Cupping Therapy in Nonspecific Chronic Low Back Pain (cupping)

Universidade Federal do Rio Grande do Norte

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Cupping Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03909672

UFRNventosa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

Cupping therapy with 2 suctions

Experimental group

Description:

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.

Treatment:

Other: Cupping Therapy

Cupping Therapy sham

Placebo Comparator group

Description:

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.

Treatment:

Other: Cupping Therapy