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

Phase 3
Conditions
Health Condition 1: G894- Chronic pain syndrome
Registration Number
CTRI/2024/02/063009
Lead Sponsor
Professor Jayantee Kalita
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

Patients with uncontrolled hypertension, diabetes, infection, organ

failure, malignancy, shoulder joint dislocation or infection, pregnancy and unwilling for consent will be excluded

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction in VAS score = 50%Timepoint: One Month
Secondary Outcome Measures
NameTimeMethod
CRPS total score, and its different domains, HADS score, DISS score and side effects.Timepoint: One month
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