Complex Regional Pain Syndrome Type I (CRPS-I)CRPS-ESWTNCT07807852
ESWT for CRPS-I After Distal Radius Fracture
A study testing 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 and Standard Rehabilitation Program in people with Complex Regional Pain Syndrome Type I (CRPS-I) and Distal Radius Fracture, run by Dilek ün oguzhanasilturk at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I (CRPS-I), Distal Radius Fracture
- What is being tested?
- 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 and Standard Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2026to 26 Sep 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
Istanbul, Istanbul, 34303
Dilek Ün Oğuzhanasiltürk, MD, +905056367184, dilekunoguzhan@gmail.com
Dilek Ün Oğuzhanasiltürk, MD
About this study
Official title: EXTRACORPOREAL SHOCKWAVE THERAPY FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I FOLLOWING DISTAL RADIUS FRACTURE: A PROSPECTIVE RANDOMIZED SHAM-CONTROLLED 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.
Read the 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.
- Being tested
- 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, Sham Extracorporeal Shock Wave Therapy (Sham ESWT), Standard Rehabilitation Program
- Keywords
- Complex Regional Pain Syndrome Type I, Distal Radius Fracture, CRPS-I, ESWT, Physical Rehabilitation, Pain, Upper Extremity Function
- Medical subject headings
- Complex Regional Pain Syndromes, Wrist Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ESWTDevice
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT); Other: Standard Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 5, and Week 12
Secondary outcomes (4)
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.
Measured: : 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.
Measured: 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.
Measured: 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
Measured: Baseline, Week 5, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start26 Jun 2026
- Primary completion26 Jun 2027 (estimated)
- Study completion26 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type I (CRPS-I)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilek ün oguzhanasilturk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807852
- Sponsor's protocol ID
- KSS-CRPS-ESWT-2026
- Acronym
- CRPS-ESWT
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXTRACORPOREAL SHOCKWAVE THERAPY FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I FOLLOWING DISTAL RADIUS FRACTURE: A PROSPECTIVE RANDOMIZED SHAM-CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07807852
- Acronym / sponsor ID
- CRPS-ESWT / KSS-CRPS-ESWT-2026
- Keywords
- Complex Regional Pain Syndrome Type I, Distal Radius Fracture, CRPS-I, ESWT, Physical Rehabilitation, Pain, Upper Extremity Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dilek ün oguzhanasilturkUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 26 Sep 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation + Active ESWT | Experimental | 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 ProgramParticipants 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. |
| Standard Rehabilitation + Sham ESWT | Sham comparator | Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT), Other: Standard Rehabilitation ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
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 |
|---|---|---|
| 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 ESWTActive 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. | Device | Standard Rehabilitation + Active ESWT |
| Sham Extracorporeal Shock Wave Therapy (Sham ESWT)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. | Device | Standard Rehabilitation + Sham ESWT |
| Standard Rehabilitation ProgramThe standard rehabilitation program will include range-of-motion exercises, stretching exercises, desensitization techniques, edema-control approaches, functional hand exercises, and a home exercise program. | Other | Standard Rehabilitation + Active ESWT, Standard Rehabilitation + Sham ESWT |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 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.
4 secondary outcomes
Change in Upper Extremity Function Measured by QuickDASH
Time frame: : Baseline, Week 5, and Week 12
Change in Wrist Range of Motion
Time frame: Baseline, Week 5, and Week 12
Change in Hand Grip Strength
Time frame: Baseline, Week 5, and Week 12
Change in Edema of the Affected Upper Extremity
Time frame: Baseline, Week 5, and Week 12
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 8 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Standard Rehabilitation Program in people with Complex Regional Pain Syndrome Type I (CRPS-I) and Distal Radius Fracture, run by Dilek ün oguzhanasilturk at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Contact Dilek Ün Oğuzhanasiltürk, MD (+90 5056367184, dilekunoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline, Week 5, and Week 12). 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 8 Sep 2026.