ExpectationsNCT05402631
Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain?
An observational study of Expectations and Back Pain, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
Trial summary
Investigators hypothesize that patients with higher expectations regarding their epidural injection experience a higher pain reduction of their lower back pain and/or leg pain after an epidural injection. Patients' expectations of an epidural injection can influence their level of pain reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Expectations, Back Pain, Back Pain Lower Back Chronic
- What is being tested?
- Epidural Injection and Periradicular Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2022to 30 Sep 2022
- Phase
- Observational
- 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
Study population: Patients of our pain management center that get a transforaminal, translaminar or caudal injection of the spine.
Who may be able to join
- Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- Age > 18 years old.
- Patients treated with a fluoroscopic guided lumbar epidural injection (transforaminal/translaminar/caudal) for back and/or leg pain
- Exclusion criteria The presence of any one of the following exclusion criteria will lead to the exclusion of the subject
- patients who did not complete the questionnaires
- patient did not sign the general consent form (EOC_M-AFRI-001/A)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
Lugano, 6900
Eva Koetsier, PhD
About this study
Official title: Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain? An Observational Cohort Study
Investigators hypothesize that patients with higher expectations regarding their epidural injection experience a higher pain reduction of their lower back pain and/or leg pain after an epidural injection. Patients' expectations of an epidural injection can influence their level of pain reduction. The primary objective of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections ('expected benefits', see under) in patients with low back pain and/or leg pain.
Investigators furthermore hypothesize that patients that have a higher match between their expectations of improvement and actual improvement are more satisfied. A secondary objective of this study is to investigate the prognostic significance of a high match between expectations of improvement and actual improvement on patient satisfaction of the treatment.
Read the detailed description
Chronic low back pain (with or without lower extremity pain) is extremely common problem in primary care and the leading cause worldwide for disability. Approximately 70 to 85% of the western population will develop low back pain at least once during their lifetime.
Low back pain is pain, muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds, with or without sciatica, and is defined as chronic when it persists for 12 weeks or more. The burden on the economy of low back pain were estimated at €2.6 billion and the direct medical costs at 6.1% of the total healthcare expenditure in Switzerland. Multiple modalities of treatments are utilized in managing chronic low back pain including analgesics, physiotherapy, injections, acupuncture, or surgery. Intralaminar and transforaminal lumbar epidural injections of corticosteroids have shown to be effective in patients with chronic low back pain and or leg pain.
Several studies demonstrated how patients' expectations are important predictors of the postsurgical health outcome. Patients' expectations are frequently studied as prognostic factors in knee and hip arthroplasty. It was shown that patients undergoing elective orthopaedic surgery whose expectations were fulfilled were found to be more satisfied with the overall treatment as compared to those whose expectations were not fulfilled. Furthermore, it was found that there is a robust small positive association between patients' positive preoperative expectations and better patient-reported postoperative outcomes. Investigators hypothesize that patient expectations of the pain treatment is also an important predictor of the pain reduction after epidural injections in patients with low back pain and/or leg pain. Therefore, the aim of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections in patients with low back pain and/or leg pain.
- Conditions
- Expectations, Back Pain, Back Pain Lower Back Chronic, Satisfaction, Patient, Injections, Epidural, Injections, Periradicular
- Being tested
- Epidural Injection, Periradicular Injection
- Keywords
- Expectations, Influence of Expectations on Outcome, Back Pain, Epidural Injections, Periradicular Injections
- Medical subject headings
- Back Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural InjectionProcedure or surgery
patient receives an epidural injection due to lower back pain
Periradicular InjectionProcedure or surgery
patient receives a periradicular injection due to lower back pain
| Study group | Role | What they receive |
|---|---|---|
| New patient with lower back pain | Not described Receives: Procedure: Epidural Injection; Procedure: Periradicular Injection | |
| known patient with lower back pain | Not described Receives: Procedure: Epidural Injection; Procedure: Periradicular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the average pain severity
The reduction of the average pain severity score of the Brief Pain Inventory Short form [Time Frame: 10 days after injection in comparison to baseline]. Brief Pain Inventory (BPI) Short form will be used to assess pain intensity after lumbar epidural injection. BPI assess for pain and its scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain in the last 24 hours. A decrease in the BPI score of 2 or more from the baseline score is considered clinically significant and indicates an improvement in severity of the patient's pain.15 We will examine the prognostic significance of patient expectations ('expected benefits', see under) on pain reduction after epidural injections in patients with low back pain and/or leg pain.
Measured: 10 days after injection
Secondary outcomes (4)
Brief Pain Inventory Short form: average pain interference score
BPI average pain interference score assesses the interference the pain has on the patient's functioning. BPI interference is measured between 0-10, where '0' indicates no interference and '10' indicates severe interference with functioning
Measured: 10 days after injection
The reduction of the immediate pain severity score of the Brief Pain Inventory Short form
Again the scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain. A decrease in the BPI score of 2 or more from the baseline score is considered clinically significant and indicates an improvement in severity of the patient's pain
Measured: 1 hour after injection
Patient Global Impression of Change (PGIC)
The PGIC rating is increasingly being used for determining clinically important change in measures such as ratings of pain. This scale is designed to quantify patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. The scales ask that a person assess his or her current health status, recall that status at a previous time-point, and then calculate the difference between the two.
