Prednisone for Complex Regional Pain Syndrome
Recruiting in Palo Alto (17 mi)
Overseen byDavid Stockton, MD, MASc, FRCSC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Must not be taking: Glucocorticoids
Disqualifiers: Diabetes, Pregnancy, Infections, others
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Wrist fractures are the most prevalent adult fracture. Complex regional pain syndrome (CRPS) is a common complication that can occur, leading to permanent disability and is costly to the patient and healthcare system. In addition, amidst the opioid epidemic, the risk of increased opioid use in patients with CRPS prompts the need to find viable treatment strategies. This study aims to evaluate an anti-inflammatory medication, prednisone, in the early treatment of CRPS. Patients with wrist fractures who undergo surgical treatment will be randomized to receiving placebo vs prednisone for 2 weeks. Clinical assessments in the follow up period will be compared.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking a glucocorticoid medication like prednisone.
What data supports the effectiveness of the drug Prednisone for treating Complex Regional Pain Syndrome?
Research shows that corticosteroid therapy, which includes drugs like Prednisone, has shown favorable results in treating Complex Regional Pain Syndrome (CRPS), with studies indicating significant improvement in pain and symptoms when used in a structured treatment plan.
12345Is prednisone safe for treating complex regional pain syndrome?
In a study comparing high-dose and low-dose oral steroid regimens for complex regional pain syndrome, no treatment-emergent adverse events like high blood pressure, blood sugar issues, or stomach problems were reported.
13678How is the drug prednisone unique in treating complex regional pain syndrome?
Prednisone is a corticosteroid that helps reduce inflammation and is used to treat complex regional pain syndrome (CRPS) by potentially providing significant pain relief and improving symptoms when other treatments have failed. It is taken orally and has shown effectiveness in clinical studies, making it a promising option for CRPS, which lacks a standard treatment.
123910Eligibility Criteria
This trial is for adults aged 19 or older who have had a wrist fracture treated with surgery. Participants must be female, have pain scores of at least 5/10 post-injury, show signs of CRPS according to the Budapest Criteria, and not be depressed as indicated by a CES-D score of 16 or higher.Inclusion Criteria
I am 19 years old or older.
I have a confirmed single closed wrist fracture.
My depression score is 16 or higher.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either prednisone or placebo for 2 weeks starting on the day of surgery
2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 2 weeks, 6 weeks, 3 months, and 6 months
6 months
4 visits (in-person)
Participant Groups
The study tests if prednisone, an anti-inflammatory drug, can prevent complex regional pain syndrome (CRPS) after wrist fractures. Patients are randomly chosen to receive either prednisone or a placebo for two weeks following surgical repair.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrednisoneExperimental Treatment1 Intervention
40 mg PO once daily for 14 days starting day of surgery
Group II: PlaceboPlacebo Group1 Intervention
placebo tablet PO once daily for 14 days starting day of surgery
Prednisone is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as Prednisone for:
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
πͺπΊ Approved in European Union as Prednisone for:
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
π¨π¦ Approved in Canada as Prednisone for:
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vancouver General HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
Canadian Orthopaedic FoundationCollaborator
References
Prednisone for Acute Complex Regional Pain Syndrome: A Retrospective Cohort Study. [2020]The objective of this study was to evaluate prednisone effectiveness on complex regional pain syndrome (CRPS) features in a community-based outpatient rehabilitation setting.
[Complex regional pain syndrome type 1. An elusive diagnosis]. [2016]Complex regional pain syndrome type 1 is a painful disorder that may complicate a traumatic lesion especially in extremities. It is infradiagnosed and potentially very disabling. Its diagnosis consists of a few clinical criteria. It does not exist a complementary diagnostic study which can be considered as gold standard. Its treatment must be multidisciplinary (e.g. medicines, physical therapy, psychological therapy and, in selected cases, invasive procedures). There have been communicated some favorable results using multiple pharmacological treatments in which corticosteroid therapy was among the ones that have reached highest levels of evidence in favor of its utility. Here we present the case of a forty-seven male patient who presented severe pain in his right lower extremity with neuropathic characteristics and a long time of evolution. He had had multiple previous consultations and he had carried out many other treatments. It has been performed a 99Tc three-phase bone scintigraphy that was compatible with the proposed diagnosis. He was treated with methyl prednisone 60 mg q24h with progressive lowering doses during fifteen days with a significant improvement of signs and symptoms. Finally he received hospital discharge for ambulatory rehabilitation treatment.
Effectiveness of prednisolone in complex regional pain syndrome treatment: A systematic narrative review. [2022]Many patients with complex regional pain syndrome (CRPS) experience refractory pain with severe restrictions in the activities of daily living. Oral prednisolone is commonly used to treat these patients.
The Treatment of Longstanding Complex Regional Pain Syndrome with Oral Steroids. [2017]Evaluate the effectiveness of oral steroids in relieving pain in patients with Complex Regional Pain Syndrome (CRPS) of more than 3 months duration.
Pamidronate effect compared with a steroid on complex regional pain syndrome type I: Pilot randomised trial. [2022]This study aims to compare the effectiveness of a bisphosphonate (pamidronate) and a steroid (prednisolone) in complex regional pain syndrome (CRPS) type I during four weeks of follow-up in hemiplegic stroke patients.
Prednisolone 20 mg vs 40 mg in complex regional pain syndrome type I: A randomized controlled trial. [2023]High dose of corticosteroid has been found beneficial in complex regional pain syndrome type I (CRPS-I). We report the efficacy and safety of prednisolone 20 mg versus 40 mg in CRPS-I in an open label randomized controlled trial.
Use of Oral Prednisolone and a 3-Phase Bone Scintigraphy in Patients with Complex Regional Pain Syndrome Type I. [2020]To compare the treatment effects of a high-dose and low-dose oral steroid regimen based on changes in the radioisotope uptake ratio (RUR) observed from three-phase bone scintigraphy (TPBS) in patients with complex regional pain syndrome type I (CRPS I), we retrospectively analyzed data of 34 patients with CRPS I from traumatic brain injury and stroke. Depending on the dose of steroid administered, patients were divided into high-dose (n = 14) and low-dose steroid groups (n = 20). We compared the severity scores, Kozin's classification scores, and RUR observed from TPBS between the two groups. There were significant changes in the severity scores and Kozin's classification between the baseline and 2 weeks from baseline (p < 0.05), however, there were no significant differences in terms of changes in the scores, classification, or the RUR observed from TPBS at 2 weeks from baseline (p > 0.05). There were no treatment-emergent adverse events (TEAEs) such as blood pressure elevation, impaired glycemic control, or gastrointestinal disturbances. Our results indicate that the efficacy profile of a low-dose oral steroid regimen is comparable to that of a high-dose regimen in alleviating symptoms in CRPS I patients. However, additional prospective, large-scale, multi-center studies are warranted to confirm our results.
Long-term functional outcome measures in corticosteroid-treated complex regional pain syndrome. [2009]The aim of this paper was to assess the effects of low-dose systemic corticosteroid therapy in complex regional pain syndrome (CRPS), to measure the long-term functional outcome, and to evaluate an arbitrary scale of severity of CRPS.
The reflex dystrophy syndrome response to treatment with systemic corticosteroids. [2013]Twenty-three patients with reflex dystrophy syndrome were randomly allocated to medication with oral prednisone, 10 mg thrice daily, or placebo, previous reports having indicated effect of systemic corticosteroids. The medication was continued until clinical remission, maximally 12 weeks. The diagnosis was based on fulfillment of at least four of seven criteria which included clinical, radiological and circulatory changes. All 13 patients in the prednisone-treated group showed more than 75% clinical improvement within the twelve-week period. Of the ten patients who received placebo, only two reported improvement. Prednisone appears to be superior to other treatment in reflex dystrophy syndrome, although the mode of action is not known.
Long-term Prednisolone in Post-stroke Complex Regional Pain Syndrome. [2018]There is no study on the long-term use of prednisolone in post-stroke complex regional pain syndrome-1 (CRPS1).