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

Universidade Federal do Rio Grande do Norte

Status: Begins enrollment in 7 months

Conditions: Low Back Pain

Treatments: Other: Exercises and dry cupping

Study type: Interventional

Funder types: Other

Identifiers

NCT05459376

UFRNMDTDryCupping

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Exercises and dry cupping

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Other: Exercises and dry cupping