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Trial record 20 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Cupping Therapy in Nonspecific Chronic Low Back Pain (cupping)

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ClinicalTrials.gov Identifier: NCT03909672
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte

Brief Summary:
Introduction: Low back pain is a very prevalent condition in the population and windsurf therapy has been presented as a non-pharmacological treatment currently used in this population. However, there is a lack of studies that evaluate such effects, besides a standardization of application of the technique in this condition. This protocol describes a placebo-controlled, randomized, double-blind study that aims to assess the effectiveness of windsurf therapy in improving pain and other symptoms of individuals with chronic non-specific back pain. Methods: Ninety individuals with chronic nonspecific and localized chronic low back pain from 18 to 59 years, will be recruited according to the inclusion criteria. Afterwards they will be randomized to one of the 2 groups: intervention group (GI) where it will be submitted applied to the windspiration with 2 suctions; and placebo group (GP) with simulated application. Both applications will occur in parallel to the vertebrae from L1 to L5 bilaterally. The application will be performed once a week for eight weeks. The volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), 4 weeks after treatment (T4) and 8 weeks after treatment (T8). The primary endpoint will be pain, and the secondary ones will be kinesiophobia, physical function, lumbar range of motion, sleep quality, patient expectation, quality of life, and psychological factors. Discussion: This is the first protocol that proposes to evaluate the effect of windsotherapy on lumbar ROM, sleep quality, kinesiophobia and psychological problems. Few studies have been done on windsurfing individuals with low back pain, requiring further studies with good methodological quality. Because there is no consensus on the use of windsurf therapy in individuals with nonspecific chronic low back pain, our protocol will be the basis for the use of the technique by health professionals and for new studies to be performed.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Cupping Therapy Not Applicable

Detailed Description:
This study will involve 4 researchers; 1 researcher responsible for evaluations; 1 researcher responsible for interventions; 1 researcher responsible for the interview, initial screening and randomization of participants, and 1 researcher who will perform the statistical analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Cupping Therapy in the Treatment of Individuals With Nonspecific Chronic Low Back Pain
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Cupping therapy with 2 suctions
Participants in the intervention group will receive the application of cupping therapy with two acrylic type 1 cups with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally. This group will consist of the application of windsheets with 2 suctions for 10 minutes, once a week, for 10 weeks. The cups shall be secured by means of elastic bands.
Other: Cupping Therapy
application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang ® brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally

Placebo Comparator: Cupping Therapy sham

The placebo group will receive the application of cupping therapy with 2 cups of acrylic type size 1 with a distance of 3 cm each cup, parallel to the vertebrae L1 to L5, bilaterally . This group will consist of applying the sham winds for 10 minutes, once a week for 10 weeks.

However, the cups will be made with small holes <2 mm in diameter to release the negative pressure in seconds. The cups will also be fixed by means of elastic bands.

Other: Cupping Therapy
application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang ® brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally




Primary Outcome Measures :
  1. Change from Numeric Rating Scale (NRS) of Pain [ Time Frame: T0 -baseline, T5 (five week) and T10 (10 week) ]
    The patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'


Secondary Outcome Measures :
  1. Change from Oswestry Disability Index (ODI) [ Time Frame: T0 -baseline, T5 (five week) and T10 (10 week) ]
    will be used to analyze the quality of life in people with low back pain. This instrument contains in 10 items that assess the impact of low back pain on several functional activities. Values range from 0 to 5, the highest value indicating greater disability. The end result is the sum of all items.

  2. Change from Six-minute walk test (6MWT) [ Time Frame: T0 -baseline, T5 (five week) and T10 (10 week) ]
    as recommended by the American Thoracic Society (2002). A distance of 30 meters will be demarcated by two cones (one in the initial mark and the other in the final mark). The volunteers will be instructed to travel the greatest number of times the distance marked for six minutes and, at the end of this time, the distance traveled will be measured. In addition, verbal encouragement will be given every minute such as "You are doing very well" and "continue like this".



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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:

  • female and male individuals aged between 18 and 59 years, normal BMI, presenting localized and non-specific lower back pain for more than 3 months;
  • have not used cupping therapy before;
  • report pain between 3 and 8 by NRS;
  • individuals who are not under physiotherapeutic treatment during the intervention;
  • individuals without neurological, vestibular, visual or auditory deficits that make evaluations impossible.

Exclusion Criteria:

  • Individuals with cutaneous lesions in the region where they will be applied to cupping therapy,
  • Individuals with uncontrolled diabetes and hypertension;
  • Irradiated and sacral lumbar pain;
  • Individuals with contraindication to windsurf therapy, are: cancer, renal failure, hepatic and cardiac insufficiency, pacemaker, pregnancy;
  • Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors);
  • Travel planning in the next 2 months

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): NCT03909672


Contacts
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Contact: Marcelo Cardoso De Souza, PT, PhD 55 84 3291.2411 84 3291.2411 marcelocardoso@facisa.ufrn.br

Locations
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Brazil
Marcelo Souza
Santa Cruz, Rio Grande Do Norte, Brazil, 59200-000
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
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Study Chair: Marcelo Cardoso De Souza, PT,PhD Universidade Federal do Rio Grande do Norte

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
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Responsible Party: Marcelo Cardoso de Souza, Professor, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03909672     History of Changes
Other Study ID Numbers: UFRNventosa
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there isn't a plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte:
low back pain
cupping therapy

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms