Low Back PainNCT06715761
Effectiveness of Manual and Instrumental Myofascial Release in Chronic Low Back Pain and the Posture of Practitioners CrossFit®
A study testing Myofascial release and Cupping therapy in people with Low Back Pain, run by Gabriela Souza de Vasconcelos at 1 site in Brazil.
Trial summary
Background: Chronic low back pain (LBP) can lead to major functional disabilities and force people to take time off work, sports or leisure activities. Regular physical exercise is an important ally in reducing the risk factors for most diseases, and CrossFit® is one of the modalities that has been gaining momentum… 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?
- Myofascial release and Cupping therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- men and women aged between 18 and 59 years;
- presence of low back pain for at least 12 weeks;
- have started regular CrossFit® activity at least 3 months ago.
Who cannot join
- perform other physical activity than CrossFit®;
- continuous use of painkillers;
- previous pathologies or spinal surgery;
- amputations;
- haematological disorders;
- fibromyalgia;
- hypersensitivity or skin lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Goias
Goiânia, Goiás, 74690-900
Gabriela de Vasconcelos, PhD, +5551995372276, gabriela_vasconcelos@ufg.br
About this study
Official title: Effectiveness of Manual and Instrumental Myofascial Release in Chronic Low Back Pain and the Posture of Practitioners CrossFit®: Protocol of a Randomized Controlled Clinical
Background: Chronic low back pain (LBP) can lead to major functional disabilities and force people to take time off work, sports or leisure activities. Regular physical exercise is an important ally in reducing the risk factors for most diseases, and CrossFit® is one of the modalities that has been gaining momentum when choosing an exercise. However, the intensity recommended in training can collaborate with the development of musculoskeletal problems such as pain and postural changes, interfering with the development of the practice, with low back pain being one of the most common disorders in these practitioners, especially caused by mechanical stress. Considering that CrossFit® practitioners have already incorporated physical exercise into their routine, passive techniques such as myofascial release (ML) have been discussed as a form of treatment for LBP. For this reason, this study was designed to verify the efficacy of ML in the LBP of CrossFit® practitioners, comprising two techniques, one manual and one instrumental, and to see if the outcome of the LBP alters the posture of the spine.
This is a randomised controlled clinical that will be conducted in a CrossFit® box in the city of Goiânia-GO, Brazil. At least 51 people will take part who have been doing CrossFit® for at least 3 months, who have LBP, are aged between 18-59 and are not undergoing any other treatment for low back pain. There will be two experimental groups, one that will receive manual MR and the other, cupping therapy, as well as a control group that will not receive any technique. The sessions will take place twice a week for 8 weeks. The primary outcome will be low back pain intensity, assessed at baseline, weekly and after 8 weeks, and the secondary outcomes, which will be postural deviations, spinal mobility and history of musculoskeletal pain, assessed at baseline and at the end of 8 weeks. There will be no blinding between therapist and participants.
Discussion: This study will investigate whether MR is effective in relation to LBP, given that some results have already shown positive responses in acute conditions, while also verifying the repercussions on the postural aspect. The results could provide additional knowledge about the best technique to use and, having applicability to our outcomes, will favour and simplify treatment, helping professionals to make clinical decisions.
- Conditions
- Low Back Pain
- Being tested
- Myofascial release, Cupping therapy
- Keywords
- Low back pain, Myofascial release, CrossFit, Posture
- 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.
Myofascial releaseOther
The sequence of myofascial release is as follows: 30 seconds of contact between the therapist's hands and the entire region of the participant's spine, sliding with medium pressure in a caudocranial direction; palpation of the erector spinae, quadratus lumborum, gluteus and piriformis muscles bilaterally, to identify trigger points, marking each point of tension with a dermographic pencil for subsequent manipulation; 3 cycles of bilateral paravertebral release, by sustained pressure with crossed hands, until the restrictive tissue barrier is found, for 60 seconds; 90 seconds of the vertical rolling technique (superficial elevation of the skin and mobilisation of the tissue with the tips of all the fingers) on the bilateral paravertebrals and, at the end, sliding along the entire length of the bilateral multifidus, with the fingers flexed, using the bony prominence between the proximal and middle phalanges as contact with the skin, in a caudocranial direction and returning craniocaudal.
