Sympathetic; DystrophyNCT07037069
Effectiveness of DT vs GMIT on Wrist Pain and Function in Patients With Reflex Sympathetic Dystrophy
A study testing Desensitization Training and Graded Motor Imagery (GMI) in people with Sympathetic; Dystrophy, run by Superior University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sympathetic; Dystrophy
- What is being tested?
- Desensitization Training and Graded Motor Imagery (GMI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Desensitization Training vs Graded Motor Imagery Training on Wrist Pain and Function in Patients With Reflex Sympathetic Dystrophy
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.
Read the 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
- Being tested
- Desensitization Training, Graded Motor Imagery (GMI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desensitization TrainingCombination 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)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.
| Study group | Role | What they receive |
|---|---|---|
| Desensitization Training Group | Experimental | Not described Receives: Combination Product: Desensitization Training |
| Graded Motor Imagery (GMI) | Experimental | Not described Receives: Combination Product: Graded Motor Imagery (GMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sympathetic; DystrophyStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037069
- Sponsor's protocol ID
- DPT/Batch-Fall20/1004
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Desensitization Training vs Graded Motor Imagery Training on Wrist Pain and Function in Patients With Reflex Sympathetic Dystrophy
- ClinicalTrials.gov ID
- NCT07037069
- Acronym / sponsor ID
- DPT/Batch-Fall20/1004
- Conditions
- Sympathetic; Dystrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desensitization Training Group | Experimental | Combination Product: Desensitization Training |
| Graded Motor Imagery (GMI) | Experimental | Combination Product: Graded Motor Imagery (GMI) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desensitization TrainingParticipants 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. | Combination product | Desensitization Training Group |
| 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. | Combination product | Graded Motor Imagery (GMI) |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 6 Month
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).
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 6 Months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desensitization Training and Graded Motor Imagery (GMI) in people with Sympathetic; Dystrophy, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 6 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.