StrokeNCT01913509

A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect

A study testing Combined Therapy of FES and BAT and Conventional Rehabilitation in people with Stroke, run by Chang Gung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Stroke
What is being tested?: Combined Therapy of FES and BAT and Conventional Rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteTaiwan
Study dates: Dec 2013to Jul 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chang Gung Memorial Hospital
Taoyuan

Other trials in Taiwan

About this study

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.

Read the 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 treatment process, daily functions, and quality of life (QOL) for stroke patients. Considering the high prevalence and detrimental effects of poststroke shoulder pain and fatigue, it is vital for monitoring these symptoms and therapeutic interventions to be developed for those suffering from poststroke pain and fatigue. Therefore, to validate existing assessments of pain/fatigue, and to evaluate the efficacy of potential pain/fatigue interventions are needed.

A vertical Numerical Rating Scale with Faces Rating Scale (NRS-FRS) could be used by all stroke patients as pain and fatigue measurement. The Brief Pain Inventory (BPI) and Brief Fatigue Inventory (BFI) measure pain/fatigue intensity and pain/fatigue interference, which might provide more information regarding pain/fatigue symptoms. The first aim of this research is to examine the psychometric properties of the vertical NRS-FRS, BPI, and BFI.

Functional electrical stimulation (FES) appears to offer benefits in relieving painful hemiplegic shoulder. Previous studies have shown that therapeutic electrical stimulation of the posterior deltoid and supraspinatus muscles significantly reduces shoulder subluxation, but inconsistent results on pain reduction, pain-free range of motion of the affected shoulder joint, and arm function. Conventional rehabilitation usually applies transcutaneous electrical nerve stimulation (TENS) to relieve pain. Bilateral arm training (BAT) is one of the novel interventions in stroke rehabilitation to improve motor recovery of the affected arm, especially proximal part of the upper-limb.Therefore, the second aim of this research is to investigate whether the combined therapy of FES and BAT (FES-BAT) could reduce hemiplegic shoulder pain and improve motor function of the affected arm as compared with TENS plus BAT (TENS-BAT). Whether interventions could further lead to better functional performance and higher QOL would be of interest.

This 3-year project is implemented in three stages and recruit 80 patients with chronic stroke. At the first stage, investigators conduct a test-retest study to investigate the reliability and validity of outcome measures on hemiplegic shoulder pain and poststroke fatigue in 80 patients. At the second stage, investigators conduct a randomized controlled trial (RCT) to investigate the relative effects of the FES-BAT versus TENS-BAT for 40 stroke patients with hemiplegic shoulder pain and moderate-to-mild motor impairment. Treatment regimens are designed to ensure that patients in the 2 groups receive an equivalent intensity of treatment (1 hour/day, 3 days/week for 4 weeks). At the third stage, investigators will determine clinimetric properties of the primary outcome measures, such as responnsiveness, minimal detectable change, and minimal clinical important change.

Conditions: Stroke
Being tested: Combined Therapy of FES and BAT, Conventional Rehabilitation
Keywords: hemiplegic shoulder pain, poststroke fatigue, functional electrical stimulation, stroke rehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combined Therapy of FES and BATDevice
FES treatment is applied to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected shoulder. Then patients receive bilateral arm training focused on reaching, shoulder abduction, and shoulder horizontal abduction.
Conventional RehabilitationDevice
Stroke patients in CR group receive the protocol which includes (1) TENS; (2) BAT. The activities are adapted based on the level of motor impairment, and functional needs of individual patients.

