Trial Outcomes & Findings for Peripheral Nerve Stimulation for Shoulder Pain: Dose Response (NCT NCT02928055)
NCT ID: NCT02928055
Last Updated: 2021-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
End of Treatment (EOT), EOT + 3 mo
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
PNS (3 hr/Day)
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.
|
PNS (6 hr/Day)
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.
|
PNS (9 hr/Day)
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
7
|
|
Overall Study
End of Treatment
|
8
|
8
|
6
|
|
Overall Study
1 Month Follow up
|
7
|
7
|
6
|
|
Overall Study
2 Month Follow up
|
6
|
7
|
5
|
|
Overall Study
3 Month Follow up
|
5
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response
Baseline characteristics by cohort
| Measure |
PNS (3 hr/Day)
n=8 Participants
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.
|
PNS (6 hr/Day)
n=8 Participants
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.
|
PNS (9 hr/Day)
n=7 Participants
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.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
55.75 years
STANDARD_DEVIATION 6.25 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
62.86 years
STANDARD_DEVIATION 5.64 • n=5 Participants
|
58.52 years
STANDARD_DEVIATION 7.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (EOT), EOT + 3 moPopulation: numbers analyzed differ at 3 month follow up due to study drop out of some subjects at 3 month follow up
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.
Outcome measures
| Measure |
PNS (3 hr/Day)
n=8 Participants
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.
|
PNS (6 hr/Day)
n=8 Participants
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.
|
PNS (9 hr/Day)
n=7 Participants
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.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3)
End of Treatment Score
|
5.6 score on a scale
Interval 2.0 to 9.0
|
6 score on a scale
Interval 3.0 to 10.0
|
5.67 score on a scale
Interval 2.0 to 9.0
|
|
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3)
3 month follow up score
|
6.5 score on a scale
Interval 5.0 to 8.0
|
5.2 score on a scale
Interval 0.0 to 10.0
|
4.4 score on a scale
Interval 3.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 moRelated adverse events are documented as Safety data.
Outcome measures
Outcome data not reported
Adverse Events
PNS (3 hr/Day)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
PNS (6 hr/Day)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
PNS (9 hr/Day)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PNS (3 hr/Day)
n=8 participants at risk
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.
|
PNS (6 hr/Day)
n=8 participants at risk
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.
|
PNS (9 hr/Day)
n=7 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall with injury
|
0.00%
0/8 • 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
|
12.5%
1/8 • Number of events 1 • 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
|
0.00%
0/7 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
other medical condition: Cancer
|
25.0%
2/8 • Number of events 2 • 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
|
0.00%
0/8 • 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
|
0.00%
0/7 • 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
|
|
Musculoskeletal and connective tissue disorders
Orthopedic surgery
|
0.00%
0/8 • 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
|
12.5%
1/8 • Number of events 1 • 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
|
0.00%
0/7 • 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
|
|
Psychiatric disorders
Anxiety(psychosocial)
|
12.5%
1/8 • Number of events 1 • 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
|
0.00%
0/8 • 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
|
0.00%
0/7 • 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
|
Other adverse events
| Measure |
PNS (3 hr/Day)
n=8 participants at risk
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.
|
PNS (6 hr/Day)
n=8 participants at risk
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.
|
PNS (9 hr/Day)
n=7 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation at Bandage site
|
62.5%
5/8 • Number of events 5 • 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
|
25.0%
2/8 • Number of events 3 • 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
|
57.1%
4/7 • Number of events 4 • 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
|
|
Skin and subcutaneous tissue disorders
Skin Irritation under Sprint Pad
|
12.5%
1/8 • Number of events 1 • 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
|
12.5%
1/8 • Number of events 1 • 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
|
0.00%
0/7 • 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
|
|
Skin and subcutaneous tissue disorders
Retained Lead Fragment
|
12.5%
1/8 • Number of events 1 • 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
|
12.5%
1/8 • Number of events 1 • 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
|
0.00%
0/7 • 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
|
|
Skin and subcutaneous tissue disorders
Accidental dislodgment of Lead
|
25.0%
2/8 • Number of events 2 • 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
|
25.0%
2/8 • Number of events 3 • 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
|
14.3%
1/7 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
Fall with injury
|
12.5%
1/8 • Number of events 1 • 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
|
25.0%
2/8 • Number of events 2 • 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
|
14.3%
1/7 • Number of events 1 • 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
|
|
Skin and subcutaneous tissue disorders
Skin Irritation at electrode site
|
12.5%
1/8 • Number of events 1 • 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
|
25.0%
2/8 • Number of events 2 • 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
|
28.6%
2/7 • Number of events 2 • 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
|
|
Musculoskeletal and connective tissue disorders
Arm fatigue/weakness/pain
|
0.00%
0/8 • 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
|
0.00%
0/8 • 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
|
28.6%
2/7 • Number of events 2 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place