Clinical trial NCT04216810: The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain
Official title: The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Low Back Pain, Postural
Lower Back Pain Chronic
Low Back Pain, Posterior Compartment
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a major public health problem and is associated with a high rate of absenteeism at work, functional disability and frequent use of health services. Suction cup therapy is a common technique of traditional Chinese medicine (TCM), which has been around for about 3,300 years in Asia and the Middle East and has as its main feature the decrease in signs and symptoms of chronic pain. The technique was widely used in the 19th century throughout Asia and Europe, and in recent years demand has been increasing, possibly due to the inefficiency of conventional therapies and medicines. Objective: To verify the effectiveness of the suction cup therapy technique associated with conventional physiotherapy in patients with chronic low back pain. Method: We will include individuals between 18 and 60 years old, both genders, with low back pain for more than 3 months, without having received physical therapy treatment for a period of 6 months. Individuals with severe spinal diseases, root conditions of the spine, carriers of vascular diseases and pregnant women will be excluded. They will be randomly divided into two groups, Conventional Physiotherapy (group 1) and Conventional Physiotherapy associated with suction cup therapy (group 2).


Eligibility criteria: Inclusion Criteria:

* nonspecific chronic low back pain without lower limb irradiation
* Aged between 18 and 60 years,
* Both genders
* Low back pain for more than 3 months
* Without having received physiotherapy treatment for a period of 6 months

Exclusion Criteria:

* individuals with severe spinal diseases (fractures, tumors and inflammatory conditions such as ankylosing spondylitis)
* root conditions of the spine (disc herniation and spondylolisthesis with neurological impairment and narrowing of the spinal canal)
* root conditions of the spine
* carriers of vascular diseases
* pregnant women.

Primary outcomes:
measure: pain intensity after and before six weeks
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Claudio Cazarini Júnior
state: São Paulo
Study officials:
References:
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citation: Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
citation: Dagenais S, Roffey DM, Wai EK, Haldeman S, Caro J. Can cost utility evaluations inform decision making about interventions for low back pain? Spine J. 2009 Nov;9(11):944-57. doi: 10.1016/j.spinee.2009.07.007. Epub 2009 Sep 12.
citation: Areeudomwong P, Buttagat V. Proprioceptive neuromuscular facilitation training improves pain-related and balance outcomes in working-age patients with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2019 Sep-Oct;23(5):428-436. doi: 10.1016/j.bjpt.2018.10.005. Epub 2018 Oct 17.