Contrast Bath and Sympathetic Skin Response

NCT ID: NCT04198532

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-03-31

Brief Summary

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This study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome .

Detailed Description

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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

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Stroke Sympathetic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Complex Regional Pain Syndrome(CRPS) group

Stroke patients with complex regional pain syndrome

Group Type EXPERIMENTAL

Contrast bath

Intervention Type OTHER

Contrast bath (hot and cold therapy)

Control Group

Stroke patients without complex regional pain syndrome

Group Type OTHER

Contrast bath

Intervention Type OTHER

Contrast bath (hot and cold therapy)

Interventions

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Contrast bath

Contrast bath (hot and cold therapy)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* stroke
* both gender

Exclusion Criteria

* peripheral neuropathy
* pace maker
* skin lesion in hands
* anxiety
* sensory or motor aphasia
* peripheral nerve injury
* hand surgery and
* reynauld disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Betul Yavuz Keles, MD

Role: STUDY_DIRECTOR

Istanbul PMR training and research hospital

Burcu Onder, Assoc prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul PMR training and research hospital

Locations

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Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul PMR Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33135537 (View on PubMed)

Other Identifiers

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IstPMRTRHCRPSCB

Identifier Type: -

Identifier Source: org_study_id