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Multimodal Treatment for Hemiplegic Shoulder Pain

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ClinicalTrials.gov Identifier: NCT02893267
Recruitment Status : Recruiting
First Posted : September 8, 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
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Richard Wilson, MetroHealth Medical Center

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.


Condition or disease Intervention/treatment Phase
Stroke Shoulder Pain Device: Peripheral Nerve Stimulation Other: Physical Therapy Other: Sham-PT Device: Sham-PNS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Treatment for Hemiplegic Shoulder Pain
Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: PNS + PT
The PNS+PT Group will receive peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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

Other: Physical Therapy
Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.

Active Comparator: PNS + sham-PT
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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

Other: Sham-PT
Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist and study staff in a therapeutic environment. Participants will undergo a hands-on evaluation and re-evaluation before and after treatment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.

Active Comparator: sham-PNS + PT
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Other: Physical Therapy
Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.

Device: Sham-PNS
The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.




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.



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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 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.

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): NCT02893267


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

Locations
United States, Illinois
Shirley Ryan Abilitylab Recruiting
Chicago, Illinois, United States, 60611
Contact: Sneha Solanki    312-238-3647    ssolanki02@sralab.org   
Principal Investigator: Richard L Harvey, MD         
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         
Sponsors and Collaborators
MetroHealth Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Shirley Ryan AbilityLab
Investigators
Principal Investigator: Richard D Wilson, MD MetroHealth Medical Center

Additional Information:
Publications:

Responsible Party: Richard Wilson, Assistant Professor, Physical Medicine and Rehabilitation, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT02893267     History of Changes
Other Study ID Numbers: IRB16-00172
R01HD084564 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms