Digestive System NeoplasmsPhase 2NCT02356406
Celiac Plexus Radiosurgery for Pain Management
A Phase 2 study testing Celiac Plexus Radiosurgery in people with Digestive System Neoplasms, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Neoplasms
- What is being tested?
- Celiac Plexus Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 2
- 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
- Patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (NRS >4). Patients with other cancer types metastatic to the celiac lymph nodes will also be eligible
- Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old.
- Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. Following gemcitabine 2 weeks are required between final dose and commencement of radiation
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Who cannot join
- Patients under 18 years of age
- Patients who are well balanced in terms of pain control
- Patients with life expectancy <8 weeks
- Patients with ECOG (Eastern cooperative oncology group) performance status 4
- Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy
- Special populations: pregnant women, prisoners, patients with major psychiatric illnesses
- Previous radiotherapy to upper abdomen
- Conditions associated with increased side effects to radiotherapy (IBD (inflammatory bowel disease) for example)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
David Hausner, M.D, 972-35302542, David.Hausner@sheba.health.gov.il
Yaacov R Lawrence, MBBS MA MRCP, 972-35302290, Yaacov.Lawrence@sheba.health.gov.il
About this study
Official title: Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.
Read the detailed description
This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment.
The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment.
The treatment duration is one and a half weeks (5 fractions delivered every other weekday).
- Conditions
- Digestive System Neoplasms
- Being tested
- Celiac Plexus Radiosurgery
- Keywords
- Radiosurgery, Celiac Plexus, Pain, Quality of Life
- Medical subject headings
- Digestive System Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac Plexus RadiosurgeryRadiation
5 fractions of SBRT (Stereotactic body radiation therapy). The target will always include the anterior-medial aspect aorta at T12-L2 (surrogate for celiac plexus). If there is adjacent tumor (e.g. pancreatic tumor that infiltrates the celiac plexus) this will be irradiated in addition.
It is expected that patients will be treated with a rapid-arc IMRT (Intensity modulation radiation therapy) dose-painting technique. Details of beam arrangement and energy used will be determined on an individual basis.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Plexus Radiosurgery | Experimental | The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial.
All eligible patients will receive the same protocol of celiac plexus radiosurgery Receives: Radiation: Celiac Plexus Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) pain score difference from baseline
Measured: 3 weeks post treatment
Secondary outcomes (4)
Numerical Rating Scale (NRS) pain score difference from baseline
Measured: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Analgesic use difference from baseline in oral morphin equivalents
Average analgesic consumption will be defined using daily oral morphine equivalents in milligrams
Measured: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
QoL difference from baseline
Measured: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Safety profile of the procedure - measuring the frequency and severity of treatment side effects, mainly GI toxicities
The safety profile will focused on fatigue and expected GI (gastro-intestinal) toxicities as nausea, vomiting and diarrhea. Acute and late toxicity will be assessed using the NCI-CTCAE (common toxicity criteria for adverse events) version 4.0
Measured: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Digestive System NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Hausner M.D, Sheba Medical Center
- Investigators
- David Hausner, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356406
- Sponsor's protocol ID
- SHEBA-14-1630-DH-CTIL
- Status last verified
- Feb 2015
- First submitted
- 21 Jan 2015
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Levy MJ, Wiersema MJ. EUS-guided celiac plexus neurolysis and celiac plexus block. Gastrointest Endosc. 2003 Jun;57(7):923-30. doi: 10.1016/s0016-5107(03)70036-4. No abstract available.
PubMed 12776048Kambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526.
PubMed 21997984Zhu Z, Friess H, diMola FF, Zimmermann A, Graber HU, Korc M, Buchler MW. Nerve growth factor expression correlates with perineural invasion and pain in human pancreatic cancer. J Clin Oncol. 1999 Aug;17(8):2419-28. doi: 10.1200/JCO.1999.17.8.2419.
PubMed 10561305Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9. doi: 10.1001/jama.291.9.1092.
PubMed 14996778Smigielski J, Piskorz L, Wawrzycki M, Kutwin L, Misiak P, Brocki M. Assessment of quality of life in patients with non-operated pancreatic cancer after videothoracoscopic splanchnicectomy. Wideochir Inne Tech Maloinwazyjne. 2011 Sep;6(3):132-7. doi: 10.5114/wiitm.2011.24690. Epub 2011 Sep 30.
