Contrast Bath and Sympathetic Skin Response

Stroke Clinical Trial

Official title:

Effects of Contrast Bath on Sympathetic Skin Response in Patients With Complex Regional Pain Syndrome Type 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198532
• Other study ID #: IstPMRTRHCRPSCB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2019
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Sympathetic Disorder

Intervention

Other:
• Contrast bath
Contrast bath (hot and cold therapy)

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and research Hospital	Istanbul
Turkey	Istanbul PMR Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sympathetic skin response	microvolts	1 day