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Low Back PaincuppingNCT03909672

Cupping Therapy in Nonspecific Chronic Low Back Pain

A study testing Cupping Therapy in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: Low back pain is a very prevalent condition in the population and windsurf therapy has been presented as a non-pharmacological treatment currently used in this population. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Low Back Pain
What is being tested?
Cupping Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteBrazil
Study dates
10 Jun 2019to 20 Feb 2020
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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • female and male individuals aged between 18 and 59 years, normal BMI, presenting localized and non-specific lower back pain for more than 3 months;
  • have not used cupping therapy before;
  • report pain between 3 and 8 by NRS;
  • individuals who are not under physiotherapeutic treatment during the intervention;
  • individuals without neurological, vestibular, visual or auditory deficits that make evaluations impossible.

Who cannot join

  • Individuals with cutaneous lesions in the region where they will be applied to cupping therapy,
  • Individuals with uncontrolled diabetes and hypertension;
  • Irradiated and sacral lumbar pain;
  • Individuals with contraindication to windsurf therapy, are: cancer, renal failure, hepatic and cardiac insufficiency, pacemaker, pregnancy;
  • Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors);
  • Travel planning in the next 2 months

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Marcelo Souza

    Santa Cruz, Rio Grande do Norte, 59200-000

Other trials in Brazil

About this study

Official title: Cupping Therapy in the Treatment of Individuals With Nonspecific Chronic Low Back Pain

Introduction: Low back pain is a very prevalent condition in the population and windsurf therapy has been presented as a non-pharmacological treatment currently used in this population. However, there is a lack of studies that evaluate such effects, besides a standardization of application of the technique in this condition. This protocol describes a placebo-controlled, randomized, double-blind study that aims to assess the effectiveness of windsurf therapy in improving pain and other symptoms of individuals with chronic non-specific back pain. Methods: Ninety individuals with chronic nonspecific and localized chronic low back pain from 18 to 59 years, will be recruited according to the inclusion criteria. Afterwards they will be randomized to one of the 2 groups: intervention group (GI) where it will be submitted applied to the windspiration with 2 suctions; and placebo group (GP) with simulated application. Both applications will occur in parallel to the vertebrae from L1 to L5 bilaterally. The application will be performed once a week for eight weeks. The volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), 4 weeks after treatment (T4) and 8 weeks after treatment (T8). The primary endpoint will be pain, and the secondary ones will be kinesiophobia, physical function, lumbar range of motion, sleep quality, patient expectation, quality of life, and psychological factors. Discussion: This is the first protocol that proposes to evaluate the effect of windsotherapy on lumbar ROM, sleep quality, kinesiophobia and psychological problems. Few studies have been done on windsurfing individuals with low back pain, requiring further studies with good methodological quality. Because there is no consensus on the use of windsurf therapy in individuals with nonspecific chronic low back pain, our protocol will be the basis for the use of the technique by health professionals and for new studies to be performed.

Read the detailed description

This study will involve 4 researchers; 1 researcher responsible for evaluations; 1 researcher responsible for interventions; 1 researcher responsible for the interview, initial screening and randomization of participants, and 1 researcher who will perform the statistical analysis.

Conditions
Low Back Pain
Being tested
Cupping Therapy
Keywords
low back pain, cupping therapy
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.

  • Cupping TherapyOther

    application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang ® brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally

Study groups in NCT03909672
Study groupRoleWhat they receive
Cupping therapy with 2 suctionsExperimentalParticipants in the intervention group will receive the application of cupping therapy with two acrylic type 1 cups with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally. This group will consist of the application of windsheets with 2 suctions for 10 minutes, once a week, for 10 weeks. The cups shall be secured by means of elastic bands.
Receives: Other: Cupping Therapy
Cupping Therapy shamPlacebo comparatorThe placebo group will receive the application of cupping therapy with 2 cups of acrylic type size 1 with a distance of 3 cm each cup, parallel to the vertebrae L1 to L5, bilaterally . This group will consist of applying the sham winds for 10 minutes, once a week for 10 weeks. However, the cups will be made with small holes <2 mm in diameter to release the negative pressure in seconds. The cups will also be fixed by means of elastic bands.
Receives: Other: Cupping Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Numeric Rating Scale (NRS) of Pain

    The patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'

    Measured: T0 -baseline, T4 (four week) and T8 (eight week)

Secondary outcomes (7)

  1. Change from Oswestry Disability Index (ODI)

    will be used to analyze the quality of life in people with low back pain. This instrument contains in 10 items that assess the impact of low back pain on several functional activities. Values range from 0 to 5, the highest value indicating greater disability. The end result is the sum of all items.