Measured: 10 days after injection
Patients' satisfaction
- This scale is designed to quantify patient's satisfaction with the treatment. Patients will be asked to define the one number that best shows how satisfied they are with the results of their pain treatment. Its scale is measured between 0 - 10, where '0' indicates extremely dissatisfied and '10' indicates extremely satisfied.
Measured: 10 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start20 Apr 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for ExpectationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Lugano
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
- Responsible party
- Principal investigator, Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano
- Investigators
- Eva Koetsier, PhD, Study director, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, SwitzerlandValeria Scheiwiller, Principal investigator, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402631
- Sponsor's protocol ID
- The EXPECT study
- Status last verified
- Sep 2022
- First submitted
- 30 May 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
PubMed 30854609GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
PubMed 29480409Last AR, Hulbert K. Chronic low back pain: evaluation and management. Am Fam Physician. 2009 Jun 15;79(12):1067-74.
PubMed 19530637Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
PubMed 10470716Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.
PubMed 28192793Wieser S, Horisberger B, Schmidhauser S, Eisenring C, Brugger U, Ruckstuhl A, Dietrich J, Mannion AF, Elfering A, Tamcan O, Muller U. Cost of low back pain in Switzerland in 2005. Eur J Health Econ. 2011 Oct;12(5):455-67. doi: 10.1007/s10198-010-0258-y. Epub 2010 Jun 5.
PubMed 20526649Bredow J, Bloess K, Oppermann J, Boese CK, Lohrer L, Eysel P. [Conservative treatment of nonspecific, chronic low back pain : Evidence of the efficacy - a systematic literature review]. Orthopade. 2016 Jul;45(7):573-8. doi: 10.1007/s00132-016-3248-7. German.
PubMed 27075679Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212.
PubMed 17256030Falco FJ, Irwin L, Zhu J. Lumbar spine injection and interventional procedures in the management of low back pain. Clin Occup Environ Med. 2006;5(3):655-702, vii-viii. doi: 10.1016/j.coem.2006.04.001.
PubMed 16963381Brunner M, Schwarz T, Zeman F, Konig M, Grifka J, Benditz A. Efficiency and predictive parameters of outcome of a multimodal pain management concept with spinal injections in patients with low back pain: a retrospective study of 445 patients. Arch Orthop Trauma Surg. 2018 Jul;138(7):901-909. doi: 10.1007/s00402-018-2916-y. Epub 2018 Mar 7.
PubMed 29511801Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.
PubMed 26223485Ng Kuet Leong VS, Kastner A, Petzke F, Przemeck M, Erlenwein J. The influence of pain expectation on pain experience after orthopedic surgery: an observational cohort study. Minerva Anestesiol. 2020 Oct;86(10):1019-1030. doi: 10.23736/S0375-9393.20.14084-7. Epub 2020 Jul 1.
PubMed 32613811Laferton JAC, Oeltjen L, Neubauer K, Ebert DD, Munder T. The effects of patients' expectations on surgery outcome in total hip and knee arthroplasty: a prognostic factor meta-analysis. Health Psychol Rev. 2022 Mar;16(1):50-66. doi: 10.1080/17437199.2020.1854051. Epub 2020 Dec 21.
PubMed 33228474Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
PubMed 15042521
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain? An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05402631
- Acronym / sponsor ID
- The EXPECT study
- Conditions
- Expectations, Back Pain, Back Pain Lower Back Chronic, Satisfaction, Patient, Injections, Epidural, Injections, Periradicular
- Keywords
- Expectations, Influence of Expectations on Outcome, Back Pain, Epidural Injections, Periradicular Injections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ospedale Regionale di LuganoUniversity, hospital or other
- Collaborators
- Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators hypothesize that patients with higher expectations regarding their epidural injection experience a higher pain reduction of their lower back pain and/or leg pain after an epidural injection. Patients' expectations of an epidural injection can influence their level of pain reduction. The primary objective of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections ('expected benefits', see under) in patients with low back pain and/or leg pain.
Investigators furthermore hypothesize that patients that have a higher match between their expectations of improvement and actual improvement are more satisfied. A secondary objective of this study is to investigate the prognostic significance of a high match between expectations of improvement and actual improvement on patient satisfaction of the treatment.
Detailed description
Chronic low back pain (with or without lower extremity pain) is extremely common problem in primary care and the leading cause worldwide for disability. Approximately 70 to 85% of the western population will develop low back pain at least once during their lifetime.
Low back pain is pain, muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds, with or without sciatica, and is defined as chronic when it persists for 12 weeks or more. The burden on the economy of low back pain were estimated at €2.6 billion and the direct medical costs at 6.1% of the total healthcare expenditure in Switzerland. Multiple modalities of treatments are utilized in managing chronic low back pain including analgesics, physiotherapy, injections, acupuncture, or surgery. Intralaminar and transforaminal lumbar epidural injections of corticosteroids have shown to be effective in patients with chronic low back pain and or leg pain.
