Knee OsteoarthritisNCT04168593
Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis
A study testing Acupuncture in people with Knee Osteoarthritis and Pain, Chronic, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis, Pain, Chronic
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Sep 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a diagnosis of knee osteoarthritis
- WOMAC-Pain greater than or equal to 15 points.
Who cannot join
- advanced degenerative central neuropathy (Parkinson's, Alzheimer's)
- diabetic peripheral neuropathy
- stroke sequela
- history of digestive bleeding
- chronic renal failure
- renal failure
Show all 13Show fewer
- heart failure
- fibromyalgia
- rheumatoid arthritis
- SLE
- severe depression
- psychiatric disorders
- concomitance with hip arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Pain, Chronic
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Cupping, Osteoarthritis, Pain
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Cupping
20 min of Acupuncture section follow by 10 min of cupping around the knee
| Study group | Role | What they receive |
|---|---|---|
| A- Placebo | Sham comparator | Sham Acupuncture and Sham Cupping Receives: Procedure: Acupuncture |
| B -Cupping | Active comparator | Sham Acupuncture and Real Cupping Receives: Procedure: Acupuncture |
| C - Acupuncture | Active comparator | Real Acupuncture and Sham Cupping Receives: Procedure: Acupuncture |
| D - Acupuncture + Cupping | Active comparator | Real Acupuncture and Real Cupping Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC - Pain
Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
Measured: value collected at 5 week
VAS
Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)
Measured: Value collected at 5 weeks
Secondary outcomes (1)
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).
Measured: Number of Participants with reduction in the use of pain medications after protocol (at 5 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Sep 2018
- Primary completion30 Oct 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin Lin, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168593
- Sponsor's protocol ID
- Acupuncture in KOA
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: these data are totally confidencial and unique to this protocol
Publications
Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.
PubMed 25865392Corbett MS, Rice SJ, Madurasinghe V, Slack R, Fayter DA, Harden M, Sutton AJ, Macpherson H, Woolacott NF. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1290-8. doi: 10.1016/j.joca.2013.05.007.
PubMed 23973143
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04168593
- Acronym / sponsor ID
- Acupuncture in KOA
- Conditions
- Knee Osteoarthritis, Pain, Chronic
- Keywords
- Acupuncture, Cupping, Osteoarthritis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A- Placebo | Sham comparator | Procedure: AcupunctureSham Acupuncture and Sham Cupping |
| B -Cupping | Active comparator | Procedure: AcupunctureSham Acupuncture and Real Cupping |
| C - Acupuncture | Active comparator | Procedure: AcupunctureReal Acupuncture and Sham Cupping |
| D - Acupuncture + Cupping | Active comparator | Procedure: AcupunctureReal Acupuncture and Real Cupping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with a diagnosis of knee osteoarthritis
- WOMAC-Pain greater than or equal to 15 points.
Key exclusion criteria (13 listed)
- advanced degenerative central neuropathy (Parkinson's, Alzheimer's)
- diabetic peripheral neuropathy
- stroke sequela
- history of digestive bleeding
- chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Cupping20 min of Acupuncture section follow by 10 min of cupping around the knee | Procedure or surgery | A- Placebo, B -Cupping, C - Acupuncture, D - Acupuncture + Cupping |
Primary outcome
WOMAC - Pain
Time frame: value collected at 5 week
Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)
VAS
Time frame: 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)
1 secondary outcome
Analgesic Consumption
Time frame: Number of Participants with reduction in the use of pain medications after protocol (at 5 week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25865392Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.
- Results publication: PubMed 23973143Corbett MS, Rice SJ, Madurasinghe V, Slack R, Fayter DA, Harden M, Sutton AJ, Macpherson H, Woolacott NF. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1290-8. doi: 10.1016/j.joca.2013.05.007.
- Individual participant dataSharing planned: No. these data are totally confidencial and unique to this protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin Lin principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Knee Osteoarthritis and Pain, Chronic, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC - Pain (time frame: value collected at 5 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168593, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.