Electrical Stimulation for Hemiplegic Shoulder Pain

NCT01123382 | Completed Results

• 1 other identifier: R01HD059777
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain has been difficult. In order to address the limitations of surface ES, the investigative team pioneered the development of percutaneous intramuscular (IM) ES for the treatment of post-stroke shoulder pain. However, prior to acceptance by the clinical community, additional gaps in the scientific and clinical knowledge need to be addressed. This study begins to do so. The primary objective is to estimate the relative pain reduction associated with IM ES vs. "usual care." We hypothesize that the IM ES group will exhibit a larger effect size with respect to pain reduction compared to "usual care". A secondary objective is to estimate the effect on health related QOL of IM ES vs. "usual care." Demonstration of improvement in QOL will validate the clinical relevance of the intervention. We hypothesize that the IM ES group will exhibit greater improvement in health related QOL compared to "usual care".

Conditions

Stroke; Shoulder Pain

Keywords

Stroke; Shoulder pain; Electrical stimulation; Neuromuscular stimulation; Intramuscular stimulation

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory Short Form

  The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.

  Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)

Secondary Outcomes (8)

• ShoulderQ VGRS Scale

  Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)

• SF-36 Bodily Pain Component

  Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)

• Pain-free External ROM, Degrees

  Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)

• Fugl-Myer Motor Assessment (FMA) - Upper Extremity

  Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)

• Pain Interference Questionnaire

  Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)

Study Arms (2)

IM Electrical Stimulation (IM ES)

EXPERIMENTAL

The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.

Device: Intramuscular Electrical Stimulator

Usual Care (UC)

ACTIVE COMPARATOR

The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.

Other: Outpatient Therapy

Interventions

Intramuscular Electrical Stimulator DEVICE

A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed. Total time of electrode implantation is no more than 29 days.

IM Electrical Stimulation (IM ES)

Outpatient Therapy OTHER

Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.

Usual Care (UC)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder pain localized to the glenohumeral joint, subacromial area or deltoid insertion associated with any of the following conditions: a) rest; b) passive abduction or external rotation ROM; c) active abduction or external rotation ROM; or d) manual palpation
• weakness of shoulder abductors (≤4/5 on MRC if isolated movement is present)
• age ≥21-yrs
• time from stroke ≥ 3-mo
• shoulder pain onset after the most recent stroke
• duration of shoulder pain ≥ 3-mo
• severity of shoulder pain on BPI-SF 3 ≥4
• cognitive ability to fulfill study requirements \[a) exhibit 3 object immediate and 30 minute recall; b) ability to use a numeric rating scale (using a 0-10 numeric rating scale) by correctly ranking the tightness they feel on the unaffected arm of 3 low-pressure inflations with a standard sphygmomanometer cuff which follow a predetermined sequence (20, 40 and 0 mm Hg); and c) ability to follow 3-stage commands\]
• availability of a reliable adult who can check the skin and assist the participant with the treatment protocol
• willing and able to report severity of shoulder pain throughout the study period
• willing to make all scheduled study visits post-implantation.

You may not qualify if:

• evidence of joint or overlying skin infection
• insensate skin
• \>1 opioid or nonopioid analgesics daily for shoulder pain
• daily intake of pain medications for any other chronic pain
• intra-articular or subacromial steroid injections to the shoulder in the previous 12-wks
• botulinum toxin injection to the trapezius, pectoralis or subscapularis muscle in the previous 12-wks
• receiving physical or occupational therapies for shoulder pain
• physician-diagnosed shoulder pathology symptomatic within the 5 yrs prior to CVA
• bleeding disorder
• INR\>3.0 for those on warfarin \[INR\>3.0\]
• poorly controlled diabetes \[HbA1c\>7.0\]
• medical instability
• pregnancy
• uncontrolled seizures (\>1/mo for 6-mo)
• uncompensated hemi-neglect

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (5)

• 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.

  PMID: 11239281 BACKGROUND

• 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.

  PMID: 15129391 BACKGROUND

• 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.

  PMID: 16244520 BACKGROUND

• 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.

  PMID: 17369520 BACKGROUND

• 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.

  PMID: 24355994 DERIVED

Related Links

• Cleveland FES Center
• The MetroHealth System - Clinical Trials

MeSH Terms

Conditions

Stroke; Shoulder Pain

Interventions

Home Infusion Therapy

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Richard WIlson, MD
• Organization: MetroHealth Medical Center

rwilson@metrohealth.org

216-957-3559

Study Officials

• John Chae, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Vice Chair Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 23, 2018
• Results First Posted: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)