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The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain (lowbackpain)

Primary Purpose

Low Back Pain, Mechanical, Low Back Pain, Postural, Lower Back Pain Chronic

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
muscle strengthening exercises
muscle strengthening exercises and dry cupping
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Claudio Cazarini Júnior

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercise group

Exercise group and dry cupping

Arm Description

Exercise group

Exercise and dry cupping

Outcomes

Primary Outcome Measures

pain intensity after and before six weeks
Numerical Visual Scale (0-100)

Secondary Outcome Measures

Full Information

First Posted
December 26, 2019
Last Updated
October 5, 2022
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04216810
Brief Title
The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain
Acronym
lowbackpain
Official Title
The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain: a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical, Low Back Pain, Postural, Lower Back Pain Chronic, Low Back Pain, Posterior Compartment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
Exercise group
Arm Title
Exercise group and dry cupping
Arm Type
Experimental
Arm Description
Exercise and dry cupping
Intervention Type
Other
Intervention Name(s)
muscle strengthening exercises
Intervention Description
segmental stabilization exercises
Intervention Type
Other
Intervention Name(s)
muscle strengthening exercises and dry cupping
Intervention Description
segmental stabilization exercises and dry cupping
Primary Outcome Measure Information:
Title
pain intensity after and before six weeks
Description
Numerical Visual Scale (0-100)
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Claudio Cazarini Júnior
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
03156001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10872758
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. doi: 10.1097/00002517-200006000-00003.
Results Reference
result
PubMed Identifier
18164449
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.
Results Reference
result
PubMed Identifier
19748833
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.
Results Reference
result
PubMed Identifier
30361077
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.
Results Reference
result

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The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain

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