ClinicalTrials.gg
RecruitingNCT07807852CRPS-ESWTUpdated Sep 8, 2026

ESWT for CRPS-I After Distal Radius Fracture

An interventional study of 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 Sham Extracorporeal Shock Wave Therapy (Sham ESWT) in Complex Regional Pain Syndrome Type I (CRPS-I) and Distal Radius Fracture, sponsored by Dilek ün oguzhanasilturk. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Dilek ün oguzhanasilturk · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Complex Regional Pain Syndromes with a site in Turkey — 7 open to participants now, 7 under way, none of them phase 3. Complex Regional Pain Syndromes · Turkey.

Planned enrollment
2nd of 10
60 · median 48
Started
2026
with 2 others
No phase
10 of 14
6 open now
Registered
13th of 14
by date
Lead sponsor
1 of 14
Dilek ün oguzhanasilturk

Among the 14 studies in Complex Regional Pain Syndromes with a site in Turkey, this one is the 2nd largest by planned enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2026, is one of 10 with no phase, and was the 13th registered.

Complex Regional Pain Syndromes

206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.

Browse Complex Regional Pain Syndromes studies →

Open to participants now

7 of the 14 studies in Complex Regional Pain Syndromes with a site in Turkey are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Complex Regional Pain Syndromes with a site in Turkey, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

Diagnosis of Complex Regional Pain Syndrome Type II (CRPS-II) Concomitant peripheral nerve injury in the upper extremity Active infection, , 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 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

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Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Standard Rehabilitation + Active ESWT

    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

  • Sham comparator
    Standard Rehabilitation + Sham ESWT

    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

  • 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.

  • DeviceSham 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.

  • OtherStandard Rehabilitation Program

    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.

06

What researchers measure

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.

    Time frame: Baseline, Week 5, and Week 12

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
  • Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
    Istanbul, Istanbul 34303, Turkey (Türkiye)
    Recruiting
    • Dilek Ün Oğuzhanasiltürk, MD · Contactdilekunoguzhan@gmail.com · +905056367184
    • Dilek Ün Oğuzhanasiltürk, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 12 months is below that.

Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartActual
Jun 26, 2026
Primary completionEst.
Jun 26, 2027
CompletionEst.
Sep 26, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07807852
Lead sponsor
Dilek ün oguzhanasilturk
Responsible party
Dilek ün oguzhanasilturk (Physical Medicine and Rehabilitation Specialist, Kanuni Sultan Suleyman Training and Research Hospital) — Sponsor-investigator
First posted
Sep 8, 2026
Start date
Jun 26, 2026
Primary completion
Jun 26, 2027 (estimated)
Completion
Sep 26, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Dilek Ün Oğuzhanasiltürk, MD
Contact
dilekunoguzhan@gmail.com
+90 5056367184

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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