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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Chang Gung University
Sponsor:
Collaborator:
Mackay Memorial Hospital
Information provided by (Responsible Party):
Li-Ling Chuang, Chang Gung University
ClinicalTrials.gov Identifier:
NCT01913509
First received: July 30, 2013
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Stroke
Device: Combined Therapy of FES and GTT
Device: Conventional Rehabilitation 1
Device: Combined Therapy of FES and BWSTT
Device: Conventional Rehabilitation 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect

Resource links provided by NLM:


Further study details as provided by Chang Gung University:

Primary Outcome Measures:
  • Vertical Numerical Rating Scale with Face Rating Scale [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
    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"


Secondary Outcome Measures:
  • Brief Pain Inventory (BPI) [ Time Frame: 5 to 10 minutes ] [ Designated as safety issue: No ]
    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: 5 to 10 minuttes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: August 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined Therapy of FES and GTT
Patients with ambulatory ability will be applied functional electrical stimulation and walking on a treadmill one hour daily, 3 days per week for 4 weeks and a total of 12 sessions to stimulate the supraspinatus muscle with an active electrode over the posterior deltoid muscle avoid shaking of the shoulder.
Device: Combined Therapy of FES and GTT
FES treatment will be applied to stimulate the supraspinatus muscle with an active electrode over the posterior deltoid muscle avoid shaking of the shoulder. At the same time, patients will walk on the treadmill while supported in a harness with a comfortable speed, using gradually increasing inclination angles and by increasing the total walking time. At the start of the training, patients walk twice for 10 minutes at 40% maximum heart rate (maxHR) and the HR is kept constant for one week, during which the walking duration increases to twice 20 minutes. In week 2, the training heart rate is set at 50% maxHR with gradually increasing durations, which is gradually increased every week to 70% maxHR at the end of 4-week intervention.
Active Comparator: Conventional Rehabilitation 1
The ambulatory stroke patients in CR group will receive a structure protocol using electrical modality such as TENS and conventional physical therapy techniques such as neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening.
Device: Conventional Rehabilitation 1
Ambulatory patients in CR group will receive the protocol which includes (1) TENS; (2) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes; (3) gross motor training for 20 minutes; (4) muscle strengthening of the affected limb for 15 to 20 minutes; and (5) assisted overground walking with aids such as ankle-foot orthoses for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment, walking capacity, and functional needs of individual patients.
Experimental: Combined Therapy of FES and BWSTT
Patients with non-ambulatory ability will receive combined Therapy of Functional electrical stimulation and Body Weight Supported Treadmill Training (FES-BWSTT).
Device: Combined Therapy of FES and BWSTT
The intervention group at Stage 3 will walk on a treadmill while body weight supported (BWSTT) in a harness, which offers the safety and mobility. Initial body weight support will be set so that the knee is within 15 degrees of extension. Initial speed of the treadmill will be set so that the therapist has time to assist the leg to swing through while maintaining a reasonable step length. The amount of body weight support will be reduced once participants can (1) swing their affected leg through without help, (2) maintain a straight knee during stance phase without hyperextension, and (3) maintain an adequate step length without help.
Active Comparator: Conventional Rehabilitation 2
The non-ambulatory patients in CR group is designed to control for the duration of patient-therapist interactions and therapeutic activities (1 hours/day, 3 days/week, for 4 weeks).
Device: Conventional Rehabilitation 2
The non-ambulatory patients in CR group will receive a structure protocol using electrical modality such as TENS and conventional physical therapy techniques such as neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening. The protocol will include (1) TENS; (2) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes; (3) gross motor training for 20 minutes; (4) muscle strengthening of the affected limb for 15 to 20 minutes; and (5) assisted overground walking with aids such as ankle-foot orthoses for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment, walking capacity, and functional needs of individual patients.

