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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response

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ClinicalTrials.gov Identifier: NCT02928055
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
Richard Wilson, MetroHealth Medical Center

Brief Summary:
The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain (HSP) reduction due to treatment with peripheral nerve stimulation. We will explore the association of subject-specific clinical and demographic information and pain relief from PNS. We will explore the possible role of central sensitization mechanisms in perpetuating pain via measures of sensory and pain perception. Lastly, we will explore the dose-response association of muscle-contraction from PNS and pain reduction, completion of activities of daily living (ADLs), and improvement in quality of life.

Condition or disease Intervention/treatment Phase
Stroke Shoulder Pain Device: Peripheral Nerve Stimulation Not Applicable

Detailed Description:

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. The deltoid muscle is stimulated for 6 hours per day for 3 weeks, causing comfortable, non-fatiguing contractions. This treatment, which occurs in the community setting, results in pain relief for up to 12 months when compared to treatment with a hemisling. A systematic review of randomized controlled trials (RCT) with pain as the primary outcome concluded that intramuscular PNS was the only treatment to provide long-term relief of pain for those with HSP. We have completed two RCTs that have demonstrated that a short-term PNS treatment (i.e., 3 or 6 weeks) provides pain relief. The first trial demonstrated efficacy in long-term pain relief in more than 60% of subjects for greater than 12 months. The second trial corroborated the finding that more than 60% of subjects receiving PNS achieved long-term pain reduction, and also showed that PNS reduces pain more than that achieved with physical therapy. The mechanism of action of PNS in reduction of HSP is not yet known. Thus, the primary objective of this RCT is explore the mechanism for HSP reduction.

The mechanisms behind PNS for the treatment of HSP are not known. First, individual variation may contribute to response to PNS, thus we will explore the association of subject-specific clinical and demographic information and pain relief from PNS. Secondly, our team and others have found that in the chronic stage central sensitization mechanisms may also have a role in perpetuating pain, as it does in other forms of chronic shoulder pain. These mechanisms will be explored via measures of sensory and pain perception. Finally, our approach to delivering PNS for HSP is different from other treatments in which PNS is delivered through skin surface electrodes (e.g., transcutaneous electrical nerve stimulation or TENS) in that our treatment produces repeated muscle contraction over the course of weeks. Treatments such as TENS generates tingling sensations (paresthesias) over the painful area, and pain relief following stimulation is short-lived, seldom lasting more than a few hours. We postulate that long-term pain relief for HSP after PNS treatment is due to the repeated muscle contraction that occurs daily over the course of treatment, thus we will explore the dose-response association of muscle-contraction from PNS and pain reduction, completion of activities of daily living (ADLs), and improvement in quality of life.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implanted PNS for Shoulder Pain in Stroke
Study Start Date : October 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: PNS (3 hr/day)
The PNS (3 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (3 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Device: Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.
Other Names:
  • Intramuscular Peripheral Nerve Stimulation
  • Intramuscular Electrical Nerve Stimulation
  • Smartpatch System

Experimental: PNS (6 hr/day)
The PNS (6 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Device: Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.
Other Names:
  • Intramuscular Peripheral Nerve Stimulation
  • Intramuscular Electrical Nerve Stimulation
  • Smartpatch System

Experimental: PNS (9 hr/day)
The PNS (9 hr/day) Group will receive peripheral nerve stimulation treatment for three weeks (9 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Device: Peripheral Nerve Stimulation
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.
Other Names:
  • Intramuscular Peripheral Nerve Stimulation
  • Intramuscular Electrical Nerve Stimulation
  • Smartpatch System




Primary Outcome Measures :
  1. Brief Pain Inventory (BPI)- Short Form (SF) question 3 (BPI-SF3) [ Time Frame: Prior 7-days ]
    Brief Pain Inventory Short Form 3: The BPI has excellent psychometrics and is recommended for the assessment of pain in clinical trials. The developers of the BPI recommend BPI SF-3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 7-d on a 0 to 10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."


Other Outcome Measures:
  1. Adverse Events (Related) [ Time Frame: Week 2 - Week 5 ]
    Related adverse events are documented as Safety data.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 MRC 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 wks;
  • receiving OT or PT for HSP;
  • bleeding disorder or 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, SCI, TBI, MS, or ipsilateral 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928055


Contacts
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Contact: Kristine Hansen, PT 216-778-5347 khansen1@metrohealth.org

Locations
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United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Kristine Hansen, PT    216-778-5347    khansen1@metrohealth.org   
Principal Investigator: Richard D Wilson, MD         
Sub-Investigator: John Chae, MD         
Sponsors and Collaborators
MetroHealth Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Investigators
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Principal Investigator: Richard D Wilson, MD MetroHealth Medical Center

Additional Information:
Publications:

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Responsible Party: Richard Wilson, Assistant Professor, Physical Medicine and Rehabilitation, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT02928055     History of Changes
Other Study ID Numbers: IRB16-00510
R01HD075542 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Richard Wilson, MetroHealth Medical Center:
Stroke
Shoulder Pain
Electrical stimulation
Neuromuscular stimulation
Intramuscular stimulation

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