Mechanical Neck PainNCT04484324
Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain
A study testing Stretching exercises in people with Mechanical Neck Pain, run by University of Sharjah at 2 sites in United Arab Emirates.
Trial summary
controversy remains about the stretching parameters needed to achieve a particular goal or treatment outcome. In clinical practice, multiple stretching techniques are used; nevertheless, there is no evidence-based agreement on the most effective parameters. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Stretching exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 5 Jul 2020to 20 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible patients had to be between 18 and 40 years of age
- have generalized neck pain for more than 3 months.
- with symptoms provoked by neck postures, movements, or palpation
Who cannot join
- Subjects' exclusion criteria included specific neck pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory or rheumatic disease. Furthermore, subjects were excluded if they had a history of spine surgery and any objective findings consistent with neurological conditions and vascular disorders.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Ibrahim Moustafa
Sharjah city, United Arab Emirate, 27272
University of Sharjah
Sharjah city, 27272
About this study
Official title: Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain: A Randomized Controlled Trial
controversy remains about the stretching parameters needed to achieve a particular goal or treatment outcome. In clinical practice, multiple stretching techniques are used; nevertheless, there is no evidence-based agreement on the most effective parameters. One of these parameters, that might be affecting the treatment outcome the most, is the stretching duration, thus far there is a little agreement on the optimal stretching duration.
This non agreement in exact stretching parameters is obvious between authors and researchers in the field of muscle energy techniques (MET) as well as those who have used and advocate various durations for the passive stretch that follows the contraction phase in MET.
Read the detailed description
comparison and subsequent conclusions about appropriate stretching times are mainly based on mechanical factors such as range of motion and flexibility, while ignoring the neural adversative mechanical tension that may be created during stretching exercises. According to the literature , stretching induced neural tension may adversely affect the central nervous system and nerve root function due to the absence of the perineurium, which is the primary load carrying structure. Thus, safe or unsafe limits of nerve elongation are not well established, despite several basic scientific and clinical studies.. Consequently, in the present study, the current study aimed to answer the question: Is it theoretically possible, that increased longitudinal strain and stress on the spinal cord and nerve root from continuous stretching exercises may subtly impair the neural function? Our hypothesis is that a duration threshold exists where, once reached, adverse neural function will be apparent resulting in a reduction of either or both latency and amplitudes of evoked potentials.
- Conditions
- Mechanical Neck Pain
- Being tested
- Stretching exercises
- Keywords
- Randomized controlled trial, muscle energy technique, Stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching exercisesOther
Also called muscle energy technique
Post-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch.
| Study group | Role | What they receive |
|---|---|---|
| 60 seconds | Experimental | 60 seconds stretching group Stretching exercises for upper Trapezius and Levator the examiner will passively place the participant's head into flexion, side-bending away and rotation towards the side to be stretched (for upper trapezius muscle) and flexion, side-bending away and rotation away from the side to be stretched (for levator scapula ). The patient introduces a light resisted effort to take the stabilized shoulder towards the ear and the ear towards the shoulder. The contraction is sustained for 10 seconds and, upon complete relaxation of effort, the therapist gently eases the head/ neck into an increased degree of side-bending and rotation, where it is stabilized, as the shoulder is stretched caudally. The examiner will depress the participant's shoulder with 100 Newton's of force measured with pressure dynamometer. Once the examiner achieved this level of force, he maintains the stretch for 60 seconds . The procedure is repeated three times. Receives: Other: Stretching exercises |
| 30 seconds | Experimental | The same procedures while the therapist will maintain the stretch for 30 seconds. Receives: Other: Stretching exercises |
| 15 seconds | Experimental | The same procedures while the therapist will maintain the stretch for 15 seconds. Receives: Other: Stretching exercises |
| control | Placebo comparator | The therapist maintains the same manual contact without stretching force Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials
Dermatomal Somatosensory Evoked Potentials will be elicited by repetitive, square wave (0.5 ms) electrical pulses (at 3 Hz) from standard clinical surface gel electrodes (20 mm) overlying cervical sensory dermatomes. Dermatomal somatosensory evoked potential will be collected at a stimulus intensity well above perception threshold.Complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C4 to C8 dermatomes being stimulated
Measured: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
Secondary outcomes (3)
The change in Neck Disability Index
The Neck Disability Index , consisting of 10 items related to daily living activities, will be our primary patient-reported outcome measure. Each item is scored out of five (with the no disability response given a score of 0) giving a total score for the questionnaire out of 50. Higher scores represent greater disability.
Measured: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
The change in Cervical range of motion
Cervical spine global range-of-motion will be measured using the valid and reliable cervical range-of-motion (CROM) device. The participant will perform flexion, extension, right/left lateral flexion, right/left rotation in upright sitting. The patient was instructed to perform each movement when he/she attained the maximum active range of motion. Three trials were conducted for each direction of movement, and the average of the three measurements will be recorded for analysis.
Measured: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
The change in Neck pain intensity
Neck pain intensity will be measured using the numerical pain rating scale . The patients will be asked to place a mark along the line indicating their current pain intensity; 0 reflecting ''no pain'' and 10 reflecting the ''worst pain''.
Measured: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start5 Jul 2020
- Primary completion11 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical 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
- Model description
- A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, University of Sharjah
- Investigators
- Ibrahim Moustafa, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484324
- Sponsor's protocol ID
- USharjah2020
- Status last verified
- Dec 2020
- First submitted
- 20 Jul 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make individual participant data and related data dictionaries available
Publications
Allison, T, G McCarthy, C C Wood, and S J Jones. 1991. "Potentials Evoked in Human and Monkey Cerebral Cortex by Stimulation of the Median Nerve. A Review of Scalp and Intracranial Recordings." Brain : A Journal of Neurology, December, 2465-2503. Baker, P F, M Ladds, and K A Rubinson. 1977. "Measurement of the Flow Properties of Isolated Axoplasm in a Defined Chemical Environment [Proceedings]." The Journal of Physiology 269 (1): 10P-11P. http://www.ncbi.nlm.nih.gov/pubmed/70528. Bandy, William D, and Jean M Irion. 1994. "The Effect of Time on Static Stretch on the Flexibility of the Hamstring Muscles." Physical Therapy 74 (9): 845-50. https://doi.org/10.1093/ptj/74.9.845. Bandy, William D, Jean M Irion, and Michelle Briggler. 1997. "The Effect of Time and Frequency of Static Stretching on Flexibility of the Hamstring Muscles." Physical Therapy 77 (10): 1090-96. https://doi.org/10.1093/ptj/77.10.1090. Bijur, Polly E, Clarke T Latimer, and E John Gallagher. 2003. "Validation of a Verbally Administered Numerical Rating Scale of Acute Pain for Use in the Emergency Department." Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine 10 (4): 390-92. http://www.ncbi.nlm.nih.gov/pubmed/12670856. Breig, Alf. 1978. Adverse Mechanical Tension in the Central Nervous System: An Analysis of Cause and Effect: Relief by Functional Neurosurgery. Almqvist & Wiksell International. Chaitow, Leon., Helge. Franke, and Leon. Chaitow. 2013. Muscle Energy Techniques. Churchill Livingstone/Elsevier. Cox, James M. 2000. "A Review of Biomechanics of the Central Nervous System. Part I: Spinal Canal Deformations Caused by Changes in Posture (Multiple Letters)." Journal of Manipulative and Physiological Therapeutics. https://doi.org/10.1016/s0161-4754(00)90252-5. Cunha, ACV, TN Burke, FJR França, AP Marques - Clinics, and undefined 2008. n.d. "Effect of Global Posture Reeducation and of Static Stretching on Pain, Range of Motion, and Quality of Life in Women with Chronic Neck Pain: A Randomized Clinical." SciELO Brasil. Accessed July 21, 2020. https://www.scielo.br/scielo.php?pid=S1807-59322008000600010&script=sci_arttext&tlng=pt. "Effectiveness of a Home Program of Ischemic Pressure Followed by Sustained Stretch for Treatment of Myofascial Trigger Points." 2016. Physical Therapy, November. https://doi.org/10.1093/ptj/80.10.997. Fejer, René, Kirsten Ohm Kyvik, and Jan Hartvigsen. 2006. "The Prevalence of Neck Pain in the World Population: A Systematic Critical Review of the Literature." European Spine Journal. Springer. https://doi.org/10.1007/s00586-004-0864-4. Fernández-de-las-Peñas, César, Luis Palomeque-del-Cerro, Cleofás Rodríguez-Blanco, Antonia Gómez-Conesa, and Juan C. Miangolarra-Page. 2007. "Changes in Neck Pain and Active Range of Motion After a Single Thoracic Spine Manipulation in Subjects Presenting with Mechanical Neck Pain: A Case Series." Journal of Manipulative and Physiological Therapeutics 30 (4): 312-20. https://doi.org/10.1016/j.jmpt.2007.03.007. Grosso MJ, Hwang R, Mroz T, Benzel E, Steinmetz M P. 2013. "Relationship between Degree of Focal Kyphosis Correction and Neurological Outcomes for Patients Undergoing Cervical Deformity Correction Surgery." J Neurosurg Spine. 18 (6): 537-44. Harrison, D D E, R Cailliet, D D E Harrison, S J Troyanovich, and S O Harrison. 1999. "A Review of Biomechanics of the Central Nervous System--Part II: Spinal Cord Strains from Postural Loads." Journal of Manipulative and Physiological Therapeutics 22 (5): 322-32. http://www.ncbi.nlm.nih.gov/pubmed/10395435. Harrison, D E, R Cailliet, D D Harrison, S J Troyanovich, and S O Harrison. n.d. "A Review of Biomechanics of the Central Nervous System--Part III: Spinal Cord Stresses from Postural Loads and Their Neurologic Effects." Journal of Manipulative and Physiological Therapeutics 22 (6): 399-410. http://www.ncbi.nlm.nih.gov/pubmed/10478773. Jeffery Brent Feland Joseph William Myrer, +2 authors G W Measom. 2001. "The Effect of Duration of Stretching of the Hamstring Muscle Group for Increasing Range of Motion in People Aged 65 Years or Older." Physical Therapy, May. https://doi.org/10.1093/ptj/81.5.1110.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04484324
- Acronym / sponsor ID
- USharjah2020
- Conditions
- Mechanical Neck Pain
- Keywords
- Randomized controlled trial, muscle energy technique, Stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 23 Jul 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.
controversy remains about the stretching parameters needed to achieve a particular goal or treatment outcome. In clinical practice, multiple stretching techniques are used; nevertheless, there is no evidence-based agreement on the most effective parameters. One of these parameters, that might be affecting the treatment outcome the most, is the stretching duration, thus far there is a little agreement on the optimal stretching duration.
This non agreement in exact stretching parameters is obvious between authors and researchers in the field of muscle energy techniques (MET) as well as those who have used and advocate various durations for the passive stretch that follows the contraction phase in MET.
