independently as possible. It is an innovative treatment that does not demand a great financial cost for its use.
- Conditions
- Chronic Pain, Pain, Neck
- Being tested
- Virtual Reality Headset, Exercise
- Keywords
- Virtual reality, Chronic pain, Neck pain, Physiotherapy, Exercise
- Medical subject headings
- Chronic Pain, Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
The subjects will wear the Virtual Reality Headset with a mobile phone inserted into it with the applications Full Dive VR and VR Ocean Aquarium 3D.
ExerciseBehavioural
The subjects will perform evidence-based exercises for the neck.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | The subjects will use "Fulldive VR" as the first degree of difficulty where only tilt movements are necessary, for the second degree of difficulty the game "VR Ocean Aquarium 3D" will be used, where bending, extension and rotation movements will be integrated, also introducing a sensory element to integrate the sound of the sea.
For these patients to perform the same work as group 2, the physiotherapist will have to count and control in each exercise the number of movements that the patient performs so as not to exceed the proposed dose in the active comparator group (3 sets of 10 repetitions of each exercise). Receives: Device: Virtual Reality Headset |
| Exercise | Active comparator | The subjects perform the exercises provided by the researchers. Which consist of neck exercises in all ranges of movement (inclinations and rotations to both sides), apart from flexion and extension. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cervical range of movement.
Measured with goniometer by the physiotherapists.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in pain perception.
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Neck Pain and Disability Perception
10 Neck Disability Index Scale that must be answered with a numeric value between 0 (no disability) and 5 (complete disability), with a maximum score of 50 points, with higher scores indicating greater neck disability.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Secondary outcomes (6)
Changes in levels of Catastrophism.
13 item Pain Catastrophic Scale that must be answered with a numeric value between 0 (not at all) and 4 (all the time), with a maximum score of 52 points, with higher scores indicating greater pain catastrophizing.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Kinesiophobia, levels of fear to movement.
11 item Tampa Scale for Kinesiophobia, the final score can range between 11 and 44 points, with higher scores indicating greater perceived kinesiophobia.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Fear-avoidance behaviours.
Fear-avoidance Beliefs Questionnaire . The instrument consists of two subscales, a four-item physical activity subscale, and a seven-item work subscale. Each item is scored from 0 to 6 and summed to produce the subscale score. Possible scores range from 0-28 to 0-42, with higher scores indicating greater fear avoidance beliefs.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Pressure Pain Thresholds using an algometer on first finger, trapezius muscle and tibia.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in endogenous pain inhibition mechanisms.
Conditioned pain modulation and temporal summation (windup), using the algometer and an occlussion band.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Anxiety Related to Pain
20 item Pain Anxiety Symptoms Scale scoring from 0 to 100 with higher scores indicating greater pain-related anxiety.
Measured: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion20 Mar 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Collaborators
- CEU San Pablo University
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- David Morales Tejera, Msc., Phdc, Principal investigator, Escuela Internacional de Doctorado de la Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265248
- Sponsor's protocol ID
- URJC-02/2020
- Status last verified
- Nov 2020
- First submitted
- 7 Feb 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de-la-Puente-Ranea L, Garcia-Calvo B, La Touche R, Fernandez-Carnero J, Gil-Martinez A. Influence of the actions observed on cervical motion in patients with chronic neck pain: a pilot study. J Exerc Rehabil. 2016 Aug 31;12(4):346-54. doi: 10.12965/jer.1632636.318. eCollection 2016 Aug.
PubMed 27656633Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
PubMed 26957772Borisut S, Vongsirinavarat M, Vachalathiti R, Sakulsriprasert P. Effects of strength and endurance training of superficial and deep neck muscles on muscle activities and pain levels of females with chronic neck pain. J Phys Ther Sci. 2013 Sep;25(9):1157-62. doi: 10.1589/jpts.25.1157. Epub 2013 Oct 20.
PubMed 24259936Gallego Izquierdo T, Pecos-Martin D, Lluch Girbes E, Plaza-Manzano G, Rodriguez Caldentey R, Mayor Melus R, Blanco Mariscal D, Falla D. Comparison of cranio-cervical flexion training versus cervical proprioception training in patients with chronic neck pain: A randomized controlled clinical trial. J Rehabil Med. 2016 Jan;48(1):48-55. doi: 10.2340/16501977-2034.
PubMed 26659920Sarig Bahat H, Weiss PL, Sprecher E, Krasovsky A, Laufer Y. Do neck kinematics correlate with pain intensity, neck disability or with fear of motion? Man Ther. 2014 Jun;19(3):252-8. doi: 10.1016/j.math.2013.10.006. Epub 2013 Nov 9.
PubMed 24291364Palacios-Cena D, Alonso-Blanco C, Hernandez-Barrera V, Carrasco-Garrido P, Jimenez-Garcia R, Fernandez-de-las-Penas C. Prevalence of neck and low back pain in community-dwelling adults in Spain: an updated population-based national study (2009/10-2011/12). Eur Spine J. 2015 Mar;24(3):482-92. doi: 10.1007/s00586-014-3567-5. Epub 2014 Sep 11.
