Osteo Arthritis KneeVentosaOANCT04331158
Dry Cupping Therapy in Knee Osteoarthritis
A study testing Dry cupping therapy in people with Osteo Arthritis Knee and Pain, Chronic, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Introduction: Knee osteoarthritis (KOA) is the biggest cause of pain and disability worldwide. As a non-pharmacological approach, ventosatherapia has been used to control pain, improve function and quality of life. However, there is a lack of high-quality scientific evidence regarding its effects on this condition. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Osteo Arthritis Knee, Pain, Chronic, Pain
- What is being tested?
- Dry cupping therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2023to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with KOA based on ACR clinical criteria;
- Knee pain intensity between 3 and 8, according to the Numerical Pain Scale (END);
- BMI less than 35 kg / m2.
Who cannot join
- Having undergone physical therapy treatment for the knee in the 3 months prior to the project;
- Be engaged in> 45 minutes / week in accumulated physical activity of at least moderate intensity;
- To have been submitted to the application and / or intervention with the wind therapy previously.
- Have used corticosteroid infiltration in the knee in the last 6 months;
- Present any medical restrictions that make it impossible for them to participate in the proposed assessments and interventions (cardiorespiratory, neurological and / or musculoskeletal changes);
- Presenting a diagnosis of fibromyalgia, rheumatoid arthritis or some systemic inflammatory arthritis;
Show all 12Show fewer
- Presenting a ligament or meniscal injury diagnosed clinically or with a positive result in the Apley tests or anterior / posterior drawer;
- Have had previous surgery on the ankle, knee or hip;
- Present a clinical diagnosis of some dementia or inability to answer the questionnaires related to the study;
- Present any contraindications for the use of ventosatherapia (skin lesion in the region where it will be applied, cancer, kidney failure, liver and heart failure, pacemaker, pregnancy);
- Having uncontrolled diabetes and hypertension;
- Have a trip scheduled for the two months following inclusion in the survey.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Marcelo Cardoso de Souza
Santa Cruz, Rio Grande do Norte, 59200-000
About this study
Official title: The Effects of Dry Cupping on Pain, Function and Quality of Life of Women With Knee Osteoarthritis: Protocol for a Placebo-controlled Randomized Trial
Introduction: Knee osteoarthritis (KOA) is the biggest cause of pain and disability worldwide. As a non-pharmacological approach, ventosatherapia has been used to control pain, improve function and quality of life. However, there is a lack of high-quality scientific evidence regarding its effects on this condition. Objective: To evaluate the effects of dry cupping on pain, function and quality of life in women with KOA. Methods: This is a randomized, blinded placebo-controlled protocol. 62 women diagnosed with KOA will be recruited, based on the clinical criteria of the American College of Rheumatology, who will be randomly divided into two groups (31 per group): dry cupping and dry cupping sham.
Read the detailed description
The intervention will be carried out for 15 minutes, twice a week, for 6 consecutive weeks, totaling 12 sessions. Both groups will be evaluated in 4 moments: before the intervention (T0), after 3 weeks of interventions (T3), at the end of the protocol (T6) and 4 weeks after the end of the interventions (follow-up - T10). The analyzed outcomes will be: Primary - pain (numerical pain scale); Secondary - Physical function (WOMAC; tests of going up / down stairs, brisk walking in 40 m and sitting / rising from a chair in 30 s), quality of life (SF-36) and global perception of the effect
- Conditions
- Osteo Arthritis Knee, Pain, Chronic, Pain
- Being tested
- Dry cupping therapy
- Keywords
- Chronic pain, Traditional Chinese Medicine, Complementary Therapie
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry cupping therapyOther
Dry cupping therapy application on the patient's skin
| Study group | Role | What they receive |
|---|---|---|
| Dry cupping group | Experimental | The dry cupping will be applied with a force of two suctions generating a negative pressure on the skin during the time of 15 minutes. Receives: Other: Dry cupping therapy |
| Dry cupping sham group | Placebo comparator | The dry cupping sham group will receive the same procedures as the dry cup group, with the difference that the negative pressure imposed after application will be released in a few seconds. Receives: Other: Dry cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Numerical Rating Scale (NRS)
Subjective measure in which individuals rate their pain on an eleven-point numerical scale. Such scale will be positioned in front of the participant and will vary from 0 to 10 points, with 0 being the complete absence of pain and 10 being the worst pain imaginable by the individual
Measured: baseline, 3 ,6 and 10 weeks after.
Secondary outcomes (8)
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Questionnaire translated and validated for the Portuguese language, specific for the evaluation of patients with KOA, contains 24 questions divided into three categories that assess pain, stiffness and self-reported physical function.38 The items are evaluated by a Likert scale and each question receives a score that varies from 0 to 96 points, according to the patient's response (none = 0; low = 1; moderate = 2; severe = 3; very severe = 4). The higher the score obtained, the worse the severity of pain, stiffness or physical function
Measured: baseline, 3 ,6 and 10 weeks after.
Change from 30-second Chair Stand Test
The sit and stand test will be performed in a chair without armrests, with a height of 43 cm, with non-slip rubber under its four supports. The back of the chair will be supported by a wall to prevent oscillations during the movements of sitting and standing. The participant will sit in the middle of the chair, with an erect back, feet apart and aligned with the joints of the respective shoulders and supported on a flat and stable floor. The test will consist of getting up from the chair as many times as possible, for 30 seconds. In this way, it will be possible to assess different levels of skill, with scores ranging from 0, for those who cannot complete a single repetition, to values greater than 20 repetitions, for the most able and well-prepared individuals
Measured: baseline, 6 and 10 weeks after.
Change from 8-step Stair Climb Test
In the test of going up and down stairs, the participant will be positioned in front of the stairs and, at the signal, must go up the indicated steps (8 steps) and go down, in the shortest time possible. The height of each step will be 20 cm and it will be a staircase with a handrail, in a lighted environment, free of traffic and external distractions. A pre-test will be carried out to identify the need for security measures. The final score will be calculated based on the time the participant performed the procedure and compared with normative values available for the test.
Measured: baseline, 6 and 10 weeks after.
Change from 40m Fast Paced Walk Test
The 40 meter fast walk test will be performed on 4 circuits of 10 meters (marked by ribbons and bounded by cones), in which the participant will be guided to walk the 10 meters, go around the cone and travel the next 10 meters again, successively, until the total distance of 40 meters is completed. The time will be timed only between the markings (start and end). The final score will be calculated based on the time the participant will perform the procedure and compared with normative values for healthy adults.
Measured: baseline, 6 and 10 weeks after.
Change from Short-Form 36 quality of life
The instrument consists of 36 questions and assesses eight different domains that influence quality of life, considering the individual's perception of aspects of his health in the past weeks. Each item has a group of responses distributed on a graduated Likert scale, with the following dimensions: physical function, physical aspect, pain, general health, vitality, social function, emotional aspect and mental health. Your total score ranges from 0 to 100, where the higher the value, the better the quality of life.
Measured: baseline, 6 and 10 weeks after.
Change from Global Perceived Effect
Global perceived effect (GPE) is a 11-point Likert scale (ranging from -5 to +5) that compares the patients' current health status with that at the onset of symptoms. Positive scores are attributed to individuals who improved when compared with baseline and negative scores to those who worsened
Measured: baseline, 3, 6 and 10 weeks after.
Change from use of analgesics and anti-inflammatories
Number of use of analgesics and anti-inflammatories at the end of the study.
Measured: baseline, 3, 6 and 10 weeks after
Change from expectation with treatment after the intervention protocol .