Detailed description
comparison and subsequent conclusions about appropriate stretching times are mainly based on mechanical factors such as range of motion and flexibility, while ignoring the neural adversative mechanical tension that may be created during stretching exercises. According to the literature , stretching induced neural tension may adversely affect the central nervous system and nerve root function due to the absence of the perineurium, which is the primary load carrying structure. Thus, safe or unsafe limits of nerve elongation are not well established, despite several basic scientific and clinical studies.. Consequently, in the present study, the current study aimed to answer the question: Is it theoretically possible, that increased longitudinal strain and stress on the spinal cord and nerve root from continuous stretching exercises may subtly impair the neural function? Our hypothesis is that a duration threshold exists where, once reached, adverse neural function will be apparent resulting in a reduction of either or both latency and amplitudes of evoked potentials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
| Arm | Type | Receives |
|---|---|---|
| 60 seconds | Experimental | Other: Stretching exercises60 seconds stretching group Stretching exercises for upper Trapezius and Levator the examiner will passively place the participant's head into flexion, side-bending away and rotation towards the side to be stretched (for upper trapezius muscle) and flexion, side-bending away and rotation away from the side to be stretched (for levator scapula ). The patient introduces a light resisted effort to take the stabilized shoulder towards the ear and the ear towards the shoulder. The contraction is sustained for 10 seconds and, upon complete relaxation of effort, the therapist gently eases the head/ neck into an increased degree of side-bending and rotation, where it is stabilized, as the shoulder is stretched caudally. The examiner will depress the participant's shoulder with 100 Newton's of force measured with pressure dynamometer. Once the examiner achieved this level of force, he maintains the stretch for 60 seconds . The procedure is repeated three times. |
| 30 seconds | Experimental | Other: Stretching exercisesThe same procedures while the therapist will maintain the stretch for 30 seconds. |
| 15 seconds | Experimental | Other: Stretching exercisesThe same procedures while the therapist will maintain the stretch for 15 seconds. |
| control | Placebo comparator | Other: Stretching exercisesThe therapist maintains the same manual contact without stretching force |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eligible patients had to be between 18 and 40 years of age
- have generalized neck pain for more than 3 months.
- with symptoms provoked by neck postures, movements, or palpation
Key exclusion criteria (1 listed)
- Subjects' exclusion criteria included specific neck pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory or rheumatic disease. Furthermore, subjects were excluded if they had a history of spine surgery and any objective findings consistent with neurological conditions and vascular disorders.
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 |
|---|---|---|
| Stretching exercisesAlso: muscle energy techniquePost-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch. | Other | 15 seconds, 30 seconds, 60 seconds, control |
Primary outcome
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials
Time frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
Dermatomal Somatosensory Evoked Potentials will be elicited by repetitive, square wave (0.5 ms) electrical pulses (at 3 Hz) from standard clinical surface gel electrodes (20 mm) overlying cervical sensory dermatomes. Dermatomal somatosensory evoked potential will be collected at a stimulus intensity well above perception threshold.Complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the C4 to C8 dermatomes being stimulated
3 secondary outcomes
The change in Neck Disability Index
Time frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
The change in Cervical range of motion
Time frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
The change in Neck pain intensity
Time frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment
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 30 Dec 2020.
