Complex Regional Pain Syndrome Type I (CRPS-I), Distal Radius Fracture
Conditions
Keywords
Complex Regional Pain Syndrome Type I, Distal Radius Fracture, CRPS-I, ESWT, Physical Rehabilitation, Pain, Upper Extremity Function
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.
Detailed description
This prospective, randomized, assessor-blinded, sham-controlled, two-arm clinical trial is designed to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in patients with complex regional pain syndrome type I (CRPS-I) following distal radius fracture. Sixty adults aged 18 to 75 years who meet the clinical diagnostic criteria for CRPS-I following distal radius fracture will be enrolled and randomized in a 1:1 ratio to an active ESWT group or a sham ESWT group. Both groups 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. Participants in the active ESWT group will receive standard rehabilitation plus active ESWT once weekly for a total of five sessions. ESWT will be applied to the affected distal forearm, wrist, and painful soft-tissue areas. Participants in the sham group will undergo the same treatment schedule and procedure using the same device, but without therapeutic energy delivery. Clinical assessments will be performed by an assessor who is unaware of treatment allocation. Evaluations will be conducted at baseline, at the end of treatment at week 5, and at the follow-up visit at week 12. The primary outcome will be change in pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes will include upper extremity function assessed using the QuickDASH, wrist range of motion, hand grip strength, and edema assessed by circumferential measurement. Adverse events, treatment tolerability, and any additional treatment requirements during follow-up will be recorded. The study aims to determine whether adding ESWT to standard rehabilitation provides greater improvement in pain and functional outcomes than standard rehabilitation with sham ESWT.
Interventions
DEVICEActive 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
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.
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.
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.
Sponsors
Dilek ün oguzhanasilturk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will remain unaware of participants' treatment allocation throughout the study.
Intervention model description
Participants will be randomized in a 1:1 ratio to two parallel groups: standard rehabilitation plus active ESWT or standard rehabilitation plus sham ESWT.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline, Week 5, and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Function Measured by QuickDASH | : Baseline, Week 5, and Week 12 | Upper extremity function will be assessed using the QuickDASH questionnaire. Changes over time will be compared between the active ESWT and sham ESWT groups. |
| Change in Wrist Range of Motion | Baseline, Week 5, and Week 12 | Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer. |
| Change in Hand Grip Strength | Baseline, Week 5, and Week 12 | Hand grip strength will be measured using a hand dynamometer and recorded in kilograms. |
| Change in Edema of the Affected Upper Extremity | Baseline, Week 5, and Week 12 | Edema will be assessed using circumferential measurement of the affected extremity |
Countries
Turkey (Türkiye)
Contacts
CONTACTDilek Ün Oğuzhanasiltürk, MD
Outcome results
None listed