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Dry Cupping Therapy in Knee Osteoarthritis (VentosaOA)

Primary Purpose

Osteo Arthritis Knee, Pain, Chronic, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dry cupping therapy
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Chronic pain, Traditional Chinese Medicine, Complementary Therapie

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Marcelo Cardoso de SouzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dry cupping group

Dry cupping sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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.
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.

Full Information

First Posted
March 29, 2020
Last Updated
January 18, 2023
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT04331158
Brief Title
Dry Cupping Therapy in Knee Osteoarthritis
Acronym
VentosaOA
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
December 2, 2023 (Anticipated)
Study Completion Date
March 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Pain, Chronic, Pain
Keywords
Chronic pain, Traditional Chinese Medicine, Complementary Therapie

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
dry cupping group and dry cupping sham group
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry cupping group
Arm Type
Experimental
Arm Description
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.
Arm Title
Dry cupping sham group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry cupping therapy
Intervention Description
Dry cupping therapy application on the patient's skin
Primary Outcome Measure Information:
Title
Change from Numerical Rating Scale (NRS)
Description
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
Time Frame
baseline, 3 ,6 and 10 weeks after.
Secondary Outcome Measure Information:
Title
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Time Frame
baseline, 3 ,6 and 10 weeks after.
Title
Change from 30-second Chair Stand Test
Description
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
Time Frame
baseline, 6 and 10 weeks after.
Title
Change from 8-step Stair Climb Test
Description
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.
Time Frame
baseline, 6 and 10 weeks after.
Title
Change from 40m Fast Paced Walk Test
Description
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.
Time Frame
baseline, 6 and 10 weeks after.
Title
Change from Short-Form 36 quality of life
Description
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.
Time Frame
baseline, 6 and 10 weeks after.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Most prevalent disease in elderly women
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo C de Souza, PT, PhD
Phone
55843342-2287
Email
marcellogv@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo C de Souza, PT, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Study Chair
Facility Information:
Facility Name
Marcelo Cardoso de Souza
City
Santa Cruz
State/Province
RN
ZIP/Postal Code
59200-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo C de Souza, Professor
Phone
55(84) 3342-2287
Email
marcellogv@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is not a plan to make individual participant data (IPD) available to other researchers
Citations:
PubMed Identifier
31871257
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.
Results Reference
background
PubMed Identifier
16627539
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.
Results Reference
background
PubMed Identifier
33361075
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.
Results Reference
derived

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Dry Cupping Therapy in Knee Osteoarthritis

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