Nerve Block + Physiotherapy for Complex Regional Pain Syndrome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tracy Cupido

Disqualifiers: Allergy, Infection, Other pain conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment for Complex Regional Pain Syndrome (CRPS), a condition that causes severe, ongoing pain and can make daily life very difficult. Researchers seek to determine if combining a brachial plexus block (a nerve block that numbs nerves to reduce pain) with physiotherapy (physical exercises to help movement and strength) is more effective than physiotherapy alone. The trial seeks adults with CRPS in their arms who can handle the treatment. By joining, participants help explore whether this new approach can offer better pain relief and improve quality of life. As an unphased trial, this study allows participants to contribute to innovative research that could lead to improved treatments for CRPS.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this treatment protocol is safe for CRPS?

Research has shown that brachial plexus blocks, like the one used in this trial, are generally well-tolerated. For example, one study found these blocks effective for people with CRPS (Complex Regional Pain Syndrome) in the upper limbs. Another study suggested that similar procedures, called sympathetic nerve blocks, might also provide significant pain relief for CRPS patients.

However, some possible side effects should be considered. Reported issues include temporary problems like partial paralysis of the diaphragm and a nerve disorder affecting the eye and face. These side effects are uncommon but can occur.

Overall, while some risks exist, the brachial plexus block has shown promise in treating pain with a reasonable safety profile. Prospective participants should discuss these factors with a healthcare provider to weigh the benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of a brachial plexus block and physiotherapy for Complex Regional Pain Syndrome (CRPS) because it integrates a new approach of using a targeted nerve block with standard physical therapy. Unlike typical treatments, which often focus on oral medications and nerve stimulation, this method uses a precise delivery of bupivacaine directly to the nerve cluster responsible for arm sensation, potentially offering more immediate pain relief. Moreover, the addition of a structured physiotherapy program aims to enhance recovery by promoting movement and reducing pain through manual therapy and graded motor imagery. This dual approach could lead to faster, more effective pain management for individuals with CRPS.

What evidence suggests that this trial's treatments could be effective for CRPS?

This trial will compare the effects of a brachial plexus block combined with physiotherapy to physiotherapy alone for treating Complex Regional Pain Syndrome (CRPS). Research has shown that combining a brachial plexus block with physiotherapy might help treat CRPS. In previous studies, patients who received similar nerve blocks experienced significantly less pain soon after the procedure. For example, one study found that pain levels dropped from 7.4 to 3.6 within the first month. Physiotherapy alone is already known to aid movement and reduce pain. Using both a nerve block and physiotherapy together could enhance these benefits, offering better pain relief and function for people with CRPS. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Complex Regional Pain Syndrome (CRPS) in the upper extremity who can consent to treatment. It's not suitable for those allergic to local anesthetics or chlorhexidine, have an infection at the injection site, had regional anesthesia for CRPS within 6 months, cannot tolerate anesthesia or physiotherapy, have another pain condition affecting the same limb, or cannot consent.

Inclusion Criteria

Able to consent to treatment

Meets the Budapest criteria for CRPS of the upper extremity

Exclusion Criteria

Allergy to chlorhexidine

Allergy to local anesthetic

I have an infection where I was injected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single-shot axillary-approach brachial plexus block with bupivacaine and complete a 6-week physiotherapy program

6 weeks

1 visit for nerve block, weekly physiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brachial Plexus Block
• Physiotherapy

Trial Overview The study is testing if a single-shot axillary brachial plexus block combined with physiotherapy is more effective than just physiotherapy alone in treating CRPS. The goal is to see if this new approach improves pain and function better than current treatments.

How Is the Trial Designed?

Group I: Axillary Brachial Plexus Block plus Physiotherapy Experimental Treatment 1 Intervention

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.

Group II: Physiotherapy alone Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Tracy Cupido

Lead Sponsor

Trials

1

Recruited

60+

Tracy Cupido

Lead Sponsor

Trials

1

Recruited

60+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Published Research Related to This Trial

Pelvic floor physiotherapy (PFPT) is an essential part of conservative treatment for women experiencing urogenital issues like urinary incontinence and pelvic organ prolapse, helping to improve their quality of life.

