Low Back Pain, MechanicallowbackpainNCT04216810
The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain
A study testing muscle strengthening exercises and muscle strengthening exercises and dry cupping in people with Low Back Pain, Mechanical and Low Back Pain, Postural, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Mechanical, Low Back Pain, Postural, Lower Back Pain Chronic
- What is being tested?
- muscle strengthening exercises and muscle strengthening exercises and dry cupping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain: a Randomized Controlled Study.
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).
- Conditions
- Low Back Pain, Mechanical, Low Back Pain, Postural, Lower Back Pain Chronic, Low Back Pain, Posterior Compartment
- Being tested
- muscle strengthening exercises, muscle strengthening exercises and dry cupping
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle strengthening exercisesOther
segmental stabilization exercises
muscle strengthening exercises and dry cuppingOther
segmental stabilization exercises and dry cupping
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | Exercise group Receives: Other: muscle strengthening exercises |
| Exercise group and dry cupping | Experimental | Exercise and dry cupping Receives: Other: muscle strengthening exercises and dry cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity after and before six weeks
Numerical Visual Scale (0-100)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Dec 2019
- Primary completion1 May 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216810
- Sponsor's protocol ID
- Sidnei Correia
- Acronym
- lowbackpain
- Status last verified
- Oct 2022
- First submitted
- 26 Dec 2019
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10872758Dagenais 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.
PubMed 18164449Dagenais 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.
PubMed 19748833Areeudomwong 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.
PubMed 30361077
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04216810
- Acronym / sponsor ID
- lowbackpain / Sidnei Correia
- Conditions
- Low Back Pain, Mechanical, Low Back Pain, Postural, Lower Back Pain Chronic, Low Back Pain, Posterior Compartment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Other: muscle strengthening exercisesExercise group |
| Exercise group and dry cupping | Experimental | Other: muscle strengthening exercises and dry cuppingExercise and dry cupping |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle strengthening exercisessegmental stabilization exercises | Other | Exercise group |
| muscle strengthening exercises and dry cuppingsegmental stabilization exercises and dry cupping | Other | Exercise group and dry cupping |
Primary outcome
pain intensity after and before six weeks
Time frame: immediately after the intervention
Numerical Visual Scale (0-100)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Results publication: PubMed 10872758Walker 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 publication: PubMed 18164449Dagenais 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 publication: PubMed 19748833Dagenais 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 publication: PubMed 30361077Areeudomwong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle strengthening exercises and muscle strengthening exercises and dry cupping in people with Low Back Pain, Mechanical and Low Back Pain, Postural, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity after and before six weeks (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216810, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.