Effectiveness of DT vs GMIT on Wrist Pain and Function in Patients With Reflex Sympathetic Dystrophy

NCT ID: NCT07037069

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-09-30

Brief Summary

This study evaluated the effectiveness of two therapeutic approaches-Desensitization Training (DT) and Graded Motor Imagery (GMI)-in reducing wrist pain and improving function in patients with Reflex Sympathetic Dystrophy (RSD). The sample size was calculated using Epitools for one-way ANOVA comparison with two independent groups. A total of 40 participants were randomly assigned into two groups: the DT group and the GMI group, each consisting of 20 patients. The DT group underwent sessions involving progressive tactile stimulation using different textures and temperatures to reduce hypersensitivity and allodynia.

Detailed Description

In contrast, the GMI group followed a structured three-phase cognitive rehabilitation protocol including laterality recognition, explicit motor imagery, and mirror therapy, aimed at re-training cortical representation and reducing pain perception. Both groups received same number of sessions. Visual Analogue Scale (VAS), Patient Rated Wrist Evaluation (PRWE) & Specific Questionnaire for two groups is used to for pain and functional assessment involving wrist

Conditions

Sympathetic; Dystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Desensitization Training Group

Group Type: EXPERIMENTAL

Desensitization Training

Intervention Type: COMBINATION_PRODUCT

Participants in this group received desensitization training aimed at reducing hypersensitivity and pain perception through progressive exposure to different tactile stimuli. Use of soft and coarse textures (cotton, wool, Velcro, brush). Rubbing, tapping, rolling over the affected wrist and hand.

Graded Motor Imagery (GMI)

Group Type: EXPERIMENTAL

Graded Motor Imagery (GMI)

Intervention Type: COMBINATION_PRODUCT

Training Sample Size: 20 participants Participants underwent a progressive 3-phase motor training program designed to target cortical reorganization and improve movement without provoking pain. Phases: Laterality Recognition - identifying left/right hand images (Recognise™ app or cards). Explicit Motor Imagery - visualizing wrist movements without actual motion. Mirror Therapy - using a mirror box to simulate movement of the affected wrist. Sessions: 30-45 minutes/day, 5 times/week, for 4 weeks.

Interventions

Desensitization Training

Participants in this group received desensitization training aimed at reducing hypersensitivity and pain perception through progressive exposure to different tactile stimuli. Use of soft and coarse textures (cotton, wool, Velcro, brush). Rubbing, tapping, rolling over the affected wrist and hand.

Intervention Type: COMBINATION_PRODUCT

Graded Motor Imagery (GMI)

Training Sample Size: 20 participants Participants underwent a progressive 3-phase motor training program designed to target cortical reorganization and improve movement without provoking pain. Phases: Laterality Recognition - identifying left/right hand images (Recognise™ app or cards). Explicit Motor Imagery - visualizing wrist movements without actual motion. Mirror Therapy - using a mirror box to simulate movement of the affected wrist. Sessions: 30-45 minutes/day, 5 times/week, for 4 weeks.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Participants aged 18 to 65 years.
• Participants must have a confirmed diagnosis of Reflex Sympathetic Dystrophy (CRPS) Type I, affecting the wrist, according to the Budapest Criteria.
• Participants must experience chronic wrist pain for at least 3 months but not more than 24 months.
• Participants must be able to offer written informed consent and participate in the study willingly.
• Participants must demonstrate sufficient cognitive function to understand the training protocols (assessed via screening tools such as the Mini-Mental State Examination).

Exclusion Criteria

• Participants who have undergone any surgical intervention for the wrist (other than the injury that led to RSD), or those with traumatic injuries that cause structural damage will be excluded.
• Participants with significant neurological disorders affecting the upper limb.
• Individuals with active psychiatric conditions, such as severe depression, anxiety, or psychosis which may impair participation in the study.
• Participants with poorly controlled medical conditions such as diabetes, cardiovascular disease, or autoimmune disorders that could interfere with treatment outcomes or the ability to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hameed Latif Hospital Lahore

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

DPT/Batch-Fall20/1004

Identifier Type: -

Identifier Source: org_study_id