    Measured: T0 -baseline and T8 (eight week)

  2. Range of motion of the lower back (ROM)

    Will be evaluated through the finger-to-floor test. This test presents high reliability and can be used for clinical practice and scientific studies.

    Measured: T0 -baseline, T4 (four week) and T8 (eight week)

  3. Short-Form 36 questionnaire (SF-36)

    Quality of life will be assessed by the Short-Form 36 (SF-36) questionnaire. The instrument consists of 36 questions and assesses eight different domains that influence quality of life, considering the individual's perception of their health aspects in the last four weeks. Each item has a group of answers distributed on a Likert-graded scale, and the following dimensions were evaluated: physical function, physical aspect, pain, general health, vitality, social function, emotional aspect and mental health. Your total score ranges from 0 to 100, where the higher the value, the better quality of life score.

    Measured: T0 -baseline and T8 (eight week)

  4. Timed Up and Go Test (TUG):

    This is a functional test which quantifies the mobility of an individual in seconds through the time in which they perform the task, i.e. in how many seconds can they lift themselves from a chair, walk 3 meters, turn, return to the chair, and sit down again. The test has already been used in individuals to assess function in individuals with low back pain. The shorter the time taken to perform a task, the better the individual's ability to perform.

    Measured: T0 -baseline and T8 (eight week)

  5. Global Perceived Effect Scale (GPE)

    Is a direct scale about the patient's self-perception when the intervention is performed.The GPE evaluates using 11 points, starting from a negative 5 (much worse than when starting the treatment), a neutral rating of 0, and 5 is positive (much improvement from starting the treatment). The Portuguese version will be used. The GPE evaluates using 11 points, starting from a negative 5 (much worse than when starting the treatment), a neutral rating of 0, and 5 is positive (much improvement from starting the treatment) .

    Measured: T8 (eight week)

  6. Hospital Anxiety and Depression Scale (HADS)

    A questionnaire which has also been validated and translated into Portuguese. This scale has 14 items, 7 for anxiety subscale and 7 for depression. For each item there is a score of 0 to 3, with a total of 21 points for the scale.

    Measured: T0 -baseline and T8 (eight week)

  7. Medication consumption

    Patients will be given a daily control list of medication use to mark the amount of their use for low back pain during the study period.

    Measured: T8 (eight week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2019
  2. Study start10 Jun 2019
  3. Primary completion10 Dec 2019
  4. Study completion20 Feb 2020

Resources

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
Single blind
Who is masked
Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03909672
Sponsor's protocol ID
UFRNventosa
Acronym
cupping
Status last verified
Feb 2020
First submitted
6 Apr 2019
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there isn't a plan to make individual participant data (IPD) available to other researchers.

Publications

  • Wang YT, Qi Y, Tang FY, Li FM, Li QH, Xu CP, Xie GP, Sun HT. The effect of cupping therapy for low back pain: A meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1187-1195. doi: 10.3233/BMR-169736.

    PubMed 28946531

  • Moura CC, Chaves ECL, Cardoso ACLR, Nogueira DA, Correa HP, Chianca TCM. Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3094. doi: 10.1590/1518-8345.2888.3094.

    PubMed 30462793

  • Almeida Silva HJ, Barbosa GM, Scattone Silva R, Saragiotto BT, Oliveira JMP, Pinheiro YT, Lins CAA, de Souza MC. Dry cupping therapy is not superior to sham cupping to improve clinical outcomes in people with non-specific chronic low back pain: a randomised trial. J Physiother. 2021 Apr;67(2):132-139. doi: 10.1016/j.jphys.2021.02.013. Epub 2021 Mar 20.

    PubMed 33757719

  • Silva HJA, Saragiotto BT, Silva RS, Lins CAA, de Souza MC. Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study. BMJ Open. 2019 Dec 22;9(12):e032416. doi: 10.1136/bmjopen-2019-032416.

    PubMed 31871257

Questions about this trial

What is this clinical trial studying?

A study testing Cupping Therapy in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte 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 6 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 21 Feb 2020. 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. Some participants in this study may receive a placebo. 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?

Change from Numeric Rating Scale (NRS) of Pain (time frame: T0 -baseline, T4 (four week) and T8 (eight week)). 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 NCT03909672, 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 21 Feb 2020.

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