Complex Regional Pain Syndrome I of Upper LimbCRPSNCT07570199
THE EFFECTS OF FUNCTIONAL ELECTRICAL STIMULATION-ASSISTED BICYCLE ERGOMETRY IN PATIENTS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME.(CRPS)
An observational study of Complex Regional Pain Syndrome I of Upper Limb and Pain, run by Zeynep Nur Köseoğlu at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical study is to evaluate the effectiveness of functional electrical stimulation (FES)-assisted cycling in patients with post-stroke Complex Regional Pain Syndrome (CRPS) Type 1. It also aims to assess its effects on pain, edema, functional status, and quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complex Regional Pain Syndrome I of Upper Limb, Pain
- What is being tested?
- Functional Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Feb 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 44 patients who developed Complex Regional Pain Syndrome (CRPS) Type 1 in the upper extremity following a cerebrovascular event, diagnosed according to the Modified Budapest Criteria, and who were admitted to an inpatient physical therapy and rehabilitation program at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital were included in the study. All participants met the inclusion criteria and provided consent to participate.
Who may be able to join
- History of ischemic or hemorrhagic stroke Patients who experienced their first stroke within the last 1 year Diagnosis of upper extremity CRPS Type 1 according to the Modified Budapest Criteria No cognitive impairment (Mini-Mental State Examination score ≥ 23) Provision of written informed consent by the patient or their legal guardian
Who cannot join
- Unstable medical condition Presence of visual impairment Presence of shoulder subluxation or contracture in the upper extremity and hand joints History of upper extremity injections within the last 6 months (e.g., suprascapular nerve block, intra-articular shoulder injections, hand/wrist intra-articular or peri-tendinous injections) History of systemic steroid use within the last 6 months Use of neuropathic pain medications within the last 6 months, including tricyclic antidepressants and gabapentinoids such as gabapentin or pregabalin Presence of neglect syndrome Presence of another etiology causing upper extremity pain Presence of another neurological disorder (e.g., progressive central nervous system disease, peripheral neuropathy) Presence of concomitant rheumatologic or orthopedic conditions in the upper extremity or hand (e.g., inflammatory arthritis, cellulitis, osteomyelitis) Presence of active deep vein thrombosis or thrombophlebitis in the upper extremity Conditions characterized by pain, swelling, and edema of the extremity, such as chronic vascular disorders Presence of malignancy History of epilepsy Presence of aphasia Pregnancy or suspicion of pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: THE EFFECTS OF FUNCTIONAL ELECTRICAL STIMULATION-ASSISTED BICYCLE ERGOMETER TRAINING ON PAIN, FUNCTIONAL OUTCOMES, AND QUALITY OF LIFE IN PATIENTS WITH POST-STROKE UPPER EXTREMITY COMPLEX REGIONAL PAIN SYNDROME.
The goal of this clinical study is to evaluate the effectiveness of functional electrical stimulation (FES)-assisted cycling in patients with post-stroke Complex Regional Pain Syndrome (CRPS) Type 1. It also aims to assess its effects on pain, edema, functional status, and quality of life. The main questions it aims to answer are:
Does FES-assisted cycling reduce pain levels in patients with CRPS Type 1 after stroke? Does FES-assisted cycling improve functional independence and motor recovery? Does FES-assisted cycling contribute to reductions in edema and improvements in quality of life?
Read more
Researchers will compare FES-assisted cycling in addition to conventional rehabilitation with conventional rehabilitation alone to determine whether FES provides additional therapeutic benefits.
Participants will:
Receive conventional rehabilitation treatment consisting of exercises, TENS, contrast bath, and whirlpool therapy Receive FES-assisted cycling (intervention group) or only conventional rehabilitation (control group) for a total of 20 sessions Be evaluated at baseline, at the end of treatment (4th week), and at the 12th week using clinical scales and outcome measures
Read the detailed description
A total of 44 patients who developed Complex Regional Pain Syndrome (CRPS) Type 1 in the upper extremity following a cerebrovascular event, diagnosed according to the Modified Budapest Criteria, and who were admitted to an inpatient physical therapy and rehabilitation program were included in the study. All participants met the inclusion criteria and provided written informed consent after being fully informed about the study procedures and treatment protocol. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.
Demographic data including age, sex, height, weight, educational level, occupation, marital status, and comorbid systemic diseases were recorded for all participants. Patients with a Mini-Mental State Examination score of 23 or higher were included in the study. All participants were evaluated at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week.
Clinical assessments included evaluation of pain, edema, spasticity, range of motion, motor function, activities of daily living, and quality of life of the upper extremity. The following outcome measures were used:
Visual Analog Scale (VAS) Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Volumetric Measurement Modified Ashworth Scale (MAS) Range of Motion (ROM) Measurement Brunnstrom Motor Staging CRPS Severity Score (CSS) Functional Independence Measure (FIM) Stroke Impact Scale (SIS)
Eligible patients were randomized into two groups using the sealed envelope method. Both groups received a conventional neurorehabilitation program consisting of whirlpool therapy, transcutaneous electrical nerve stimulation (TENS), contrast bath, and therapeutic exercises.
In addition to conventional therapy, patients in the intervention group received upper extremity functional electrical stimulation (FES)-assisted cycling using a cycle ergometer. This intervention was applied for 30 minutes per day, 5 days per week, for a total of 4 weeks.
The groups were defined as follows:
Group 1: Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer Group 2: Exercise + TENS + whirlpool therapy + contrast bath
- Being tested
- Functional Electrical Stimulation
- Keywords
- Stroke, Complex Regional Pain Syndrome, Functional Electrical Stimulation, Rehabilitation, Pain
- Medical subject headings
- Pain, Stroke, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
Although the FES cycling ergometer is a treatment modality used in various patient groups in neurological rehabilitation, no study has been found in the literature evaluating its effectiveness in patients with upper extremity CRPS following stroke. Therefore, the aim of this study was to investigate the effects of FES cycling ergometer, added to a conventional physical therapy and rehabilitation program, on pain, edema, functional status, and quality of life in patients diagnosed with post-stroke upper extremity CRPS Type 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer Receives: Device: Functional Electrical Stimulation | |
| Group 2 | Exercise + TENS + whirlpool therapy + contrast bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
volumetric measurement
The total volume of the hand was measured using a volumetric device based on the water displacement method. The volumeter method has been used since the 1950s and is considered a highly valid and reliable measurement tool with a very low margin of error. It is accepted as the "gold standard" for assessing hand edema, particularly in cases of diffuse swelling.
The patient immersed the affected extremity into the volumeter, positioning the hand so that the web space between the third and fourth fingers rested on a plastic rod. The displaced water was collected in a beaker and subsequently measured using a graduated cylinder. Measurements were recorded in milliliters.Considering that water temperature may influence measurement results, it was maintained between 20-35 °C.
Measured: All measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week, by the same investigator, with the patient in a seated position and at the same time of day.
visual analog scala
Pain intensity was assessed subjectively using a 10-cm Visual Analog Scale (VAS) (Appendix 2). Participants were shown a horizontal line with the left end defined as "0 = no pain" and the right end as "10 = unbearable pain," and were asked to mark the point that best represented their current pain level. The distance from the starting point to the marked point was measured in millimeters and recorded, with higher scores indicating greater pain intensity.
Measured: Within the scope of the study, measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week. Pain was evaluated separately under three conditions: at rest, during movement, and at night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start15 Jul 2024
- Primary completion15 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome I of Upper LimbStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Zeynep Nur Köseoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Nur Köseoğlu, Ankara City Hospital Bilkent
- Investigators
- Güldal Funda Yüzer Nakıpoğlu, Prof. Dr., Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570199
- Sponsor's protocol ID
- TABED 1-24-352
- Acronym
- CRPS
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data privacy
Publications
Sousa ASP, Moreira J, Silva C, Mesquita I, Macedo R, Silva A, Santos R. Usability of Functional Electrical Stimulation in Upper Limb Rehabilitation in Post-Stroke Patients: A Narrative Review. Sensors (Basel). 2022 Feb 12;22(4):1409. doi: 10.3390/s22041409.
PubMed 35214311Devrimsel G, Turkyilmaz AK, Yildirim M, Beyazal MS. The effects of whirlpool bath and neuromuscular electrical stimulation on complex regional pain syndrome. J Phys Ther Sci. 2015 Jan;27(1):27-30. doi: 10.1589/jpts.27.27. Epub 2015 Jan 9.
PubMed 25642030
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF FUNCTIONAL ELECTRICAL STIMULATION-ASSISTED BICYCLE ERGOMETER TRAINING ON PAIN, FUNCTIONAL OUTCOMES, AND QUALITY OF LIFE IN PATIENTS WITH POST-STROKE UPPER EXTREMITY COMPLEX REGIONAL PAIN SYNDROME.
- ClinicalTrials.gov ID
- NCT07570199
- Acronym / sponsor ID
- CRPS / TABED 1-24-352
- Keywords
- Stroke, Complex Regional Pain Syndrome, Functional Electrical Stimulation, Rehabilitation, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zeynep Nur KöseoğluUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 6 May 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.
The goal of this clinical study is to evaluate the effectiveness of functional electrical stimulation (FES)-assisted cycling in patients with post-stroke Complex Regional Pain Syndrome (CRPS) Type 1. It also aims to assess its effects on pain, edema, functional status, and quality of life. The main questions it aims to answer are:
Does FES-assisted cycling reduce pain levels in patients with CRPS Type 1 after stroke? Does FES-assisted cycling improve functional independence and motor recovery? Does FES-assisted cycling contribute to reductions in edema and improvements in quality of life?
Researchers will compare FES-assisted cycling in addition to conventional rehabilitation with conventional rehabilitation alone to determine whether FES provides additional therapeutic benefits.
Participants will:
Receive conventional rehabilitation treatment consisting of exercises, TENS, contrast bath, and whirlpool therapy Receive FES-assisted cycling (intervention group) or only conventional rehabilitation (control group) for a total of 20 sessions Be evaluated at baseline, at the end of treatment (4th week), and at the 12th week using clinical scales and outcome measures
Detailed description
A total of 44 patients who developed Complex Regional Pain Syndrome (CRPS) Type 1 in the upper extremity following a cerebrovascular event, diagnosed according to the Modified Budapest Criteria, and who were admitted to an inpatient physical therapy and rehabilitation program were included in the study. All participants met the inclusion criteria and provided written informed consent after being fully informed about the study procedures and treatment protocol. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.
Demographic data including age, sex, height, weight, educational level, occupation, marital status, and comorbid systemic diseases were recorded for all participants. Patients with a Mini-Mental State Examination score of 23 or higher were included in the study. All participants were evaluated at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week.
Clinical assessments included evaluation of pain, edema, spasticity, range of motion, motor function, activities of daily living, and quality of life of the upper extremity. The following outcome measures were used:
Visual Analog Scale (VAS) Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Volumetric Measurement Modified Ashworth Scale (MAS) Range of Motion (ROM) Measurement Brunnstrom Motor Staging CRPS Severity Score (CSS) Functional Independence Measure (FIM) Stroke Impact Scale (SIS)
Eligible patients were randomized into two groups using the sealed envelope method. Both groups received a conventional neurorehabilitation program consisting of whirlpool therapy, transcutaneous electrical nerve stimulation (TENS), contrast bath, and therapeutic exercises.
In addition to conventional therapy, patients in the intervention group received upper extremity functional electrical stimulation (FES)-assisted cycling using a cycle ergometer. This intervention was applied for 30 minutes per day, 5 days per week, for a total of 4 weeks.
The groups were defined as follows:
Group 1: Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer Group 2: Exercise + TENS + whirlpool therapy + contrast bath
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Functional Electrical StimulationExercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer |
| Group 2 | – | –Exercise + TENS + whirlpool therapy + contrast bath |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 44 patients who developed Complex Regional Pain Syndrome (CRPS) Type 1 in the upper extremity following a cerebrovascular event, diagnosed according to the Modified Budapest Criteria, and who were admitted to an inpatient physical therapy and rehabilitation program at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital were included in the study. All participants met the inclusion criteria and provided consent to participate.
Key inclusion criteria (1 listed)
- History of ischemic or hemorrhagic stroke Patients who experienced their first stroke within the last 1 year Diagnosis of upper extremity CRPS Type 1 according to the Modified Budapest Criteria No cognitive impairment (Mini-Mental State Examination score ≥ 23) Provision of written informed consent by the patient or their legal guardian
Key exclusion criteria (1 listed)
- Unstable medical condition Presence of visual impairment Presence of shoulder subluxation or contracture in the upper extremity and hand joints History of upper extremity injections within the last 6 months (e.g., suprascapular nerve block, intra-articular shoulder injections, hand/wrist intra-articular or peri-tendinous injections) History of systemic steroid use within the last 6 months Use of neuropathic pain medications within the last 6 months, including tricyclic antidepressants and gabapentinoids such as gabapentin or pregabalin Presence of neglect syndrome Presence of another etiology causing upper extremity pain Presence of another neurological disorder (e.g., progressive central nervous system disease, peripheral neuropathy) Presence of concomitant rheumatologic or orthopedic conditions in the upper extremity or hand (e.g., inflammatory arthritis, cellulitis, osteomyelitis) Presence of active deep vein thrombosis or thrombophlebitis in the upper extremity Conditions characterized by pain, swelling, and edema of the extremity, such as chronic vascular disorders Presence of malignancy History of epilepsy Presence of aphasia Pregnancy or suspicion of pregnancy
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 |
|---|---|---|
| Functional Electrical StimulationAlthough the FES cycling ergometer is a treatment modality used in various patient groups in neurological rehabilitation, no study has been found in the literature evaluating its effectiveness in patients with upper extremity CRPS following stroke. Therefore, the aim of this study was to investigate the effects of FES cycling ergometer, added to a conventional physical therapy and rehabilitation program, on pain, edema, functional status, and quality of life in patients diagnosed with post-stroke upper extremity CRPS Type 1. | Device | Group 1 |
Primary outcome
volumetric measurement
Time frame: All measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week, by the same investigator, with the patient in a seated position and at the same time of day.
The total volume of the hand was measured using a volumetric device based on the water displacement method. The volumeter method has been used since the 1950s and is considered a highly valid and reliable measurement tool with a very low margin of error. It is accepted as the "gold standard" for assessing hand edema, particularly in cases of diffuse swelling. The patient immersed the affected extremity into the volumeter, positioning the hand so that the web space between the third and fourth fingers rested on a plastic rod. The displaced water was collected in a beaker and subsequently measured using a graduated cylinder. Measurements were recorded in milliliters.Considering that water temperature may influence measurement results, it was maintained between 20-35 °C.
visual analog scala
Time frame: Within the scope of the study, measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week. Pain was evaluated separately under three conditions: at rest, during movement, and at night.
Pain intensity was assessed subjectively using a 10-cm Visual Analog Scale (VAS) (Appendix 2). Participants were shown a horizontal line with the left end defined as "0 = no pain" and the right end as "10 = unbearable pain," and were asked to mark the point that best represented their current pain level. The distance from the starting point to the marked point was measured in millimeters and recorded, with higher scores indicating greater pain intensity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 35214311Sousa ASP, Moreira J, Silva C, Mesquita I, Macedo R, Silva A, Santos R. Usability of Functional Electrical Stimulation in Upper Limb Rehabilitation in Post-Stroke Patients: A Narrative Review. Sensors (Basel). 2022 Feb 12;22(4):1409. doi: 10.3390/s22041409.
- Background: PubMed 25642030Devrimsel G, Turkyilmaz AK, Yildirim M, Beyazal MS. The effects of whirlpool bath and neuromuscular electrical stimulation on complex regional pain syndrome. J Phys Ther Sci. 2015 Jan;27(1):27-30. doi: 10.1589/jpts.27.27. Epub 2015 Jan 9.
- Individual participant dataSharing planned: No. Data privacy
Related trials for Complex Regional Pain Syndrome I of Upper Limb
Recruiting
The Effects of Whirlpool and Contrast Bath in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture
Distal Radius Fracture, Complex Regional Pain Syndrome Type I
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. This study is not recruiting at the moment.
Güldal Funda Yüzer Nakıpoğlu, Prof. Dr. study director
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndrome I of Upper Limb and Pain, run by Zeynep Nur Köseoğlu 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 1 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: finished, as of the sponsor's last update on 6 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volumetric measurement (time frame: All measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week, by the same investigator, with the patient in a seated position and at the same time of day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07570199, which also lists 2 linked publications.
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 6 May 2026.