PubMed 25208501Nederhand MJ, Ijzerman MJ, Hermens HJ, Turk DC, Zilvold G. Predictive value of fear avoidance in developing chronic neck pain disability: consequences for clinical decision making. Arch Phys Med Rehabil. 2004 Mar;85(3):496-501. doi: 10.1016/j.apmr.2003.06.019.
PubMed 15031840Rudolfsson T, Djupsjobacka M, Hager C, Bjorklund M. Effects of neck coordination exercise on sensorimotor function in chronic neck pain: a randomized controlled trial. J Rehabil Med. 2014 Oct;46(9):908-14. doi: 10.2340/16501977-1869.
PubMed 25182501Sarig Bahat H, Sprecher E, Sela I, Treleaven J. Neck motion kinematics: an inter-tester reliability study using an interactive neck VR assessment in asymptomatic individuals. Eur Spine J. 2016 Jul;25(7):2139-48. doi: 10.1007/s00586-016-4388-5. Epub 2016 Jan 30.
PubMed 26831536Sarig Bahat H, Takasaki H, Chen X, Bet-Or Y, Treleaven J. Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial. Man Ther. 2015 Feb;20(1):68-78. doi: 10.1016/j.math.2014.06.008. Epub 2014 Jul 5.
PubMed 25066503
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Exercises Using Virtual Reality Headsets on Pain and Disability in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04265248
- Acronym / sponsor ID
- URJC-02/2020
- Conditions
- Chronic Pain, Pain, Neck
- Keywords
- Virtual reality, Chronic pain, Neck pain, Physiotherapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Collaborators
- CEU San Pablo University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this research is to assess the effectiveness of virtual reality as a treatment to reduce pain and disability in patients with chronic neck pain compared to a regular exercise program for the neck.
Detailed description
Chronic neck pain is one of the most common causes of pain and disability. Its prevalence is approximately 15% in adults and it is one of the main causes of medical leave and the increase of drug consumption. Recent research has found that neck pain is a common pathology among the population. Among the variables associated with neck pain, besides rheumatology, include genetic, psychopathological variables (such as depression, anxiety, coping skills, somatization), sleep disorders, smoking and a sedentary lifestyle, among others. All those variables alter the nervous system in a proprioceptive level, so that deep and superficial flexor, as well as the rest of the muscles, they do not receive correct information that prevents them from processing properly the obtained information. Therefore, alterations also occur at central nervous system levels as in the processing of pain and its control by inhibitory descending systems.
One of the most effective treatments for this pathology is active exercise. The main objective is the activation and strengthening of the deep flexor muscles by craniocervical flexion. It is also important to re-educate all the movements performed with the neck; extension, rotation and inclination are essential movements that also require good initial control of deep flexor muscles and its dynamism is essential to interact with our surroundings.
The action observation which consists of observing an action carried out by another person is based on the ability of the nervous system to assimilate the images seen and process them until they reach the motor cortex, and thanks to the mirror neurons, the painful pattern decreases until it disappears. Thus, visualising a painful situation provokes and evokes in the brain, a painful experience, even when this is not actually happening. Therefore, it has been proved that it can produce changes in the motor cortex since the observation reinforces the cortical representation of the action, thus achieving an improvement in strength and functionality in patients with chronic pain.
Taking all this into account, in this study the investigators propose the idea of working with virtual reality headset in patients with chronic neck pain. This treatment offers great visual, auditory and vestibular feedback that makes it an attractive and stimulating exercise for the patient. It has the ability to individualize treatments and patient needs. These virtual environments can graduate and increase the complexity of the task while decreasing the help and feedback provided by the therapist. The goal of a virtual reality based treatment is to make patients more participatory in their real environments as independently as possible. It is an innovative treatment that does not demand a great financial cost for its use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual Reality HeadsetThe subjects will use "Fulldive VR" as the first degree of difficulty where only tilt movements are necessary, for the second degree of difficulty the game "VR Ocean Aquarium 3D" will be used, where bending, extension and rotation movements will be integrated, also introducing a sensory element to integrate the sound of the sea. For these patients to perform the same work as group 2, the physiotherapist will have to count and control in each exercise the number of movements that the patient performs so as not to exceed the proposed dose in the active comparator group (3 sets of 10 repetitions of each exercise). |
| Exercise | Active comparator | Behavioral: ExerciseThe subjects perform the exercises provided by the researchers. Which consist of neck exercises in all ranges of movement (inclinations and rotations to both sides), apart from flexion and extension. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic chronic neck pain.
- Understands and accept the informed consent form.
- Meets the age limits criteria.
Key exclusion criteria (11 listed)
- Patients under 18 or over 65 years old.
- Pregnancy.
- Specific neck pain due to metastases, neoplasms, infectious or inflammatory. processes, fractures, or traumatic history of cervical injury.
- Positive neurological signs or evidence of spinal cord compression (abnormal diffuse sensitivity, hyperreflexia or diffuse weakness).
- Cervical osteoarthritis.
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 |
|---|---|---|
| Virtual Reality HeadsetThe subjects will wear the Virtual Reality Headset with a mobile phone inserted into it with the applications Full Dive VR and VR Ocean Aquarium 3D. | Device | Virtual Reality |
| ExerciseThe subjects will perform evidence-based exercises for the neck. | Behavioural | Exercise |
Primary outcome
Changes in cervical range of movement.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Measured with goniometer by the physiotherapists.
Changes in pain perception.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Self reported Visual Analog Scale. Minimum value is 0 (best); Maximun value is 10 (worst).
Changes in Neck Pain and Disability Perception
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
10 Neck Disability Index Scale that must be answered with a numeric value between 0 (no disability) and 5 (complete disability), with a maximum score of 50 points, with higher scores indicating greater neck disability.
6 secondary outcomes
Changes in levels of Catastrophism.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Kinesiophobia, levels of fear to movement.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Fear-avoidance behaviours.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in levels of hyperalgesia to pressure and maximum pressure tolerance.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in endogenous pain inhibition mechanisms.
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
Changes in Anxiety Related to Pain
Time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.
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 20 Nov 2020.
- Background: PubMed 27656633de-la-Puente-Ranea L, Garcia-Calvo B, La Touche R, Fernandez-Carnero J, Gil-Martinez A. Influence of the actions observed on cervical motion in patients with chronic neck pain: a pilot study. J Exerc Rehabil. 2016 Aug 31;12(4):346-54. doi: 10.12965/jer.1632636.318. eCollection 2016 Aug.
- Background: PubMed 26957772Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
- Background: PubMed 24259936Borisut S, Vongsirinavarat M, Vachalathiti R, Sakulsriprasert P. Effects of strength and endurance training of superficial and deep neck muscles on muscle activities and pain levels of females with chronic neck pain. J Phys Ther Sci. 2013 Sep;25(9):1157-62. doi: 10.1589/jpts.25.1157. Epub 2013 Oct 20.
- Background: PubMed 26659920Gallego Izquierdo T, Pecos-Martin D, Lluch Girbes E, Plaza-Manzano G, Rodriguez Caldentey R, Mayor Melus R, Blanco Mariscal D, Falla D. Comparison of cranio-cervical flexion training versus cervical proprioception training in patients with chronic neck pain: A randomized controlled clinical trial. J Rehabil Med. 2016 Jan;48(1):48-55. doi: 10.2340/16501977-2034.
- Background: PubMed 24291364Sarig Bahat H, Weiss PL, Sprecher E, Krasovsky A, Laufer Y. Do neck kinematics correlate with pain intensity, neck disability or with fear of motion? Man Ther. 2014 Jun;19(3):252-8. doi: 10.1016/j.math.2013.10.006. Epub 2013 Nov 9.
- Background: PubMed 25208501Palacios-Cena D, Alonso-Blanco C, Hernandez-Barrera V, Carrasco-Garrido P, Jimenez-Garcia R, Fernandez-de-las-Penas C. Prevalence of neck and low back pain in community-dwelling adults in Spain: an updated population-based national study (2009/10-2011/12). Eur Spine J. 2015 Mar;24(3):482-92. doi: 10.1007/s00586-014-3567-5. Epub 2014 Sep 11.
- Background: PubMed 15031840Nederhand MJ, Ijzerman MJ, Hermens HJ, Turk DC, Zilvold G. Predictive value of fear avoidance in developing chronic neck pain disability: consequences for clinical decision making. Arch Phys Med Rehabil. 2004 Mar;85(3):496-501. doi: 10.1016/j.apmr.2003.06.019.
- Background: PubMed 25182501Rudolfsson T, Djupsjobacka M, Hager C, Bjorklund M. Effects of neck coordination exercise on sensorimotor function in chronic neck pain: a randomized controlled trial. J Rehabil Med. 2014 Oct;46(9):908-14. doi: 10.2340/16501977-1869.
- Background: PubMed 26831536Sarig Bahat H, Sprecher E, Sela I, Treleaven J. Neck motion kinematics: an inter-tester reliability study using an interactive neck VR assessment in asymptomatic individuals. Eur Spine J. 2016 Jul;25(7):2139-48. doi: 10.1007/s00586-016-4388-5. Epub 2016 Jan 30.
- Background: PubMed 25066503Sarig Bahat H, Takasaki H, Chen X, Bet-Or Y, Treleaven J. Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial. Man Ther. 2015 Feb;20(1):68-78. doi: 10.1016/j.math.2014.06.008. Epub 2014 Jul 5.
- 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.
David Morales Tejera, Msc., Phdc principal investigator
Escuela Internacional de Doctorado de la Universidad Rey Juan Carlos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset and Exercise in people with Chronic Pain and Pain, Neck, run by Josue Fernandez Carnero at 2 sites in Spain.
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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Changes in cervical range of movement. (time frame: Before and after the treatment (2 weeks), after 1 month and after 3 months.). The study lists 3 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 NCT04265248, which also lists 10 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 20 Nov 2020.