Clinical trial NCT03909672: Cupping Therapy in Nonspecific Chronic Low Back Pain
Official title: Cupping Therapy in the Treatment of Individuals With Nonspecific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
cupping therapy
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Numeric Rating Scale (NRS) of Pain
timeFrame: T0 -baseline, T4 (four week) and T8 (eight week)
Secondary outcomes:
measure: Change from Oswestry Disability Index (ODI)
timeFrame: T0 -baseline and T8 (eight week)
measure: Range of motion of the lower back (ROM)
timeFrame: T0 -baseline, T4 (four week) and T8 (eight week)
measure: Short-Form 36 questionnaire (SF-36)
timeFrame: T0 -baseline and T8 (eight week)
measure: Timed Up and Go Test (TUG):
timeFrame: T0 -baseline and T8 (eight week)
measure: Global Perceived Effect Scale (GPE)
timeFrame: T8 (eight week)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: T0 -baseline and T8 (eight week)
measure: Medication consumption
timeFrame: T8 (eight week)
Other outcomes:
Locations:
city: Santa Cruz
country: Brazil
facility: Marcelo Souza
state: Rio Grande Do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Marcelo Cardoso De Souza, PT,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.