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Efficacy and safety of Prednisolone 20 mg vs Placebo in Diabetic patients with Frozen Shoulder

Comparison of efficacy and safety of Prednisolone 20 mg vs Placebo in Diabetic patients with Complex Regional Pain Syndrome of upper extremity - PPDCRPS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063009
Enrollment
40
Registered
2024-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G894- Chronic pain syndrome

Interventions

Intervention1: Prednisolone: Prednisolone 20 mg for 2 weeks, then 15 mg for 5 days followed by 10 mg for 5 days followed by 5 mg for 5 days then stopped. Frequency- Once Daily Total Duration- 1 month

Sponsors

Professor Jayantee Kalita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A) Continuous pain which is disproportionate to any inciting factor. B) At least one symptom in three of the four following domains. 1) Sensory: hyperesthesia with or without allodynia. 2) Vasomotor: Asymmetry in temperature or skin color, skin color changes of the affected limb. 3) Sudomotor/edema: Presence of edema, sweating changes or sweating asymmetry. 4) Motor/ trophic: Reduced range of motion or motor dysfunction with or without trophic changes of the limb. C). At least one sign in = 2 of the following domains. 1) Sensory: Hyperalgesia (to pin prick) with or without allodynia (light touch, deep somatic presence or joint movements). 2) Vasomotor: Evidence of temperature or skin color asymmetry, or skin color changes. 3) Sudomotor/edema: edema, sweating changes or sweating asymmetry. 4) Motor or trophic: Evidence of deduced range of movement, motor dysfunction (weakness, dystonia or tremor) and or trophic changes in nail, skin or hair. 5) No other diagnosis could explain the symptoms or signs

Exclusion criteria

Exclusion criteria: Patients with uncontrolled hypertension, diabetes, infection, organ failure, malignancy, shoulder joint dislocation or infection, pregnancy and unwilling for consent will be excluded

Design outcomes

Primary

MeasureTime frame
Reduction in VAS score = 50%Timepoint: One Month

Secondary

MeasureTime frame
CRPS total score, and its different domains, HADS score, DISS score and side effects.Timepoint: One month

Countries

India

Contacts

Public ContactDr Jayantee Kalita

Department of Neurology

jayanteek@yahoo.com9450411673

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026