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

NCT05459376 | Not Yet Recruiting DMC

• 1 other identifier: UFRNMDTDryCupping
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in Disability - ODI

  The Oswestry Disability Index (ODI) questionnaire will be used to analyze disability in people with low back pain.This instrument contains 10 items that assess the impact of low back pain on various functional activities. Values range from 0 to 5, with the highest value indicating greater disability. The final result is the sum of all items. The validated version in Portuguese is used.

  baseline and 8 weeks after

Secondary Outcomes (5)

• Change Numerical Pain Scale - NPS

  baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention

• Change in Functional test - Timed Up and Go (TUG)

  baseline and 8 weeks after

• Change in Trunk range of motion - Range of motion (ROM)

  baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention

• Change in participant perception

  baseline and 8 weeks after

• Change in participant expectation

  baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Exercises and dry cupping

Sham Group

SHAM COMPARATOR

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.

Other: Exercises and dry cupping

Interventions

Exercises and dry cupping 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

Also known as: exercises

Intervention Group; Sham Group

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Marcelo Cardoso de Souza

Natal, Rio Grande do Norte, 59200-000, Brazil

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marcelo C de Souza, PT, PhD

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo C de Souza, PT, PhD

CONTACT

55 84 3342-2385; marcelo.cardoso@ufrn.br

Germanna B Medeiros, PT, PhD

CONTACT

55 84 3342 2287; contato@facisa.ufrn.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All assessments will be carried out by researcher A who will not be involved with the interventions and will remain blind to the identification of groups. Each participant will remain identified by numbers and not names. Participants will be informed about the aim of the study to assess the additional effect of two different cupping techniques, the classic and the sham, in association with active exercise. In order not to compromise the blinding of the study, all participants will undergo the same assessment before the interventions. Intervention times will be differentiated so that there is no contact between the groups and possible exchanges of information. Data collected during participant assessments will not be revealed to the researchers responsible for the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: Intervention Group and Sham Group

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 15, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)