Cupping Therapy in Nonspecific Chronic Low Back Pain

NCT ID: NCT03909672

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2020-02-20

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.

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cupping Therapy

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Cupping Therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Cardoso de Souza, PT, PhD.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo Cardoso De Souza, PT,PhD

Role: STUDY_CHAIR

Universidade Federal do Rio Grande do Norte

Locations

Marcelo Souza

Santa Cruz, Rio Grande do Norte, Brazil

Countries

Brazil

References

Wang YT, Qi Y, Tang FY, Li FM, Li QH, Xu CP, Xie GP, Sun HT. The effect of cupping therapy for low back pain: A meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1187-1195. doi: 10.3233/BMR-169736.

Reference Type: BACKGROUND

PMID: 28946531 (View on PubMed)

Moura CC, Chaves ECL, Cardoso ACLR, Nogueira DA, Correa HP, Chianca TCM. Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3094. doi: 10.1590/1518-8345.2888.3094.

Reference Type: RESULT

PMID: 30462793 (View on PubMed)

Almeida Silva HJ, Barbosa GM, Scattone Silva R, Saragiotto BT, Oliveira JMP, Pinheiro YT, Lins CAA, de Souza MC. Dry cupping therapy is not superior to sham cupping to improve clinical outcomes in people with non-specific chronic low back pain: a randomised trial. J Physiother. 2021 Apr;67(2):132-139. doi: 10.1016/j.jphys.2021.02.013. Epub 2021 Mar 20.

Reference Type: DERIVED

PMID: 33757719 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31871257 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

UFRNventosa

Identifier Type: -

Identifier Source: org_study_id