NCT06715761

Brief 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 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.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

November 13, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Low back painMyofascial releaseCrossFitPosture

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline and post intervention (8 weeks)

  • Spine mobility

    Baseline and post intervention (8 weeks)

  • History of musculoskeletal pain

    Baseline and post intervention (8 weeks)

Study Arms (3)

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

Interventions

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.

Myofascial release group (MRG)

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

Cupping therapy group (CTG)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • perform other physical activity than CrossFit®;
  • continuous use of painkillers;
  • previous pathologies or spinal surgery;
  • amputations;
  • haematological disorders;
  • fibromyalgia;
  • hypersensitivity or skin lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Goias

Goiânia, Goiás, 74690-900, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release TherapyCupping Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Gabriela de Vasconcelos, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2024

First Posted

December 4, 2024

Study Start

November 1, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations