ESWT for CRPS-I After Distal Radius Fracture

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorDilek ün oguzhanasilturk

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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 Program
Other 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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Standard Rehabilitation + Active ESWTExperimental treatment 2 interventions

Group B: Standard Rehabilitation + Sham ESWTSham comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline, Week 5, and Week 12

Secondary outcomes

Change in Upper Extremity Function Measured by QuickDASH

Upper extremity function will be assessed using the QuickDASH questionnaire. Changes over time will be compared between the active ESWT and sham ESWT groups.

Time frame

: Baseline, Week 5, and Week 12

Change in Wrist Range of Motion

Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer.

Time frame

Baseline, Week 5, and Week 12

Change in Hand Grip Strength

Hand grip strength will be measured using a hand dynamometer and recorded in kilograms.

Time frame

Baseline, Week 5, and Week 12

Change in Edema of the Affected Upper Extremity

Edema will be assessed using circumferential measurement of the affected extremity

Time frame

Baseline, Week 5, and Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dilek ün oguzhanasilturk

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Sponsor institution

Source ClinicalTrials.gov

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