Efficacy of an integrated approach utilizing pregabalin and mirror therapy in management of Complex Regional Pain syndrome type 1
- Conditions
- Health Condition 1: - Health Condition 2: G63- Polyneuropathy in diseases classified elsewhere
- Registration Number
- CTRI/2019/01/017272
- Lead Sponsor
- niversity College of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Patients having chronic continuous pain, which is disproportionate to any inciting event with diagnosis of CRPS type 1, as confirmed by-
Budapest criteria of CRPS for clinical use (IASP 2016)
Must report at least one symptom in three of the four following categories:
•Sensory: reports of hyperesthesia and/or allodynia
•Vasomotor: reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry.
•Sudomotor: reports of edema and/or sweating changes and/or sweating asymmetry.
•Motor/trophic: reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nails, skin).
Must display at least one sign at the time of evaluation in two or more of the following four categories:
•Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure, allodynia to innocuous cold (25 â?¦C) or innocuous warm (40 â?¦C), and/or joint movement).
•Vasomotor: evidence of temperature asymmetry and/or skin color changes and/or skin color asymmetry.
•Sudomotor/edema: evidence of edema and/or sweating changes and/or sweating asymmetry.
•Motor/trophic: evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nails, skin).
The presence of pain at any other site due to any other cause.
An intra-articular injection into the joints during the previous 6 months or use of systemic corticosteroids during the previous 4 months;
Uncontrolled co-morbid medical conditions;
Cognitive impairments that might interfere with understanding instructions for various questionnaires, motor testing, and treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving NRS- Pain score of â?¤3/10 at various designated intervals of time and neuropathic component of pain using NPSI scores.Timepoint: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.
- Secondary Outcome Measures
Name Time Method Degrees of resolution of oedema, and motor/trophic changes in affected limbTimepoint: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.;Modulation of mRNA gene expression of mTORC1 and IL-6 genesTimepoint: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.;NRS-sleep scoreTimepoint: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.;SF-12 questionnaire scoresTimepoint: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week.