Lateral EpicondylitisNCT04445727
Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis
A study testing Vitamin C, spinal manipulation and Transcutaneous electrical nerve stimulation (TENS) in people with Lateral Epicondylitis and Tennis Elbow, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
A randomized clinical trial will be conducted. 130 subjects diagnosed with lateral epicondylitis will be studied. 3 intervention groups will be formed. Experimental group 1 will receive a 1000mg daily vitamin C supplement along with the usual practice of manual therapy and TENS. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Vitamin C, spinal manipulation and Transcutaneous electrical nerve stimulation (TENS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 21 May 2020to 11 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elbow pain patients medically diagnosed with epicondylitis by ultrasound of more than 4 weeks of evolution.
- Age between 35 and 55 years (both inclusive).
- Have signed the informed consent.
Who cannot join
- Have received corticosteroid infiltrations in the previous 3 months. Having received physical therapy treatment for the same reason in last 3 months.
- Bilateral symptoms.
- Fibromyalgia syndrome.
- Previous trauma to the upper limb.
- Fractures or prior dislocation of the shoulder or elbow.
- Previous surgeries on the shoulder or elbow.
Show all 14Show fewer
- Psychiatric treatment.
- Cognitive deficit.
- Owning defibrillator or pacemaker.
- Acute infectious diseases.
- Uncontrolled systemic pathologies (heart disease, pacemaker, coagulation disorders).
- Pregnant women.
- History of rheumatic disease affecting the elbow such as rheumatoid arthritis, gout, reflex sympathetic dystrophy, plaque psoriasis. • Oncological processes.
- Aversion or fear of the application of currents.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Pablo Federico Scillone Tessore
San Sebastián de los Reyes, Madrid, 28702
About this study
Official title: Efficacy of Vitamin C Supplement Addiction vs. High-speed Spinal Manipulation to Routine Physiotherapy Treatment in Lateral Epicondylitis
A randomized clinical trial will be conducted. 130 subjects diagnosed with lateral epicondylitis will be studied. 3 intervention groups will be formed. Experimental group 1 will receive a 1000mg daily vitamin C supplement along with the usual practice of manual therapy and TENS. Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS. In group 3 or control, manual therapy and transcutaneous electrotherapy (TENS) will be applied. All groups will receive the same manual therapy program and TENS, one session per week for 6 consecutive weeks. Data analysis: The data will be entered in the SPSS statistical package (version 21.0) for analysis). Statistical analysis will be performed with a 95% confidence interval, meaning that those whose P is <0.05 will be considered significant values.
Read the detailed description
The 130 subjects will be randomized into 3 groups: Experimental group 1 will receive a supplement of vitamin C (ascorbic complex) of the Bonusan brand, a daily dose of 1000mg should be consumed along with the usual practice of manual therapy and TENS. This group will maintain the daily intake of vitamin C for the 6 weeks that the treatment lasts, they will be informed of the possible side effects of adaptation to the supplement, such as, for example, diarrhea since excess vitamin C, in the case if there is, it lodges in the large intestine, which attracts fluid and produces osmotic diarrhea. This group will have direct communication with the doctor who collaborates in this investigation for any situation, query or unwanted symptom. Vitamin C has been used in other degenerative-type pathologies of collagen tissue such as Achilles tendinopathies and supraspinatus musculature. The investigators have also found references to the effect of vitamin C as pain treatment. Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS. Vertebral manipulations would seek a reflexogenic effect through the sympathetic nerve pathway of the lower cervical ganglion. The transcutaneous TENS-type stimulation is evidenced to have an analgesic effect using self-adhesive patches placed longitudinally at the myo-junction. tendon with a size of 50X50 mm, a frequency of 100 Hz and a pulse duration of 200μs for 25 minutes. Both the vertebral manipulation intervention and the TENS placement will be performed by a professional health physiotherapist with 27 years of clinical experience in the application of the aforementioned techniques.
In group 3 or control, manual therapy and transcutaneous electrotherapy (TENS) will be applied. All groups will receive the same manual therapy program and TENS, one session per week for 6 consecutive weeks.
All the aforementioned interventions will be included in a 45 minute session for the 3 groups alike. They will be in charge of a highly qualified physiotherapist for all the therapies when carrying out which expresses his consent for the study in. Said professional uses all these therapies in consultation daily.
8 The aforementioned therapies can generate some adverse effects that the participants should be aware of and that is reflected in the informed consent that they must complete before the start of the evaluation and the interventions. In the first place, in the TENS, no bibliography has been found that warns of any unwanted effect, which it can refer to is an increase in skin tone under the patch due to the local effect and heat conduction of the same. which should disappear within 30 minutes after application.
