ESWT for CRPS-I After Distal Radius Fracture

NCT07807852 | Recruiting

• 1 other identifier: KSS-CRPS-ESWT-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Complex regional pain syndrome type I (CRPS-I) can develop after a distal radius fracture and may cause persistent pain, swelling, limited wrist and hand movement, and difficulty using the affected upper limb. This study will evaluate whether extracorporeal shock wave therapy (ESWT), when added to a standard rehabilitation program, improves symptoms and function in adults with CRPS-I following distal radius fracture. A total of 60 participants will be randomly assigned to one of two groups. Both groups will receive a standard rehabilitation program. One group will also receive active ESWT, while the other group will receive sham ESWT using the same treatment procedure without therapeutic energy delivery. ESWT or sham ESWT will be administered once weekly for five weeks. Participants will be evaluated before treatment, at the end of the 5-week treatment period, and at the 12-week follow-up. The main outcome will be change in pain intensity. Other outcomes will include upper extremity function, wrist range of motion, hand grip strength, and swelling. Adverse events and treatment tolerability will also be recorded.

Conditions

Complex Regional Pain Syndrome Type I (CRPS-I); Distal Radius Fracture

Keywords

Complex Regional Pain Syndrome Type I; Distal Radius Fracture; CRPS-I; ESWT; Physical Rehabilitation; Pain; Upper Extremity Function

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measured by Visual Analog Scale (VAS)

  Pain intensity will be assessed using a 0-10 cm Visual Analog Scale (VAS). Change in VAS score over time will be compared between the active ESWT and sham ESWT groups.

  Baseline, Week 5, and Week 12

Secondary Outcomes (4)

• Change in Upper Extremity Function Measured by QuickDASH

  : Baseline, Week 5, and Week 12

• Change in Wrist Range of Motion

  Baseline, Week 5, and Week 12

• Change in Hand Grip Strength

  Baseline, Week 5, and Week 12

• Change in Edema of the Affected Upper Extremity

  Baseline, Week 5, and Week 12

Study Arms (2)

Standard Rehabilitation + Active ESWT

EXPERIMENTAL

Participants will receive a standard rehabilitation program consisting of range-of-motion exercises, stretching exercises, desensitization techniques, edema-control approaches, functional hand exercises, and a home exercise program. In addition, active extracorporeal shock wave therapy (ESWT) will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas.

Device: Active ESWT will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas.Associated Arm: Standard Rehabilitation + Active ESWT; Other: Standard Rehabilitation Program

Standard Rehabilitation + Sham ESWT

SHAM COMPARATOR

Participants will receive the same standard rehabilitation program as the active ESWT group. In addition, sham extracorporeal shock wave therapy (ESWT) will be applied once weekly for a total of five sessions using the same device, treatment duration, and application procedure as the active ESWT group, but without therapeutic energy delivery.

Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT); Other: Standard Rehabilitation Program

Interventions

Sham Extracorporeal Shock Wave Therapy (Sham ESWT) DEVICE

Sham ESWT will be administered once weekly for a total of five sessions using the same device, treatment duration, application procedure, and session schedule as active ESWT. However, no therapeutic energy will be delivered during the sham intervention.

Standard Rehabilitation + Sham ESWT

Standard Rehabilitation Program OTHER

The standard rehabilitation program will include range-of-motion exercises, stretching exercises, desensitization techniques, edema-control approaches, functional hand exercises, and a home exercise program.

Standard Rehabilitation + Active ESWT; Standard Rehabilitation + Sham ESWT

Active ESWT will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas.Associated Arm: Standard Rehabilitation + Active ESWT DEVICE

Active ESWT will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas. Treatment will be delivered at a low-to-moderate energy level according to device safety recommendations and patient tolerance. Unlike sham ESWT, therapeutic energy will be delivered.

Standard Rehabilitation + Active ESWT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ge between 18 and 75 years Diagnosis of Complex Regional Pain Syndrome Type I (CRPS-I), stage 1-2, following distal radius fracture Meeting the Budapest clinical diagnostic criteria for CRPS-I Symptom duration between 1 and 6 months Visual Analog Scale (VAS) pain score ≥4 Ability to participate in study assessments, with or without an assistive device Adequate cognitive capacity to understand the study procedures Willingness to participate in the study and provide written informed consent

You may not qualify if:

• Diagnosis of Complex Regional Pain Syndrome Type II (CRPS-II) Concomitant peripheral nerve injury in the upper extremity Active infection, malignancy, or open wound Severe skin lesion or impaired skin integrity in the treatment area Bleeding diathesis or severe coagulation disorder Anticoagulant treatment that constitutes a contraindication to ESWT Pregnancy or breastfeeding ESWT applied to the relevant region within the previous 3 months Inability to comply with assessments or study procedures due to severe psychiatric disease or cognitive impairment Inability to attend the study regularly Any condition considered by the investigator to make participation inappropriate

Sponsors & Collaborators

• Dilek ün oguzhanasilturk: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Istanbul, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Wrist Fractures; Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dilek Ün Oğuzhanasiltürk, MD

CONTACT

+90 5056367184; dilekunoguzhan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will remain unaware of participants' treatment allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Model Details: Participants will be randomized in a 1:1 ratio to two parallel groups: standard rehabilitation plus active ESWT or standard rehabilitation plus sham ESWT.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): September 26, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)