Clinical trial NCT05459376: Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain
Official title: Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain: Protocol for a Sham-controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group and Sham Group
Primary purpose: TREATMENT

Brief summary: Introduction: Currently, clinical practice guidelines recommend exercise as a first-line approach to the treatment of chronic low back pain (LBP). On the other hand, passive techniques such as cupping therapy have gained space in the management of this population, however, important gaps regarding the combination of cupping therapy with active exercises in individuals with nonspecific chronic low back pain are still present in the literature. In this context, this protocol describes a sham-controlled, randomized and blinded study that aims to evaluate the additional effects of cupping therapy in association with McKenzie method exercises on pain and functional outcomes of individuals with nonspecific chronic low back pain. Methods: 108 individuals with nonspecific and localized chronic low back pain in the age group of 18 to 59 years will be recruited and evaluated, regarding the inclusion and exclusion criteria. Subsequently, they will be randomized to one of 2 groups: intervention group, in which they will be submitted to the McKenzie method intervention and later the addition of the dry suction cup; and sham group, in which, after the intervention of the McKenzie method, the application of the sham cup will be added.

Detailed description: The individuals will be classified and treated according to the McKenzie method (MDT) and then they will receive the application of cups in parallel to the vertebrae from L1 to L5, bilaterally. Interventions will be carried out twice a week for eight weeks. Volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), with 4 weeks of intervention (T4) and with 8 weeks of intervention (T8)

The individuals will be classified and treated according to the McKenzie method and then they will receive the application of cups in parallel to the vertebrae from L1 to L5, bilaterally. Interventions will be carried out twice a week for eight weeks. Volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), with 4 weeks of intervention (T4) and with 8 weeks of intervention (T8). The primary outcome will be physical function, functionality (Timed Up and Go test), while the secondary outcomes will be pain intensity (Numerical Pain Scale), lumbar range of motion (finger to floor test), patient expectation and patient perception (Global Perceived Effect Scale).

Eligibility criteria: Inclusion Criteria:

* Individuals, male and female, 18 to 59 years, non-obese, with non-specific localized LBP for more than 3 months;
* Report pain intensity between 3 and 8 according to the numerical pain scale;

Exclusion Criteria:

* Have previously performed cupping therapy in some body segment;
* Present neurological, vestibular, visual or auditory deficits that make assessments impossible;
* Being in the gestational period;
* Having severe spinal disease (including fractures, tumour, inflammatory diseases, or tumours);
* Have undergone previous spinal surgery;
* Present with radiating or sacroiliac back pain; another rheumatic disease such as fibromyalgia,or ankylosing spondylitis.

Primary outcomes:
measure: Change in Disability - ODI
timeFrame: baseline and 8 weeks after
Secondary outcomes:
measure: Change Numerical Pain Scale - NPS
timeFrame: baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention
measure: Change in Functional test - Timed Up and Go (TUG)
timeFrame: baseline and 8 weeks after
measure: Change in Trunk range of motion - Range of motion (ROM)
timeFrame: baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention
measure: Change in participant perception
timeFrame: baseline and 8 weeks after
measure: Change in participant expectation
timeFrame: baseline
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Marcelo Cardoso de Souza
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Marcelo C de Souza, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: Almeida Silva HJ, Avila MA, Castro KMS, Pinheiro YT, Lins CAA, Medeiros Barbosa G, de Souza MC. Exploring patient experiences of participating in a real and sham dry cupping intervention for nonspecific low back pain: A qualitative study. PLoS One. 2022 May 19;17(5):e0268656. doi: 10.1371/journal.pone.0268656. eCollection 2022.