Cupping therapyOther
The acrylic cups (DongBang®) will be placed on the meridional points, as Traditional Chinese Medicine calls them, 1 cup in the central region of each popliteal fossa, the so-called B40 or Wei Zhong point, 6 cups in the region of the quadratus lumborum muscles, more specifically on the BL23 or Shenshu points (approximately 5 centimetres lateral to the edge of the L2 spinous process), BL24 or Qihaishu (approximately 5 centimetres lateral to the edge of the spinous process of L3) and BL25 or Dachangshu (approximately 5 centimetres lateral to the edge of the spinous process of L4) bilaterally, as well as a cup on a single point of the participant's choice, where they report the most lower back pain (ashi point). The cups will be attached to the skin using a gun, applying two suction pressures, and the participant will be asked to signal whether the pressure is strong or weak. The cups will remain attached for 12 minutes on the B40 meridian and 15 minutes on the other meridians. If a cup lo
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release group (MRG) | Experimental | Not described Receives: Other: Myofascial release |
| Cupping therapy group (CTG) | Active comparator | Not described Receives: Other: Cupping therapy |
| Control group (CG) | No intervention | Wait-and-see |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity, related to chronic low back pain, will be measured using the Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "the worst pain possible". Participants will indicate their usual pain.
Measured: Baseline, once a week throughout the intervention period (at the beginning of each week) and post intervention (8 weeks)
Secondary outcomes (3)
Spinal postural deviations
Spinal postural deviations will be measured using a flexible lead ruler called a Flexicurve (Trident®). Initially, the anatomical points of the spinous processes of the C7, T1, T6, T12, L1, L4, L5, S1 and S2 vertebrae will be marked on the participant's skin with a white dermatographic pencil (Hintz®). The flexicurve will then be moulded and the anatomical reference points will also be marked on the body of the ruler. After this, the ruler will be positioned in the centre of the page of a 420mmX549mm piece of graph paper (Tracing Pad®), where its shape will be reproduced. For the analysis, the drawings with the shapes of the curvatures of the spine will be photographed and entered into the Dynamic Posture software.
Measured: Baseline and post intervention (8 weeks)
Spine mobility
Spinal mobility will be analysed using Finger Tip Test. For the Finger Tip Test, the participant will stand and then be instructed to flex their trunk as if they wanted to touch their hands to the floor. The distance between the distal phalanx of the 3rd finger of the hand and the floor will be measured with a tape measure (Incoterm®).
Measured: Baseline and post intervention (8 weeks)
History of musculoskeletal pain
A history of musculoskeletal pain will be taken using the Questionnaire For Evaluation Of Musculoskeletal Pain In Exercise Practitioners (Q-ADOM). The questionnaire is used to screen for musculoskeletal pain in exercise practitioners and, although it has domains that can cover any type of pain, the participant will be instructed to answer the visual analogue scale (item 1) and the other items, only considering the intensity of the pain and the symptoms related to their chronic low back pain.
Measured: Baseline and post intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Nov 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriela Souza de Vasconcelos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriela Souza de Vasconcelos, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715761
- Sponsor's protocol ID
- Federal University of Goiás
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual and Instrumental Myofascial Release in Chronic Low Back Pain and the Posture of Practitioners CrossFit®: Protocol of a Randomized Controlled Clinical
- ClinicalTrials.gov ID
- NCT06715761
- Acronym / sponsor ID
- Federal University of Goiás
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Myofascial release, CrossFit, Posture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Gabriela Souza de VasconcelosUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 4 Dec 2024 (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.
Background: Chronic low back pain (LBP) can lead to major functional disabilities and force people to take time off work, sports or leisure activities. Regular physical exercise is an important ally in reducing the risk factors for most diseases, and CrossFit® is one of the modalities that has been gaining momentum when choosing an exercise. However, the intensity recommended in training can collaborate with the development of musculoskeletal problems such as pain and postural changes, interfering with the development of the practice, with low back pain being one of the most common disorders in these practitioners, especially caused by mechanical stress. Considering that CrossFit® practitioners have already incorporated physical exercise into their routine, passive techniques such as myofascial release (ML) have been discussed as a form of treatment for LBP. For this reason, this study was designed to verify the efficacy of ML in the LBP of CrossFit® practitioners, comprising two techniques, one manual and one instrumental, and to see if the outcome of the LBP alters the posture of the spine.
