Trial Outcomes & Findings for Electrical Stimulation for Hemiplegic Shoulder Pain (NCT NCT01123382)
NCT ID: NCT01123382
Last Updated: 2018-01-23
Results Overview
The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
IM Electrical Stimulation (IM ES)
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
Received Intervention
|
12
|
10
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
IM Electrical Stimulation (IM ES)
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Electrical Stimulation for Hemiplegic Shoulder Pain
Baseline characteristics by cohort
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
n=5 Participants
|
55.5 years
n=7 Participants
|
55.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Shoulder pain > 18 mos
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Time Since Stroke
|
2.1 years
n=5 Participants
|
2.3 years
n=7 Participants
|
2.1 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Brief Pain Inventory Short Form
Week 0
|
7.5 units on a scale
Standard Error 0.7
|
7.6 units on a scale
Standard Error 0.7
|
|
Brief Pain Inventory Short Form
Week 1
|
6.1 units on a scale
Standard Error 0.7
|
6.8 units on a scale
Standard Error 0.7
|
|
Brief Pain Inventory Short Form
Week 4
|
2.6 units on a scale
Standard Error 0.7
|
5.0 units on a scale
Standard Error 0.8
|
|
Brief Pain Inventory Short Form
Week 10
|
3.2 units on a scale
Standard Error 0.7
|
6.1 units on a scale
Standard Error 0.8
|
|
Brief Pain Inventory Short Form
Week 16
|
3.0 units on a scale
Standard Error 0.7
|
6.1 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)The ShoulderQ Visual Graphics Rating Scale (VGRS) T is a structured questionnaire designed to assess severity of HSP at rest during the day, on movement, and at night on a 0-30 scale where higher numbers indicate greater pain.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
ShoulderQ VGRS Scale
Week 0
|
16.5 units on a scale
Standard Error 1.7
|
16.5 units on a scale
Standard Error 1.8
|
|
ShoulderQ VGRS Scale
Week 1
|
14.8 units on a scale
Standard Error 1.8
|
15.6 units on a scale
Standard Error 1.8
|
|
ShoulderQ VGRS Scale
Week 4
|
6.3 units on a scale
Standard Error 1.8
|
11.0 units on a scale
Standard Error 2.0
|
|
ShoulderQ VGRS Scale
Week 10
|
6.7 units on a scale
Standard Error 2.1
|
10.5 units on a scale
Standard Error 2.2
|
|
ShoulderQ VGRS Scale
Week 16
|
7.6 units on a scale
Standard Error 2.4
|
13.1 units on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)The SF-36v2 is a population-norm based health related quality of life measure, presented in T-scores where population average equals a score of 50 with a standard deviation of 10. Maximum is 100, with higher score indicating greater health realated quality of life.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
SF-36 Bodily Pain Component
Week 0
|
36.1 units on a scale
Standard Error 1.9
|
36.4 units on a scale
Standard Error 2.0
|
|
SF-36 Bodily Pain Component
Week 1
|
41.2 units on a scale
Standard Error 2.0
|
38.3 units on a scale
Standard Error 2.1
|
|
SF-36 Bodily Pain Component
Week 4
|
47.9 units on a scale
Standard Error 2.2
|
44.9 units on a scale
Standard Error 2.6
|
|
SF-36 Bodily Pain Component
Week 10
|
48.3 units on a scale
Standard Error 2.7
|
41.2 units on a scale
Standard Error 3.1
|
|
SF-36 Bodily Pain Component
Week 16
|
49.3 units on a scale
Standard Error 3.3
|
46.9 units on a scale
Standard Error 3.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)Passive pain-free Externa ROM is a motor recovery measure. The subject was supine with the shoulder adducted with hand resting on the abdomen, elbow flexed, and with the humerus supported by the mat. The axis of a universal goniometer was centered on the olecranon process of the ulna projecting through the humeral shaft toward the humeral head. The subject's shoulder was externally rotated passively to the pain threshold, defined as the start of any pain. Pain at rest was recorded as 0 degrees.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Pain-free External ROM, Degrees
Week 0
|
50.5 degrees
Standard Error 14.4
|
26.7 degrees
Standard Error 15.0
|
|
Pain-free External ROM, Degrees
Week 1
|
56.2 degrees
Standard Error 14.6
|
34.0 degrees
Standard Error 15.2
|
|
Pain-free External ROM, Degrees
Week 4
|
80.8 degrees
Standard Error 14.6
|
43.7 degrees
Standard Error 15.9
|
|
Pain-free External ROM, Degrees
Week 10
|
77.0 degrees
Standard Error 14.6
|
37.4 degrees
Standard Error 15.6
|
|
Pain-free External ROM, Degrees
Week 16
|
76.9 degrees
Standard Error 14.6
|
41.5 degrees
Standard Error 15.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)The Fugl-Myer Motor Assessment (FMA) is a motor recovery measure. Volitional movement of the upper limb (shoulder, elbow, forearm, wrist, and hand) is examined in and out of synergies. Each item was graded on a 3-point ordinal scale and summed to provide a maximum score of 66, with higher scores indicating lower impairment.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Fugl-Myer Motor Assessment (FMA) - Upper Extremity
Week 0
|
26.7 units on a scale
Standard Error 6.6
|
23.0 units on a scale
Standard Error 6.9
|
|
Fugl-Myer Motor Assessment (FMA) - Upper Extremity
Week 1
|
27.2 units on a scale
Standard Error 6.6
|
24.6 units on a scale
Standard Error 6.9
|
|
Fugl-Myer Motor Assessment (FMA) - Upper Extremity
Week 4
|
29.4 units on a scale
Standard Error 6.6
|
24.1 units on a scale
Standard Error 6.9
|
|
Fugl-Myer Motor Assessment (FMA) - Upper Extremity
Week 10
|
29.6 units on a scale
Standard Error 6.6
|
25.0 units on a scale
Standard Error 6.9
|
|
Fugl-Myer Motor Assessment (FMA) - Upper Extremity
Week 16
|
29.9 units on a scale
Standard Error 6.6
|
26.2 units on a scale
Standard Error 6.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)BPI-9 from Brief Pain Inventory, Short Form. Pain interference is on a 0 - 10 scale, with 0 being no interference, and 10 being complete interference.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Pain Interference Questionnaire
Week 0
|
3.6 units on a scale
Standard Error 0.7
|
5.0 units on a scale
Standard Error 0.7
|
|
Pain Interference Questionnaire
Week 1
|
2.3 units on a scale
Standard Error 0.7
|
4.6 units on a scale
Standard Error 0.7
|
|
Pain Interference Questionnaire
Week 4
|
0.8 units on a scale
Standard Error 0.7
|
2.1 units on a scale
Standard Error 0.8
|
|
Pain Interference Questionnaire
Week 10
|
0.8 units on a scale
Standard Error 0.7
|
3.0 units on a scale
Standard Error 0.8
|
|
Pain Interference Questionnaire
Week 16
|
1.1 units on a scale
Standard Error 0.7
|
3.5 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)A measure of isometric strength in response to audio cue. Isometric shoulder abduction moment was measured with a Biodex Biomechanical Measurement System (Biodex Medical Systems, Shirley, NY). The average moment during the last second of the audible tone was calculated for each trial and those values were averaged over the three trials. Subjects underwent testing of both shoulders, non-paretic side first, and the results are presented as the ratio of the paretic shoulder to the non-paretic shoulder to decrease the influence of intra-subject variability between measurements.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected
Week 4
|
0.4 ratio of affected to unaffected arm
Standard Error 0.1
|
0.3 ratio of affected to unaffected arm
Standard Error 0.1
|
|
Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected
Week 0
|
0.3 ratio of affected to unaffected arm
Standard Error 0.1
|
0.3 ratio of affected to unaffected arm
Standard Error 0.1
|
|
Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected
Week 1
|
0.4 ratio of affected to unaffected arm
Standard Error 0.1
|
0.3 ratio of affected to unaffected arm
Standard Error 0.1
|
|
Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected
Week 10
|
0.5 ratio of affected to unaffected arm
Standard Error 0.1
|
0.3 ratio of affected to unaffected arm
Standard Error 0.1
|
|
Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected
Week 16
|
0.5 ratio of affected to unaffected arm
Standard Error 0.1
|
0.4 ratio of affected to unaffected arm
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials. Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart. The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction. Delay of initiation (DOI) was defined as the duration between onset of the audibe tone and the onset of EMG signal. Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation. The mean DOI of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOI were used as summary metrics.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Delay in Initiation of Shoulder Abduction EMG Activity
Week 0
|
1.4 ratio of affected to unaffected arm
Standard Error 0.2
|
1.6 ratio of affected to unaffected arm
Standard Error 0.2
|
|
Delay in Initiation of Shoulder Abduction EMG Activity
Week 1
|
1.3 ratio of affected to unaffected arm
Standard Error 0.2
|
1.3 ratio of affected to unaffected arm
Standard Error 0.3
|
|
Delay in Initiation of Shoulder Abduction EMG Activity
Week 4
|
1.2 ratio of affected to unaffected arm
Standard Error 0.2
|
1.4 ratio of affected to unaffected arm
Standard Error 0.3
|
|
Delay in Initiation of Shoulder Abduction EMG Activity
Week 10
|
1.2 ratio of affected to unaffected arm
Standard Error 0.2
|
1.2 ratio of affected to unaffected arm
Standard Error 0.3
|
|
Delay in Initiation of Shoulder Abduction EMG Activity
Week 16
|
1.4 ratio of affected to unaffected arm
Standard Error 0.2
|
1.2 ratio of affected to unaffected arm
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials. Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart. The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction. Delay of termination (DOT) was defined as the duration between cessation of the audible tone and return of the EMG signal to baseline. Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation, and return to steady for delay of termination. The mean DOT of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOT were used as summary metrics.
Outcome measures
| Measure |
IM Electrical Stimulation (IM ES)
n=13 Participants
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 Participants
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Delay in Termination of Shoulder Abduction EMG Activity
Week 0
|
2.3 ratio of affected to unaffected arm
Standard Error 0.5
|
1.3 ratio of affected to unaffected arm
Standard Error 0.6
|
|
Delay in Termination of Shoulder Abduction EMG Activity
Week 1
|
2.6 ratio of affected to unaffected arm
Standard Error 0.6
|
3.7 ratio of affected to unaffected arm
Standard Error 0.6
|
|
Delay in Termination of Shoulder Abduction EMG Activity
Week 4
|
1.7 ratio of affected to unaffected arm
Standard Error 0.6
|
2.0 ratio of affected to unaffected arm
Standard Error 0.7
|
|
Delay in Termination of Shoulder Abduction EMG Activity
Week 10
|
1.9 ratio of affected to unaffected arm
Standard Error 0.7
|
1.5 ratio of affected to unaffected arm
Standard Error 0.5
|
|
Delay in Termination of Shoulder Abduction EMG Activity
Week 16
|
1.7 ratio of affected to unaffected arm
Standard Error 0.5
|
2.6 ratio of affected to unaffected arm
Standard Error 0.7
|
Adverse Events
IM Electrical Stimulation (IM ES)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Usual Care (UC)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IM Electrical Stimulation (IM ES)
n=13 participants at risk
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 participants at risk
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Cardiac disorders
Chest pain, hospitalization
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Headache, hospitalization
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
IM Electrical Stimulation (IM ES)
n=13 participants at risk
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.
|
Usual Care (UC)
n=12 participants at risk
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Electrode dislodgement
|
7.7%
1/13 • Number of events 1
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Retained Electrode Fragment
|
23.1%
3/13 • Number of events 3
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Pruritus at electrode or bandage site
|
46.2%
6/13 • Number of events 6
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Pain after electrode implantation
|
15.4%
2/13 • Number of events 2
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place