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 Face 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 intensity and interference, which might provide more information. The first aim of this research will be 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. Electrical stimulation of the posterior deltoid and supraspinatus muscles has shown beneficial effects on pain, subluxation, range of motion, and arm function. It is suggested that graded treadmill training (GTT) could be useful in relieving fatigue by improving fitness reserve and lowering of the energy cost of hemiparetic gait. For non-ambulatory stroke patients, body weight supported treadmill training (BWSTT) is an encouraging intensive, task-specific practice. Therefore, the second aim of this research will investigate whether the combined therapy of FES and GTT (FES-GTT) or that of FES and BWSTT (FES-BWSTT) could reduce hemiplegic shoulder pain and poststroke fatigue as compared with conventional rehabilitation (CR). Whether interventions could lead to better functional performance and higher QOL would be of interest.

This 3-year project will be implemented in four stages and will recruit 160 patients with chronic stroke. At the first stage, we will 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, we will conduct a randomized controlled trial (RCT) to investigate the relative effects of the FES-GTT versus CR for 40 ambulatory stroke patients with hemiplegic shoulder pain, poststroke fatigue, and moderate-to-mild motor impairment. At the third stage, we will conduct another RCT to investigate the relative effects of the FES-BWSTT versus CR for 40 non-ambulatory stroke patients with hemiplegic shoulder pain, poststroke fatigue, and moderate motor impairment. Treatment regimens will be designed to ensure that patients in the 2 groups at stage 2 and 3 receive an equivalent intensity of treatment (1 hour/day, 3 days/week for 4 weeks). The fourth stage determines clinimetric properties of the outcome measures.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. first-ever stroke with onset duration more than 6 months;
  2. self-reported at least mild intensity of hemiplegic shoulder pain and poststroke fatigue in the past 7 days (the NRS score ≥ 1);
  3. Brunnstrom stage IV or above and an initial Fugl-Meyer Assessment score of 65 to 100 indicating moderate or mild movement impairment for Stage 2 and Brunnstrom stage III or above and an initial Fugl-Meyer Assessment score of 56 to 79 indicating moderate motor impairment for Stage 3;
  4. no serious cognitive deficits (a score of more than 20 on the Mini Mental State Exam);
  5. no excessive spasticity in the hip and knee joints of the affected lower extremity (Modified Ashworth Scale score ≤3) ;
  6. no lower extremity fracture within 6 months;
  7. no participation in any experimental rehabilitation or drug studies during the study period; and (8) willing to provide written informed consent prior to study entry.

Exclusion Criteria:

  1. history of ventricular arrhythmias, or with a cardiac pacemaker, especially those with cardiac failure with conduction problems;
  2. previous contralateral stroke with persistent neurological deficit;
  3. a shoulder pathology not related to the stroke (tumor, infection, scapular instability, winged scapula);
  4. complicated regional pain syndrome or brachial plexus lesion;
  5. diagnosis of epilepsy with history of recurring seizures in the past six months;
  6. 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;
  7. acute pain after operation; and
  8. auditory, visual, physical, or mental disabilities that would interfere with patients' ability to comprehend instructions for completing the outcome measures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913509

Contacts
Contact: Li-Ling Chuang 886-3-2118800 ext 3177 lchuang@mail.cgu.edu.tw

Locations
Taiwan
Chang Gung Memorial Hospital Not yet recruiting
Tao-Yuan, Taiwan
Contact: Li-Ling Chuang, Ph.D    886-3-2118800 ext 3177    lchuang@mail.cgu.edu.tw   
Principal Investigator: Li-Ling Chuang, PhD         
Sponsors and Collaborators
Chang Gung University
Mackay Memorial Hospital
Investigators
Principal Investigator: Li-Ling Chuang, PhD Chang Gung University
  More Information

Publications:
Responsible Party: Li-Ling Chuang, Assistant Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT01913509     History of Changes
Other Study ID Numbers: NSC102-2314-B-182-003, NMRPD1C0071
Study First Received: July 30, 2013
Last Updated: July 31, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung University:
hemiplegic shoulder pain
poststroke fatigue
functional electrical stimulation
graded treadmill training
stroke rehabilitation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Fatigue
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014