Complex Regional Pain SyndromesPhase 2NCT04744675
Peripheral Nerve Injections for CRPS
A Phase 2 study testing Triamcinolone Acetonide 40mg/mL, Saline Injection and Bupivacaine in people with Complex Regional Pain Syndromes, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
Background Complex regional pain syndrome (CRPS) is characterized by intense pain, loss of function, and associated with motor, trophic, sudomotor, and/or vasomotor changes of the affected extremity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Triamcinolone Acetonide 40mg/mL, Saline Injection and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 30 May 2024to Jun 2025
- 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
- Able to provide signed and dated informed consent form
- Male or female, aged ≥18 years old
- Satisfy the Budapest Criteria for upper extremity CRPS
- A VAS score of at least 40 mm in the upper extremity to avoid flooring effect for injection-related pain reduction
Who cannot join
- Uncontrolled hypertension (>180/110)
- Sepsis
- Bleeding diathesis
- Active cancer
- Brachial plexus injuries
- Neurological language deficits precluding participation
Show all 9Show fewer
- Mini mental state examination score < 23
- Acute mental illness (An acute mental illness is characterized by clinically significant symptoms of any metal health illness that requires immediate treatment. The physician making the recommendation to be part of the study. If the patient exhibits symptoms of any mental health illness that is not being treated by either the recommending physician or another member of the patient's care team the patient will not be recommended to participate in the study)
- Patients who are pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Elisabeth Bruyere Hospital
Ottawa, Ontario, K1N5C8
About this study
Official title: Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome: a Feasibility Study for a Proposed Randomized Design
Background Complex regional pain syndrome (CRPS) is characterized by intense pain, loss of function, and associated with motor, trophic, sudomotor, and/or vasomotor changes of the affected extremity. Upper extremity CRPS is seen frequently in electrodiagnostic, neurology, and musculoskeletal clinics and occurs in up to one-third of patients who have undergone common surgical procedures (i.e. carpal tunnel surgery). To date, there is a limited understanding of the underlying pathophysiology of CRPS. As a consequence, few effective treatment options are available.
Peripheral nerve blocks have proven to be successful in reducing pain for several musculoskeletal and neurologic conditions. Similarly, this procedure could be used to block somatic and autonomic sensory fibers which are thought to contribute to CRPS. In a small exploratory study, investigators found peripheral nerve blocks in the upper extremity (suprascapular and median nerves) were well-tolerated in patients with CRPS and resulted in a 56% and 37% pain reduction in the shoulder and hand 2 weeks after injection, respectively. While this is highly encouraging, large randomized placebo-controlled trials (RCTs) are necessary to demonstrate effectiveness and safety of nerve blocks for this population before it is accepted into clinical practice. This proposal is a phase II feasibility study that will test the critical elements necessary for performing such a RCT.
Read more
Methods The investigators will recruit participants (≥18 years old) from The Ottawa Hospital, Bruyère Continuing Care (Elisabeth Bruyère Hospital, St-Vincent Hospital), and Providence Care Hospital (Kingston, ON), meeting the well-established clinical Budapest criteria for upper extremity CRPS and having a visual analog scale (VAS) pain score of at least 40 mm (to avoid flooring effect). Participants will be block-randomized by the Ottawa Methods Centre to receive injections of either A) intervention (suprascapular, median, and ulnar nerves) with bupivacaine and triamcinolone acetonide, or B) placebo (saline). All participants will receive standard care for CRPS.
Primary outcomes will focus on crucial methodologic aspects for the future RCT, including: (1) level of recruitment, (2) rate of acceptance from eligible patients to the randomization procedure, (3) blinding efficacy, (4) degree of patient retention, (5) rate of data completion, and (6) rate of adverse events for both the placebo and intervention groups.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Triamcinolone Acetonide 40mg/mL, Saline Injection, Bupivacaine
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 40mg/mLDrug
Also called Kenalog
Triamcinolone acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intramuscular, intra-articular, and intrabursal injection.
Saline InjectionDrug
Saline is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium chloride and, in some formulations, potassium chloride and potassium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body.
BupivacaineDrug
Also called Marcaine
Bupivacaine is an anesthetic that is commonly used as a local numbing agent, including intramuscular, intra-articular and intrabursal injections.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The intervention group will receive:
1. Suprascapular nerve block - 3 mL of 0.5% Bupivacaine and 1 mL of 40 mg/mL Kenalog
2. Median nerve block - 3.5 mL of 0.5% Bupivacaine and 0.5 mL of 40 mg/mL Kenalog
3. Ulnar nerve block - 3.5 mL of 0.5% Bupivacaine and 0.5 mL of 40 mg/mL Kenalog Receives: Drug: Triamcinolone Acetonide 40mg/mL; Drug: Bupivacaine |
| Placebo | Placebo comparator | Placebo
The placebo group will receive:
1. Suprascapular nerve injection - 4 mL of normal saline
2. Median nerve injection - 4 mL of normal saline
3. Ulnar nerve injection - 4 mL of normal saline Receives: Drug: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of participants who are successfully recruit into the study.
Measured: Week -2
Randomization
Number of participants who accept being randomized into either the intervention or placebo treatment arms and receive the injection accordingly.
Measured: Week 0
Blinding - Participant
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 0
Blinding - Participant
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 2
Blinding - Participant
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 6
Blinding - Participant
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 12
Blinding - Interventionist
The interventionist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 0
Blinding - Physiotherapist
The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 2
Blinding - Physiotherapist
The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 6
Blinding - Physiotherapist
The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Measured: Week 12
Retention
The percentage of participants who remained in the study for the entire duration of their planned involvement.
Measured: Week 12
Data completion
The percentage of participants who complete all of the study questionnaires
Measured: Week 12
Rate of Adverse events
We will track adverse events the participants experience
Measured: Week 12
Secondary outcomes (51)
Pain - Visual Analog Scale
We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Measured: Week -2
Pain - Visual Analog Scale
We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Measured: Week 0 - Immediately before injection
Pain - Visual Analog Scale
We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Measured: Week 0 - Immediately after injection
Pain - Visual Analog Scale
We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Measured: Week 2
Pain - Visual Analog Scale
We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Measured: Week 6
Pain - Visual Analog Scale
We will track the pain experienced by the participants on a visual analog scale. The lowest score is 0 the highest score is 10. A higher value indicates a higher amount of pain experienced by the participant
Measured: Week 12
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 4 and the highest possible score is 30, and a higher score indicates a worse outcome.
Measured: Week -2
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 4 and the highest possible score is 30, and a higher score indicates a worse outcome.
Measured: Week 0
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 4 and the highest possible score is 30, and a higher score indicates a worse outcome.
Measured: Week 2
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 4 and the highest possible score is 30, and a higher score indicates a worse outcome.
Measured: Week 6
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 4 and the highest possible score is 30, and a higher score indicates a worse outcome.
Measured: Week 12
Pain - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week -2
Pain - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 0
Pain - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 2
Pain - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 6
Pain - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 12
Disease Severity - Complex Regional Pain Syndrome Severity Score
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 17, and a higher score indicates a worse outcome.
Measured: Week -2
Disease Severity - Complex Regional Pain Syndrome Severity Score
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 17, and a higher score indicates a worse outcome.
Measured: Week 0
Disease Severity - Complex Regional Pain Syndrome Severity Score
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 17, and a higher score indicates a worse outcome.
Measured: Week 2
Disease Severity - Complex Regional Pain Syndrome Severity Score
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 17, and a higher score indicates a worse outcome.
Measured: Week 6
Disease Severity - Complex Regional Pain Syndrome Severity Score
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 17, and a higher score indicates a worse outcome.
Measured: Week 12
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 100, and a higher score indicates a worse outcome.
Measured: Week -2
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 100, and a higher score indicates a worse outcome.
Measured: Week 0
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 100, and a higher score indicates a worse outcome.
Measured: Week 2
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 100, and a higher score indicates a worse outcome.
Measured: Week 6
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 0 and the highest possible score is 100, and a higher score indicates a worse outcome.
Measured: Week 12
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 8 and the highest possible score is 40, and a higher score indicates a better outcome.
Measured: Week -2
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 8 and the highest possible score is 40, and a higher score indicates a better outcome.
Measured: Week 0
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 8 and the highest possible score is 40, and a higher score indicates a better outcome.
Measured: Week 2
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 8 and the highest possible score is 40, and a higher score indicates a better outcome.
Measured: Week 6
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 8 and the highest possible score is 40, and a higher score indicates a better outcome.
Measured: Week 12
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 16 and the highest possible score is 80, and a higher score indicates a worse outcome.
Measured: Week -2
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 16 and the highest possible score is 80, and a higher score indicates a worse outcome.
Measured: Week 0
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 16 and the highest possible score is 80, and a higher score indicates a worse outcome.
Measured: Week 2
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 16 and the highest possible score is 80, and a higher score indicates a worse outcome.
Measured: Week 6
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 16 and the highest possible score is 80, and a higher score indicates a worse outcome.
Measured: Week 12
Emotional and Psychological Function - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week -2
Emotional and Psychological Function - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 0
Emotional and Psychological Function - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 2
Emotional and Psychological Function - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 6
Emotional and Psychological Function - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 12
Quality of Life - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week -2
Quality of Life - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 0
Quality of Life - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 2
Quality of Life - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 6
Quality of Life - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 1 and the highest possible score is 5, and a higher score indicates a worse outcome.
Measured: Week 12
Total Score - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 5 and the highest possible score is 25, and a higher score indicates a worse outcome.
Measured: Week -2
Total Score - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 5 and the highest possible score is 25, and a higher score indicates a worse outcome.
Measured: Week 0
Total Score - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 5 and the highest possible score is 25, and a higher score indicates a worse outcome.
Measured: Week 2
Total Score - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 5 and the highest possible score is 25, and a higher score indicates a worse outcome.
Measured: Week 6
Total Score - EQ-5D-5L
These outcomes will allow us to better understand the holistic effect of the intervention. The lowest possible score is 5 and the highest possible score is 25, and a higher score indicates a worse outcome.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start30 May 2024
- Primary completion30 Jul 2024
- Study completionJun 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Campbell, MD, Principal investigator, Elisabeth Bruyere Hospital and The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744675
- Sponsor's protocol ID
- 20200600-01H
- Status last verified
- Sep 2024
- First submitted
- 21 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome: a Feasibility Study for a Proposed Randomized Design
- ClinicalTrials.gov ID
- NCT04744675
- Acronym / sponsor ID
- 20200600-01H
- Conditions
- Complex Regional Pain Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 9 Feb 2021 (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.
Background Complex regional pain syndrome (CRPS) is characterized by intense pain, loss of function, and associated with motor, trophic, sudomotor, and/or vasomotor changes of the affected extremity. Upper extremity CRPS is seen frequently in electrodiagnostic, neurology, and musculoskeletal clinics and occurs in up to one-third of patients who have undergone common surgical procedures (i.e. carpal tunnel surgery). To date, there is a limited understanding of the underlying pathophysiology of CRPS. As a consequence, few effective treatment options are available.
Peripheral nerve blocks have proven to be successful in reducing pain for several musculoskeletal and neurologic conditions. Similarly, this procedure could be used to block somatic and autonomic sensory fibers which are thought to contribute to CRPS. In a small exploratory study, investigators found peripheral nerve blocks in the upper extremity (suprascapular and median nerves) were well-tolerated in patients with CRPS and resulted in a 56% and 37% pain reduction in the shoulder and hand 2 weeks after injection, respectively. While this is highly encouraging, large randomized placebo-controlled trials (RCTs) are necessary to demonstrate effectiveness and safety of nerve blocks for this population before it is accepted into clinical practice. This proposal is a phase II feasibility study that will test the critical elements necessary for performing such a RCT.
Methods The investigators will recruit participants (≥18 years old) from The Ottawa Hospital, Bruyère Continuing Care (Elisabeth Bruyère Hospital, St-Vincent Hospital), and Providence Care Hospital (Kingston, ON), meeting the well-established clinical Budapest criteria for upper extremity CRPS and having a visual analog scale (VAS) pain score of at least 40 mm (to avoid flooring effect). Participants will be block-randomized by the Ottawa Methods Centre to receive injections of either A) intervention (suprascapular, median, and ulnar nerves) with bupivacaine and triamcinolone acetonide, or B) placebo (saline). All participants will receive standard care for CRPS.
