Status:
COMPLETED
A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect
Lead Sponsor:
Chang Gung University
Collaborating Sponsors:
Mackay Memorial Hospital
Chang Gung Memorial Hospital
Conditions:
Stroke
Eligibility:
All Genders
Phase:
NA
Brief Summary
The investigators anticipate this research will shed light on metric properties of outcome measures of pain and fatigue and the effects of the combined therapy for stroke patients. The overall finding...
Detailed Description
Hemiplegic shoulder pain affects from 16%-84% of stroke patients and fatigue occurs among 39%-72% of stroke victims, which can have an adverse impact on rehabilitation outcomes by interrupting treatme...
Eligibility Criteria
Inclusion
- first-ever stroke with onset duration more than 3 months;
- self-reported at least mild intensity of hemiplegic shoulder pain and poststroke fatigue in the past 7 days (the NRS score ≥ 2);
- Brunnstrom stage III or above and an initial Fugl-Meyer Assessment score of 56 to 79 or 65-100 indicating moderate or mild movement impairment for Stage 2;
- no serious cognitive deficits (a score of more than 22 on the Mini Mental State Exam);
- no participation in any experimental rehabilitation or drug studies during the study period; and (6) willing to provide written informed consent prior to study entry.
Exclusion
- history of ventricular arrhythmias, or with a cardiac pacemaker, especially those with cardiac failure with conduction problems;
- previous contralateral stroke with persistent neurological deficit;
- a shoulder pathology not related to the stroke (tumor, infection, scapular instability, winged scapula);
- complicated regional pain syndrome or brachial plexus lesion;
- diagnosis of epilepsy with history of recurring seizures in the past six months;
- under irregular analgesia or other fatigue-relieving treatment during the study period because we expect that pain/fatigue medications might complicate measurements of shoulder pain and fatigue. If patients are on regular treatment, it has been so for more than one week;
- acute pain after operation; and
- auditory, visual, physical, or mental disabilities that would interfere with patients' ability to comprehend instructions for completing the outcome measures.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01913509
Start Date
December 1 2013
End Date
July 1 2017
Last Update
August 1 2018
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan