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The Effectiveness of Adding Windy Therapy in Patients With Nonspecific Chronic Lumbar Pain (lowbackpain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216810
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:
Low back pain is a major public health problem and is associated with a high rate of absenteeism at work, functional disability and frequent use of health services. Suction cup therapy is a common technique of traditional Chinese medicine (TCM), which has been around for about 3,300 years in Asia and the Middle East and has as its main feature the decrease in signs and symptoms of chronic pain. The technique was widely used in the 19th century throughout Asia and Europe, and in recent years demand has been increasing, possibly due to the inefficiency of conventional therapies and medicines. Objective: To verify the effectiveness of the suction cup therapy technique associated with conventional physiotherapy in patients with chronic low back pain. Method: We will include individuals between 18 and 60 years old, both genders, with low back pain for more than 3 months, without having received physical therapy treatment for a period of 6 months. Individuals with severe spinal diseases, root conditions of the spine, carriers of vascular diseases and pregnant women will be excluded. They will be randomly divided into two groups, Conventional Physiotherapy (group 1) and Conventional Physiotherapy associated with suction cup therapy (group 2).

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Low Back Pain, Postural Lower Back Pain Chronic Low Back Pain, Posterior Compartment Other: muscle strengthening exercises Other: muscle strengthening exercises and dry cupping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Adding Windy Therapy in Patients With Nonspecific Chronic Lumbar Pain: a Randomized Controlled Study.
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Active Comparator: Exercise group Other: muscle strengthening exercises
segmental stabilization exercises

Experimental: Exercise group and dry cupping Other: muscle strengthening exercises and dry cupping
segmental stabilization exercises and dry cupping




Primary Outcome Measures :
  1. pain intensity - Numerical Visual Scale [ Time Frame: evolution of scale points after six weeks ]
    pain intensity assessment with Numerical Visual Scale

  2. pain intensity - Numerical Visual Scale [ Time Frame: evolution of scale points after eighteen weeks ]
    pain intensity assessment with Visual Scale



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nonspecific chronic low back pain without lower limb irradiation
  • Aged between 18 and 60 years,
  • Both genders
  • Low back pain for more than 3 months
  • Without having received physiotherapy treatment for a period of 6 months

Exclusion Criteria:

  • individuals with severe spinal diseases (fractures, tumors and inflammatory conditions such as ankylosing spondylitis)
  • root conditions of the spine (disc herniation and spondylolisthesis with neurological impairment and narrowing of the spinal canal)
  • root conditions of the spine
  • carriers of vascular diseases
  • pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216810


Locations
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Brazil
Claudio Cazarini Júnior Recruiting
Sao Paulo, São Paulo, Brazil, 03156001
Contact: Claudio Cazarini    5511999872295    claudio_cazarini@terra.com.br   
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Publications of Results:
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Responsible Party: Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT04216810    
Other Study ID Numbers: Sidnei Correia
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms