Complex Regional Pain SyndromesNCT05589259
Feasibility Study of Combined Peripheral Nerve Block and Physiotherapy for CRPS
A study testing Axillary Brachial Plexus Block plus Physiotherapy and Physiotherapy alone in people with Complex Regional Pain Syndromes, run by Tracy Cupido at 1 site in Canada.
Trial summary
Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic… Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Axillary Brachial Plexus Block plus Physiotherapy and Physiotherapy alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Meets the Budapest criteria for CRPS of the upper extremity
- Able to consent to treatment.
Who cannot join
- Allergy to local anesthetic
- Allergy to chlorhexidine
- Infection at site of injection
- Previous treatment of current CRPS with a regional anesthetic technique within 6 months
- Unable to tolerate regional anesthesia or physiotherapy
- Another pain condition that affects the same limb
- Patient refusal or inability to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Treatment Approach to Complex Regional Pain Syndrome (CRPS): A Feasibility Study of Combined Peripheral Nerve Block and Physiotherapy
Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic pain on patient quality of life and on healthcare costs. Due to the complexity of chronic pain and differences between the multitudes of pain conditions, developing effective treatments is challenging. This is especially true for Complex Regional Pain Syndrome (CRPS).
CRPS is characterized by severe pain out of proportion to tissue trauma, with local autonomic and inflammatory changes. The severity of pain from CRPS may result in an inability to work, depression, sleep disorders, or suicidal ideation.
Read more
Although its prevalence is low in Canada, CRPS is considered one the most debilitating and least understood pain conditions. As most current treatment options have low evidence of effectiveness, there is no definitive treatment available and most often, patients are struggling to maintain an acceptable quality of life. Thus, there is a pressing need to identify new and improved treatments for adults with CRPS.
An early hypothesis of CRPS pathophysiology posited that sympathetic nervous system over-activity led to many of the signs and symptoms of CRPS. As such, sympathetic nerve blocks, including stellate ganglion and lumbar sympathetic blocks, have been repeatedly investigated as a potential treatment of CRPS. However, a recent meta-analysis suggests that these blocks provided no benefits for those suffering with CRPS. Newer evidence suggests that a peripheral microvascular dysfunction may underlie CRPS pathophysiology. However, no clinical trials have investigated the efficacy of a treatment targeting this peripheral pathway.
The goal of this project is to assess the efficacy of a single-shot axillary approach to the brachial plexus block plus physiotherapy as a novel treatment protocol for CRPS. Our primary hypothesis is that providing a brachial plexus block in conjunction with a physiotherapy program would be superior to physiotherapy alone in treating pain and function in CRPS. Since this is a novel treatment protocol for CRPS, the purpose of our proposed study is to determine the feasibility of conducting a fully powered clinical trial.
Read the detailed description
Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic pain on patient quality of life and on healthcare costs. Due to the complexity of chronic pain and differences between the multitudes of pain conditions, developing effective treatments is challenging. This is especially true for Complex Regional Pain Syndrome (CRPS).
CRPS is characterized by severe pain out of proportion to tissue trauma, with local autonomic and inflammatory changes. The severity of pain from CRPS may result in an inability to work, depression, sleep disorders, or suicidal ideation.
Although its prevalence is low in Canada, CRPS is considered one the most debilitating and least understood pain conditions. As most current treatment options have low evidence of effectiveness, there is no definitive treatment available and most often, patients are struggling to maintain an acceptable quality of life. Thus, there is a pressing need to identify new and improved treatments for adults with CRPS.
An early hypothesis of CRPS pathophysiology posited that sympathetic nervous system over-activity led to many of the signs and symptoms of CRPS. As such, sympathetic nerve blocks, including stellate ganglion and lumbar sympathetic blocks, have been repeatedly investigated as a potential treatment of CRPS. However, a recent meta-analysis suggests that these blocks provided no benefits for those suffering with CRPS. Newer evidence suggests that a peripheral microvascular dysfunction may underlie CRPS pathophysiology. However, no clinical trials have investigated the efficacy of a treatment targeting this peripheral pathway. Current evidence of the efficacy of peripheral nerve block in treating CRPS are mostly derived from small case studies involving cost- and labour-intense regimens, including in-patient protocols with continuous nerve blocks.
