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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to test a new treatment for adults with Complex Regional Pain Syndrome (CRPS), a severe chronic pain condition. The treatment involves an injection near the shoulder to block pain signals, followed by a program of physical exercises. Researchers hope this combination will be more effective than exercises alone in reducing pain and improving function.

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 data supports the effectiveness of the treatment Nerve Block + Physiotherapy for Complex Regional Pain Syndrome?

Pelvic floor physiotherapy (PFPT) is effective in managing pelvic and sexual pain disorders, and pelvic floor muscle training (PFMT) can reduce pelvic floor dysfunction postpartum. While these studies focus on different conditions, they suggest that physiotherapy components of the treatment may help improve pain and function. ^{1 2 3 4 5}

Is pelvic floor muscle training safe for humans?

Pelvic floor muscle training (PFMT) is generally considered safe for humans, as it is commonly recommended during pregnancy and after birth to prevent and treat incontinence, and is used in managing urogenital dysfunction. ^{1 3 4 6 7}

How does the Nerve Block + Physiotherapy treatment for Complex Regional Pain Syndrome differ from other treatments?

This treatment is unique because it combines a nerve block, which numbs specific nerves to reduce pain, with physiotherapy that includes techniques like manual therapy and exercises to improve function. This dual approach targets both the nerve pain and physical rehabilitation, which is different from treatments that focus solely on medication or physical therapy alone. ^{1 8 9 10 11}

Eligibility Criteria

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

I am 18 years old or older.

Exclusion Criteria

Allergy to chlorhexidine

Allergy to local anesthetic

I have an infection where I was injected.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training for women with lumbopelvic pain: A systematic review and meta-analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Pelvic Floor Muscle Training With Smartphone Reminders on Women in the Postpartum Period: A Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Training women's pelvic floor muscles during pregnancy and postpartum at primary health centers: a best practice implementation project. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. [2022]

6. United States 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. [2018]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A pilot trial of movement-based pelvic floor physical therapy to address pelvic floor myofascial pain and lower urinary tract symptoms. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Patients with Pelvic Floor Muscle Spasm Have a Superior Response to Pelvic Floor Physical Therapy at Specialized Centers. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A Novel Multimodal Treatment Method and Pilot Feasibility Study for Vaginismus: Initial Experience With the Combination of Sacral Erector Spinae Plane Block and Progressive Dilatation. [2020]