Trial Outcomes & Findings for Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS) (NCT NCT03752619)
NCT ID: NCT03752619
Last Updated: 2025-06-17
Results Overview
The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
COMPLETED
NA
116 participants
Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment
2025-06-17
Participant Flow
Recruitment process at MetroHealth and UTSW included the clinics of the investigators and via referral from the PM\&R and orthopedic clinics at each institution. Additionally potential participants were recruited from local area via approved recruitment strategies.
no pre assignment conditions were used. Subject who met the inclusion and exclusion criteria for the study were enrolled and randomized to a treatment group.
Participant milestones
| Measure |
Contraction Producing Peripheral Nerve Stimulation
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
56
|
|
Overall Study
COMPLETED
|
57
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Contraction Producing Peripheral Nerve Stimulation
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Baseline characteristics by cohort
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 Participants
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 Participants
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Total
n=116 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
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
Mean Age
|
55.6 years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 13.84 • n=7 Participants
|
54.35 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
56 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Short Form (SF) Question 3 (BPI-SF3)
|
6.90 units on a scale
STANDARD_DEVIATION 1.76 • n=5 Participants
|
7.05 units on a scale
STANDARD_DEVIATION 1.72 • n=7 Participants
|
6.97 units on a scale
STANDARD_DEVIATION 1.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatmentPopulation: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
Outcome measures
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 Participants
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 Participants
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Change in - Short Form (SF) Question 3 (BPI-SF3)
Baseline(week 1)
|
6.90 units on a scale
Standard Deviation 1.76
|
7.05 units on a scale
Standard Deviation 1.72
|
|
Change in - Short Form (SF) Question 3 (BPI-SF3)
End of treatment (week 9)
|
3.58 units on a scale
Standard Deviation 2.59
|
3.96 units on a scale
Standard Deviation 2.41
|
|
Change in - Short Form (SF) Question 3 (BPI-SF3)
12 week post treatment
|
3.51 units on a scale
Standard Deviation 2.90
|
3.53 units on a scale
Standard Deviation 2.69
|
|
Change in - Short Form (SF) Question 3 (BPI-SF3)
24 weeks post treatment
|
3.04 units on a scale
Standard Deviation 2.63
|
3.51 units on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatmentPopulation: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders.The assessor measures the amount of time that the participant is able to perform each task using a stop watch. The task is completed 3 times- waist level, shoulder level, and eye level. Each task is continued for a maximum of 300 seconds or until a stopping criteria is reached. An overall summary score is calculated by averaging the time for the 3 tasks. Higher numbers indicate higher capacity (range 0-300 seconds).
Outcome measures
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 Participants
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 Participants
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
Baseline(week 1)
|
105.76 Time in seconds
Standard Deviation 82.76
|
129.95 Time in seconds
Standard Deviation 75.41
|
|
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
End of treatment (week 9)
|
146.96 Time in seconds
Standard Deviation 79.27
|
168.32 Time in seconds
Standard Deviation 83.70
|
|
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
12 week post treatment
|
140.33 Time in seconds
Standard Deviation 86.54
|
175.31 Time in seconds
Standard Deviation 81.13
|
|
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
24 weeks post treatment
|
154.36 Time in seconds
Standard Deviation 82.88
|
173.61 Time in seconds
Standard Deviation 76.76
|
SECONDARY outcome
Timeframe: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatmentPopulation: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The questions ask severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: \_\_\_\_\_/ 80 x 100 = %. Total SPADI score: \_\_\_\_\_ 130 x 100 = % Higher numbers indicate a higher level of disability (range 0-100%).
Outcome measures
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 Participants
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 Participants
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
Baseline(week 1)
|
48.97 percentage of total disability
Standard Deviation 22.19
|
41.30 percentage of total disability
Standard Deviation 20.57
|
|
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
End of treatment (week 9)
|
25.78 percentage of total disability
Standard Deviation 22.49
|
21.76 percentage of total disability
Standard Deviation 21.07
|
|
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
12 week post treatment
|
23.52 percentage of total disability
Standard Deviation 23.64
|
18.88 percentage of total disability
Standard Deviation 21.73
|
|
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
24 weeks post treatment
|
21.90 percentage of total disability
Standard Deviation 22.03
|
20.75 percentage of total disability
Standard Deviation 21.30
|
SECONDARY outcome
Timeframe: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatmentPopulation: Numbers of analyzed different between visit due to subject withdrawal, subject compliance.
Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role. Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100 with higher scores indicating better health.
Outcome measures
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 Participants
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 Participants
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Change in Quality of Life - Short Form - 12(QoL - SF 12)
Baseline (week 1)
|
38.43 units on a scale
Standard Deviation 7.90
|
39.72 units on a scale
Standard Deviation 8
|
|
Change in Quality of Life - Short Form - 12(QoL - SF 12)
End of Treatment(week 5)
|
44.67 units on a scale
Standard Deviation 9.48
|
45.85 units on a scale
Standard Deviation 8.56
|
|
Change in Quality of Life - Short Form - 12(QoL - SF 12)
12 weeks post treatment
|
45.63 units on a scale
Standard Deviation 8.56
|
46.39 units on a scale
Standard Deviation 9.54
|
|
Change in Quality of Life - Short Form - 12(QoL - SF 12)
24 weeks post treatment
|
46.97 units on a scale
Standard Deviation 9.32
|
46.94 units on a scale
Standard Deviation 8.99
|
Adverse Events
Contraction Producing Peripheral Nerve Stimulation
Non Contracting Producing Peripheral Nerve Stimulation
Serious adverse events
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 participants at risk
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 participants at risk
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
other Musculoskeletal Injury
|
0.00%
0/60 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
5.4%
3/56 • Number of events 3 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
|
Infections and infestations
other Infection
|
0.00%
0/60 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
1.8%
1/56 • Number of events 1 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
|
Cardiac disorders
Other Medical condition
|
1.7%
1/60 • Number of events 1 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
1.8%
1/56 • Number of events 1 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
|
Psychiatric disorders
Mental Health Concerns
|
1.7%
1/60 • Number of events 2 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
0.00%
0/56 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
Other adverse events
| Measure |
Contraction Producing Peripheral Nerve Stimulation
n=60 participants at risk
This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
Non Contracting Producing Peripheral Nerve Stimulation
n=56 participants at risk
This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
45.0%
27/60 • Number of events 44 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
37.5%
21/56 • Number of events 32 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
|
Musculoskeletal and connective tissue disorders
Other Musculoskeletal pain/injury
|
21.7%
13/60 • Number of events 15 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
25.0%
14/56 • Number of events 16 • adverse Event were collected for the time frame subject was enrolled in the study. Eligibility through EOT +6 months, an average of 7 months per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place