NCT04216810

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

December 26, 2019

Last Update Submit

October 5, 2022

Conditions

Low Back Pain, MechanicalLow Back Pain, PosturalLower Back Pain ChronicLow Back Pain, Posterior Compartment

Outcome Measures

Primary Outcomes (1)

  • pain intensity after and before six weeks

    Numerical Visual Scale (0-100)

    immediately after the intervention

Study Arms (2)

Exercise group

ACTIVE COMPARATOR

Exercise group

Other: muscle strengthening exercises

Exercise group and dry cupping

EXPERIMENTAL

Exercise and dry cupping

Other: muscle strengthening exercises and dry cupping

Interventions

muscle strengthening exercisesOTHER

segmental stabilization exercises

Exercise group
muscle strengthening exercises and dry cuppingOTHER

segmental stabilization exercises and dry cupping

Exercise group and dry cupping

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Cazarini Júnior

São Paulo, São Paulo, 03156001, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 10872758RESULT

  • 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.

    PMID: 18164449RESULT

  • 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.

    PMID: 19748833RESULT

  • 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.

    PMID: 30361077RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2019

First Posted

January 3, 2020

Study Start

December 1, 2019

Primary Completion

May 1, 2021

Study Completion

July 1, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)