Health Condition 1: - Health Condition 2: G63- Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
University College of Medical Sciences