The goal of this project is to assess the efficacy of a single-shot axillary brachial plexus block plus physiotherapy as a novel treatment protocol for CRPS. Our primary hypothesis is that providing a brachial plexus block in conjunction with a physiotherapy program would be superior to physiotherapy alone in treating pain and function in CRPS. Since this is a novel treatment protocol for CRPS, the purpose of our proposed study is to determine the feasibility of conducting a fully powered clinical trial. The specific aims of the feasibility trial are to assess: 1) the capacity (recruitment and staffing) required for conducting a fully powered trial, 2) the design of the novel treatment protocol, and 3) the patient response to treatment and trial protocol.
Statement of Relevance The incidence of CRPS in the US is estimated to be 5.4-26.2 per 100,000 person-years. Although unknown, the incidence of CRPS in Ontario is likely similar considering similar prevalence of chronic pain with the US. CRPS is known to be severely debilitating, leading to decreased quality of life and substantial lost productivity, which can be long-term if not quickly and properly treated. Historically, proposed treatments have been variable, resource intensive and results have been mixed. Therefore, specialized pain clinics in Ontario and across Canada are struggling to provide effective and quality care for this patient population. To date there is no definitive treatment for CRPS. Thus, pain specialists have no other choice to trial several treatment options to possibly find one beneficial for their patients.
By testing the efficacy of a single shot brachial plexus block followed by physiotherapy, on an outpatient basis, with the combination of home-based structured physiotherapy, the investigators hope to define a reproducible and effective outpatient treatment for CRPS. If the investigators can demonstrate superiority of a brachial plexus block with physiotherapy over physiotherapy alone, the investigators will be laying the groundwork for further research into not only a new treatment protocol of CRPS that is feasible and scalable for pain clinics in Ontario and around the world but also translating animal models of CRPS pathophysiology to humans.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Axillary Brachial Plexus Block plus Physiotherapy, Physiotherapy alone
- Keywords
- chronic pain, pain management
- Medical subject headings
- Complex Regional Pain Syndromes, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary Brachial Plexus Block plus PhysiotherapyProcedure or surgery
Participants will receive a single-shot axillary-approach brachial plexus block. For the procedure, a 22g or larger peripheral intravenous cannula will be placed, and skin will be sterilized with chlorhexidine. Using aseptic technique, the anesthesiologist will anesthetize the skin and tract with 5cc of 1% lidocaine using a 25g 1.5" needle. After this, a 50mm 21g Pajunk needle will be guided under ultrasound with an in-plane technique to anesthetize the median, ulnar, radial, and musculocutaneous nerves. Identification of the axillary artery, vein and surrounding vessels will be done to ensure an intravascular injection is avoided. Once proper location is confirmed, the anesthesiologist will aspirate to ensure the needle is not intravascular. Once aspiration is confirmed negative, bupivacaine 0.25% 1.5mg/kg (lean body weight) will be injected in divided doses.
30 minutes after placement of the block, the standardized physiotherapy protocol will begin.
Physiotherapy aloneProcedure or surgery
Participants in the EXP arm and the CON arm will complete the same physiotherapy program.
