A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect (NCT01913509) | Clinical Trial Compass
CompletedNot Applicable
A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect
Taiwan110 participantsStarted 2013-12
Plain-language 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 findings will contribute to guide the choice of proper assessment tool and the development of effective rehabilitation programs.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. history of ventricular arrhythmias, or with a cardiac pacemaker, especially those with cardiac failure with conduction problems;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vertical Numerical Rating Scale with Faces Rating Scale
. 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.