NCT04331158

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

March 29, 2020

Last Update Submit

June 12, 2025

Conditions

Keywords

Chronic painTraditional Chinese MedicineComplementary Therapie

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline, 3 ,6 and 10 weeks after.

Secondary Outcomes (8)

  • Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    baseline, 3 ,6 and 10 weeks after.

  • Change from 30-second Chair Stand Test

    baseline, 6 and 10 weeks after.

  • Change from 8-step Stair Climb Test

    baseline, 6 and 10 weeks after.

  • Change from 40m Fast Paced Walk Test

    baseline, 6 and 10 weeks after.

  • Change from Short-Form 36 quality of life

    baseline, 6 and 10 weeks after.

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Other: Dry cupping therapy

Interventions

Dry cupping therapy application on the patient's skin

Dry cupping groupDry cupping sham group

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMost prevalent disease in elderly women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcelo Cardoso de Souza

Santa Cruz, Rio Grande do Norte, 59200-000, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 31871257BACKGROUND
  • 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.

    PMID: 16627539BACKGROUND
  • Cavalcanti 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.

  • 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.

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcelo C de Souza, PT, PhD

    Universidade Federal do Rio Grande do Norte

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To avoid any type of selection bias, the confidential allocation method will be through opaque envelopes, sealed and numbered consecutively. The randomization process will be carried out by an independent researcher who will not be involved in other study procedures. The group in which the participant will be allocated will be revealed to the researcher responsible for the consultations prior to the first intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: dry cupping group and dry cupping sham group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 2, 2020

Study Start

February 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 2, 2023

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

there is not a plan to make individual participant data (IPD) available to other researchers

Locations