Several studies demonstrated how patients' expectations are important predictors of the postsurgical health outcome. Patients' expectations are frequently studied as prognostic factors in knee and hip arthroplasty. It was shown that patients undergoing elective orthopaedic surgery whose expectations were fulfilled were found to be more satisfied with the overall treatment as compared to those whose expectations were not fulfilled. Furthermore, it was found that there is a robust small positive association between patients' positive preoperative expectations and better patient-reported postoperative outcomes. Investigators hypothesize that patient expectations of the pain treatment is also an important predictor of the pain reduction after epidural injections in patients with low back pain and/or leg pain. Therefore, the aim of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections in patients with low back pain and/or leg pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New patient with lower back pain | – | Procedure: Epidural Injection, Procedure: Periradicular Injection |
| known patient with lower back pain | – | Procedure: Epidural Injection, Procedure: Periradicular Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of our pain management center that get a transforaminal, translaminar or caudal injection of the spine.
Key inclusion criteria (6 listed)
- Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- Age > 18 years old.
- Patients treated with a fluoroscopic guided lumbar epidural injection (transforaminal/translaminar/caudal) for back and/or leg pain
- Exclusion criteria The presence of any one of the following exclusion criteria will lead to the exclusion of the subject
- patients who did not complete the questionnaires
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Epidural Injectionpatient receives an epidural injection due to lower back pain | Procedure or surgery | New patient with lower back pain, known patient with lower back pain |
| Periradicular Injectionpatient receives a periradicular injection due to lower back pain | Procedure or surgery | New patient with lower back pain, known patient with lower back pain |
Primary outcome
Reduction of the average pain severity
Time frame: 10 days after injection
The reduction of the average pain severity score of the Brief Pain Inventory Short form [Time Frame: 10 days after injection in comparison to baseline]. Brief Pain Inventory (BPI) Short form will be used to assess pain intensity after lumbar epidural injection. BPI assess for pain and its scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain in the last 24 hours. A decrease in the BPI score of 2 or more from the baseline score is considered clinically significant and indicates an improvement in severity of the patient's pain.15 We will examine the prognostic significance of patient expectations ('expected benefits', see under) on pain reduction after epidural injections in patients with low back pain and/or leg pain.
4 secondary outcomes
Brief Pain Inventory Short form: average pain interference score
Time frame: 10 days after injection
The reduction of the immediate pain severity score of the Brief Pain Inventory Short form
Time frame: 1 hour after injection
Patient Global Impression of Change (PGIC)
Time frame: 10 days after injection
Patients' satisfaction
Time frame: 10 days after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Results publication: PubMed 30854609Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
- Results publication: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Results publication: PubMed 29480409Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
- Results publication: PubMed 19530637Last AR, Hulbert K. Chronic low back pain: evaluation and management. Am Fam Physician. 2009 Jun 15;79(12):1067-74.
- Results publication: PubMed 10470716Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
- Results publication: PubMed 28192793Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.
- Results publication: PubMed 20526649Wieser S, Horisberger B, Schmidhauser S, Eisenring C, Brugger U, Ruckstuhl A, Dietrich J, Mannion AF, Elfering A, Tamcan O, Muller U. Cost of low back pain in Switzerland in 2005. Eur J Health Econ. 2011 Oct;12(5):455-67. doi: 10.1007/s10198-010-0258-y. Epub 2010 Jun 5.
- Results publication: PubMed 27075679Bredow J, Bloess K, Oppermann J, Boese CK, Lohrer L, Eysel P. [Conservative treatment of nonspecific, chronic low back pain : Evidence of the efficacy - a systematic literature review]. Orthopade. 2016 Jul;45(7):573-8. doi: 10.1007/s00132-016-3248-7. German.
- Results publication: PubMed 17256030Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212.
- Results publication: PubMed 16963381Falco FJ, Irwin L, Zhu J. Lumbar spine injection and interventional procedures in the management of low back pain. Clin Occup Environ Med. 2006;5(3):655-702, vii-viii. doi: 10.1016/j.coem.2006.04.001.
- Results publication: PubMed 29511801Brunner M, Schwarz T, Zeman F, Konig M, Grifka J, Benditz A. Efficiency and predictive parameters of outcome of a multimodal pain management concept with spinal injections in patients with low back pain: a retrospective study of 445 patients. Arch Orthop Trauma Surg. 2018 Jul;138(7):901-909. doi: 10.1007/s00402-018-2916-y. Epub 2018 Mar 7.
- Results publication: PubMed 26223485Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.
- 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.
Eva Koetsier, PhD study director
Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
Valeria Scheiwiller principal investigator
Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Expectations and Back Pain, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
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 0 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 3 Oct 2022. 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 Switzerland. 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?
Contact Eva Koetsier, PhD (+41 (0)91 811 75 90, eva.koetsier@usi.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the average pain severity (time frame: 10 days after injection). 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 NCT05402631, which also lists 15 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 3 Oct 2022.