Bone MetastasesFURTHERNCT04307914
Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases
A study testing External beam radiotherapy and MR-HIFU in people with Bone Metastases and Bone Neoplasm, run by UMC Utrecht at 6 sites in 4 countries.
Trial summary
The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Bone Neoplasm, Bone Lesion
- What is being tested?
- External beam radiotherapy and MR-HIFU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 10 Mar 2020to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient capable of giving informed consent
- Age ≥ 18 years
- Painful metastatic bone lesion (NRS > 2)
- Patient-localised pain with a distinct pathological substrate on recent CT/MRI
- Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist
- Participant has a reasonable performance score (KPS ≥ 50% or Zubrod/ECOG/WHO < 3)
- Life expectancy ≥ 3 months
Who cannot join
- Participant is not able to fit in the MR gantry
- Need for surgery of targeted location due to (impending) pathological fracture
- Unavoidable critical structures or dense tissues in target area
- Contra-indications for MRI or sedation/anesthesia
- Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
- Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
Show all 15Show fewer
- All patients meeting the FURTHER in- and exclusion criteria as described above will be included in this study, either in the FURTHER RCT or FUTHER Registry. The following inclusion criteria are used to decide upon the arm patients will participate in. If patients meet all of the following RCT inclusion criteria, they will be asked to participate in the FURTHER RCT. Alternatively, patients who do not meet one or more of these criteria will be asked to participate in the FURTHER Registry.
- Painful bone lesion (NRS ≥ 4)
- Indication for EBRT treatment of a bone lesion
- Exclusively palliative intention of EBRT treatment plan
- No previous surgery on the target location
- No neurological symptoms due to nerve involvement of target lesion
- No (impending) pathological fracture)
- EBRT replacable by MR-HIFU based on medical history or phyiscal findings judged by multidisciplinary team
- Target lesion location is completely accessible for MR-HIFU
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Netherlands2 sites
University Medical Center Utrecht
Utrecht, Utrecht, 3508GA
Isala Klinieken Zwolle
Zwolle
About this study
The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.
Read the detailed description
Rationale: Cancer induced bone pain (CIBP) as a result of bone metastases strongly interferes with quality of life and daily functioning of patients with advanced cancer. The current standard of care for patients with painful bone metastasis includes palliative external beam radiotherapy (EBRT). While EBRT is a well-established treatment option, it takes up to 4-6 weeks for EBRT to induce optimal pain relief, and 30-40% of patients do not respond to EBRT. Pain palliation may be improved by including magnetic resonance image guided high intensity focused ultrasound (MR-HIFU) as alternative or in addition to EBRT.
Objective: The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT), as a palliative treatment option to relieve CIBP.
Study design: The FURTHER study consists of a prospective, multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium. The UMC Utrecht is coordinating center. Within the FURTHER RCT, a total of 216 patients with painful bone metastases will be included. These patients will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or EBRT followed by MR-HIFU. In the Netherlands, we expect to enroll a minimum of 70 patients, and a maximum of 120 patients in three Dutch study sites. Within the FURTHER Registry, data of around 60-90 patients will be captured.
Study population: The study will be performed in male and female adult (≥ 18 years) cancer patients capable of giving informed consent having painful non-spinal bone metastases (pain score on Numerical Rating Scale (NRS) ≥ 4).
Intervention: The intervention under study is MR-HIFU alone or in combination with EBRT. The intervention is aimed at rapid and persistent relief of CIBP. In the FURTHER RCT, the intervention will be compared to standard treatment EBRT.
Main study endpoints: Primary outcome of the study will be pain response at 14 days after the first day of treatment. Secondary outcomes include pain response at 14 days after inclusion, and pain scores, toxicity, adverse events, quality of life and survival in the first 6 months after treatment, and cost-effectiveness of the treatments.
- Conditions
- Bone Metastases, Bone Neoplasm, Bone Lesion, Bone Cancer, Pain, Cancer Induced Bone Pain
- Being tested
- External beam radiotherapy, MR-HIFU
- Keywords
- Bone Metastases, Cancer Induced Bone Pain, Pain palliation, Raiotherapy, Radiation oncology, Noninvasive, MR-HIFU, MRgFUS, HIFU, Focused Ultrasound
- Medical subject headings
- Bone Neoplasms, Pain, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiotherapyRadiation
The current standard of care for patients with uncomplicated painful bone metastases is palliative locoregional external beam radiotherapy, often in combination with systemic therapy and analgesics.
