Osteoarthritis, Knee
Conditions
Keywords
acupuncture
Brief summary
185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to participate in this study designed to test the effectiveness of a special type of electrical acupuncture called periosteal stimulation (PST). Participants will be divided into three groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of the participants will receive booster sessions periodically over the course of the next 6 months. Everyone will be called monthly during the 6 month period and then will be asked to return for an evaluation on site at the end of this period.
Detailed description
We have performed a promising initial trial of periosteal stimulation (PST, that is, electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain. The primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST. Our secondary aims are to 1) improve physical performance in these individuals, and 2) ascertain the physical and psychological predictors of response to PST. In a randomized controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1) control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters over 6 months. Prior to initiating the intervention, immediately after the last session, and 6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3) physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go), and 4) psychological function (mood, coping, self-efficacy). Monthly telephone calls will assess pain, interim illness and physical activity.
Interventions
OTHERPeriosteal 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.
OTHERControl-Periosteal Stimulation
Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* English speaking, * Knee pain on most days of the past 3 months that is more severe than pain in other parts of the lower body, * Advanced knee OA by x-ray, * age 50-89
Exclusion criteria
* Non-ambulatory or severely impaired mobility (i.e., require the use of a walker), * Folstein MMSE \< 24, * Severe uncorrected visual or hearing impairment, * Knee pain due to factors other than OA, * Large knee effusion, * History of corticosteroid or hyaluronic acid injection in the affected knee(s) during the preceding 3 months, * Acute or terminal illness, * Immune suppression, * Anticoagulation therapy, * Pacemaker, * Prior PST treatment * Active participation in other studies currently * Age \>89
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (WOMAC) | 9 months following baseline | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| 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. | 64 |
| 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. | 63 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 2 | Total | Arm 3 | Arm 1 |
|---|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 8.7 | 66.5 years STANDARD_DEVIATION 9.3 | 66.8 years STANDARD_DEVIATION 10.4 | 67.1 years STANDARD_DEVIATION 8.9 |
| Arthritis Self-Efficacy score, function | 76.3 units on a scale STANDARD_DEVIATION 16.9 | 76.6 units on a scale STANDARD_DEVIATION 16.8 | 76.1 units on a scale STANDARD_DEVIATION 16.4 | 77.5 units on a scale STANDARD_DEVIATION 17 |
| Arthritis Self-Efficacy score, other symptoms | 65.9 units on a scale STANDARD_DEVIATION 20.3 | 68.3 units on a scale STANDARD_DEVIATION 20.8 | 68.6 units on a scale STANDARD_DEVIATION 20.9 | 70.5 units on a scale STANDARD_DEVIATION 21.1 |
| Arthritis Self-Efficacy score, pain | 59.5 units on a scale STANDARD_DEVIATION 22.6 | 62.6 units on a scale STANDARD_DEVIATION 22 | 63.9 units on a scale STANDARD_DEVIATION 21.7 | 64.3 units on a scale STANDARD_DEVIATION 21.6 |
| BMI | 33.1 kg/m2 STANDARD_DEVIATION 6.2 | 32.4 kg/m2 STANDARD_DEVIATION 6.5 | 32.5 kg/m2 STANDARD_DEVIATION 6.9 | 31.6 kg/m2 STANDARD_DEVIATION 6.5 |
| CES-D | 14.7 units on a scale STANDARD_DEVIATION 11.2 | 12.9 units on a scale STANDARD_DEVIATION 10.4 | 12.3 units on a scale STANDARD_DEVIATION 9.6 | 11.7 units on a scale STANDARD_DEVIATION 10.3 |
| Cognitive Strategies Questionnaire, catastrophizing scale | 12.1 units on a scale STANDARD_DEVIATION 9.7 | 9.6 units on a scale STANDARD_DEVIATION 8.9 | 8.8 units on a scale STANDARD_DEVIATION 9.2 | 7.9 units on a scale STANDARD_DEVIATION 7.8 |
| Duration of knee pain | 6.2 years STANDARD_DEVIATION 6.8 | 6.4 years STANDARD_DEVIATION 7.2 | 7.2 years STANDARD_DEVIATION 8.3 | 5.7 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 188 Participants | 63 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Mean number of opioids | 0.3 opioids STANDARD_DEVIATION 0.6 | 0.2 opioids STANDARD_DEVIATION 0.4 | 0.2 opioids STANDARD_DEVIATION 0.4 | 0.1 opioids STANDARD_DEVIATION 0.3 |
| Mean number of pain medications | 1.2 medication STANDARD_DEVIATION 0.9 | 1.1 medication STANDARD_DEVIATION 0.9 | 1.0 medication STANDARD_DEVIATION 0.9 | 1.1 medication STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 56 Participants | 16 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 134 Participants | 47 Participants | 45 Participants |
| Region of Enrollment United States | 64 participants | 190 participants | 63 participants | 63 participants |
| Sex: Female, Male Female | 10 Participants | 29 Participants | 11 Participants | 8 Participants |
| Sex: Female, Male Male | 54 Participants | 161 Participants | 52 Participants | 55 Participants |
| Short Physical Performance Battery | 6.1 units on a scale STANDARD_DEVIATION 1.9 | 6.1 units on a scale STANDARD_DEVIATION 1.7 | 6.2 units on a scale STANDARD_DEVIATION 1.5 | 6.1 units on a scale STANDARD_DEVIATION 1.8 |
| Timed stair climb | 14.5 seconds STANDARD_DEVIATION 7.8 | 13.6 seconds STANDARD_DEVIATION 6.6 | 13.9 seconds STANDARD_DEVIATION 7.3 | 12.5 seconds STANDARD_DEVIATION 4.7 |
| Timed Up and Go | 13.1 seconds STANDARD_DEVIATION 3.8 | 13.1 seconds STANDARD_DEVIATION 4.7 | 13.9 seconds STANDARD_DEVIATION 6.9 | 12.3 seconds STANDARD_DEVIATION 3.4 |
| WOMAC | 9.9 units on a scale STANDARD_DEVIATION 4 | 9.8 units on a scale STANDARD_DEVIATION 3.6 | 10.6 units on a scale STANDARD_DEVIATION 3.6 | 9.0 units on a scale STANDARD_DEVIATION 3.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 63 | 0 / 64 | 1 / 63 |
| serious Total, serious adverse events | 3 / 63 | 1 / 64 | 1 / 63 |
Outcome results
Primary
Pain (WOMAC)
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)
Time frame: 9 months following baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Pain (WOMAC) | 6.1 units on a scale | Standard Error 3.5 |
| Arm 2 | Pain (WOMAC) | 6.6 units on a scale | Standard Error 3.6 |
| Arm 3 | Pain (WOMAC) | 7.9 units on a scale | Standard Error 7.7 |