Study groups in NCT01913509
Study group	Role	What they receive
Combined Therapy of FES and BAT	Experimental	Patients with hemiplegic shoulder pain is applied functional electrical stimulation and bilateral arm training (FES-BAT) one hour daily, 3 days per week for 4 weeks and a total of 12 sessions to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected arm. Receives: Device: Combined Therapy of FES and BAT
Conventional Rehabilitation	Active comparator	The stroke patients in CR group receive a structure protocol using electrical modality such as transcutaneous electrical nerve stimulation (TENS) and bilateral arm training (TENS-BAT) one hour daily, 3 days per week for 4 weeks and a total of 12 sessions. Receives: Device: Conventional Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Vertical Numerical Rating Scale with Faces Rating Scale
The NRS supplemented with the Wong-Baker FRS is a combination of the 0- to 10-point vertical NRS with word anchors and the six facial expressions of the FRS facilitating scoring the intensity of participants' pain/fatigue. The question for measuring pain/fatigue will be: "How much hemiplegic shoulder pain/poststroke fatigue do you feel today? Please point to the number that best reflects your current level of hemiplegic shoulder pain/poststroke fatigue"
Measured: 2 minutes
Brief Pain Inventory (BPI)
The BPI includes four ratings of the intensity of pain (items 3-7), and seven that cover the impact of pain. Since pain can be quite variable over a day, the BPI asks patients to rate their pain at the time of responding to the questionnaire (pain now), and also at its worst, least, and average over the previous day, with 0 being "no pain" and 10 being "pain as bad as you can imagine." The pain now, worst, least, and average rating will be combined to give a composite index of pain severity. Interference of pain is to estimate the degree to which pain limits patients' functions in the past one week, with 0 being "no interference" and 10 being "interferes completely." The BPI asks for ratings of the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The mean of these scores will be used as a pain interference score.
Measured: 3 minutes
Brief Fatigue Inventory (BFI)
The BFI was developed to measure the severity of fatigue and the impact of fatigue on daily functioning in cancer populations. The BFI uses a 0-10 numeric rating scale to measure fatigue severity (worst fatigue, usual fatigue, fatigue now) and interference with life activities (general activity, mood, walking ability, normal work, relationships to others, sleep, and enjoyment of life) in the past 24 hours, with 0 (no fatigue/no interference) to 10 (fatigue as bad as you can imagine/completely interferences). A composite fatigue severity score is the average of the three severity items and a composite fatigue interference score is the average of the six interference items. A global fatigue score will be obtained by averaging all the items on the BFI.
Measured: 3 minutes
Fugel Meyer Assessment (FMA)
The FMA was developed to measure the motor impairments of stroke patients.
Measured: 5 to 10 minutes

Secondary outcomes (4)

Functional Independent Measure (FIM)
The FIM is used to measure daily functions of stroke patients.
Measured: 3 minutes
Stroke Impact Scale (SIS) version 3
The SIS is used to assess quality of life in stroke patients.
Measured: 5 minutes
Nottingham Extended Activities of Daily Living Scale (NEADL)
The NEADL is used to assess instrumental ADL ability of stroke patients.
Measured: 3 minutes
10-meter walk test
The 10-meter walk test is used to measure preferred gait speed and fasted gait speed.
Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jul 2017

First posted1 Aug 2013 (estimated)
Study startDec 2013
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01913509
Sponsor's protocol ID: NSC102-2314-B-182-003
Other IDs: NMRPD1C0071
Status last verified: Jul 2018
First submitted: 30 Jul 2013
Last updated: 1 Aug 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Lerdal A, Bakken LN, Kouwenhoven SE, Pedersen G, Kirkevold M, Finset A, Kim HS. Poststroke fatigue--a review. J Pain Symptom Manage. 2009 Dec;38(6):928-49. doi: 10.1016/j.jpainsymman.2009.04.028.
PubMed 19811888
Naess H, Lunde L, Brogger J. The effects of fatigue, pain, and depression on quality of life in ischemic stroke patients: the Bergen Stroke Study. Vasc Health Risk Manag. 2012;8:407-13. doi: 10.2147/VHRM.S32780. Epub 2012 Jun 27.
PubMed 22910531
Chuang LL, Chen YL, Chen CC, Li YC, Wong AM, Hsu AL, Chang YJ. Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2017 Nov 28;14(1):122. doi: 10.1186/s12984-017-0332-0.
PubMed 29183339

