Peripheral Nerve Stimulation for Shoulder Pain: Dose Response

NCT ID: NCT02928055

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-10-30

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.

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.

Conditions

Stroke; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Intramuscular Peripheral Nerve Stimulation; Intramuscular Electrical Nerve Stimulation; Smartpatch System

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 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard Wilson, MD

Assistant Professor, Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard D Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24355994 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17369520 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22448759 (View on PubMed)

Chae J, Yu D, Walker M. Percutaneous, intramuscular neuromuscular electrical stimulation for the treatment of shoulder subluxation and pain in chronic hemiplegia: a case report. Am J Phys Med Rehabil. 2001 Apr;80(4):296-301. doi: 10.1097/00002060-200104000-00014.

Reference Type: BACKGROUND

PMID: 11277137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16244520 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21530732 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11239281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15129391 (View on PubMed)

Yu DT, Chae J, Walker ME, Hart RL, Petroski GF. Comparing stimulation-induced pain during percutaneous (intramuscular) and transcutaneous neuromuscular electric stimulation for treating shoulder subluxation in hemiplegia. Arch Phys Med Rehabil. 2001 Jun;82(6):756-60. doi: 10.1053/apmr.2001.23310.

Reference Type: BACKGROUND

PMID: 11387579 (View on PubMed)

Koog YH, Jin SS, Yoon K, Min BI. Interventions for hemiplegic shoulder pain: systematic review of randomised controlled trials. Disabil Rehabil. 2010;32(4):282-91. doi: 10.3109/09638280903127685.

Reference Type: BACKGROUND

PMID: 20055567 (View on PubMed)

Snels IA, Beckerman H, Lankhorst GJ, Bouter LM. Treatment of hemiplegic shoulder pain in the Netherlands: results of a national survey. Clin Rehabil. 2000 Feb;14(1):20-7. doi: 10.1191/026921500668239146.

Reference Type: BACKGROUND

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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.

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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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Wilson RD, Harris MA, Bennett ME, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of shoulder pain from subacromial impingement syndrome. PM R. 2012 Aug;4(8):624-8. doi: 10.1016/j.pmrj.2012.03.002.

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Provided Documents

Document Type: Study Protocol

View Document

Related Links

http://fescenter.org/index.php

Cleveland FES Center

http://www.metrohealth.org

The MetroHealth System - Clinical Trials

Other Identifiers

R01HD075542

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB16-00510

Identifier Type: -

Identifier Source: org_study_id