An Implantable Microstimulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Shoulder Pain Chronic Clinical Trial

— BBPM  

Official title:

Feasibility Study of the Bioness Battery-Powered Microstimulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567541
• Other study ID #: CP-BBPM-001
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2007
• Last updated: August 18, 2015
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Bioness Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goal of this research study is to investigate the safety and effectiveness of a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.

Description:

This is a prospective, dual-center, randomized, controlled, double-blinded parallel study designed to evaluate the feasibility and safety of using the The primary purpose of this study is to demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the treatment of chronic, intractable, pain in this case represented by chronic regional shoulder pain in hemiplegic stroke patients. This is a 48-week study with a two-year follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Chronic post-stroke duration greater than or equal to 6 months

• Unilateral hemiplegic shoulder pain persisting for =6 months

• Hemiparesis (shoulder abduction graded <5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has chronic pain

• Shoulder pain = 6/10 (on 0-10 numeric rating scale (NRS) for worst pain in last week (BPI #12))

• Ability to give informed consent and understand study requirements

• Ability to quantify pain using a 0-10 numeric rating scale. (A screening tool will be used to ensure that participants can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other.)

• Willing and able to understand and comply with all study-related procedures during the course of the study

• Motivated to maintain an accurate diary for the study duration

Exclusion Criteria:

• Hemineglect (i.e., extinguish to double simultaneous stimulation)

• Shoulder trauma or diagnosed shoulder pathology prior to stroke; history of any shoulder surgery, regardless of whether procedure preceded for followed stroke.

• Need to take >1 pain medication (opioid or non-opioid) for shoulder pain

• Regular use of pain medication for chronic pain other than shoulder pain

• Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder

• Unable, per their prescribing physician, to stop antiplatelet medications (e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)) for at least 7 days prior to device implantation.

• Cardiac pacemaker

• Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve) or implanted pump or infusion device

• Prosthetic heart valve or valvular heart disease requiring antibiotic prophylaxis

• History of cardiac arrhythmia with hemodynamic instability

• Uncontrolled seizures (> 1 seizure per month)

• Pregnant or plan on becoming pregnant during the study period

• Medical instability

• Currently require, or likely to require, diathermy

• Currently require, or anticipated to require, MRI within 8 weeks of projected device implantation date

• History of adverse reactions to local anesthetic (e.g., lidocaine)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain
• Shoulder Pain Chronic

Intervention

Device:
• Battery Powered Microstimulator (BBPM)
The Battery Powered Microstimulator (BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.

Locations

Country	Name	City	State
United States	The Center for Pain Relief	Charleston	West Virginia
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bioness Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the feasibility of using the BBPM for treatment of chronic shoulder pain as evidenced by appropriate muscular contraction and/or paresthesias with no significant adverse events.		From baseline to follow up	Yes
Secondary	Greater than 30% Pain Reduction measured by using Brief Pain Inventory (BPI #12) at each time point without increasing pain medication -Range of motion will be quantified using a goniometer -Motor functions will be measured by Fugl-Meyer Test		From baseline to follow-up	No
Secondary	Range of Motion: pain-free passive shoulder abduction, flexion and external rotation will be quantified.		baseline to end of study	No
Secondary	-Interference of shoulder pain in daily activities and function measured by using BPI#23 -Quality of Life assessed by using he EuroQol -Reported use of pain medication -Examined for shoulder subluxation -Examined for cutaneous shoulder sensation		baseline to end of study	Yes