Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain

Официальное название

Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain: Protocol for a Sham-controlled Randomized Trial

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Exercises and dry cupping
  Participants in the intervention group will receive an assessment, classification as to MDT syndrome and indication of the preferred direction of movement, whether flexion, extension or lateral displacement of the spine

Первичные конечные точки

• Change in Disability - ODI [Срок оценки: baseline and 8 weeks after]

Вторичные конечные точки (5)

• Change Numerical Pain Scale - NPS [Срок оценки: baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention]
• Change in Functional test - Timed Up and Go (TUG) [Срок оценки: baseline and 8 weeks after]
• Change in Trunk range of motion - Range of motion (ROM) [Срок оценки: baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention]
• Change in participant perception [Срок оценки: baseline and 8 weeks after]
• Change in participant expectation [Срок оценки: baseline]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Marcelo Cardoso de Souza — Natal

Публикации

• 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
• 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. PMID 35587506
• da Silva KMP, Almeida Silva HJ, Pontes-Silva A, DeSantana JM, Avila MA, Barbosa GM, de Souza MC. What are the effects of dry cupping therapy combined with the McKenzie method on clinical outcomes in chronic low back pain? A protocol for a randomized, sham-controlled trial. BMC Complement Med Ther. 2025 Jul 2;25(1):219. doi: 10.1186/s12906-025-04940-9. PMID 40604805

Идентификаторы

NCT: NCT05459376 · UFRNMDTDryCupping

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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