NCT04198532

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

December 12, 2019

Last Update Submit

December 24, 2019

Conditions

StrokeSympathetic Disorder

Outcome Measures

Primary Outcomes (1)

  • sympathetic skin response

    microvolts

    1 day

Study Arms (2)

Complex Regional Pain Syndrome(CRPS) group

EXPERIMENTAL

Stroke patients with complex regional pain syndrome

Other: Contrast bath

Control Group

OTHER

Stroke patients without complex regional pain syndrome

Other: Contrast bath

Interventions

Contrast bathOTHER

Contrast bath (hot and cold therapy)

Complex Regional Pain Syndrome(CRPS) groupControl Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke
  • both gender

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul PMR Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33135537DERIVED

MeSH Terms

Conditions

StrokeAutonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Betul Yavuz Keles, MD

    Istanbul PMR training and research hospital

    STUDY DIRECTOR

  • Burcu Onder, Assoc prof

    Istanbul PMR training and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 13, 2019

Study Start

January 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

TU(2)