Trial Outcomes & Findings for Multimodal Treatment for Hemiplegic Shoulder Pain (NCT NCT02893267)
NCT ID: NCT02893267
Last Updated: 2025-12-22
Results Overview
Brief Pain Inventory 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." Lower score means better outcome Baseline is absolute value and change value is reported for 4 weeks, 16 weeks and 28 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
Baseline, 4 weeks(end of treatment), 16 weeks, 28 weeks
Results posted on
2025-12-22
Participant Flow
Participant milestones
| Measure |
PNS + PT
The PNS+PT Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1 week electrode stabilization period,and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same 4 week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip.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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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. Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positionand Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
|
PNS + Sham-PT
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment for 3weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as appropriate. The treatment period is 3 weeks after which the lead is removed. Total time of electrode implantation is no more than 29 days. Sham-PT: Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist in a therapeutic environment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
|
Sham-PNS + PT
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
Sham-PNS: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
33
|
|
Overall Study
COMPLETED
|
27
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodal Treatment for Hemiplegic Shoulder Pain
Baseline characteristics by cohort
| Measure |
PNS + PT
n=31 Participants
The PNS+PT Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1 week electrode stabilization period,and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same 4 week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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. Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Position and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
|
PNS + Sham-PT
n=32 Participants
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment for 3weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as appropriate. The treatment period is 3 weeks after which the lead is removed. Total time of electrode implantation is no more than 29 days. Sham-PT: Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist in a therapeutic environment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
|
Sham-PNS + PT
n=33 Participants
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
Sham-PNS: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=18 Participants
|
24 Participants
n=102 Participants
|
23 Participants
n=30 Participants
|
76 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=18 Participants
|
8 Participants
n=102 Participants
|
10 Participants
n=30 Participants
|
20 Participants
n=37 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 8.4 • n=18 Participants
|
59.5 years
STANDARD_DEVIATION 9.6 • n=102 Participants
|
58.9 years
STANDARD_DEVIATION 9.9 • n=30 Participants
|
58.2 years
STANDARD_DEVIATION 9.35 • n=37 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=18 Participants
|
13 Participants
n=102 Participants
|
13 Participants
n=30 Participants
|
36 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=18 Participants
|
19 Participants
n=102 Participants
|
20 Participants
n=30 Participants
|
60 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=18 Participants
|
11 Participants
n=102 Participants
|
15 Participants
n=30 Participants
|
43 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=18 Participants
|
20 Participants
n=102 Participants
|
14 Participants
n=30 Participants
|
47 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=18 Participants
|
32 participants
n=102 Participants
|
33 participants
n=30 Participants
|
96 participants
n=37 Participants
|
|
Short Form (SF) Question 3 (BPI-SF3) absolute value
|
7.129 units on a scale
n=18 Participants
|
7.406 units on a scale
n=102 Participants
|
8.061 units on a scale
n=30 Participants
|
7.542 units on a scale
n=37 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks(end of treatment), 16 weeks, 28 weeksPopulation: Some participants drop out, withdraw consent, or are lost before later visits or assessments. Their later data points are missing, so they're not included in analyses for those timepoints.
Brief Pain Inventory 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." Lower score means better outcome Baseline is absolute value and change value is reported for 4 weeks, 16 weeks and 28 weeks.
Outcome measures
| Measure |
PNS + PT
n=31 Participants
The PNS+PT Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1 week electrode stabilization period,and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same 4 week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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. Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positionand Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
|
PNS + sham-PT
n=32 Participants
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment for 3weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as appropriate. The treatment period is 3 weeks after which the lead is removed. Total time of electrode implantation is no more than 29 days. Sham-PT: Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist in a therapeutic environment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
|
sham-PNS + PT
n=33 Participants
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
Sham-PNS: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline
Baseline (absolute Value)
|
7.1 units on a scale
Interval 6.1 to 8.1
|
7.4 units on a scale
Interval 6.4 to 8.4
|
8.1 units on a scale
Interval 7.1 to 9.1
|
|
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline
End of Treatment (change value)
|
-2.8 units on a scale
Interval -3.9 to -1.8
|
-2.4 units on a scale
Interval -3.4 to 1.4
|
-2.4 units on a scale
Interval -3.4 to -1.4
|
|
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline
16 weeks (change value)
|
-3.9 units on a scale
Interval -5.0 to -2.9
|
-2.4 units on a scale
Interval -3.4 to -1.4
|
-2.9 units on a scale
Interval -4.0 to -1.9
|
|
Brief Pain Inventory (BPI)- Short Form (SF) Question 3 (BPI-SF3) - Mean Change From Baseline
28 weeks (change value)
|
-2.8 units on a scale
Interval -4.3 to -1.4
|
-2.1 units on a scale
Interval -3.2 to -1.0
|
-3.1 units on a scale
Interval -4.0 to -2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2 - Week 5Population: All subject who completed Baseline, Treatment and End of treatment assessments are included in the related adverse events reporting
Related adverse events are documented as Safety data.
