Cupping Therapy in Nonspecific Chronic Low Back Pain

NCT03909672 | Completed DMC

• 1 other identifier: UFRNventosa
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; cupping therapy

Outcome Measures

Primary Outcomes (1)

• Change from Numeric Rating Scale (NRS) of Pain

  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'

  T0 -baseline, T4 (four week) and T8 (eight week)

Secondary Outcomes (7)

• Change from Oswestry Disability Index (ODI)

  T0 -baseline and T8 (eight week)

• Range of motion of the lower back (ROM)

  T0 -baseline, T4 (four week) and T8 (eight week)

• Short-Form 36 questionnaire (SF-36)

  T0 -baseline and T8 (eight week)

• Timed Up and Go Test (TUG):

  T0 -baseline and T8 (eight week)

• Global Perceived Effect Scale (GPE)

  T8 (eight week)

Study Arms (2)

Cupping therapy with 2 suctions

EXPERIMENTAL

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

Cupping Therapy sham

PLACEBO COMPARATOR

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

Interventions

Cupping Therapy 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; Cupping therapy with 2 suctions

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Marcelo Souza

Santa Cruz, Rio Grande do Norte, 59200-000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 28946531 BACKGROUND

• 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.

  PMID: 30462793 RESULT

• 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.

  PMID: 33757719 DERIVED

• 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.

  PMID: 31871257 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Cupping Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Marcelo Cardoso De Souza, PT,PhD

  Universidade Federal do Rio Grande do Norte

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 10, 2019
• Study Start: June 10, 2019
• Primary Completion: December 10, 2019
• Study Completion: February 20, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)