A 5-point Likert scale was applied to assess patient expectation in terms of the intervention. The scale will be placed in front of the participant, who will be asked the following question: 'with dry cupping intervention do you think your situation will: (1) worsen considerably, (2) worsen a little, (3) neither improve nor worsen, (4) improve a little or (5) improve considerably
Measured: baseline and 10 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Feb 2023
- Primary completion1 Sep 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- dry cupping group and dry cupping sham group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, PT, PhD., Universidade Federal do Rio Grande do Norte
- Investigators
- Marcelo C de Souza, PT, PhD, Study chair, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331158
- Sponsor's protocol ID
- UFRNventosaOA
- Acronym
- VentosaOA
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2020
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is not a plan to make individual participant data (IPD) available to other researchers
Publications
Silva HJA, Saragiotto BT, Silva RS, Lins CAA, de Souza MC. Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study. BMJ Open. 2019 Dec 22;9(12):e032416. doi: 10.1136/bmjopen-2019-032416.
PubMed 31871257Peat G, Thomas E, Duncan R, Wood L, Hay E, Croft P. Clinical classification criteria for knee osteoarthritis: performance in the general population and primary care. Ann Rheum Dis. 2006 Oct;65(10):1363-7. doi: 10.1136/ard.2006.051482. Epub 2006 Apr 20.
PubMed 16627539Cavalcanti RR, Almeida Silva HJ, Pontes-Silva A, Avila MA, de Souza CG, Sousa CO, Scattone Silva R, Barbosa GM, de Souza MC. Dry cupping therapy has no effect on pain, function, or quality of life in women with knee osteoarthritis: Randomized placebo-controlled trial. Braz J Phys Ther. 2026 Jan-Feb;30(1):101259. doi: 10.1016/j.bjpt.2025.101259. Epub 2025 Oct 2.
PubMed 41043303Pontes NS, Barbosa GM, Almeida Silva HJ, Scattone Silva R, Souza CG, Lins CAA, de Souza MC. Effects of dry cupping on pain, function and quality of life in women with knee osteoarthritis: a protocol for a sham-controlled randomised trial. BMJ Open. 2020 Dec 24;10(12):e039857. doi: 10.1136/bmjopen-2020-039857.
PubMed 33361075
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dry Cupping on Pain, Function and Quality of Life of Women With Knee Osteoarthritis: Protocol for a Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04331158
- Acronym / sponsor ID
- VentosaOA / UFRNventosaOA
- Conditions
- Osteo Arthritis Knee, Pain, Chronic, Pain
- Keywords
- Chronic pain, Traditional Chinese Medicine, Complementary Therapie
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Knee osteoarthritis (KOA) is the biggest cause of pain and disability worldwide. As a non-pharmacological approach, ventosatherapia has been used to control pain, improve function and quality of life. However, there is a lack of high-quality scientific evidence regarding its effects on this condition. Objective: To evaluate the effects of dry cupping on pain, function and quality of life in women with KOA. Methods: This is a randomized, blinded placebo-controlled protocol. 62 women diagnosed with KOA will be recruited, based on the clinical criteria of the American College of Rheumatology, who will be randomly divided into two groups (31 per group): dry cupping and dry cupping sham.
Detailed description
The intervention will be carried out for 15 minutes, twice a week, for 6 consecutive weeks, totaling 12 sessions. Both groups will be evaluated in 4 moments: before the intervention (T0), after 3 weeks of interventions (T3), at the end of the protocol (T6) and 4 weeks after the end of the interventions (follow-up - T10). The analyzed outcomes will be: Primary - pain (numerical pain scale); Secondary - Physical function (WOMAC; tests of going up / down stairs, brisk walking in 40 m and sitting / rising from a chair in 30 s), quality of life (SF-36) and global perception of the effect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- dry cupping group and dry cupping sham group
| Arm | Type | Receives |
|---|---|---|
| Dry cupping group | Experimental | Other: Dry cupping therapyThe dry cupping will be applied with a force of two suctions generating a negative pressure on the skin during the time of 15 minutes. |
| Dry cupping sham group | Placebo comparator | Other: Dry cupping therapyThe dry cupping sham group will receive the same procedures as the dry cup group, with the difference that the negative pressure imposed after application will be released in a few seconds. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with KOA based on ACR clinical criteria;
- Knee pain intensity between 3 and 8, according to the Numerical Pain Scale (END);
- BMI less than 35 kg / m2.
