Clinical trial NCT02893267: Multimodal Treatment for Hemiplegic Shoulder Pain
Official title: Multimodal Treatment for Hemiplegic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Shoulder Pain
Keywords: Stroke
Shoulder Pain
Electrical stimulation
Neuromuscular stimulation
Intramuscular stimulation
Physical Therapy
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Case Western Reserve University
name: Shirley Ryan AbilityLab
First posted: 2016-09-08
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Study Summary: This is a multi-site, placebo controlled, double-blinded RCT to confirm the superiority of PNS over PT in reducing HSP, and to determine if multimodal treatment of HSP with PNS + PT is more efficacious than PNS or PT alone. The standard of care for treating shoulder pain is to try several options, most commonly including medications, injections and therapy. Candidates considering this study likely have tried some treatments but without lasting success. Ninety-six participants will be randomized to receive PNS + PT, PNS + sham-PT, or sham-PNS + PT. The PNS + PT group will receive active PNS therapy for 6 hours per day for 3 weeks along with 8 sessions of PT to improve biomechanics of the affected shoulder. The PNS+ sham-PT group will receive active PNS therapy and sham-PT, consisting of placebo ultrasound, application of inert gel, lower limb strengthening, and walking exercises. The sham-PNS + PT group will receive a percutaneous lead in a similar manner as the active therapy groups, but with sham-stimulation, along with 8 sessions of PT. Measures of pain, pain interference with ADLs, QoL, shoulder biomechanics (shoulder abduction torque, shoulder kinematics, and Fugl-Meyer score), and measures of central sensitization (pain thresholds, secondary hyperalgesia, and temporal summation) will be assessed at baseline and at weeks 4 (end of treatment), 8, 12, 16, 20, 24, and 28.

Eligibility criteria: 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.

Primary outcomes:
measure: Brief Pain Inventory (BPI)- Short Form (SF) question 3 (BPI-SF3)
timeFrame: Prior 7-days
Secondary outcomes:
Other outcomes:
measure: Adverse Events (Related)
timeFrame: Week 2 - Week 5
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Abilitylab
state: Illinois
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Richard D Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson RD, Gunzler DD, Bennett ME, Chae J. Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. Am J Phys Med Rehabil. 2014 Jan;93(1):17-28. doi: 10.1097/PHM.0000000000000011.
citation: Chae J, Ng A, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Intramuscular electrical stimulation for shoulder pain in hemiplegia: does time from stroke onset predict treatment success? Neurorehabil Neural Repair. 2007 Nov-Dec;21(6):561-7. doi: 10.1177/1545968306298412. Epub 2007 Mar 16.
citation: Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Mar 26.
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citation: Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005 Nov;84(11):832-42. doi: 10.1097/01.phm.0000184154.01880.72.
citation: Wilson RD, Bennett ME, Lechman TE, Stager KW, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Arch Phys Med Rehabil. 2011 May;92(5):837-40. doi: 10.1016/j.apmr.2010.11.003.
citation: Yu DT, Chae J, Walker ME, Fang ZP. Percutaneous intramuscular neuromuscular electric stimulation for the treatment of shoulder subluxation and pain in patients with chronic hemiplegia: a pilot study. Arch Phys Med Rehabil. 2001 Jan;82(1):20-5. doi: 10.1053/apmr.2001.18666.
citation: Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular neuromuscular electric stimulation for poststroke shoulder pain: a multicenter randomized clinical trial. Arch Phys Med Rehabil. 2004 May;85(5):695-704. doi: 10.1016/j.apmr.2003.07.015.
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citation: Soo Hoo J, Paul T, Chae J, Wilson RD. Central hypersensitivity in chronic hemiplegic shoulder pain. Am J Phys Med Rehabil. 2013 Jan;92(1):1-9; quiz 10-3. doi: 10.1097/PHM.0b013e31827df862.
citation: Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014 Dec;17(8):771-6; discussion 776. doi: 10.1111/ner.12152. Epub 2014 Feb 11.
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