PHYSIOTHERAPY PROTOCOL The physiotherapy program will include manipulation with or without a block. The goal of manipulation is to break up adhesions, possibly overcoming microvascular dysfunction. After the manipulation, participants will take part in a 6-week program which will include a weekly one-hour session with a physiotherapist at the KHSC-CPC and a home exercise program (HEP). During each session, the physiotherapist will work with the participants to increase ROM and limb function using manual therapy, stretching, and strengthening exercises specific to the affected joint(s) and most importantly using GMI. At the end of each session, the physiotherapist will prescribe exercises to complete at home.
| Study group | Role | What they receive |
|---|---|---|
| Axillary Brachial Plexus Block plus Physiotherapy | Experimental | Participants who are randomized to the experimental group (EXP arm) will receive a single-shot axillary-approach brachial plexus block with 1.5mg/kg (up to 50mg total) bupivacaine 0.25% at the Kingston Health Sciences Centre Chronic Pain Clinic (KHSC-CPC). Prior to treatment, a blinded third party will perform a baseline physical exam. Under the brachial plexus block, the physiotherapist will provide standard of care, including manual therapy. The patient will then complete a 6-week physiotherapy program, including GMI. Following the 6 week program, a blind observer will repeat the physical exam. Receives: Procedure: Axillary Brachial Plexus Block plus Physiotherapy |
| Physiotherapy alone | Active comparator | Participants who are randomized to not receive a block (CON arm) will also have a baseline physical exam performed by a blinded third party. Following baseline data collection, the physiotherapist will provide standard of care, including manual therapy. They will then complete a 6-week home exercise program, including GMI. Following the 6 week program, a blinded observer will repeat the physical exam. Receives: Procedure: Physiotherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessment
Assess the ability to recruit 60 patients (30 per arm) to complete the study protocol.
Protocol data: Attrition (with reasons) will be monitored by the research coordinator. Data completeness will be computed from data entered from surveys and electronic diaries. Treatment compliance data (visit attendance and average hours/day of home exercise completed weekly) will be collected.
Staff time will be monitored using logs by each team member (e.g., physician, physiotherapist, blind assessor, nurses).
Patient satisfaction: A custom patient satisfaction questionnaire will also be completed with post-treatment clinical assessment questionnaire to capture patients' impression of the study protocol (e.g., time commitment, treatment length).
Measured: 2 years
Secondary outcomes (1)
Cost
Estimate the cost of a randomized controlled study in order to apply for future funding.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Feb 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tracy Cupido
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tracy Cupido, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589259
- Sponsor's protocol ID
- CRPS-BP-PT
- Status last verified
- Mar 2024
- First submitted
- 24 Sep 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment Approach to Complex Regional Pain Syndrome (CRPS): A Feasibility Study of Combined Peripheral Nerve Block and Physiotherapy
- ClinicalTrials.gov ID
- NCT05589259
- Acronym / sponsor ID
- CRPS-BP-PT
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- chronic pain, pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tracy CupidoUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 Oct 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.
Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic pain on patient quality of life and on healthcare costs. Due to the complexity of chronic pain and differences between the multitudes of pain conditions, developing effective treatments is challenging. This is especially true for Complex Regional Pain Syndrome (CRPS).
CRPS is characterized by severe pain out of proportion to tissue trauma, with local autonomic and inflammatory changes. The severity of pain from CRPS may result in an inability to work, depression, sleep disorders, or suicidal ideation.
Although its prevalence is low in Canada, CRPS is considered one the most debilitating and least understood pain conditions. As most current treatment options have low evidence of effectiveness, there is no definitive treatment available and most often, patients are struggling to maintain an acceptable quality of life. Thus, there is a pressing need to identify new and improved treatments for adults with CRPS.
An early hypothesis of CRPS pathophysiology posited that sympathetic nervous system over-activity led to many of the signs and symptoms of CRPS. As such, sympathetic nerve blocks, including stellate ganglion and lumbar sympathetic blocks, have been repeatedly investigated as a potential treatment of CRPS. However, a recent meta-analysis suggests that these blocks provided no benefits for those suffering with CRPS. Newer evidence suggests that a peripheral microvascular dysfunction may underlie CRPS pathophysiology. However, no clinical trials have investigated the efficacy of a treatment targeting this peripheral pathway.
The goal of this project is to assess the efficacy of a single-shot axillary approach to the brachial plexus block plus physiotherapy as a novel treatment protocol for CRPS. Our primary hypothesis is that providing a brachial plexus block in conjunction with a physiotherapy program would be superior to physiotherapy alone in treating pain and function in CRPS. Since this is a novel treatment protocol for CRPS, the purpose of our proposed study is to determine the feasibility of conducting a fully powered clinical trial.