MR-HIFUProcedure or surgery
Also called MRgFUS, MR guided High Intensity Focused Ultrasound
MR-HIFU is a non-invasive treatment modality that delivers acoustic energy to heat tissue to ablative temperatures of more than 60°C. The combination of focused ultrasound with magnetic resonance imaging (MRI) enables physicians to perform localized tumor tissue ablation, with real-time temperature monitoring using magnetic resonance (MR) thermometry.
| Study group | Role | What they receive |
|---|---|---|
| External Beam Radiotherapy | Active comparator | In the control arm, patients will undergo standard radiotherapy for painful bone metastases.The radiation schedule is at the discretion of the treating radiation oncologist. Receives: Radiation: External beam radiotherapy |
| MR-HIFU | Experimental | In the intervention arm, patients will be offered MR-HIFU treatment instead of standard radiotherapy. Treatment will be given following the international guidelines for MR-HIFU. Receives: Procedure: MR-HIFU |
| Combination EBRT + MR-HIFU | Experimental | In the combination arm, patients will undergo standard radiotherapy followed by MR-HIFU in a short timeframe. Receives: Radiation: External beam radiotherapy; Procedure: MR-HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response - 14 days after completion of treatment
Patient reported pain response will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) and the pain severity index calculated from the Brief Pain Inventory (BPI) questionnaire [Cleeland 1994]. In addition, analgesic and anti-neuropathic drug use is recorded, and all opioid analgesics are expressed as the oral equivalent daily morphine use (OMED). The primary endpoint of the RCT will follow the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone metastases (Chow 2012). Patients will be categorized as responders when a complete or partial pain response is achieved. All other patients will be categorized as non-responders.
Measured: 14 days
Secondary outcomes (11)
Pain response - 14 days after inclusion
Patient reported pain response will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) and the pain severity index calculated from the Brief Pain Inventory (BPI) questionnaire [Cleeland 1994]. In addition, analgesic and anti-neuropathic drug use is recorded, and all opioid analgesics are expressed as the oral equivalent daily morphine use (OMED). This endpoint will follow the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone metastases (Chow 2012). Patients will be categorized as responders when a complete or partial pain response is achieved. All other patients will be categorized as non-responders.
Measured: 14 days
Patient reported pain scores - patient pain diary
Patient reported pain scores will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable). This will be assessed using a daily patient pain diary during the first 21 days after completion of treatment.
Measured: 21 days
Patient reported pain scores - BPI
Patient reported pain scores will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable). This will be assessed using the Brief Pain Inventory (BPI) questionnaire at 7 time points during the total follow up of 6 months.
Measured: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Physician reported toxicity - CTCAE 5.0
Assessed in seven telephone calls during the first six months following completion of treatment according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: at 3 days, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - EORTC BM22
During the follow up time of 6 months, patients will receive the EORTC BM22 quality of life questionnaire at baseline, one, two, four and six weeks, and three and six months following completion of treatment.
Measured: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - EORTC C15-PAL
During the follow up time of 6 months, patients will receive the EORTC C15-PAL quality of life questionnaire at baseline, one, two, four and six weeks, and three and six months following completion of treatment.
Measured: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - EQ-5D-5L
During the follow up time of 6 months, patients will receive the EQ-5D-5L quality of life questionnaire at baseline, one, two, four and six weeks, and three and six months following completion of treatment.
Measured: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - PGIC
During the follow up time of 6 months, patients will receive the Patient Global Impression of Change scale (a 7 point likert scale about overall improvement after treatment) at one, two, four and six weeks, and three and six months following completion of treatment.
Measured: at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - HADS
During the follow up time of 6 months, patients will receive the Hospital Anxiety and Depression Scale (HADS) questionnaire at one, two, four and six weeks, and three and six months following completion of treatment.
Assessed among patients, patients' partners and caregivers by the Hospital Anxiety and Depression Scale (HADS) at baseline, two and four weeks, and three and six months fol-lowing completion of treatment.
Measured: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Local tumour control
Assessed using CT and/or MRI imaging at patient discretion at three and/or six months after completion of treatment.
Measured: 3 and 6 months
Cost-effectiveness of the treatment
A hypothetical diagnosis related group (DRG) will be calculated from the perspective of the statutory health insurance (SHI).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start10 Mar 2020
- Primary completion1 Sep 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or EBRT followed by MR-HIFU. In addition, data of around 60-90 patients will be captured within the FURTHER Registry arm.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Universitätsklinikum Köln, University of Roma La Sapienza, Istituto Ortopedico Rizzoli, University of Bologna, Isala
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307914
- Sponsor's protocol ID
- NL71303.041.19
- Acronym
- FURTHER
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Slotman DJ, Bartels MMTJ, Ferrer CJ, Bos C, Bartels LW, Boomsma MF, Phernambucq ECJ, Nijholt IM, Morganti AG, Siepe G, Buwenge M, Grull H, Bratke G, Yeo SY, Blanco Sequeiros R, Minn H, Huhtala M, Napoli A, De Felice F, Catalano C, Bazzocchi A, Gasperini C, Campanacci L, Simoes Correa Galendi J, Muller D, Braat MNGJA, Moonen C, Verkooijen HM; FURTHER consortium. Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial. Trials. 2022 Dec 29;23(1):1061. doi: 10.1186/s13063-022-06942-1.
PubMed 36582001
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases
- ClinicalTrials.gov ID
- NCT04307914
- Acronym / sponsor ID
- FURTHER / NL71303.041.19
- Conditions
- Bone Metastases, Bone Neoplasm, Bone Lesion, Bone Cancer, Pain, Cancer Induced Bone Pain
- Keywords
- Bone Metastases, Cancer Induced Bone Pain, Pain palliation, Raiotherapy, Radiation oncology, Noninvasive, MR-HIFU, MRgFUS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Turku University Hospital, Universitätsklinikum Köln, University of Roma La Sapienza, Istituto Ortopedico Rizzoli, University of Bologna, Isala
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Mar 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.
The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.
Detailed description
Rationale: Cancer induced bone pain (CIBP) as a result of bone metastases strongly interferes with quality of life and daily functioning of patients with advanced cancer. The current standard of care for patients with painful bone metastasis includes palliative external beam radiotherapy (EBRT). While EBRT is a well-established treatment option, it takes up to 4-6 weeks for EBRT to induce optimal pain relief, and 30-40% of patients do not respond to EBRT. Pain palliation may be improved by including magnetic resonance image guided high intensity focused ultrasound (MR-HIFU) as alternative or in addition to EBRT.
Objective: The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT), as a palliative treatment option to relieve CIBP.
Study design: The FURTHER study consists of a prospective, multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium. The UMC Utrecht is coordinating center. Within the FURTHER RCT, a total of 216 patients with painful bone metastases will be included. These patients will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or EBRT followed by MR-HIFU. In the Netherlands, we expect to enroll a minimum of 70 patients, and a maximum of 120 patients in three Dutch study sites. Within the FURTHER Registry, data of around 60-90 patients will be captured.
Study population: The study will be performed in male and female adult (≥ 18 years) cancer patients capable of giving informed consent having painful non-spinal bone metastases (pain score on Numerical Rating Scale (NRS) ≥ 4).
Intervention: The intervention under study is MR-HIFU alone or in combination with EBRT. The intervention is aimed at rapid and persistent relief of CIBP. In the FURTHER RCT, the intervention will be compared to standard treatment EBRT.
