Knee Osteoarthritis, Pain, Chronic
Conditions
Keywords
Acupuncture, Cupping, Osteoarthritis, Pain
Brief summary
Given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the Institute of Orthopedics and Traumatology outpatient clinic of the University of São Paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.
Detailed description
120 patients with indications for surgical knee treatment from IOT-HCFMUSP will be invited to participate in the project. Inclusion applications and those who agree to sign a free and informed consent form (IC) will be included. During the period of inclusion of patients, will be clarified regarding the application and evaluation methods that will be used through consultation and initial medical evaluation. Then, the included patients are randomized into four existing groups: Group A - Acupuncture Sham + Cupping Sham; Group B - Sham Acupuncture + Real Cupping; Group C - Real Acupuncture + Sham Cupping; Group D - Real Acupuncture + Real Cupping.
Interventions
PROCEDUREAcupuncture
20 min of Acupuncture section follow by 10 min of cupping around the knee
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients with a diagnosis of knee osteoarthritis * WOMAC-Pain greater than or equal to 15 points.
Exclusion criteria
* advanced degenerative central neuropathy (Parkinson's, Alzheimer's) * diabetic peripheral neuropathy * stroke sequela * history of digestive bleeding * chronic renal failure * renal failure * heart failure * fibromyalgia * rheumatoid arthritis * SLE * severe depression * psychiatric disorders * concomitance with hip arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC - Pain | value collected at 5 week | Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition) |
| VAS | Value collected at 5 weeks | Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Consumption | Number of Participants with reduction in the use of pain medications after protocol (at 5 week) | number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no). |
Countries
Brazil
Participant flow
Recruitment details
recruitment by phone from a list of patients with advanced KOA who is waiting for a TKR. the inclusion criteria is applied.
Pre-assignment details
by phone we applied the WOMAC-Pain and invite who have 15 points or more
Participants by arm
| Arm | Count |
|---|---|
| A- Placebo Sham Acupuncture and Sham Cupping
20 min of Acupuncture section using placebo needle follow by 10 min of cupping sham (no negative pressure) around the knee | 30 |
| B -Cupping Sham Acupuncture and Real Cupping
20 min of Acupuncture section using placebo needle follow by 10 min of real cupping around the knee | 30 |
| C - Acupuncture Real Acupuncture and Sham Cupping
20 min of Real Acupuncture section follow by 10 min of sham cupping around the knee | 30 |
| D - Acupuncture + Cupping Real Acupuncture and Real Cupping
20 min of Real Acupuncture section follow by 10 min of real cupping around the knee | 30 |
| Total | 120 |
Baseline characteristics
| Characteristic | A- Placebo | B -Cupping | C - Acupuncture | D - Acupuncture + Cupping | Total |
|---|---|---|---|---|---|
| Age, Customized Age distribution | 66.1 years STANDARD_DEVIATION 10.88 | 66.1 years STANDARD_DEVIATION 10.86 | 68.1 years STANDARD_DEVIATION 11.15 | 66.8 years STANDARD_DEVIATION 8.09 | 66.8 years STANDARD_DEVIATION 10.17 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Brazil | 30 participants | 30 participants | 30 participants | 30 participants | 120 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 23 Participants | 25 Participants | 92 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 7 Participants | 5 Participants | 28 Participants |
| VAS | 84.03 units on a scale STANDARD_DEVIATION 13.75 | 89.57 units on a scale STANDARD_DEVIATION 11.81 | 82.83 units on a scale STANDARD_DEVIATION 12.97 | 91.30 units on a scale STANDARD_DEVIATION 11.43 | 89.92 units on a scale STANDARD_DEVIATION 12.88 |
| WOMAC-Pain | 16.83 units on a scale STANDARD_DEVIATION 1.74 | 16.50 units on a scale STANDARD_DEVIATION 1.38 | 16.40 units on a scale STANDARD_DEVIATION 1.43 | 16.90 units on a scale STANDARD_DEVIATION 1.75 | 16.66 units on a scale STANDARD_DEVIATION 1.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 1 / 30 | 2 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
VAS
Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)
Time frame: Value collected at 5 weeks
Population: We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | VAS | 67.43 units on a scale | Standard Deviation 23.09 |
| Group B | VAS | 61.57 units on a scale | Standard Deviation 25.57 |
| Group C | VAS | 47.87 units on a scale | Standard Deviation 27.23 |
| Group D | VAS | 47.43 units on a scale | Standard Deviation 28.99 |
Primary
WOMAC - Pain
Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
Time frame: value collected at 5 week
Population: We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | WOMAC - Pain | 11.60 units on a scale | Standard Deviation 4.17 |
| Group B | WOMAC - Pain | 11.30 units on a scale | Standard Deviation 4.23 |
| Group C | WOMAC - Pain | 10.80 units on a scale | Standard Deviation 4.64 |
| Group D | WOMAC - Pain | 9.83 units on a scale | Standard Deviation 4.76 |
Secondary
Analgesic Consumption
number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no).
Time frame: Number of Participants with reduction in the use of pain medications after protocol (at 5 week)
Population: We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Analgesic Consumption | 72 Participants |
| Group B | Analgesic Consumption | 12 Participants |
| Group C | Analgesic Consumption | 18 Participants |
| Group D | Analgesic Consumption | 19 Participants |
| Group D | Analgesic Consumption | 23 Participants |