Key exclusion criteria (12 listed)
- Having undergone physical therapy treatment for the knee in the 3 months prior to the project;
- Be engaged in> 45 minutes / week in accumulated physical activity of at least moderate intensity;
- To have been submitted to the application and / or intervention with the wind therapy previously.
- Have used corticosteroid infiltration in the knee in the last 6 months;
- Present any medical restrictions that make it impossible for them to participate in the proposed assessments and interventions (cardiorespiratory, neurological and / or musculoskeletal changes);
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 |
|---|---|---|
| Dry cupping therapyDry cupping therapy application on the patient's skin | Other | Dry cupping group, Dry cupping sham group |
Primary outcome
Change from Numerical Rating Scale (NRS)
Time frame: baseline, 3 ,6 and 10 weeks after.
Subjective measure in which individuals rate their pain on an eleven-point numerical scale. Such scale will be positioned in front of the participant and will vary from 0 to 10 points, with 0 being the complete absence of pain and 10 being the worst pain imaginable by the individual
8 secondary outcomes
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline, 3 ,6 and 10 weeks after.
Change from 30-second Chair Stand Test
Time frame: baseline, 6 and 10 weeks after.
Change from 8-step Stair Climb Test
Time frame: baseline, 6 and 10 weeks after.
Change from 40m Fast Paced Walk Test
Time frame: baseline, 6 and 10 weeks after.
Change from Short-Form 36 quality of life
Time frame: baseline, 6 and 10 weeks after.
Change from Global Perceived Effect
Time frame: baseline, 3, 6 and 10 weeks after.
Change from use of analgesics and anti-inflammatories
Time frame: baseline, 3, 6 and 10 weeks after
Change from expectation with treatment after the intervention protocol .
Time frame: baseline and 10 weeks after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 31871257Silva HJA, Saragiotto BT, Silva RS, Lins CAA, de Souza MC. Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study. BMJ Open. 2019 Dec 22;9(12):e032416. doi: 10.1136/bmjopen-2019-032416.
- Background: PubMed 16627539Peat G, Thomas E, Duncan R, Wood L, Hay E, Croft P. Clinical classification criteria for knee osteoarthritis: performance in the general population and primary care. Ann Rheum Dis. 2006 Oct;65(10):1363-7. doi: 10.1136/ard.2006.051482. Epub 2006 Apr 20.
- Derived from this study: PubMed 41043303Cavalcanti RR, Almeida Silva HJ, Pontes-Silva A, Avila MA, de Souza CG, Sousa CO, Scattone Silva R, Barbosa GM, de Souza MC. Dry cupping therapy has no effect on pain, function, or quality of life in women with knee osteoarthritis: Randomized placebo-controlled trial. Braz J Phys Ther. 2026 Jan-Feb;30(1):101259. doi: 10.1016/j.bjpt.2025.101259. Epub 2025 Oct 2.
- Derived from this study: PubMed 33361075Pontes NS, Barbosa GM, Almeida Silva HJ, Scattone Silva R, Souza CG, Lins CAA, de Souza MC. Effects of dry cupping on pain, function and quality of life in women with knee osteoarthritis: a protocol for a sham-controlled randomised trial. BMJ Open. 2020 Dec 24;10(12):e039857. doi: 10.1136/bmjopen-2020-039857.
- Individual participant dataSharing planned: No. there is not a plan to make individual participant data (IPD) available to other researchers
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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.
Marcelo C de Souza, PT, PhD study chair
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry cupping therapy in people with Osteo Arthritis Knee and Pain, Chronic, run by Universidade Federal do Rio Grande do Norte 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 3 inclusion and 12 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 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Numerical Rating Scale (NRS) (time frame: baseline, 3 ,6 and 10 weeks after.). 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 NCT04331158, which also lists 4 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 17 Jun 2025.