Main study endpoints: Primary outcome of the study will be pain response at 14 days after the first day of treatment. Secondary outcomes include pain response at 14 days after inclusion, and pain scores, toxicity, adverse events, quality of life and survival in the first 6 months after treatment, and cost-effectiveness of the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or EBRT followed by MR-HIFU. In addition, data of around 60-90 patients will be captured within the FURTHER Registry arm.
| Arm | Type | Receives |
|---|---|---|
| External Beam Radiotherapy | Active comparator | Radiation: External beam radiotherapyIn the control arm, patients will undergo standard radiotherapy for painful bone metastases.The radiation schedule is at the discretion of the treating radiation oncologist. |
| MR-HIFU | Experimental | Procedure: MR-HIFUIn the intervention arm, patients will be offered MR-HIFU treatment instead of standard radiotherapy. Treatment will be given following the international guidelines for MR-HIFU. |
| Combination EBRT + MR-HIFU | Experimental | Radiation: External beam radiotherapy, Procedure: MR-HIFUIn the combination arm, patients will undergo standard radiotherapy followed by MR-HIFU in a short timeframe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient capable of giving informed consent
- Age ≥ 18 years
- Painful metastatic bone lesion (NRS > 2)
- Patient-localised pain with a distinct pathological substrate on recent CT/MRI
- Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist
Key exclusion criteria (15 listed)
- Participant is not able to fit in the MR gantry
- Need for surgery of targeted location due to (impending) pathological fracture
- Unavoidable critical structures or dense tissues in target area
- Contra-indications for MRI or sedation/anesthesia
- Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
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 |
|---|---|---|
| External beam radiotherapyThe current standard of care for patients with uncomplicated painful bone metastases is palliative locoregional external beam radiotherapy, often in combination with systemic therapy and analgesics. | Radiation | Combination EBRT + MR-HIFU, External Beam Radiotherapy |
| MR-HIFUAlso: MRgFUS, MR guided High Intensity Focused UltrasoundMR-HIFU is a non-invasive treatment modality that delivers acoustic energy to heat tissue to ablative temperatures of more than 60°C. The combination of focused ultrasound with magnetic resonance imaging (MRI) enables physicians to perform localized tumor tissue ablation, with real-time temperature monitoring using magnetic resonance (MR) thermometry. | Procedure or surgery | Combination EBRT + MR-HIFU, MR-HIFU |
Primary outcome
Pain response - 14 days after completion of treatment
Time frame: 14 days
Patient reported pain response will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) and the pain severity index calculated from the Brief Pain Inventory (BPI) questionnaire [Cleeland 1994]. In addition, analgesic and anti-neuropathic drug use is recorded, and all opioid analgesics are expressed as the oral equivalent daily morphine use (OMED). The primary endpoint of the RCT will follow the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone metastases (Chow 2012). Patients will be categorized as responders when a complete or partial pain response is achieved. All other patients will be categorized as non-responders.
11 secondary outcomes
Pain response - 14 days after inclusion
Time frame: 14 days
Patient reported pain scores - patient pain diary
Time frame: 21 days
Patient reported pain scores - BPI
Time frame: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Physician reported toxicity - CTCAE 5.0
Time frame: at 3 days, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - EORTC BM22
Time frame: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - EORTC C15-PAL
Time frame: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - EQ-5D-5L
Time frame: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - PGIC
Time frame: at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Patient reported quality of life - HADS
Time frame: on baseline, at 1, 2, 4 and 6 weeks, and at 3 and 6 months
Local tumour control
Time frame: 3 and 6 months
Cost-effectiveness of the treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 36582001Slotman DJ, Bartels MMTJ, Ferrer CJ, Bos C, Bartels LW, Boomsma MF, Phernambucq ECJ, Nijholt IM, Morganti AG, Siepe G, Buwenge M, Grull H, Bratke G, Yeo SY, Blanco Sequeiros R, Minn H, Huhtala M, Napoli A, De Felice F, Catalano C, Bazzocchi A, Gasperini C, Campanacci L, Simoes Correa Galendi J, Muller D, Braat MNGJA, Moonen C, Verkooijen HM; FURTHER consortium. Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial. Trials. 2022 Dec 29;23(1):1061. doi: 10.1186/s13063-022-06942-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External beam radiotherapy and MR-HIFU in people with Bone Metastases and Bone Neoplasm, run by UMC Utrecht at 6 sites in 4 countries.
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 7 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Netherlands, Finland, Germany. 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?
This study is still under way. Results are not available in the source record yet.
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 response - 14 days after completion of treatment (time frame: 14 days). 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 NCT04307914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.