Myofascial PainPhase 4NCT02230371
Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles
A Phase 4 study testing Granisetron in people with Myofascial Pain and Temporomandibular Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to to investigate if local treatment with intramuscular injections of granisetron are effective in alleviating pain in patients with chronic myofascial pain in the orofacial muscles The study hypothesis is that local administration of granisetron reduces pain and allodynia/hyperalgesia in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain, Temporomandibular Disorders
- What is being tested?
- Granisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- a diagnosis of myofascial pain according to the research diagnostic criteria for TMD Axis I (RDC/TMD)
- duration of TMD pain ≥ 3 months
- self-assessed average myofascial-TMD pain intensity of ≥ 30 mm on a 100-mm visual analogue scale (VAS) during one week prior to examination
- familiar pain upon digital palpation of the masseter and/or the temporalis muscles.
- The patients remain included with one or several co-diagnoses of; a) disc displacement with or without reduction, b) osteoarthrosis in the any of the temporomandibular joints (TMJ), and c) episodic or chronic tension type headache
Who cannot join
- diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
- whiplash associated disorder
- neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial dystonia)
- history of psychiatric disorders
- pain of dental origin
- use of muscle relaxants or any medication that might influence the response to pain
- pregnancy or lactation
- known hypersensitivity to granisetron
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Dental Medicine
Huddinge, 141 04
About this study
Official title: The Serotonin Receptor Type 3 Antagonist Granisetron as a New Treatment Approach for Patients With Chronic Myofascial Pain in the Orofacial Muscles
The aim of this study is to to investigate if local treatment with intramuscular injections of granisetron are effective in alleviating pain in patients with chronic myofascial pain in the orofacial muscles
The study hypothesis is that local administration of granisetron reduces pain and allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and that this effect of granisetron on pain is larger than the effect from placebo
Read the detailed description
This randomized, placebo-controlled, double blind trial (RCT) is carried out during the period of May 2006 to December 2014 as a multicenter study. The two participating centers are the Section of Orofacial Pain and Jaw Function, Department of Dental Medicine, Karolinska Institutet, Sweden and Department of Clinical Oral Physiology at the Eastman Institute, Folktandvården Stockholms län AB, Stockholm, Sweden. The patients are divided randomly into two groups that receive either granisetron or placebo. The randomization is performed by computer (www.randomization.com) by a research assistant not participating in data collection.
The study comprise seven visits; V1) Screening for study participation, V2) First treatment, V3) Second treatment, V4) Third treatment, and V5 to V7) Follow-ups at 1, 2 and 12 months (Fig. Y1) V1 (baseline) include a general health questionnaire, the RDC/TMD Axis II questionnaires (25), the McGill Pain Questionnaire (MPQ) (27), pain drawings of the lateral side of the head (each side separately), and a 1-week pain diary. In addition, a clinical examination according to the RDC/TMD Axis I is performed, including registration of the maximum voluntary mouth opening capacity (MUMO), and also registration of the pressure pain threshold (PPT) as well as blood sampling.
V2-V4 include a shortened clinical examination according to RDC including registration of MUMO and PPT, treatment with intramuscular injections of study substance and a 1-week pain diary. At V3 and V4 a patient's global assessment of treatment outcome questionnaire is also included.
V5-V7 include the RDC/TMD Axis II questionnaires, the McGill Pain Questionnaire (MPQ), pain drawings of the lateral side of the head (each side separately), a 1-week pain diary, a patient's global assessment of treatment outcome questionnaire, a clinical examination according to the RDC/TMD Axis I including registration of MUMO and PPT, and registration of adverse events.
Three orofacial pain specialists (N.C., L.F., B.H.M.) and one dentist attending a specialist training program (S.O.) will be calibrated in the RDC/TMD examination technique to a gold standard examiner (M.E.) during one day, and will perform the study. They and the patients are blinded to group assignment (i.e. study substance) during the entire trial and the substances used will not be revealed until the last patient has undergone the last follow-up.
- Conditions
- Myofascial Pain, Temporomandibular Disorders
- Being tested
- Granisetron, Control (placebo)
- Keywords
- Myofascial pain, TMD, 5-HT3, Granisetron, Placebo-controlled, Patients, Randomized, Double-blind
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranisetronDrug
Also called Kytril (Roche)
If the patient does not have any pain after the first or second injection of granisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden), there will be no more injections but the patient will still come for the follow ups.