- Results publicationAllison, T, G McCarthy, C C Wood, and S J Jones. 1991. "Potentials Evoked in Human and Monkey Cerebral Cortex by Stimulation of the Median Nerve. A Review of Scalp and Intracranial Recordings." Brain : A Journal of Neurology, December, 2465-2503. Baker, P F, M Ladds, and K A Rubinson. 1977. "Measurement of the Flow Properties of Isolated Axoplasm in a Defined Chemical Environment [Proceedings]." The Journal of Physiology 269 (1): 10P-11P. http://www.ncbi.nlm.nih.gov/pubmed/70528. Bandy, William D, and Jean M Irion. 1994. "The Effect of Time on Static Stretch on the Flexibility of the Hamstring Muscles." Physical Therapy 74 (9): 845-50. https://doi.org/10.1093/ptj/74.9.845. Bandy, William D, Jean M Irion, and Michelle Briggler. 1997. "The Effect of Time and Frequency of Static Stretching on Flexibility of the Hamstring Muscles." Physical Therapy 77 (10): 1090-96. https://doi.org/10.1093/ptj/77.10.1090. Bijur, Polly E, Clarke T Latimer, and E John Gallagher. 2003. "Validation of a Verbally Administered Numerical Rating Scale of Acute Pain for Use in the Emergency Department." Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine 10 (4): 390-92. http://www.ncbi.nlm.nih.gov/pubmed/12670856. Breig, Alf. 1978. Adverse Mechanical Tension in the Central Nervous System: An Analysis of Cause and Effect: Relief by Functional Neurosurgery. Almqvist & Wiksell International. Chaitow, Leon., Helge. Franke, and Leon. Chaitow. 2013. Muscle Energy Techniques. Churchill Livingstone/Elsevier. Cox, James M. 2000. "A Review of Biomechanics of the Central Nervous System. Part I: Spinal Canal Deformations Caused by Changes in Posture (Multiple Letters)." Journal of Manipulative and Physiological Therapeutics. https://doi.org/10.1016/s0161-4754(00)90252-5. Cunha, ACV, TN Burke, FJR França, AP Marques - Clinics, and undefined 2008. n.d. "Effect of Global Posture Reeducation and of Static Stretching on Pain, Range of Motion, and Quality of Life in Women with Chronic Neck Pain: A Randomized Clinical." SciELO Brasil. Accessed July 21, 2020. https://www.scielo.br/scielo.php?pid=S1807-59322008000600010&script=sci_arttext&tlng=pt. "Effectiveness of a Home Program of Ischemic Pressure Followed by Sustained Stretch for Treatment of Myofascial Trigger Points." 2016. Physical Therapy, November. https://doi.org/10.1093/ptj/80.10.997. Fejer, René, Kirsten Ohm Kyvik, and Jan Hartvigsen. 2006. "The Prevalence of Neck Pain in the World Population: A Systematic Critical Review of the Literature." European Spine Journal. Springer. https://doi.org/10.1007/s00586-004-0864-4. Fernández-de-las-Peñas, César, Luis Palomeque-del-Cerro, Cleofás Rodríguez-Blanco, Antonia Gómez-Conesa, and Juan C. Miangolarra-Page. 2007. "Changes in Neck Pain and Active Range of Motion After a Single Thoracic Spine Manipulation in Subjects Presenting with Mechanical Neck Pain: A Case Series." Journal of Manipulative and Physiological Therapeutics 30 (4): 312-20. https://doi.org/10.1016/j.jmpt.2007.03.007. Grosso MJ, Hwang R, Mroz T, Benzel E, Steinmetz M P. 2013. "Relationship between Degree of Focal Kyphosis Correction and Neurological Outcomes for Patients Undergoing Cervical Deformity Correction Surgery." J Neurosurg Spine. 18 (6): 537-44. Harrison, D D E, R Cailliet, D D E Harrison, S J Troyanovich, and S O Harrison. 1999. "A Review of Biomechanics of the Central Nervous System--Part II: Spinal Cord Strains from Postural Loads." Journal of Manipulative and Physiological Therapeutics 22 (5): 322-32. http://www.ncbi.nlm.nih.gov/pubmed/10395435. Harrison, D E, R Cailliet, D D Harrison, S J Troyanovich, and S O Harrison. n.d. "A Review of Biomechanics of the Central Nervous System--Part III: Spinal Cord Stresses from Postural Loads and Their Neurologic Effects." Journal of Manipulative and Physiological Therapeutics 22 (6): 399-410. http://www.ncbi.nlm.nih.gov/pubmed/10478773. Jeffery Brent Feland Joseph William Myrer, +2 authors G W Measom. 2001. "The Effect of Duration of Stretching of the Hamstring Muscle Group for Increasing Range of Motion in People Aged 65 Years or Older." Physical Therapy, May. https://doi.org/10.1093/ptj/81.5.1110.
- Individual participant dataSharing planned: Yes. There is a plan to make individual participant data and related data dictionaries available
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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.
Ibrahim Moustafa principal investigator
University of Sharjah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching exercises in people with Mechanical Neck Pain, run by University of Sharjah at 2 sites in United Arab Emirates.
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 1 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 30 Dec 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 United Arab Emirates. 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?
The change in peak-to-peak amplitudes of dermatomal somatosensory evoked potentials (time frame: will be measured at two intervals ;pre-treatment and 24 Hours after treatment). 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 NCT04484324, which also lists 1 linked publication.
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 30 Dec 2020.