Skip to content

Efficacy of an integrated approach utilizing pregabalin and mirror therapy in management of Complex Regional Pain syndrome type 1

Efficacy of an integrated approach encompassing pregabalin and mirror therapy in management of complex regional pain syndrome type 1- A pilot study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017272
Enrollment
40
Registered
2019-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: - Health Condition 2: G63- Polyneuropathy in diseases classified elsewhere

Interventions

Intervention1: Group M: Patients will receive Cap pregabalin 75 mg BD, scrub descrub therapy for CRPS and mirror therapy for 12 weeks Control Intervention1: Group C: Patients will receive Cap pregabal

Sponsors

University College of Medical Sciences
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Geetanjali T Chilkoti

University College of Medical Sciences

anishmalik14@yahoo.com7015430346

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026