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect
ClinicalTrials.gov ID: NCT01913509
Acronym / sponsor ID: NSC102-2314-B-182-003
Conditions: Stroke
Keywords: hemiplegic shoulder pain, poststroke fatigue, functional electrical stimulation, stroke rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Chang Gung UniversityUniversity, hospital or other
Collaborators: Mackay Memorial Hospital, Chang Gung Memorial Hospital
Study start: Dec 2013
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 1 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Combined Therapy of FES and BAT	Experimental	Device: Combined Therapy of FES and BATPatients with hemiplegic shoulder pain is applied functional electrical stimulation and bilateral arm training (FES-BAT) one hour daily, 3 days per week for 4 weeks and a total of 12 sessions to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected arm.
Conventional Rehabilitation	Active comparator	Device: Conventional RehabilitationThe stroke patients in CR group receive a structure protocol using electrical modality such as transcutaneous electrical nerve stimulation (TENS) and bilateral arm training (TENS-BAT) one hour daily, 3 days per week for 4 weeks and a total of 12 sessions.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Combined Therapy of FES and BATFES treatment is applied to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected shoulder. Then patients receive bilateral arm training focused on reaching, shoulder abduction, and shoulder horizontal abduction.	Device	Combined Therapy of FES and BAT
Conventional RehabilitationStroke patients in CR group receive the protocol which includes (1) TENS; (2) BAT. The activities are adapted based on the level of motor impairment, and functional needs of individual patients.	Device	Conventional Rehabilitation

Primary outcome

Vertical Numerical Rating Scale with Faces Rating Scale
Time frame: 2 minutes
The NRS supplemented with the Wong-Baker FRS is a combination of the 0- to 10-point vertical NRS with word anchors and the six facial expressions of the FRS facilitating scoring the intensity of participants' pain/fatigue. The question for measuring pain/fatigue will be: "How much hemiplegic shoulder pain/poststroke fatigue do you feel today? Please point to the number that best reflects your current level of hemiplegic shoulder pain/poststroke fatigue"
Brief Pain Inventory (BPI)
Time frame: 3 minutes
The BPI includes four ratings of the intensity of pain (items 3-7), and seven that cover the impact of pain. Since pain can be quite variable over a day, the BPI asks patients to rate their pain at the time of responding to the questionnaire (pain now), and also at its worst, least, and average over the previous day, with 0 being "no pain" and 10 being "pain as bad as you can imagine." The pain now, worst, least, and average rating will be combined to give a composite index of pain severity. Interference of pain is to estimate the degree to which pain limits patients' functions in the past one week, with 0 being "no interference" and 10 being "interferes completely." The BPI asks for ratings of the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The mean of these scores will be used as a pain interference score.
Brief Fatigue Inventory (BFI)
Time frame: 3 minutes
The BFI was developed to measure the severity of fatigue and the impact of fatigue on daily functioning in cancer populations. The BFI uses a 0-10 numeric rating scale to measure fatigue severity (worst fatigue, usual fatigue, fatigue now) and interference with life activities (general activity, mood, walking ability, normal work, relationships to others, sleep, and enjoyment of life) in the past 24 hours, with 0 (no fatigue/no interference) to 10 (fatigue as bad as you can imagine/completely interferences). A composite fatigue severity score is the average of the three severity items and a composite fatigue interference score is the average of the six interference items. A global fatigue score will be obtained by averaging all the items on the BFI.
Fugel Meyer Assessment (FMA)
Time frame: 5 to 10 minutes
The FMA was developed to measure the motor impairments of stroke patients.

4 secondary outcomes

Functional Independent Measure (FIM)
Time frame: 3 minutes
Stroke Impact Scale (SIS) version 3
Time frame: 5 minutes
Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: 3 minutes
10-meter walk test
Time frame: 2 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
Background: PubMed 19811888Lerdal A, Bakken LN, Kouwenhoven SE, Pedersen G, Kirkevold M, Finset A, Kim HS. Poststroke fatigue--a review. J Pain Symptom Manage. 2009 Dec;38(6):928-49. doi: 10.1016/j.jpainsymman.2009.04.028.
Background: PubMed 22910531Naess H, Lunde L, Brogger J. The effects of fatigue, pain, and depression on quality of life in ischemic stroke patients: the Bergen Stroke Study. Vasc Health Risk Manag. 2012;8:407-13. doi: 10.2147/VHRM.S32780. Epub 2012 Jun 27.
Derived from this study: PubMed 29183339Chuang LL, Chen YL, Chen CC, Li YC, Wong AM, Hsu AL, Chang YJ. Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2017 Nov 28;14(1):122. doi: 10.1186/s12984-017-0332-0.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Li-Ling Chuang, PhD principal investigator

Chang Gung University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Combined Therapy of FES and BAT and Conventional Rehabilitation in people with Stroke, run by Chang Gung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertical Numerical Rating Scale with Faces Rating Scale (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01913509, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.