Control (placebo)Drug
Also called Isotonic saline 9%
If the patient does not have any pain after the first or second injection of granisetron (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden), there will be no more injections but the patient will still come for the follow ups.
| Study group | Role | What they receive |
|---|---|---|
| Granisetron | Experimental | Granisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden) is injected into a maximum of six muscle sites in each patient. The most painful sites to palpation of the masticatory muscles is chosen, either in the same muscle (maximum 3 sites per muscle) or in a different. The injected volume into each site is0.5 mL, hence the maximum dose of granisetron a patient can receive is 3 mg per treatment. This is repeated after one and two weeks. Receives: Drug: Granisetron |
| Control (placebo) | Placebo comparator | Placebo (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden) is injected into a maximum of six muscle sites in each patient. The most painful sites to palpation of the masticatory muscles is chosen, either in the same muscle (maximum 3 sites per muscle) or in a different. The injected volume into each site is 0.5 mL. This is repeated after one and two weeks. Receives: Drug: Control (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week
Measured: 8 weeks after treatment
Pain intensity
Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week
Measured: 6 months after treatment
Secondary outcomes (7)
Physical and emotional functioning
Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:
Graded Chronic Pain Scale SCL-90R
Measured: 8 weeks after treatment
Physical and emotional functioning
Assessed with Axis II of the RDC/TMD (research diagnostic criteria for temporomandibular disorders), including the questionnaires:
Graded Chronic Pain Scale SCL-90R
Measured: 6 months after treatment
Adverse events
Any possible adverse event is registered
Measured: 1 week after the first injection
Adverse events
Any possible adverse event is registered
Measured: 1 week after the second injection
Adverse events
Any possible adverse event is registered
Measured: 1 week after the third injection
Adverse events
Any possible adverse event is registered
Measured: 8 weeks after the third injection
Adverse events
Any possible adverse event is registered
Measured: 6 months after the third injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startMar 2007
- Primary completionOct 2014
- Study completionDec 2014
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 Myofascial PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Folktandvården Stockholms län AB
- Responsible party
- Principal investigator, Nikolaos Christidis, Karolinska Institutet
- Investigators
- Nikolaos Christidis, PhD, DDS, Principal investigator, Karolinska Institutet, Department of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230371
- Sponsor's protocol ID
- NC3
- Other IDs
- 2005-006042-41, 2005
- Status last verified
- Mar 2021
- First submitted
- 27 Aug 2014
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Christidis N, Kopp S, Ernberg M. The effect on mechanical pain threshold over human muscles by oral administration of granisetron and diclofenac-sodium. Pain. 2005 Feb;113(3):265-270. doi: 10.1016/j.pain.2004.10.016.
PubMed 15661432Christidis N, Nilsson A, Kopp S, Ernberg M. Intramuscular injection of granisetron into the masseter muscle increases the pressure pain threshold in healthy participants and patients with localized myalgia. Clin J Pain. 2007 Jul-Aug;23(6):467-72. doi: 10.1097/AJP.0b013e318058abb1.
PubMed 17575485Ernberg M, Lundeberg T, Kopp S. Effect of propranolol and granisetron on experimentally induced pain and allodynia/hyperalgesia by intramuscular injection of serotonin into the human masseter muscle. Pain. 2000 Feb;84(2-3):339-46. doi: 10.1016/s0304-3959(99)00221-3.
PubMed 10666539Ernberg M, Lundeberg T, Kopp S. Pain and allodynia/hyperalgesia induced by intramuscular injection of serotonin in patients with fibromyalgia and healthy individuals. Pain. 2000 Mar;85(1-2):31-9. doi: 10.1016/s0304-3959(99)00233-x.
PubMed 10692600Ernberg M, Hedenberg-Magnusson B, Alstergren P, Kopp S. The level of serotonin in the superficial masseter muscle in relation to local pain and allodynia. Life Sci. 1999;65(3):313-25. doi: 10.1016/s0024-3205(99)00250-7.
PubMed 10447217Farber L, Stratz T, Bruckle W, Spath M, Pongratz D, Lautenschlager J, Kotter I, Zoller B, Peter HH, Neeck G, Alten R, Muller W. Efficacy and tolerability of tropisetron in primary fibromyalgia--a highly selective and competitive 5-HT3 receptor antagonist. German Fibromyalgia Study Group. Scand J Rheumatol Suppl. 2000;113:49-54. doi: 10.1080/030097400446643.
PubMed 11028832Spath M, Stratz T, Neeck G, Kotter I, Hammel B, Amberger CC, Haus U, Farber L, Pongratz D, Muller W. Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia. Scand J Rheumatol. 2004;33(4):267-70. doi: 10.1080/03009740410005818.
PubMed 15370724Ettlin T. Trigger point injection treatment with the 5-HT3 receptor antagonist tropisetron in patients with late whiplash-associated disorder. First results of a multiple case study. Scand J Rheumatol Suppl. 2004;119:49-50.