Outcome measures
| Measure |
PNS + PT
n=31 Participants
The PNS+PT Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1 week electrode stabilization period,and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same 4 week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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. Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positionand Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
|
PNS + sham-PT
n=32 Participants
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment for 3weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as appropriate. The treatment period is 3 weeks after which the lead is removed. Total time of electrode implantation is no more than 29 days. Sham-PT: Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist in a therapeutic environment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
|
sham-PNS + PT
n=33 Participants
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
Sham-PNS: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
|
|---|---|---|---|
|
Adverse Events (Number of Participants With Related Adverse Events)
|
13 Participants
|
15 Participants
|
14 Participants
|
Adverse Events
PNS + PT
Serious events: 2 serious events
Other events: 19 other events
Deaths: 1 deaths
PNS + Sham-PT
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Sham-PNS + PT
Serious events: 5 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PNS + PT
n=31 participants at risk
The PNS+PT Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1 week electrode stabilization period,and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same 4 week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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. Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positionand Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
|
PNS + Sham-PT
n=32 participants at risk
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment for 3weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as appropriate. The treatment period is 3 weeks after which the lead is removed. Total time of electrode implantation is no more than 29 days. Sham-PT: Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist in a therapeutic environment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
|
Sham-PNS + PT
n=33 participants at risk
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
Sham-PNS: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/31 • Adverse Events were collected over the duration of the study of ~ 7 months
|
3.1%
1/32 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
0.00%
0/31 • Adverse Events were collected over the duration of the study of ~ 7 months
|
0.00%
0/32 • Adverse Events were collected over the duration of the study of ~ 7 months
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Renal and urinary disorders
Kidney Stones
|
0.00%
0/31 • Adverse Events were collected over the duration of the study of ~ 7 months
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
0.00%
0/33 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/31 • Adverse Events were collected over the duration of the study of ~ 7 months
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
0.00%
0/33 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Cardiac disorders
Cardiac Event
|
3.2%
1/31 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
0.00%
0/32 • Adverse Events were collected over the duration of the study of ~ 7 months
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Nervous system disorders
Seizure
|
3.2%
1/31 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
0.00%
0/32 • Adverse Events were collected over the duration of the study of ~ 7 months
|
0.00%
0/33 • Adverse Events were collected over the duration of the study of ~ 7 months
|
Other adverse events
| Measure |
PNS + PT
n=31 participants at risk
The PNS+PT Group will receive peripheral nerve stimulation treatment for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1 week electrode stabilization period,and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same 4 week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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. Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positionand Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
|
PNS + Sham-PT
n=32 participants at risk
The PNS + sham-PT Group will receive peripheral nerve stimulation treatment for 3weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a 1week electrode stabilization period, and also receive eight 60-minute sessions of sham outpatient physical therapy not focused on shoulder pain over the same four week period. Peripheral Nerve Stimulation: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad 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 stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as appropriate. The treatment period is 3 weeks after which the lead is removed. Total time of electrode implantation is no more than 29 days. Sham-PT: Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist in a therapeutic environment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
|
Sham-PNS + PT
n=33 participants at risk
The sham-PNS + PT Group will receive sham peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period, and also receive eight 60-minute sessions of outpatient physical therapy focused on shoulder pain over the same four week period.
Physical Therapy: Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
Sham-PNS: The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation, related or possible related
|
41.9%
13/31 • Number of events 13 • Adverse Events were collected over the duration of the study of ~ 7 months
|
50.0%
16/32 • Number of events 16 • Adverse Events were collected over the duration of the study of ~ 7 months
|
24.2%
8/33 • Number of events 8 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain, related or possible related
|
6.5%
2/31 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Skin and subcutaneous tissue disorders
Retained Lead Fragment after Lead explant
|
6.5%
2/31 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected over the duration of the study of ~ 7 months
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected over the duration of the study of ~ 7 months
|
|
Surgical and medical procedures
Accidental Dislodgement of Lead
|
6.5%
2/31 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected over the duration of the study of ~ 7 months
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected over the duration of the study of ~ 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place