Detailed description
Chronic pain is a debilitating condition affecting 1 in 5 Canadians with a yearly economic cost of over $40 billion in healthcare spending and loss of productivity. Since the prevalence of chronic pain is increasing, especially as the population ages, effective low-cost treatment is key to reduce the impact of chronic pain on patient quality of life and on healthcare costs. Due to the complexity of chronic pain and differences between the multitudes of pain conditions, developing effective treatments is challenging. This is especially true for Complex Regional Pain Syndrome (CRPS).
CRPS is characterized by severe pain out of proportion to tissue trauma, with local autonomic and inflammatory changes. The severity of pain from CRPS may result in an inability to work, depression, sleep disorders, or suicidal ideation.
Although its prevalence is low in Canada, CRPS is considered one the most debilitating and least understood pain conditions. As most current treatment options have low evidence of effectiveness, there is no definitive treatment available and most often, patients are struggling to maintain an acceptable quality of life. Thus, there is a pressing need to identify new and improved treatments for adults with CRPS.
An early hypothesis of CRPS pathophysiology posited that sympathetic nervous system over-activity led to many of the signs and symptoms of CRPS. As such, sympathetic nerve blocks, including stellate ganglion and lumbar sympathetic blocks, have been repeatedly investigated as a potential treatment of CRPS. However, a recent meta-analysis suggests that these blocks provided no benefits for those suffering with CRPS. Newer evidence suggests that a peripheral microvascular dysfunction may underlie CRPS pathophysiology. However, no clinical trials have investigated the efficacy of a treatment targeting this peripheral pathway. Current evidence of the efficacy of peripheral nerve block in treating CRPS are mostly derived from small case studies involving cost- and labour-intense regimens, including in-patient protocols with continuous nerve blocks.
The goal of this project is to assess the efficacy of a single-shot axillary brachial plexus block plus physiotherapy as a novel treatment protocol for CRPS. Our primary hypothesis is that providing a brachial plexus block in conjunction with a physiotherapy program would be superior to physiotherapy alone in treating pain and function in CRPS. Since this is a novel treatment protocol for CRPS, the purpose of our proposed study is to determine the feasibility of conducting a fully powered clinical trial. The specific aims of the feasibility trial are to assess: 1) the capacity (recruitment and staffing) required for conducting a fully powered trial, 2) the design of the novel treatment protocol, and 3) the patient response to treatment and trial protocol.
Statement of Relevance The incidence of CRPS in the US is estimated to be 5.4-26.2 per 100,000 person-years. Although unknown, the incidence of CRPS in Ontario is likely similar considering similar prevalence of chronic pain with the US. CRPS is known to be severely debilitating, leading to decreased quality of life and substantial lost productivity, which can be long-term if not quickly and properly treated. Historically, proposed treatments have been variable, resource intensive and results have been mixed. Therefore, specialized pain clinics in Ontario and across Canada are struggling to provide effective and quality care for this patient population. To date there is no definitive treatment for CRPS. Thus, pain specialists have no other choice to trial several treatment options to possibly find one beneficial for their patients.
By testing the efficacy of a single shot brachial plexus block followed by physiotherapy, on an outpatient basis, with the combination of home-based structured physiotherapy, the investigators hope to define a reproducible and effective outpatient treatment for CRPS. If the investigators can demonstrate superiority of a brachial plexus block with physiotherapy over physiotherapy alone, the investigators will be laying the groundwork for further research into not only a new treatment protocol of CRPS that is feasible and scalable for pain clinics in Ontario and around the world but also translating animal models of CRPS pathophysiology to humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary Brachial Plexus Block plus Physiotherapy | Experimental | Procedure: Axillary Brachial Plexus Block plus PhysiotherapyParticipants who are randomized to the experimental group (EXP arm) will receive a single-shot axillary-approach brachial plexus block with 1.5mg/kg (up to 50mg total) bupivacaine 0.25% at the Kingston Health Sciences Centre Chronic Pain Clinic (KHSC-CPC). Prior to treatment, a blinded third party will perform a baseline physical exam. Under the brachial plexus block, the physiotherapist will provide standard of care, including manual therapy. The patient will then complete a 6-week physiotherapy program, including GMI. Following the 6 week program, a blind observer will repeat the physical exam. |
| Physiotherapy alone | Active comparator | Procedure: Physiotherapy aloneParticipants who are randomized to not receive a block (CON arm) will also have a baseline physical exam performed by a blinded third party. Following baseline data collection, the physiotherapist will provide standard of care, including manual therapy. They will then complete a 6-week home exercise program, including GMI. Following the 6 week program, a blinded observer will repeat the physical exam. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Meets the Budapest criteria for CRPS of the upper extremity
- Able to consent to treatment.
Key exclusion criteria (7 listed)
- Allergy to local anesthetic
- Allergy to chlorhexidine
- Infection at site of injection
- Previous treatment of current CRPS with a regional anesthetic technique within 6 months
- Unable to tolerate regional anesthesia or physiotherapy
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 |
|---|---|---|
| Axillary Brachial Plexus Block plus PhysiotherapyParticipants will receive a single-shot axillary-approach brachial plexus block. For the procedure, a 22g or larger peripheral intravenous cannula will be placed, and skin will be sterilized with chlorhexidine. Using aseptic technique, the anesthesiologist will anesthetize the skin and tract with 5cc of 1% lidocaine using a 25g 1.5" needle. After this, a 50mm 21g Pajunk needle will be guided under ultrasound with an in-plane technique to anesthetize the median, ulnar, radial, and musculocutaneous nerves. Identification of the axillary artery, vein and surrounding vessels will be done to ensure an intravascular injection is avoided. Once proper location is confirmed, the anesthesiologist will aspirate to ensure the needle is not intravascular. Once aspiration is confirmed negative, bupivacaine 0.25% 1.5mg/kg (lean body weight) will be injected in divided doses. 30 minutes after placement of the block, the standardized physiotherapy protocol will begin. | Procedure or surgery | Axillary Brachial Plexus Block plus Physiotherapy |
| Physiotherapy aloneParticipants in the EXP arm and the CON arm will complete the same physiotherapy program. PHYSIOTHERAPY PROTOCOL The physiotherapy program will include manipulation with or without a block. The goal of manipulation is to break up adhesions, possibly overcoming microvascular dysfunction. After the manipulation, participants will take part in a 6-week program which will include a weekly one-hour session with a physiotherapist at the KHSC-CPC and a home exercise program (HEP). During each session, the physiotherapist will work with the participants to increase ROM and limb function using manual therapy, stretching, and strengthening exercises specific to the affected joint(s) and most importantly using GMI. At the end of each session, the physiotherapist will prescribe exercises to complete at home. | Procedure or surgery | Physiotherapy alone |
Primary outcome
Feasibility Assessment
Time frame: 2 years
Assess the ability to recruit 60 patients (30 per arm) to complete the study protocol. Protocol data: Attrition (with reasons) will be monitored by the research coordinator. Data completeness will be computed from data entered from surveys and electronic diaries. Treatment compliance data (visit attendance and average hours/day of home exercise completed weekly) will be collected. Staff time will be monitored using logs by each team member (e.g., physician, physiotherapist, blind assessor, nurses). Patient satisfaction: A custom patient satisfaction questionnaire will also be completed with post-treatment clinical assessment questionnaire to capture patients' impression of the study protocol (e.g., time commitment, treatment length).
1 secondary outcome
Cost
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Brachial Plexus Block plus Physiotherapy and Physiotherapy alone in people with Complex Regional Pain Syndromes, run by Tracy Cupido at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 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 15 Mar 2024. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2024.