- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04331158
Dry Cupping Therapy in Knee Osteoarthritis (VentosaOA)
January 18, 2023 updated by: Marcelo Cardoso de Souza, PT, PhD., Universidade Federal do Rio Grande do Norte
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marcelo C de Souza, PT, PhD
- Phone Number: 55843342-2287
- Email: marcellogv@hotmail.com
Study Locations
-
-
RN
-
Santa Cruz, RN, Brazil, 59200-000
- Recruiting
- Marcelo Cardoso de Souza
-
Contact:
- Marcelo C de Souza, Professor
- Phone Number: 55(84) 3342-2287
- Email: marcellogv@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry cupping group
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.
|
Dry cupping therapy application on the patient's skin
|
Placebo Comparator: Dry cupping sham group
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.
|
Dry cupping therapy application on the patient's skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, 3 ,6 and 10 weeks after.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: baseline, 3 ,6 and 10 weeks after.
|
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
|
baseline, 3 ,6 and 10 weeks after.
|
Change from 30-second Chair Stand Test
Time Frame: baseline, 6 and 10 weeks after.
|
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
|
baseline, 6 and 10 weeks after.
|
Change from 8-step Stair Climb Test
Time Frame: baseline, 6 and 10 weeks after.
|
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.
|
baseline, 6 and 10 weeks after.
|
Change from 40m Fast Paced Walk Test
Time Frame: baseline, 6 and 10 weeks after.
|
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.
|
baseline, 6 and 10 weeks after.
|
Change from Short-Form 36 quality of life
Time Frame: baseline, 6 and 10 weeks after.
|
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.
|
baseline, 6 and 10 weeks after.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Marcelo C de Souza, PT, PhD, Universidade Federal do Rio Grande do Norte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Peat 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.
- Pontes 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2022
Primary Completion (Anticipated)
December 2, 2023
Study Completion (Anticipated)
March 2, 2024
Study Registration Dates
First Submitted
March 29, 2020
First Submitted That Met QC Criteria
March 30, 2020
First Posted (Actual)
April 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 18, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRNventosaOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
there is not a plan to make individual participant data (IPD) available to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Dry cupping therapy
-
Cancer Institute and Hospital, Chinese Academy...UnknownMuscle Spasticity | Oxygen Metabolism
-
Riphah International UniversityCompleted
-
Cairo UniversityUnknown
-
Riphah International UniversityCompletedMyofascial Trigger Point Pain | Quadratus Lumborum Syndrome | Positional Fault of Pelvis | Myofascial Trigger Point in Quadratus LumborumPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Imam Abdulrahman Bin Faisal UniversityCompletedPlantar Fasciitis | Chronic Plantar Fasciitis | Heel Spur Syndrome
-
Universidade Federal do Rio Grande do NorteNot yet recruiting
-
Universität Duisburg-EssenCompletedNeck Pain | Neck Pain Musculoskeletal | Mechanical/Motor Problems With Neck and TrunkGermany
-
University of South CarolinaRecruitingHamstring Contractures | Muscle TightnessUnited States
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil