Shoulder Pain Chronic
Conditions
Keywords
shoulder, pain, stroke, subluxation
Brief summary
The goal of this research study is to investigate safety and gather initial effectiveness data for 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 possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
Detailed description
This is a prospective, multi-center, randomized, controlled, double-blinded parallel study designed to evaluate feasibility and safety. 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 efficacy study with safety data collection throughout the study period and up to 2 years for all available subjects. Each study arm will receive therapeutic level stimulation for a total of 12 consecutive weeks (Weeks 1-12 for Active treatment group and Weeks 24-36 for the sham group) during the 48 weeks.
Interventions
DEVICEBattery Powered Microneuromodulator (BBPM)
The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).
Sponsors
Bioness Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of Chronic Shoulder Pain | From baseline to 48 week follow up | Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active BBPM Stimulation Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. | 7 |
| Sham BBPM Stimulation Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is 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, the device will be reprogrammed to deliver therapeutic stimulation. | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Active BBPM Stimulation | Sham BBPM Stimulation | Total |
|---|---|---|---|
| Age, Customized 35-55 years old | 1 participants | 3 participants | 4 participants |
| Age, Customized 56-80 years old | 6 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized non-white | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized white | 5 participants | 7 participants | 12 participants |
| Region of Enrollment United States | 7 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 7 | 9 / 9 |
| serious Total, serious adverse events | 2 / 7 | 6 / 9 |
Outcome results
Primary
Relief of Chronic Shoulder Pain
Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.
Time frame: From baseline to 48 week follow up
Population: Intent to Treat population was analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active BBPM Stimulation | Relief of Chronic Shoulder Pain | 0 participants |
| Sham BBPM Stimulation | Relief of Chronic Shoulder Pain | 0 participants |