Primary outcomes will focus on crucial methodologic aspects for the future RCT, including: (1) level of recruitment, (2) rate of acceptance from eligible patients to the randomization procedure, (3) blinding efficacy, (4) degree of patient retention, (5) rate of data completion, and (6) rate of adverse events for both the placebo and intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Triamcinolone Acetonide 40mg/mL, Drug: BupivacaineThe intervention group will receive: 1. Suprascapular nerve block - 3 mL of 0.5% Bupivacaine and 1 mL of 40 mg/mL Kenalog 2. Median nerve block - 3.5 mL of 0.5% Bupivacaine and 0.5 mL of 40 mg/mL Kenalog 3. Ulnar nerve block - 3.5 mL of 0.5% Bupivacaine and 0.5 mL of 40 mg/mL Kenalog |
| Placebo | Placebo comparator | Drug: Saline InjectionPlacebo The placebo group will receive: 1. Suprascapular nerve injection - 4 mL of normal saline 2. Median nerve injection - 4 mL of normal saline 3. Ulnar nerve injection - 4 mL of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide signed and dated informed consent form
- Male or female, aged ≥18 years old
- Satisfy the Budapest Criteria for upper extremity CRPS
- A VAS score of at least 40 mm in the upper extremity to avoid flooring effect for injection-related pain reduction
Key exclusion criteria (9 listed)
- Uncontrolled hypertension (>180/110)
- Sepsis
- Bleeding diathesis
- Active cancer
- Brachial plexus injuries
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 |
|---|---|---|
| Triamcinolone Acetonide 40mg/mLAlso: KenalogTriamcinolone acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intramuscular, intra-articular, and intrabursal injection. | Drug | Treatment |
| Saline InjectionSaline is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium chloride and, in some formulations, potassium chloride and potassium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body. | Drug | Placebo |
| BupivacaineAlso: MarcaineBupivacaine is an anesthetic that is commonly used as a local numbing agent, including intramuscular, intra-articular and intrabursal injections. | Drug | Treatment |
Primary outcome
Recruitment
Time frame: Week -2
Number of participants who are successfully recruit into the study.
Randomization
Time frame: Week 0
Number of participants who accept being randomized into either the intervention or placebo treatment arms and receive the injection accordingly.
Blinding - Participant
Time frame: Week 0
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Participant
Time frame: Week 2
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Participant
Time frame: Week 6
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Participant
Time frame: Week 12
The participants will be asked which arm they believe they are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Interventionist
Time frame: Week 0
The interventionist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Physiotherapist
Time frame: Week 2
The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Physiotherapist
Time frame: Week 6
The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Blinding - Physiotherapist
Time frame: Week 12
The physiotherapist will be asked which arm they believe the participant is are part of and this response will be compared to their actual group allocation. The level of agreement between the actual group allocation and the guess provided will be compared using Bang's blinding index, we will consider blinding effective if the index is between -0.2 and 0.2 (zero being perfect blinding).
Retention
Time frame: Week 12
The percentage of participants who remained in the study for the entire duration of their planned involvement.
Data completion
Time frame: Week 12
The percentage of participants who complete all of the study questionnaires
Rate of Adverse events
Time frame: Week 12
We will track adverse events the participants experience
51 secondary outcomes
Pain - Visual Analog Scale
Time frame: Week -2
Pain - Visual Analog Scale
Time frame: Week 0 - Immediately before injection
Pain - Visual Analog Scale
Time frame: Week 0 - Immediately after injection
Pain - Visual Analog Scale
Time frame: Week 2
Pain - Visual Analog Scale
Time frame: Week 6
Pain - Visual Analog Scale
Time frame: Week 12
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week -2
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 0
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 2
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 6
Pain - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 12
Pain - EQ-5D-5L
Time frame: Week -2
Pain - EQ-5D-5L
Time frame: Week 0
Pain - EQ-5D-5L
Time frame: Week 2
Pain - EQ-5D-5L
Time frame: Week 6
Pain - EQ-5D-5L
Time frame: Week 12
Disease Severity - Complex Regional Pain Syndrome Severity Score
Time frame: Week -2
Disease Severity - Complex Regional Pain Syndrome Severity Score
Time frame: Week 0
Disease Severity - Complex Regional Pain Syndrome Severity Score
Time frame: Week 2
Disease Severity - Complex Regional Pain Syndrome Severity Score
Time frame: Week 6
Disease Severity - Complex Regional Pain Syndrome Severity Score
Time frame: Week 12
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time frame: Week -2
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time frame: Week 0
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time frame: Week 2
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time frame: Week 6
Function - Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time frame: Week 12
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week -2
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 0
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 2
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 6
Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 12
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week -2
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 0
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 2
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 6
Emotional and Psychological Function - Patient-Reported Outcomes Measurement Information System 29 Profile V2
Time frame: Week 12
Emotional and Psychological Function - EQ-5D-5L
Time frame: Week -2
Emotional and Psychological Function - EQ-5D-5L
Time frame: Week 0
Emotional and Psychological Function - EQ-5D-5L
Time frame: Week 2
Emotional and Psychological Function - EQ-5D-5L
Time frame: Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Mark Campbell, MD principal investigator
Elisabeth Bruyere Hospital and The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone Acetonide 40mg/mL, Saline Injection and Bupivacaine in people with Complex Regional Pain Syndromes, run by Ottawa Hospital Research Institute at 2 sites 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 4 inclusion and 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
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?
Recruitment (time frame: Week -2). The study lists 13 primary outcomes in all. 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 19 Sep 2024.