This is a randomised controlled clinical that will be conducted in a CrossFit® box in the city of Goiânia-GO, Brazil. At least 51 people will take part who have been doing CrossFit® for at least 3 months, who have LBP, are aged between 18-59 and are not undergoing any other treatment for low back pain. There will be two experimental groups, one that will receive manual MR and the other, cupping therapy, as well as a control group that will not receive any technique. The sessions will take place twice a week for 8 weeks. The primary outcome will be low back pain intensity, assessed at baseline, weekly and after 8 weeks, and the secondary outcomes, which will be postural deviations, spinal mobility and history of musculoskeletal pain, assessed at baseline and at the end of 8 weeks. There will be no blinding between therapist and participants.
Discussion: This study will investigate whether MR is effective in relation to LBP, given that some results have already shown positive responses in acute conditions, while also verifying the repercussions on the postural aspect. The results could provide additional knowledge about the best technique to use and, having applicability to our outcomes, will favour and simplify treatment, helping professionals to make clinical decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myofascial release group (MRG) | Experimental | Other: Myofascial release |
| Cupping therapy group (CTG) | Active comparator | Other: Cupping therapy |
| Control group (CG) | No intervention | –Wait-and-see |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- men and women aged between 18 and 59 years;
- presence of low back pain for at least 12 weeks;
- have started regular CrossFit® activity at least 3 months ago.
Key exclusion criteria (7 listed)
- perform other physical activity than CrossFit®;
- continuous use of painkillers;
- previous pathologies or spinal surgery;
- amputations;
- haematological disorders;
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 |
|---|---|---|
| Myofascial releaseThe sequence of myofascial release is as follows: 30 seconds of contact between the therapist's hands and the entire region of the participant's spine, sliding with medium pressure in a caudocranial direction; palpation of the erector spinae, quadratus lumborum, gluteus and piriformis muscles bilaterally, to identify trigger points, marking each point of tension with a dermographic pencil for subsequent manipulation; 3 cycles of bilateral paravertebral release, by sustained pressure with crossed hands, until the restrictive tissue barrier is found, for 60 seconds; 90 seconds of the vertical rolling technique (superficial elevation of the skin and mobilisation of the tissue with the tips of all the fingers) on the bilateral paravertebrals and, at the end, sliding along the entire length of the bilateral multifidus, with the fingers flexed, using the bony prominence between the proximal and middle phalanges as contact with the skin, in a caudocranial direction and returning craniocaudal. | Other | Myofascial release group (MRG) |
| Cupping therapyThe acrylic cups (DongBang®) will be placed on the meridional points, as Traditional Chinese Medicine calls them, 1 cup in the central region of each popliteal fossa, the so-called B40 or Wei Zhong point, 6 cups in the region of the quadratus lumborum muscles, more specifically on the BL23 or Shenshu points (approximately 5 centimetres lateral to the edge of the L2 spinous process), BL24 or Qihaishu (approximately 5 centimetres lateral to the edge of the spinous process of L3) and BL25 or Dachangshu (approximately 5 centimetres lateral to the edge of the spinous process of L4) bilaterally, as well as a cup on a single point of the participant's choice, where they report the most lower back pain (ashi point). The cups will be attached to the skin using a gun, applying two suction pressures, and the participant will be asked to signal whether the pressure is strong or weak. The cups will remain attached for 12 minutes on the B40 meridian and 15 minutes on the other meridians. If a cup lo | Other | Cupping therapy group (CTG) |
Primary outcome
Pain intensity
Time frame: Baseline, once a week throughout the intervention period (at the beginning of each week) and post intervention (8 weeks)
Pain intensity, related to chronic low back pain, will be measured using the Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "the worst pain possible". Participants will indicate their usual pain.
3 secondary outcomes
Spinal postural deviations
Time frame: Baseline and post intervention (8 weeks)
Spine mobility
Time frame: Baseline and post intervention (8 weeks)
History of musculoskeletal pain
Time frame: Baseline and post intervention (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release and Cupping therapy in people with Low Back Pain, run by Gabriela Souza de Vasconcelos 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela de Vasconcelos, PhD (+5551995372276, gabriela_vasconcelos@ufg.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, once a week throughout the intervention period (at the beginning of each week) and post intervention (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.