Trial Outcomes & Findings for Periosteal Stimulation for Knee Osteoarthritis (NCT NCT00865046)
NCT ID: NCT00865046
Last Updated: 2015-01-26
Results Overview
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
9 months following baseline
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
Arm 1
PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Arm 2
PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Arm 3
control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
64
|
63
|
|
Overall Study
COMPLETED
|
57
|
59
|
62
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Arm 2
PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Arm 3
control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
0
|
Baseline Characteristics
Periosteal Stimulation for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Arm 1
n=63 Participants
PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Arm 2
n=64 Participants
PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Arm 3
n=63 Participants
control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
188 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
134 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
|
63 participants
n=5 Participants
|
64 participants
n=7 Participants
|
63 participants
n=5 Participants
|
190 participants
n=4 Participants
|
|
WOMAC
|
9.0 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
9.9 units on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 3.6 • n=4 Participants
|
|
Short Physical Performance Battery
|
6.1 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Timed stair climb
|
12.5 seconds
STANDARD_DEVIATION 4.7 • n=5 Participants
|
14.5 seconds
STANDARD_DEVIATION 7.8 • n=7 Participants
|
13.9 seconds
STANDARD_DEVIATION 7.3 • n=5 Participants
|
13.6 seconds
STANDARD_DEVIATION 6.6 • n=4 Participants
|
|
Timed Up and Go
|
12.3 seconds
STANDARD_DEVIATION 3.4 • n=5 Participants
|
13.1 seconds
STANDARD_DEVIATION 3.8 • n=7 Participants
|
13.9 seconds
STANDARD_DEVIATION 6.9 • n=5 Participants
|
13.1 seconds
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
CES-D
|
11.7 units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants
|
14.7 units on a scale
STANDARD_DEVIATION 11.2 • n=7 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Cognitive Strategies Questionnaire, catastrophizing scale
|
7.9 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 9.7 • n=7 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
9.6 units on a scale
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
BMI
|
31.6 kg/m2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
33.1 kg/m2
STANDARD_DEVIATION 6.2 • n=7 Participants
|
32.5 kg/m2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
32.4 kg/m2
STANDARD_DEVIATION 6.5 • n=4 Participants
|
|
Mean number of pain medications
|
1.1 medication
STANDARD_DEVIATION 1.0 • n=5 Participants
|
1.2 medication
STANDARD_DEVIATION 0.9 • n=7 Participants
|
1.0 medication
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.1 medication
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Mean number of opioids
|
0.1 opioids
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.3 opioids
STANDARD_DEVIATION 0.6 • n=7 Participants
|
0.2 opioids
STANDARD_DEVIATION 0.4 • n=5 Participants
|
0.2 opioids
STANDARD_DEVIATION 0.4 • n=4 Participants
|
|
Duration of knee pain
|
5.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
6.2 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
7.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
6.4 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Arthritis Self-Efficacy score, pain
|
64.3 units on a scale
STANDARD_DEVIATION 21.6 • n=5 Participants
|
59.5 units on a scale
STANDARD_DEVIATION 22.6 • n=7 Participants
|
63.9 units on a scale
STANDARD_DEVIATION 21.7 • n=5 Participants
|
62.6 units on a scale
STANDARD_DEVIATION 22 • n=4 Participants
|
|
Arthritis Self-Efficacy score, function
|
77.5 units on a scale
STANDARD_DEVIATION 17.0 • n=5 Participants
|
76.3 units on a scale
STANDARD_DEVIATION 16.9 • n=7 Participants
|
76.1 units on a scale
STANDARD_DEVIATION 16.4 • n=5 Participants
|
76.6 units on a scale
STANDARD_DEVIATION 16.8 • n=4 Participants
|
|
Arthritis Self-Efficacy score, other symptoms
|
70.5 units on a scale
STANDARD_DEVIATION 21.1 • n=5 Participants
|
65.9 units on a scale
STANDARD_DEVIATION 20.3 • n=7 Participants
|
68.6 units on a scale
STANDARD_DEVIATION 20.9 • n=5 Participants
|
68.3 units on a scale
STANDARD_DEVIATION 20.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: 9 months following baselineThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)
Outcome measures
| Measure |
Arm 1
n=57 Participants
PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Arm 2
n=59 Participants
PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Arm 3
n=62 Participants
control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
|---|---|---|---|
|
Pain (WOMAC)
|
6.1 units on a scale
Standard Error 3.5
|
6.6 units on a scale
Standard Error 3.6
|
7.9 units on a scale
Standard Error 7.7
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=63 participants at risk
PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Arm 2
n=64 participants at risk
PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Arm 3
n=63 participants at risk
control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
|---|---|---|---|
|
General disorders
Death
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
0.00%
0/63
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
0.00%
0/63
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/63
|
0.00%
0/64
|
1.6%
1/63 • Number of events 1
|
|
Infections and infestations
abscess
|
0.00%
0/63
|
1.6%
1/64 • Number of events 1
|
0.00%
0/63
|
Other adverse events
| Measure |
Arm 1
n=63 participants at risk
PST once a week for 10 weeks, then tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
|
Arm 2
n=64 participants at risk
PST once a week for 10 weeks, then control-PST tapering over 6 months
Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
Arm 3
n=63 participants at risk
control-PST for 10 weeks
Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
1.6%
1/63 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
0.00%
0/63
|
|
General disorders
sweating
|
0.00%
0/63
|
0.00%
0/64
|
0.00%
0/63
|
|
General disorders
Lightheaded
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
0.00%
0/63
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place