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

NCT07037069 | Active Not Recruiting DMC

• 1 other identifier: DPT/Batch-Fall20/1004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sympathetic; Dystrophy

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  A Visual Analogue Scale (VAS) is a measurement tool used to assess subjective characteristics, like pain intensity. It typically involves a 10 cm line with endpoints labeled "no pain" and "worst pain imaginable". The patient marks a point on the line that represents their pain level, and the score is determined by measuring the distance in millimeters (0-100) from the "no pain" end. VAS scores are commonly categorized as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

  6 Month

• Patient-Rated Wrist Evaluation (PRWE)

  The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to assess pain and functional disability in individuals with wrist problems. It consists of two modules: a pain module with 5 items and a function module with 10 items, each scored on a scale of 0 to 10. The PRWE provides a way for patients to self-report their experiences with wrist pain and its impact on their daily activities

  6 Months

Study Arms (2)

Desensitization Training Group

EXPERIMENTAL

Combination Product: Desensitization Training

Graded Motor Imagery (GMI)

EXPERIMENTAL

Combination Product: Graded Motor Imagery (GMI)

Interventions

Desensitization Training 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.

Desensitization Training Group

Graded Motor Imagery (GMI) 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.

Graded Motor Imagery (GMI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Hameed Latif Hospital Lahore

Lahore, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: March 4, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)