PubMed 15515414Muller W, Stratz T. Local treatment of tendinopathies and myofascial pain syndromes with the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:44-8.
PubMed 15515413Christidis N, Omrani S, Fredriksson L, Gjelset M, Louca S, Hedenberg-Magnusson B, Ernberg M. Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial. J Headache Pain. 2015;16:104. doi: 10.1186/s10194-015-0588-3. Epub 2015 Dec 3.
PubMed 26634569
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Serotonin Receptor Type 3 Antagonist Granisetron as a New Treatment Approach for Patients With Chronic Myofascial Pain in the Orofacial Muscles
- ClinicalTrials.gov ID
- NCT02230371
- Acronym / sponsor ID
- NC3
- Conditions
- Myofascial Pain, Temporomandibular Disorders
- Keywords
- Myofascial pain, TMD, 5-HT3, Granisetron, Placebo-controlled, Patients, Randomized, Double-blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Folktandvården Stockholms län AB
- Study start
- Mar 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- 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 aim of this study is to to investigate if local treatment with intramuscular injections of granisetron are effective in alleviating pain in patients with chronic myofascial pain in the orofacial muscles
The study hypothesis is that local administration of granisetron reduces pain and allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and that this effect of granisetron on pain is larger than the effect from placebo
Detailed description
This randomized, placebo-controlled, double blind trial (RCT) is carried out during the period of May 2006 to December 2014 as a multicenter study. The two participating centers are the Section of Orofacial Pain and Jaw Function, Department of Dental Medicine, Karolinska Institutet, Sweden and Department of Clinical Oral Physiology at the Eastman Institute, Folktandvården Stockholms län AB, Stockholm, Sweden. The patients are divided randomly into two groups that receive either granisetron or placebo. The randomization is performed by computer (www.randomization.com) by a research assistant not participating in data collection.
The study comprise seven visits; V1) Screening for study participation, V2) First treatment, V3) Second treatment, V4) Third treatment, and V5 to V7) Follow-ups at 1, 2 and 12 months (Fig. Y1) V1 (baseline) include a general health questionnaire, the RDC/TMD Axis II questionnaires (25), the McGill Pain Questionnaire (MPQ) (27), pain drawings of the lateral side of the head (each side separately), and a 1-week pain diary. In addition, a clinical examination according to the RDC/TMD Axis I is performed, including registration of the maximum voluntary mouth opening capacity (MUMO), and also registration of the pressure pain threshold (PPT) as well as blood sampling.
V2-V4 include a shortened clinical examination according to RDC including registration of MUMO and PPT, treatment with intramuscular injections of study substance and a 1-week pain diary. At V3 and V4 a patient's global assessment of treatment outcome questionnaire is also included.
V5-V7 include the RDC/TMD Axis II questionnaires, the McGill Pain Questionnaire (MPQ), pain drawings of the lateral side of the head (each side separately), a 1-week pain diary, a patient's global assessment of treatment outcome questionnaire, a clinical examination according to the RDC/TMD Axis I including registration of MUMO and PPT, and registration of adverse events.
Three orofacial pain specialists (N.C., L.F., B.H.M.) and one dentist attending a specialist training program (S.O.) will be calibrated in the RDC/TMD examination technique to a gold standard examiner (M.E.) during one day, and will perform the study. They and the patients are blinded to group assignment (i.e. study substance) during the entire trial and the substances used will not be revealed until the last patient has undergone the last follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granisetron | Experimental | Drug: GranisetronGranisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden) is injected into a maximum of six muscle sites in each patient. The most painful sites to palpation of the masticatory muscles is chosen, either in the same muscle (maximum 3 sites per muscle) or in a different. The injected volume into each site is0.5 mL, hence the maximum dose of granisetron a patient can receive is 3 mg per treatment. This is repeated after one and two weeks. |
| Control (placebo) | Placebo comparator | Drug: Control (placebo)Placebo (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden) is injected into a maximum of six muscle sites in each patient. The most painful sites to palpation of the masticatory muscles is chosen, either in the same muscle (maximum 3 sites per muscle) or in a different. The injected volume into each site is 0.5 mL. This is repeated after one and two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- a diagnosis of myofascial pain according to the research diagnostic criteria for TMD Axis I (RDC/TMD)
- duration of TMD pain ≥ 3 months
- self-assessed average myofascial-TMD pain intensity of ≥ 30 mm on a 100-mm visual analogue scale (VAS) during one week prior to examination
- familiar pain upon digital palpation of the masseter and/or the temporalis muscles.