PubMed 23255971Didolkar MS, Coleman CW, Brenner MJ, Chu KU, Olexa N, Stanwyck E, Yu A, Neerchal N, Rabinowitz S. Image-guided stereotactic radiosurgery for locally advanced pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg. 2010 Oct;14(10):1547-59. doi: 10.1007/s11605-010-1323-7. Epub 2010 Sep 14.
PubMed 20839073Rwigema JC, Parikh SD, Heron DE, Howell M, Zeh H, Moser AJ, Bahary N, Quinn A, Burton SA. Stereotactic body radiotherapy in the treatment of advanced adenocarcinoma of the pancreas. Am J Clin Oncol. 2011 Feb;34(1):63-9. doi: 10.1097/COC.0b013e3181d270b4.
PubMed 20308870Macchia G, Morganti AG, Cilla S, Ippolito E, Massaccesi M, Picardi V, Mattiucci GC, Bonomo P, Tambaro R, Pacelli F, Piermattei A, De Spirito M, Valentini V, Cellini N, Deodato F. Quality of life and toxicity of stereotactic radiotherapy in pancreatic tumors: a case series. Cancer Invest. 2012 Feb;30(2):149-55. doi: 10.3109/07357907.2011.640649.
PubMed 22250589Chuong MD, Springett GM, Freilich JM, Park CK, Weber JM, Mellon EA, Hodul PJ, Malafa MP, Meredith KL, Hoffe SE, Shridhar R. Stereotactic body radiation therapy for locally advanced and borderline resectable pancreatic cancer is effective and well tolerated. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):516-22. doi: 10.1016/j.ijrobp.2013.02.022. Epub 2013 Apr 5.
PubMed 23562768Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
PubMed 18055266Iwata K, Yasuda I, Enya M, Mukai T, Nakashima M, Doi S, Iwashita T, Tomita E, Moriwaki H. Predictive factors for pain relief after endoscopic ultrasound-guided celiac plexus neurolysis. Dig Endosc. 2011 Apr;23(2):140-5. doi: 10.1111/j.1443-1661.2010.01046.x. Epub 2010 Dec 7.
PubMed 21429019Hammer L, Hausner D, Ben-Ayun M, Shacham-Shmueli E, Morag O, Margalit O, Boursi B, Yarom N, Jacobson G, Katzman T, Abrams R, Dicker A, Golan T, Symon Z, Lawrence YR. Single-Fraction Celiac Plexus Radiosurgery: A Preliminary Proof-of-Concept Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2022 Jul 1;113(3):588-593. doi: 10.1016/j.ijrobp.2022.02.038. Epub 2022 Mar 4.
PubMed 35257800
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
- ClinicalTrials.gov ID
- NCT02356406
- Acronym / sponsor ID
- SHEBA-14-1630-DH-CTIL
- Conditions
- Digestive System Neoplasms
- Keywords
- Radiosurgery, Celiac Plexus, Pain, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 5 Feb 2015 (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.
This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.
Detailed description
This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment.
The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment.
The treatment duration is one and a half weeks (5 fractions delivered every other weekday).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celiac Plexus Radiosurgery | Experimental | Radiation: Celiac Plexus RadiosurgeryThe study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (NRS >4). Patients with other cancer types metastatic to the celiac lymph nodes will also be eligible
- Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old.
- Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. Following gemcitabine 2 weeks are required between final dose and commencement of radiation
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Key exclusion criteria (8 listed)
- Patients under 18 years of age
- Patients who are well balanced in terms of pain control
- Patients with life expectancy <8 weeks
- Patients with ECOG (Eastern cooperative oncology group) performance status 4
- Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy
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 |
|---|---|---|
| Celiac Plexus Radiosurgery5 fractions of SBRT (Stereotactic body radiation therapy). The target will always include the anterior-medial aspect aorta at T12-L2 (surrogate for celiac plexus). If there is adjacent tumor (e.g. pancreatic tumor that infiltrates the celiac plexus) this will be irradiated in addition. It is expected that patients will be treated with a rapid-arc IMRT (Intensity modulation radiation therapy) dose-painting technique. Details of beam arrangement and energy used will be determined on an individual basis. | Radiation | Celiac Plexus Radiosurgery |
Primary outcome
Numerical Rating Scale (NRS) pain score difference from baseline
Time frame: 3 weeks post treatment
4 secondary outcomes
Numerical Rating Scale (NRS) pain score difference from baseline
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Analgesic use difference from baseline in oral morphin equivalents
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
QoL difference from baseline
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Safety profile of the procedure - measuring the frequency and severity of treatment side effects, mainly GI toxicities
Time frame: 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Background: PubMed 12776048Levy MJ, Wiersema MJ. EUS-guided celiac plexus neurolysis and celiac plexus block. Gastrointest Endosc. 2003 Jun;57(7):923-30. doi: 10.1016/s0016-5107(03)70036-4. No abstract available.
- Background: PubMed 21997984Kambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526.
- Background: PubMed 10561305Zhu Z, Friess H, diMola FF, Zimmermann A, Graber HU, Korc M, Buchler MW. Nerve growth factor expression correlates with perineural invasion and pain in human pancreatic cancer. J Clin Oncol. 1999 Aug;17(8):2419-28. doi: 10.1200/JCO.1999.17.8.2419.
- Background: PubMed 14996778Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9. doi: 10.1001/jama.291.9.1092.
- Background: PubMed 23255971Smigielski J, Piskorz L, Wawrzycki M, Kutwin L, Misiak P, Brocki M. Assessment of quality of life in patients with non-operated pancreatic cancer after videothoracoscopic splanchnicectomy. Wideochir Inne Tech Maloinwazyjne. 2011 Sep;6(3):132-7. doi: 10.5114/wiitm.2011.24690. Epub 2011 Sep 30.
- Background: PubMed 20839073Didolkar MS, Coleman CW, Brenner MJ, Chu KU, Olexa N, Stanwyck E, Yu A, Neerchal N, Rabinowitz S. Image-guided stereotactic radiosurgery for locally advanced pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg. 2010 Oct;14(10):1547-59. doi: 10.1007/s11605-010-1323-7. Epub 2010 Sep 14.
- Background: PubMed 20308870Rwigema JC, Parikh SD, Heron DE, Howell M, Zeh H, Moser AJ, Bahary N, Quinn A, Burton SA. Stereotactic body radiotherapy in the treatment of advanced adenocarcinoma of the pancreas. Am J Clin Oncol. 2011 Feb;34(1):63-9. doi: 10.1097/COC.0b013e3181d270b4.
- Background: PubMed 22250589Macchia G, Morganti AG, Cilla S, Ippolito E, Massaccesi M, Picardi V, Mattiucci GC, Bonomo P, Tambaro R, Pacelli F, Piermattei A, De Spirito M, Valentini V, Cellini N, Deodato F. Quality of life and toxicity of stereotactic radiotherapy in pancreatic tumors: a case series. Cancer Invest. 2012 Feb;30(2):149-55. doi: 10.3109/07357907.2011.640649.
- Background: PubMed 23562768Chuong MD, Springett GM, Freilich JM, Park CK, Weber JM, Mellon EA, Hodul PJ, Malafa MP, Meredith KL, Hoffe SE, Shridhar R. Stereotactic body radiation therapy for locally advanced and borderline resectable pancreatic cancer is effective and well tolerated. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):516-22. doi: 10.1016/j.ijrobp.2013.02.022. Epub 2013 Apr 5.
- Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Background: PubMed 18055266Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- Background: PubMed 21429019Iwata K, Yasuda I, Enya M, Mukai T, Nakashima M, Doi S, Iwashita T, Tomita E, Moriwaki H. Predictive factors for pain relief after endoscopic ultrasound-guided celiac plexus neurolysis. Dig Endosc. 2011 Apr;23(2):140-5. doi: 10.1111/j.1443-1661.2010.01046.x. Epub 2010 Dec 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hausner, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celiac Plexus Radiosurgery in people with Digestive System Neoplasms, run by Sheba Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2015. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 David Hausner, M.D (972-35302542, david.hausner@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) pain score difference from baseline (time frame: 3 weeks post 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 NCT02356406, which also lists 13 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 6 Feb 2015.