BACKGROUND: There is no study on the long-term use of prednisolone in post-stroke complex regional pain syndrome-1 (CRPS1). OBJECTIVE: To evaluate the efficacy and safety of long-term low dose prednisolone in post-stroke CRPS-I. STUDY DESIGN: Open-labeled randomized controlled trial. SETTING: Tertiary care teaching institute. METHODS:Seventy-seven out of396 (19.4%) patients with stroke had CRPS-1 and 58 met the inclusion criteria. Their clinical details and CRPS, Visual Analogue Scale (VAS), modified Rankin Scale (mRS), andBarthel Index (BI) scores were noted. The patients were prescribed 40 mg prednisolone for 2 weeks followed by tapering in the next 2 weeks. Patients who responded were randomly assigned prednisolone 10 mg daily (group I) or no prednisolone (group II). They were followed up for the first and second month of randomization and their CRPS, VAS, mRS, and BI scores were noted. The primary outcome was improvement in CRPS score and secondary outcomes were VAS, mRS, BI scores, and severe adverse events (SAE). RESULTS:Fifty-six of fifty-eight (96.5%) patients responded to the initial high dose prednisolone and 26 each were assigned group I and group II treatment. Group I patients had further improvement in CRPS score. Fifty percent of patients in group II had deterioration at one month and needed reinstitution of prednisolone; following which 77% of them improved in the next month. The improvement in CRPS score paralleled the VAS score but not mRS and BI scores in the first and second months in group I compared to group II. There was no SAE necessitating withdrawal of prednisolone. LIMITATION: The design of the study is not double blind. CONCLUSION: In post-stroke CRPS-I, continuation of low dose prednisolone for 2 months is safe and effective.Key words: Shoulder hand syndrome, CRPS, corticosteroid, prednisolone, stroke, Visual Analogue Scale.
RCT Entities:
BACKGROUND: There is no study on the long-term use of prednisolone in post-stroke complex regional pain syndrome-1 (CRPS1). OBJECTIVE: To evaluate the efficacy and safety of long-term low dose prednisolone in post-stroke CRPS-I. STUDY DESIGN: Open-labeled randomized controlled trial. SETTING: Tertiary care teaching institute. METHODS: Seventy-seven out of 396 (19.4%) patients with stroke had CRPS-1 and 58 met the inclusion criteria. Their clinical details and CRPS, Visual Analogue Scale (VAS), modified Rankin Scale (mRS), and Barthel Index (BI) scores were noted. The patients were prescribed 40 mg prednisolone for 2 weeks followed by tapering in the next 2 weeks. Patients who responded were randomly assigned prednisolone 10 mg daily (group I) or no prednisolone (group II). They were followed up for the first and second month of randomization and their CRPS, VAS, mRS, and BI scores were noted. The primary outcome was improvement in CRPS score and secondary outcomes were VAS, mRS, BI scores, and severe adverse events (SAE). RESULTS: Fifty-six of fifty-eight (96.5%) patients responded to the initial high dose prednisolone and 26 each were assigned group I and group II treatment. Group I patients had further improvement in CRPS score. Fifty percent of patients in group II had deterioration at one month and needed reinstitution of prednisolone; following which 77% of them improved in the next month. The improvement in CRPS score paralleled the VAS score but not mRS and BI scores in the first and second months in group I compared to group II. There was no SAE necessitating withdrawal of prednisolone. LIMITATION: The design of the study is not double blind. CONCLUSION: In post-stroke CRPS-I, continuation of low dose prednisolone for 2 months is safe and effective.Key words: Shoulder hand syndrome, CRPS, corticosteroid, prednisolone, stroke, Visual Analogue Scale.
Authors: Zheng Bo; Yang Jian; Li Yan; Gu Gangfeng; Luo Xiaojing; Luo Xiaolan; Chen Zhao; Huang Ke; Fan Yang; Li Maoxia; Wang Jian Journal: Oxid Med Cell Longev Date: 2022-08-18 Impact factor: 7.310