Key exclusion criteria (8 listed)
- diagnosed systemic muscular or joint diseases (e.g. fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
- whiplash associated disorder
- neuropathic pain or neurological disorders (e.g. myasthenia gravis, orofacial dystonia)
- history of psychiatric disorders
- pain of dental origin
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 |
|---|---|---|
| GranisetronAlso: Kytril (Roche)If the patient does not have any pain after the first or second injection of granisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden), there will be no more injections but the patient will still come for the follow ups. | Drug | Granisetron |
| Control (placebo)Also: Isotonic saline 9%If the patient does not have any pain after the first or second injection of granisetron (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden), there will be no more injections but the patient will still come for the follow ups. | Drug | Control (placebo) |
Primary outcome
Pain intensity
Time frame: 8 weeks after treatment
Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week
Pain intensity
Time frame: 6 months after treatment
Change of the median weekly pain intensity compared to baseline A 100-mm VAS is used for each day of the week
7 secondary outcomes
Physical and emotional functioning
Time frame: 8 weeks after treatment
Physical and emotional functioning
Time frame: 6 months after treatment
Adverse events
Time frame: 1 week after the first injection
Adverse events
Time frame: 1 week after the second injection
Adverse events
Time frame: 1 week after the third injection
Adverse events
Time frame: 8 weeks after the third injection
Adverse events
Time frame: 6 months after the third injection
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 24 Mar 2021.
- Background: PubMed 15661432Christidis N, Kopp S, Ernberg M. The effect on mechanical pain threshold over human muscles by oral administration of granisetron and diclofenac-sodium. Pain. 2005 Feb;113(3):265-270. doi: 10.1016/j.pain.2004.10.016.
- Background: PubMed 17575485Christidis N, Nilsson A, Kopp S, Ernberg M. Intramuscular injection of granisetron into the masseter muscle increases the pressure pain threshold in healthy participants and patients with localized myalgia. Clin J Pain. 2007 Jul-Aug;23(6):467-72. doi: 10.1097/AJP.0b013e318058abb1.
- Background: PubMed 10666539Ernberg M, Lundeberg T, Kopp S. Effect of propranolol and granisetron on experimentally induced pain and allodynia/hyperalgesia by intramuscular injection of serotonin into the human masseter muscle. Pain. 2000 Feb;84(2-3):339-46. doi: 10.1016/s0304-3959(99)00221-3.
- Background: PubMed 10692600Ernberg M, Lundeberg T, Kopp S. Pain and allodynia/hyperalgesia induced by intramuscular injection of serotonin in patients with fibromyalgia and healthy individuals. Pain. 2000 Mar;85(1-2):31-9. doi: 10.1016/s0304-3959(99)00233-x.
- Background: PubMed 10447217Ernberg M, Hedenberg-Magnusson B, Alstergren P, Kopp S. The level of serotonin in the superficial masseter muscle in relation to local pain and allodynia. Life Sci. 1999;65(3):313-25. doi: 10.1016/s0024-3205(99)00250-7.
- Background: PubMed 11028832Farber L, Stratz T, Bruckle W, Spath M, Pongratz D, Lautenschlager J, Kotter I, Zoller B, Peter HH, Neeck G, Alten R, Muller W. Efficacy and tolerability of tropisetron in primary fibromyalgia--a highly selective and competitive 5-HT3 receptor antagonist. German Fibromyalgia Study Group. Scand J Rheumatol Suppl. 2000;113:49-54. doi: 10.1080/030097400446643.
- Background: PubMed 15370724Spath M, Stratz T, Neeck G, Kotter I, Hammel B, Amberger CC, Haus U, Farber L, Pongratz D, Muller W. Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia. Scand J Rheumatol. 2004;33(4):267-70. doi: 10.1080/03009740410005818.
- Background: PubMed 15515414Ettlin T. Trigger point injection treatment with the 5-HT3 receptor antagonist tropisetron in patients with late whiplash-associated disorder. First results of a multiple case study. Scand J Rheumatol Suppl. 2004;119:49-50.
- Background: PubMed 15515413Muller W, Stratz T. Local treatment of tendinopathies and myofascial pain syndromes with the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:44-8.
- Derived from this study: PubMed 26634569Christidis N, Omrani S, Fredriksson L, Gjelset M, Louca S, Hedenberg-Magnusson B, Ernberg M. Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial. J Headache Pain. 2015;16:104. doi: 10.1186/s10194-015-0588-3. Epub 2015 Dec 3.
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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.
Nikolaos Christidis, PhD, DDS principal investigator
Karolinska Institutet, Department of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granisetron in people with Myofascial Pain and Temporomandibular Disorders, run by Karolinska Institutet at 1 site in Sweden.
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 6 inclusion and 8 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain intensity (time frame: 8 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230371, 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 24 Mar 2021.