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

NCT ID: NCT05459376

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-01-01

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).

Conditions

Low Back Pain

Study Design

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

Study Groups

Intervention Group

Participants in the intervention group will receive an assessment, classification as to McKenzie method (MDT) syndrome and indication of the preferred direction of movement, whether flexion, extension or lateral displacement of the spine ; will receive basic information about low back pain (LBP), its prevalence and prognosis; plus how and why to exercise; and types of responses that may occur in response to the exercise program. Guidance for performing the exercises at home. Dry suction cup application with 6 size 1 acrylic cups (4.5 cm internal diameter) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae, bilaterally according to the acupoint boundaries, B23, B24 and B25 . This group will consist of performing MDT exercises and dry cupping with 2 suctions for 10 minutes, 2 times a week, for 8 weeks.

Group Type: EXPERIMENTAL

Exercises and dry cupping

Intervention Type: OTHER

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

Sham Group

The sham group will follow the same principles of evaluation, classification and intervention according to the McKenzie method (MDT) (described in the intervention group) and will have a placebo dry cup application with 6 size 1 acrylic cups (4.5 cm internal diameter) with a distance of 3 cm each cup, parallel to the vertebrae L1 to L5, bilaterally . This group will consist of placebo dry cupping for 10 minutes, 2 times a week, for 8 weeks. However, cups will be prepared with small holes \<2 mm in diameter to release negative pressure in seconds.

Group Type: SHAM_COMPARATOR

Exercises and dry cupping

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

exercises

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.

• 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.

Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo C de Souza, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Locations

Marcelo Cardoso de Souza

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

Central Contacts

Marcelo C de Souza, PT, PhD

Role: CONTACT

marcelo.cardoso@ufrn.br

55 84 3342-2385

Germanna B Medeiros, PT, PhD

Role: CONTACT

contato@facisa.ufrn.br

55 84 3342 2287

References

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: BACKGROUND

PMID: 33757719 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35587506 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40604805 (View on PubMed)

Other Identifiers

UFRNMDTDryCupping

Identifier Type: -

Identifier Source: org_study_id