Electrical Stimulation for Hemiplegic Shoulder Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Chae, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01123382
First received: May 12, 2010
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain has been difficult. In order to address the limitations of surface ES, the investigative team pioneered the development of percutaneous intramuscular (IM) ES for the treatment of post-stroke shoulder pain. However, prior to acceptance by the clinical community, additional gaps in the scientific and clinical knowledge need to be addressed. This study begins to do so. The primary objective is to estimate the relative pain reduction associated with IM ES vs. "usual care." We hypothesize that the IM ES group will exhibit a larger effect size with respect to pain reduction compared to "usual care". A secondary objective is to estimate the effect on health related QOL of IM ES vs. "usual care." Demonstration of improvement in QOL will validate the clinical relevance of the intervention. We hypothesize that the IM ES group will exhibit greater improvement in health related QOL compared to "usual care".


Condition Intervention Phase
Stroke
Shoulder Pain
Device: Intramuscular Electrical Stimulator
Other: Outpatient Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrical Stimulation for Hemiplegic Shoulder Pain

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Brief Pain Inventory Short Form [ Time Frame: Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks ] [ Designated as safety issue: No ]
    The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities.


Secondary Outcome Measures:
  • ShoulderQ Questionnaire [ Time Frame: Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks ] [ Designated as safety issue: No ]
    The ShoulderQ questionnaire is a post-stroke shoulder specific pain measure.

  • SF-36 [ Time Frame: Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks ] [ Designated as safety issue: No ]
    The SF-36 is a health related QOL measure.

  • Voluntary pain-free abduction ROM [ Time Frame: Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks ] [ Designated as safety issue: No ]
    Voluntary pain-free abduction ROM is a motor recovery measure.

  • Fugl-Myer Motor Assessment (FMA) [ Time Frame: Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks ] [ Designated as safety issue: No ]
    The Fugl-Myer Motor Assessment (FMA) is a motor recovery measure.

  • "Intervention Interference" Questionnaire [ Time Frame: End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks ] [ Designated as safety issue: No ]
    The "Intervention Interference" questionnaire documents how the treatment interventions interfere with daily activities and QOL.


Estimated Enrollment: 24
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IM Electrical Stimulation (IM ES)
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) following a one week electrode stabilization period.
Device: Intramuscular Electrical Stimulator
A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed. Total time of electrode implantation is no more than 29 days.
Active Comparator: Usual Care (UC)
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Other: Outpatient Therapy
Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • shoulder pain localized to the glenohumeral joint, subacromial area or deltoid insertion associated with any of the following conditions: a) rest; b) passive abduction or external rotation ROM; c) active abduction or external rotation ROM; or d) manual palpation
  • weakness of shoulder abductors (≤4/5 on MRC if isolated movement is present)
  • age ≥21-yrs
  • time from stroke ≥ 3-mo
  • shoulder pain onset after the most recent stroke
  • duration of shoulder pain ≥ 3-mo
  • severity of shoulder pain on BPI-SF 3 ≥4
  • cognitive ability to fulfill study requirements [a) exhibit 3 object immediate and 30 minute recall; b) ability to use a numeric rating scale (using a 0-10 numeric rating scale) by correctly ranking the tightness they feel on the unaffected arm of 3 low-pressure inflations with a standard sphygmomanometer cuff which follow a predetermined sequence (20, 40 and 0 mm Hg); and c) ability to follow 3-stage commands]
  • availability of a reliable adult who can check the skin and assist the participant with the treatment protocol
  • willing and able to report severity of shoulder pain throughout the study period
  • willing to make all scheduled study visits post-implantation.

Exclusion Criteria:

  • evidence of joint or overlying skin infection
  • insensate skin
  • >1 opioid or nonopioid analgesics daily for shoulder pain
  • daily intake of pain medications for any other chronic pain
  • intra-articular or subacromial steroid injections to the shoulder in the previous 12-wks
  • botulinum toxin injection to the trapezius, pectoralis or subscapularis muscle in the previous 12-wks
  • receiving physical or occupational therapies for shoulder pain
  • physician-diagnosed shoulder pathology symptomatic within the 5 yrs prior to CVA
  • bleeding disorder
  • INR>3.0 for those on warfarin [INR>3.0]
  • poorly controlled diabetes [HbA1c>7.0]
  • medical instability
  • pregnancy
  • uncontrolled seizures (>1/mo for 6-mo)
  • uncompensated hemi-neglect
  • severely impaired communication
  • moderate to severe depression
  • other confounding conditions such as ipsilateral upper limb lower motorneuron lesion, Parkinson's Disease, spinal cord injury, traumatic brain injury or multiple sclerosis
  • other medical issues such as complex regional pain syndrome, bicipital tendonitis, myofacial pain syndrome, etc.
  • the following cardiac conditions: a) history of arrhythmia with hemodynamic instability, such as ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation; b) any implantable stimulator such as demand pacemakers or defibrillators; and c) valvular heart disease including artificial valves (due to risk of infection and endocarditis)
  • likely non-compliance factors such as distance from the center, inadequate social support, or psychiatric/psychologic factors
  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: NCT01123382

Contacts
Contact: Peggy Maloney, RN 216-778-8563 mmaloney@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peggy Maloney, RN    216-778-8563    mmaloney@metrohealth.org   
Principal Investigator: John Chae, MD         
Sub-Investigator: Richard Wilson, MD         
Sub-Investigator: Lynne Sheffler, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: John Chae, MD MetroHealth Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Chae, Prof Vice Chair Physical Medicine and Rehabilitation, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01123382     History of Changes
Other Study ID Numbers: R01HD059777
Study First Received: May 12, 2010
Last Updated: December 22, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Stroke
Shoulder pain
Electrical stimulation
Neuromuscular stimulation
Intramuscular stimulation

Additional relevant MeSH terms:
Shoulder Pain
Stroke
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014