PFPT employs various techniques such as behavioral therapy, exercise, manual therapy, biofeedback, and electrical stimulation, making it a versatile approach to managing pelvic and sexual pain disorders linked to bladder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physiotherapy for women with urogenital dysfunction: indications and methods. Rosenbaum, TY.[2017]

In a study of 49 women undergoing vaginal reconstruction, pelvic floor physical therapy (PFPT) showed initial improvements in muscle function at 12 weeks, but these benefits did not persist by the 24-week follow-up.

Overall quality of life and bladder symptoms improved for all participants by 24 weeks post-surgery, indicating that while PFPT did not provide additional long-term benefits, patients experienced ongoing improvements in their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. Pauls, RN., Crisp, CC., Novicki, K., et al.[2022]

Pelvic floor muscle training (PFMT) during pregnancy can significantly reduce the risk of urinary incontinence for up to 6 months after delivery, as shown in a review of 22 trials with 8,485 women.

For postnatal women with existing incontinence, PFMT also appears to help reduce symptoms, but its effectiveness in a mixed group of women (with and without incontinence) is less clear, indicating that targeted PFMT may be more beneficial than a general approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training for prevention and treatment of urinary and fecal incontinence in antenatal and postnatal women: a short version Cochrane review. Boyle, R., Hay-Smith, EJ., Cody, JD., et al.[2018]

Pelvic floor muscle training (PFMT) is highly effective for women with stress urinary incontinence (UI), showing a significant cure rate with a relative risk (RR) of 8.38 based on high-quality evidence from 21 trials involving 1281 women.

For women with any type of urinary incontinence, PFMT also demonstrates moderate quality evidence of being associated with a cure (RR 5.5) or improvement, reinforcing its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Dumoulin, C., Hay-Smith, J., Habée-Séguin, GM., et al.[2022]

A randomized controlled trial with 148 postpartum women showed that using a smartphone app for pelvic floor muscle training (PFMT) significantly increased adherence to the training (53.9% vs 20.8%) compared to a control group without reminders.

While the app improved muscle activation and endurance of pelvic floor muscles, it did not lead to significant changes in symptoms of stress urinary incontinence, indicating that while adherence and muscle performance improved, symptom relief may require additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Pelvic Floor Muscle Training With Smartphone Reminders on Women in the Postpartum Period: A Randomized Controlled Trial. Chu, L., Jin, X., Wu, S., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22142381/

Management of complex regional pain syndrome type I in ... Results: CIBP group showed statistically significant improvement in NPSS compared with CSG group during the first 12 hours after the procedures (P value <0.05).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05589259

Feasibility Study of Combined Peripheral Nerve Block and ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1877065710001107

Use of continuous interscalene brachial plexus block and ... In the first month of treatment, the mean VNRS pain score fell from 7.4 to 3.6, the Constant score rose from 21.7 to 56.6% and the joint range of motion ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ccr3.4554

Bier block as a successful management of a patient with ... Bier block was successful in the pain management of complex regional pain syndrome (CRPS) type 1.

5. link.springer.com link.springer.com/article/10.1007/s40141-023-00426-2

Complex Regional Pain Syndrome: Updates and Current ... Overall, the current evidence suggests that sympathetic ganglion block is associated with meaningful pain relief in CRPS (level I, degree B).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11173314/

Axillary Brachial Plexus Block Compared with Other Regional ... The attainment of adequate surgical anesthesia 30 min after block placement was considered a primary outcome measure. Additionally, successful ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2950553424000856

Adverse event reporting in ultrasound-guided brachial ... Interscalene blocks accounted for 58 % of all reported adverse events, with hemidiaphragmatic paresis and Horner's syndrome being the most reported outcomes.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05589259?term=AREA%5BConditionSearch%5D(Complex%20regional%20pain%20syndrome%20OR%20%22Complex%20regional%20pain%20syndromes%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=5

Feasibility Study of Combined Peripheral Nerve Block and ... 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 ...

9. rapm.bmj.com rapm.bmj.com/content/26/1/68

Axillary Brachial Plexus Block With Patient Controlled ... Conclusions Axillary BPB with PCA may provide patients with CRPS I of the upper limb a feasible and effective treatment. Reg Anesth Pain Med 2001;26:68-71.