In high-speed vertebral manipulation in the cervical region, in 6% of cases, post-manipulation dizziness may occur due to the local vascular change that occurs . The vitamin C supplement can produce some type of heartburn diarrhea, especially in the first days of taking, since this vitamin is absorbed in the intestine .
Alterations at the elbow can cause pain and functional limitation. To quantify these effects, there are different measurement scales. The evaluation to quantify the pain will be carried out with the numerical pain scale (0-10). The Disabilities of the Arm Shoulder and Hand (DASH) questionnaire will be used to determine the functionality of the upper limb, the Shoulder Pain and Disability Index SPADI will be used to assess shoulder function, Global perception of change will also be evaluated, Global Rating of Change Scale (GROC) a 15-point scale where -7 indicates much worse than before, 0 the same as before and +7 much better than before . Finally, the pressure pain threshold (PDU) will be evaluated using a digital algometer .
Measurement variables will be analyzed before treatment, after it, and at 3 and 6 months after the last treatment session.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Vitamin C, spinal manipulation, Transcutaneous electrical nerve stimulation (TENS)
- Keywords
- Acid, Ascorbic, Transcutaneous Electric Nerve Stimulation, Spinal Manipulation, Musculoskeletal Manipulations
- Medical subject headings
- Tennis Elbow, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CCombination product
Also called tens, manual therapy
Will apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks.
spinal manipulationCombination product
Also called tens, manual therapy
Applied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks.
Transcutaneous electrical nerve stimulation (TENS)Combination product
Also called manual therapy
Received a manual therapy intervention and Tens. one session will be held per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| vitamin c | Experimental | daily dose of 1000 mg vitamin c in order to regenerate collagen Receives: Combination Product: Transcutaneous electrical nerve stimulation (TENS) |
| spinal manipulation | Experimental | Spinal manipulation in cervical and dorsal with high speed and short amplitude techniques Receives: Combination Product: Transcutaneous electrical nerve stimulation (TENS) |
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | electrotherapy for an analgesic purpose Receives: Combination Product: Vitamin C; Combination Product: spinal manipulation |
| manual therapy | Experimental | manual muscle treatment for epicondyl musculature Receives: Combination Product: Vitamin C; Combination Product: spinal manipulation; Combination Product: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be measured using an analog visual Scale
For this, patients will be indicated how they should complete the scale, providing a numerical value from 0 to 10, being 10 0 no pain, and 10 the most severe or intense pain. The numerical pain scale is a simple, solid, sensitive and reproducible instrument, useful for reassessing patient pain
Measured: 6 weeks
Secondary outcomes (1)
Disabilities of the Arm, Shoulder and Hand Scale
The questionnaire will consist of 30 questions about their symptoms and the ability to carry out certain activities and has been validated in Spanish. The patient should answer the questions by circling the number that best describes their condition during the past week. Each item will be answered on a scale from 1 to 5, where 1 indicates that it has no difficulty executing, has no symptoms or impact, and 5 indicates that it cannot be performed, that it has very severe symptoms and a strong impact.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start21 May 2020
- Primary completion22 Jan 2021 (estimated)
- Study completion11 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies 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
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Federico Scillone Tessore, Universidad Rey Juan Carlos
- Investigators
- Ana I de la Llave Rincón, Study director, Universidad Rey Juan CarlosJosé J Arias Buría, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445727
- Sponsor's protocol ID
- PScillone
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Notarnicola A, Pesce V, Vicenti G, Tafuri S, Forcignano M, Moretti B. SWAAT study: extracorporeal shock wave therapy and arginine supplementation and other nutraceuticals for insertional Achilles tendinopathy. Adv Ther. 2012 Sep;29(9):799-814. doi: 10.1007/s12325-012-0046-4. Epub 2012 Aug 24.
PubMed 22923162Leijn E, Monnens LA, Cornelissen EA. Intravenous iron supplementation in children on hemodialysis. J Nephrol. 2004 May-Jun;17(3):423-6.
PubMed 15365964Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Bocker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.
PubMed 25246239Malek Mahdavi A, Mahdavi R, Kolahi S, Zemestani M, Vatankhah AM. L-Carnitine supplementation improved clinical status without changing oxidative stress and lipid profile in women with knee osteoarthritis. Nutr Res. 2015 Aug;35(8):707-15. doi: 10.1016/j.nutres.2015.06.003. Epub 2015 Jun 16.
PubMed 26149189Lee GW, Yang HS, Yeom JS, Ahn MW. The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial. Clin Orthop Surg. 2017 Sep;9(3):317-324. doi: 10.4055/cios.2017.9.3.317. Epub 2017 Aug 4.
PubMed 28861199Coombes BK, Bisset L, Vicenzino B. Bilateral cervical dysfunction in patients with unilateral lateral epicondylalgia without concomitant cervical or upper limb symptoms: a cross-sectional case-control study. J Manipulative Physiol Ther. 2014 Feb;37(2):79-86. doi: 10.1016/j.jmpt.2013.12.005. Epub 2013 Dec 28.
PubMed 24378321Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
PubMed 19028251
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin C Supplement Addiction vs. High-speed Spinal Manipulation to Routine Physiotherapy Treatment in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04445727
- Acronym / sponsor ID
- PScillone
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- Acid, Ascorbic, Transcutaneous Electric Nerve Stimulation, Spinal Manipulation, Musculoskeletal Manipulations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 22 Jan 2021 (estimated)
- Study completion
- 11 Mar 2021 (estimated)
- First posted
- 24 Jun 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.
A randomized clinical trial will be conducted. 130 subjects diagnosed with lateral epicondylitis will be studied. 3 intervention groups will be formed. Experimental group 1 will receive a 1000mg daily vitamin C supplement along with the usual practice of manual therapy and TENS. Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS. In group 3 or control, manual therapy and transcutaneous electrotherapy (TENS) will be applied. All groups will receive the same manual therapy program and TENS, one session per week for 6 consecutive weeks. Data analysis: The data will be entered in the SPSS statistical package (version 21.0) for analysis). Statistical analysis will be performed with a 95% confidence interval, meaning that those whose P is <0.05 will be considered significant values.
Detailed description
The 130 subjects will be randomized into 3 groups: Experimental group 1 will receive a supplement of vitamin C (ascorbic complex) of the Bonusan brand, a daily dose of 1000mg should be consumed along with the usual practice of manual therapy and TENS. This group will maintain the daily intake of vitamin C for the 6 weeks that the treatment lasts, they will be informed of the possible side effects of adaptation to the supplement, such as, for example, diarrhea since excess vitamin C, in the case if there is, it lodges in the large intestine, which attracts fluid and produces osmotic diarrhea. This group will have direct communication with the doctor who collaborates in this investigation for any situation, query or unwanted symptom. Vitamin C has been used in other degenerative-type pathologies of collagen tissue such as Achilles tendinopathies and supraspinatus musculature. The investigators have also found references to the effect of vitamin C as pain treatment. Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS. Vertebral manipulations would seek a reflexogenic effect through the sympathetic nerve pathway of the lower cervical ganglion. The transcutaneous TENS-type stimulation is evidenced to have an analgesic effect using self-adhesive patches placed longitudinally at the myo-junction. tendon with a size of 50X50 mm, a frequency of 100 Hz and a pulse duration of 200μs for 25 minutes. Both the vertebral manipulation intervention and the TENS placement will be performed by a professional health physiotherapist with 27 years of clinical experience in the application of the aforementioned techniques.
In group 3 or control, manual therapy and transcutaneous electrotherapy (TENS) will be applied. All groups will receive the same manual therapy program and TENS, one session per week for 6 consecutive weeks.
All the aforementioned interventions will be included in a 45 minute session for the 3 groups alike. They will be in charge of a highly qualified physiotherapist for all the therapies when carrying out which expresses his consent for the study in. Said professional uses all these therapies in consultation daily.
8 The aforementioned therapies can generate some adverse effects that the participants should be aware of and that is reflected in the informed consent that they must complete before the start of the evaluation and the interventions. In the first place, in the TENS, no bibliography has been found that warns of any unwanted effect, which it can refer to is an increase in skin tone under the patch due to the local effect and heat conduction of the same. which should disappear within 30 minutes after application.
In high-speed vertebral manipulation in the cervical region, in 6% of cases, post-manipulation dizziness may occur due to the local vascular change that occurs . The vitamin C supplement can produce some type of heartburn diarrhea, especially in the first days of taking, since this vitamin is absorbed in the intestine .
Alterations at the elbow can cause pain and functional limitation. To quantify these effects, there are different measurement scales. The evaluation to quantify the pain will be carried out with the numerical pain scale (0-10). The Disabilities of the Arm Shoulder and Hand (DASH) questionnaire will be used to determine the functionality of the upper limb, the Shoulder Pain and Disability Index SPADI will be used to assess shoulder function, Global perception of change will also be evaluated, Global Rating of Change Scale (GROC) a 15-point scale where -7 indicates much worse than before, 0 the same as before and +7 much better than before . Finally, the pressure pain threshold (PDU) will be evaluated using a digital algometer .
Measurement variables will be analyzed before treatment, after it, and at 3 and 6 months after the last treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin c | Experimental | Combination Product: Transcutaneous electrical nerve stimulation (TENS)daily dose of 1000 mg vitamin c in order to regenerate collagen |
| spinal manipulation | Experimental | Combination Product: Transcutaneous electrical nerve stimulation (TENS)Spinal manipulation in cervical and dorsal with high speed and short amplitude techniques |
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Combination Product: Vitamin C, Combination Product: spinal manipulationelectrotherapy for an analgesic purpose |
| manual therapy | Experimental | Combination Product: Vitamin C, Combination Product: spinal manipulation, Combination Product: Transcutaneous electrical nerve stimulation (TENS)manual muscle treatment for epicondyl musculature |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elbow pain patients medically diagnosed with epicondylitis by ultrasound of more than 4 weeks of evolution.
- Age between 35 and 55 years (both inclusive).
- Have signed the informed consent.
Key exclusion criteria (14 listed)
- Have received corticosteroid infiltrations in the previous 3 months. Having received physical therapy treatment for the same reason in last 3 months.
- Bilateral symptoms.
- Fibromyalgia syndrome.
- Previous trauma to the upper limb.
- Fractures or prior dislocation of the shoulder or elbow.
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 |
|---|---|---|
| Vitamin CAlso: tens, manual therapyWill apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks. | Combination product | Transcutaneous electrical nerve stimulation (TENS), manual therapy |
| spinal manipulationAlso: tens, manual therapyApplied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks. | Combination product | Transcutaneous electrical nerve stimulation (TENS), manual therapy |
| Transcutaneous electrical nerve stimulation (TENS)Also: manual therapyReceived a manual therapy intervention and Tens. one session will be held per week for 6 weeks. | Combination product | manual therapy, spinal manipulation, vitamin c |
Primary outcome
Pain will be measured using an analog visual Scale
Time frame: 6 weeks
For this, patients will be indicated how they should complete the scale, providing a numerical value from 0 to 10, being 10 0 no pain, and 10 the most severe or intense pain. The numerical pain scale is a simple, solid, sensitive and reproducible instrument, useful for reassessing patient pain
1 secondary outcome
Disabilities of the Arm, Shoulder and Hand Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Results publication: PubMed 22923162Notarnicola A, Pesce V, Vicenti G, Tafuri S, Forcignano M, Moretti B. SWAAT study: extracorporeal shock wave therapy and arginine supplementation and other nutraceuticals for insertional Achilles tendinopathy. Adv Ther. 2012 Sep;29(9):799-814. doi: 10.1007/s12325-012-0046-4. Epub 2012 Aug 24.
- Results publication: PubMed 15365964Leijn E, Monnens LA, Cornelissen EA. Intravenous iron supplementation in children on hemodialysis. J Nephrol. 2004 May-Jun;17(3):423-6.
- Results publication: PubMed 25246239Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Bocker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.
- Results publication: PubMed 26149189Malek Mahdavi A, Mahdavi R, Kolahi S, Zemestani M, Vatankhah AM. L-Carnitine supplementation improved clinical status without changing oxidative stress and lipid profile in women with knee osteoarthritis. Nutr Res. 2015 Aug;35(8):707-15. doi: 10.1016/j.nutres.2015.06.003. Epub 2015 Jun 16.
- Results publication: PubMed 28861199Lee GW, Yang HS, Yeom JS, Ahn MW. The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial. Clin Orthop Surg. 2017 Sep;9(3):317-324. doi: 10.4055/cios.2017.9.3.317. Epub 2017 Aug 4.
- Results publication: PubMed 24378321Coombes BK, Bisset L, Vicenzino B. Bilateral cervical dysfunction in patients with unilateral lateral epicondylalgia without concomitant cervical or upper limb symptoms: a cross-sectional case-control study. J Manipulative Physiol Ther. 2014 Feb;37(2):79-86. doi: 10.1016/j.jmpt.2013.12.005. Epub 2013 Dec 28.
- Results publication: PubMed 19028251Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
- 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.
Ana I de la Llave Rincón study director
Universidad Rey Juan Carlos
José J Arias Buría study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C, spinal manipulation and Transcutaneous electrical nerve stimulation (TENS) in people with Lateral Epicondylitis and Tennis Elbow, run by Universidad Rey Juan Carlos at 1 site 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 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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 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?
Results are not available in the source record.
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?
Pain will be measured using an analog visual Scale (time frame: 6 weeks). 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 NCT04445727, which also lists 7 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 26 Jun 2020.