Electrical Stimulation for Hemiplegic Shoulder Pain

Recruiting

Phase 2 Results N/A

Trial Description

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".

Conditions

Interventions

  • Intramuscular Electrical Stimulator Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: IM Electrical Stimulation (IM ES)
    Description: The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) following a one week electrode stabilization period.
  • Outpatient Therapy Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual Care (UC)
    Description: The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Brief Pain Inventory Short Form Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks No
Secondary ShoulderQ Questionnaire Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks No
Secondary SF-36 Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks No
Secondary Voluntary pain-free abduction ROM Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks No
Secondary Fugl-Myer Motor Assessment (FMA) Baseline; Start of Treatment; End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks No
Secondary "Intervention Interference" Questionnaire End of Treatment (EOT); EOT + 6 wks; EOT + 12 wks No

Sponsors