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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04216810
Other study ID # Sidnei Correia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date July 1, 2022

Study information

Verified date October 2022
Source Faculdade de Ciências Médicas da Santa Casa de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date July 1, 2022
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
muscle strengthening exercises
segmental stabilization exercises
muscle strengthening exercises and dry cupping
segmental stabilization exercises and dry cupping

Locations

Country Name City State
Brazil Claudio Cazarini Júnior Sao Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. do — View 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. Review. — View 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. Review. — View Citation

Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain intensity after and before six weeks Numerical Visual Scale (0-100) immediately after the intervention
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