Clinical trial NCT04331158: Dry Cupping Therapy in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Pain, Chronic
Pain
Keywords: Chronic pain
Traditional Chinese Medicine
Complementary Therapie
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 62
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dry cupping group and dry cupping sham group
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Numerical Rating Scale (NRS)
timeFrame: baseline, 3 ,6 and 10 weeks after.
Secondary outcomes:
measure: Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline, 3 ,6 and 10 weeks after.
measure: Change from 30-second Chair Stand Test
timeFrame: baseline, 6 and 10 weeks after.
measure: Change from 8-step Stair Climb Test
timeFrame: baseline, 6 and 10 weeks after.
measure: Change from 40m Fast Paced Walk Test
timeFrame: baseline, 6 and 10 weeks after.
measure: Change from Short-Form 36 quality of life
timeFrame: baseline, 6 and 10 weeks after.
measure: Change from Global Perceived Effect
timeFrame: baseline, 3, 6 and 10 weeks after.
measure: Change from use of analgesics and anti-inflammatories
timeFrame: baseline, 3, 6 and 10 weeks after
measure: Change from expectation with treatment after the intervention protocol .
timeFrame: baseline and 10 weeks after
Other outcomes:
Locations:
city: Santa Cruz
country: Brazil
facility: Marcelo Cardoso de Souza
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Marcelo C de Souza, PT, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.