StrokeNCT04198532
Contrast Bath and Sympathetic Skin Response
A study testing Contrast bath in people with Stroke and Sympathetic Disorder, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome . Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Sympathetic Disorder
- What is being tested?
- Contrast bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Mar 2019
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke
- both gender
Who cannot join
- peripheral neuropathy
- pace maker
- skin lesion in hands
- anxiety
- sensory or motor aphasia
- peripheral nerve injury
- hand surgery and
- reynauld disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Istanbul
Istanbul PMR Training and Research Hospital
Istanbul
About this study
Official title: Effects of Contrast Bath on Sympathetic Skin Response in Patients With Complex Regional Pain Syndrome Type 1
This study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome .
Read the detailed description
Contrast bath(CB) is a thermal modality. It is usually performed by keeping hands in hot and cold water for certain periods of time. CB is a mostly advised intervention in complex regional pain syndrome (CRPS) altough there is no certain evidence The investigators will study on stroke patients. Change in sympathetic skin response after the contrast bath will be evaluated.
Stroke patients who admitted to the inpatient rehabilitation programme in Istanbul Physical Medicine and Rehabilitation Training and Research Hospital were evaluated for this study. Patients who had CRPS after stroke were included in the study (CRPS group). Also patients who had not CRPS and had similar age, gender and stroke duration with CRPS group were included in control group. Stroke patients with pacemaker, polyneuropathy, neglect, sensory or motor aphasia, peripheral nerve injury, hand surgery and reynauld disease were excluded from the study.
Age, gender, dominant arm, comorbidities, stroke side, aetiology and duration were recorded. Brunnstrom stages were used to evaluate arm and hand. Spasticity of upper extremity was assed by modified aschworth scale.
In CRPS group, CRPS severity scale was performed to evaluate the CRPS severity. This scale includes sensorial, autonomic and motor function. Also, neuropathic pain was assesed by Douleur Neuropathique 4 (DN4) Questionnaire and visual analog scale(VAS).
Contrast bath was performed to patients' plegic side . There were two baths , one include hot water and other had cold degrees. Patients hold their plegic hands in hot water for 4 minutes, in cold water for 1 minute after hot water. Hot and cold bath were repeated four times.
Sympathetic skin response (SSR) was measured before the contrast bath and 30 minutes after the contrast bath finished. SSR was recorded from plegic side and contralateral side. The active electrode was placed at the palm of the hand and the reference electrode at dorsum of the hand to record the median nerve SSR. The latency and the amplitude of SSR was measured.
- Conditions
- Stroke, Sympathetic Disorder
- Being tested
- Contrast bath
- Medical subject headings
- Stroke, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast bathOther
Contrast bath (hot and cold therapy)
| Study group | Role | What they receive |
|---|---|---|
| Complex Regional Pain Syndrome(CRPS) group | Experimental | Stroke patients with complex regional pain syndrome Receives: Other: Contrast bath |
| Control Group | Other | Stroke patients without complex regional pain syndrome Receives: Other: Contrast bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
sympathetic skin response
microvolts
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Betul Yavuz Keles, MD, Study director, Istanbul PMR training and research hospitalBurcu Onder, Assoc prof, Principal investigator, Istanbul PMR training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198532
- Sponsor's protocol ID
- IstPMRTRHCRPSCB
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yavuz Keles B, Onder B, Kesiktas FN, Ones K, Paker N. Acute effects of contrast bath on sympathetic skin response in patients with poststroke complex regional pain syndrome. Somatosens Mot Res. 2020 Dec;37(4):320-325. doi: 10.1080/08990220.2020.1830756. Epub 2020 Oct 14.
PubMed 33135537
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Contrast Bath on Sympathetic Skin Response in Patients With Complex Regional Pain Syndrome Type 1
- ClinicalTrials.gov ID
- NCT04198532
- Acronym / sponsor ID
- IstPMRTRHCRPSCB
- Conditions
- Stroke, Sympathetic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 Dec 2019 (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.
This study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome .
Detailed description
Contrast bath(CB) is a thermal modality. It is usually performed by keeping hands in hot and cold water for certain periods of time. CB is a mostly advised intervention in complex regional pain syndrome (CRPS) altough there is no certain evidence The investigators will study on stroke patients. Change in sympathetic skin response after the contrast bath will be evaluated.
Stroke patients who admitted to the inpatient rehabilitation programme in Istanbul Physical Medicine and Rehabilitation Training and Research Hospital were evaluated for this study. Patients who had CRPS after stroke were included in the study (CRPS group). Also patients who had not CRPS and had similar age, gender and stroke duration with CRPS group were included in control group. Stroke patients with pacemaker, polyneuropathy, neglect, sensory or motor aphasia, peripheral nerve injury, hand surgery and reynauld disease were excluded from the study.
Age, gender, dominant arm, comorbidities, stroke side, aetiology and duration were recorded. Brunnstrom stages were used to evaluate arm and hand. Spasticity of upper extremity was assed by modified aschworth scale.
In CRPS group, CRPS severity scale was performed to evaluate the CRPS severity. This scale includes sensorial, autonomic and motor function. Also, neuropathic pain was assesed by Douleur Neuropathique 4 (DN4) Questionnaire and visual analog scale(VAS).
Contrast bath was performed to patients' plegic side . There were two baths , one include hot water and other had cold degrees. Patients hold their plegic hands in hot water for 4 minutes, in cold water for 1 minute after hot water. Hot and cold bath were repeated four times.
Sympathetic skin response (SSR) was measured before the contrast bath and 30 minutes after the contrast bath finished. SSR was recorded from plegic side and contralateral side. The active electrode was placed at the palm of the hand and the reference electrode at dorsum of the hand to record the median nerve SSR. The latency and the amplitude of SSR was measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Regional Pain Syndrome(CRPS) group | Experimental | Other: Contrast bathStroke patients with complex regional pain syndrome |
| Control Group | Other | Other: Contrast bathStroke patients without complex regional pain syndrome |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stroke
- both gender
Key exclusion criteria (8 listed)
- peripheral neuropathy
- pace maker
- skin lesion in hands
- anxiety
- sensory or motor aphasia
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 |
|---|---|---|
| Contrast bathContrast bath (hot and cold therapy) | Other | Complex Regional Pain Syndrome(CRPS) group, Control Group |
Primary outcome
sympathetic skin response
Time frame: 1 day
microvolts
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 26 Dec 2019.
- Derived from this study: PubMed 33135537Yavuz Keles B, Onder B, Kesiktas FN, Ones K, Paker N. Acute effects of contrast bath on sympathetic skin response in patients with poststroke complex regional pain syndrome. Somatosens Mot Res. 2020 Dec;37(4):320-325. doi: 10.1080/08990220.2020.1830756. Epub 2020 Oct 14.
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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. This study is not recruiting at the moment.
Betul Yavuz Keles, MD study director
Istanbul PMR training and research hospital
Burcu Onder, Assoc prof principal investigator
Istanbul PMR training and research hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast bath in people with Stroke and Sympathetic Disorder, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites 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 2 inclusion and 8 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
sympathetic skin response (time frame: 1 day). 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 NCT04198532, which also lists 1 linked publication.
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 26 Dec 2019.