Multimodal Treatment for Hemiplegic Shoulder Pain

Status:	Recruiting
Conditions:	Neurology, Orthopedic
Therapuetic Areas:	Neurology, Orthopedics / Podiatry
Healthy:	No
Age Range:	21 - 89
Updated:	4/17/2018
Start Date:	January 2017
End Date:	December 2021
Contact:	Kristine Hansen, PT
Email:	khansen1@metrohealth.org
Phone:	216-778-5347

Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke
survivors. HSP is associated with poor rehabilitation outcomes, including interference with
activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for
HSP have been proposed, most do not result in long-term relief of pain.

The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for
the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular
electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic
review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only
treatment to provide long-term relief of pain for those with HSP. However, physical therapy
(PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for
HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical
community, the superiority of PNS to a course of PT must be demonstrated. The investigators
completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced
successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus,
the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot
RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice,
may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to
determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief
than PNS alone or PT alone. Mechanisms also will be explored.

Inclusion Criteria:

- shoulder pain localized to the glenohumeral joint, subacromial area or deltoid
insertion associated with: a) rest; b) passive abduction or external rotation range of
motion (ROM); c) active abduction ROM; or, d) manual palpation;

- shoulder pain onset or worsening after the most recent stroke;

- weakness of shoulder abductors (≤4/5 on Medical Research Council (MRC) scale if
isolated movement is present);

- ≥ 21-yrs old; < 90-yrs old;

- time of stroke ≥ 3-mo;

- duration of HSP ≥3-mo;

- HSP with moderate to severe pain (BPI SF-3 ≥ 4);

- cognitive and communication ability to fulfill study requirements (cognitive ability
based upon a score of ≥24 on the Mini Mental Status Exam (MMSE));

- availability of reliable adult who can assist with study procedures if necessary;

- willing and able to report shoulder pain and other conditions and complete study
visits throughout the 4 month study period.

Exclusion Criteria:

- joint or overlying skin infection or history of recurrent skin infections;

- insensate skin;

- need to take > 1 opioid and > 1 nonopioid analgesic medication for HSP;

- regular intake of pain medications for another chronic pain;

- botox injection or subacromial steroid injections to the shoulder within the past 12
weeks;

- receiving occupational therapy (OT) or PT for HSP;

- bleeding disorder or international normalized ratio (INR) > 3.0;

- sensitivity to skin surface electrodes and/or medical-grade adhesives, gels, tapes;

- medical instability;

- pregnancy;

- uncontrolled seizures (>1/mo for 6-mo);

- history of cardiac arrhythmia with hemodynamic instability;

- history of lidocaine allergy;

- history of Parkinson's disease, spinal cord injury (SCI), traumatic brain injury
(TBI), multiple sclerosis (MS), or ipsilateral upper extremity (UE) lower motor neuron
lesion;

- history of complex regional pain syndrome, myofacial pain syndrome, other pain
conditions (investigator discretion);

- cardiac pacemaker or other implanted electronic device;

- history of valvular heart disease (artificial valves, requiring antibiotics for
procedures, etc.);

- severely impaired communication.

We found this trial at

sites

Shirley Ryan AbilityLab

355 East Erie Street
Chicago, Illinois 60611

Principal Investigator: Richard L Harvey, MD

Phone: 312-238-3647

from

Chicago, IL