N/A
N=28
Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain
Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT01094301 ↗Enrolled (actual)
28
Serious AEs
17.9%
Results posted
Sep 2018
Primary outcome: Primary: Pain Intensity (Trial Stage) — 8.2; 6.1; 5.0; 2.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The SPR System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- SPR Therapeutics, Inc.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity (Trial Stage) |
8.2; 6.1; 5.0; 2.1; 1.0; 3.1 | — |
| PRIMARY Pain Intensity (Implant Stage) |
2.0; 0.3; 0.4; 1.6; 0.6; 0.8 | — |
| PRIMARY Device-Related Adverse Events |
20; 8 | — |
| PRIMARY Number of Subjects Who Were a Trial Stage Success |
13 | — |
| PRIMARY Number of Subjects Who Were an Implant Stage Success |
5 | — |
| SECONDARY Pain Interference (Trial Stage) |
6.2; 4.7; 3.2; 1.3; 2.9 | — |
| SECONDARY Pain-Free Passive Range of Motion (Trial Stage) |
89.8; 102.8; 119.5; 17.5; 31.2 | — |
| SECONDARY Quality of Life (Trial Stage) |
32.2; 36.2; 39.4; 3.4; 29.8; 30.7 | — |
| SECONDARY Number of Participants Completing the Economic Impact Survey |
25; 3 | — |
| SECONDARY Emotional Functioning (Trial Stage) |
13.4; 14.8; 12.9; 1.6; 0 | — |
| SECONDARY User Satisfaction (Trial Stage) |
18; 19; 20 | — |
| SECONDARY Global Impact of Stimulation Therapy (Trial Stage) |
0; 0; 0; 5; 17; 4 | — |
| SECONDARY Quality of Life (Implant Stage) |
42.6; 46.7; 45.1; 43.7; 50.1; 38.3 | — |
| SECONDARY Pain Interference (Implant Stage) |
0.5; 0.1; 0.2; 0.3; 0.1; 0.1 | — |
| SECONDARY Pain-Free Passive Range of Motion (Implant Stage) |
125.2; 119.8; 141.2; 146.6; 151.4 | — |
| SECONDARY Emotional Functioning (Implant Stage) |
10.2; 8.4; 10.6; 12.4; 12.6 | — |
| SECONDARY Global Impact of Stimulation Therapy (Implant Stage) |
0; 0; 0; 0; 3; 1 | — |
| SECONDARY User Satisfaction (Implant Stage) |
5; 5; 5; 5; 5; 5 | — |
| SECONDARY Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage) |
3.8; 3.7; 3.3 | — |
Summary
Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.
Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.
Eligibility Criteria
Trial Stage Inclusion Criteria:
- At least 21 years of age
- Post-stroke shoulder pain
Trial Stage Exclusion Criteria:
- Use of habit-forming (narcotic) medications
- History of recurrent skin infections
- Bleeding disorder
- Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome
- Heart arrhythmia or artificial heart valves
- Uncontrolled seizures
- Implanted Electronic Device
Implant Stage Inclusion Criteria
- Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4
Data sourced from ClinicalTrials.gov (NCT01094301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.