An interventional study of Peripheral Nerve Stimulation in Stroke and Shoulder Pain, sponsored by MetroHealth Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment
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.
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.
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Exclusion Criteria:
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.
Device: Peripheral Nerve Stimulation
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.
Device: Peripheral Nerve Stimulation
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.
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 (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.
Also known as: Intramuscular Peripheral Nerve Stimulation, Intramuscular Electrical Nerve Stimulation, Smartpatch System
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3)
Brief Pain Inventory(BPI) 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." A lower score is better.
Time frame: End of Treatment (EOT), EOT + 3 mo
Adverse Events (Related)
Related adverse events are documented as Safety data.
Time frame: Electrode Implant, Start of Stimulation, 1 week after start of stimulation, 2 weeks after start of stimulation, end of treatment (EOT), EOT + 1mo, EOT + 2 mo, EOT + 3 mo
| Milestone | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) |
|---|---|---|---|
| Started | 8 | 8 | 7 |
| End of treatment | 8 | 8 | 6 |
| 1 month follow up | 7 | 7 | 6 |
| 2 month follow up | 6 | 7 | 5 |
| 3 month follow up | 5 | 6 | 5 |
| Completed | 5 | 6 | 5 |
| Not completed | 3 | 2 | 2 |
Brief Pain Inventory(BPI) 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." A lower score is better.
| score on a scale | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) |
|---|---|---|---|
| End of Treatment Score | 5.6 (2 to 9) | 6 (3 to 10) | 5.67 (2 to 9) |
| 3 month follow up score | 6.5 (5 to 8) | 5.2 (0 to 10) | 4.4 (3 to 8) |
Related adverse events are documented as Safety data.
Results for this outcome have not been posted.
Collected over adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +3 months, an average of 4 months per participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PNS (3 hr/Day) | 0/8 (0%) | 3/8 (37.5%) | 6/8 (75%) |
| PNS (6 hr/Day) | 0/8 (0%) | 2/8 (25%) | 6/8 (75%) |
| PNS (9 hr/Day) | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Event | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) |
|---|---|---|---|
| other medical condition: CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/8 | 0/8 | 0/7 |
| Fall with injuryMusculoskeletal and connective tissue disorders | 0/8 | 1/8 | 0/7 |
| Orthopedic surgeryMusculoskeletal and connective tissue disorders | 0/8 | 1/8 | 0/7 |
| Anxiety(psychosocial)Psychiatric disorders | 1/8 | 0/8 | 0/7 |
| Event | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) |
|---|---|---|---|
| Skin Irritation at Bandage siteSkin and subcutaneous tissue disorders | 5/8 | 2/8 | 4/7 |
| Skin Irritation at electrode siteSkin and subcutaneous tissue disorders | 1/8 | 2/8 | 2/7 |
| Arm fatigue/weakness/painMusculoskeletal and connective tissue disorders | 0/8 | 0/8 | 2/7 |
| Accidental dislodgment of LeadSkin and subcutaneous tissue disorders | 2/8 | 2/8 | 1/7 |
| Fall with injuryMusculoskeletal and connective tissue disorders | 1/8 | 2/8 | 1/7 |
| Skin Irritation under Sprint PadSkin and subcutaneous tissue disorders | 1/8 | 1/8 | 0/7 |
| Retained Lead FragmentSkin and subcutaneous tissue disorders | 1/8 | 1/8 | 0/7 |
| Age, Categorical(Participants) | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 7 | 4 | 19 |
| >=65 years | 0 | 1 | 3 | 4 |
| Age, Continuous(years) | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) | Total |
|---|---|---|---|---|
| Mean | 55.75 ± 6.25 | 57.5 ± 8.64 | 62.86 ± 5.64 | 58.52 ± 7.35 |
| Sex: Female, Male(Participants) | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) | Total |
|---|---|---|---|---|
| Female | 5 | 4 | 3 | 12 |
| Male | 3 | 4 | 4 | 11 |
| Ethnicity (NIH/OMB)(Participants) | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 8 | 8 | 6 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 4 | 4 | 2 | 10 |
| White | 3 | 4 | 5 | 12 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | PNS (3 hr/Day) | PNS (6 hr/Day) | PNS (9 hr/Day) | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 7 | 23 |
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