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Study of treatment with Shockwaves in patients with Chronic Pain in the Lumbar Spine

Use of Shock Waves in the treatment of Chronic Low Back Pain - prospective, randomized, double-blind clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6dtfb2r
Enrollment
Unknown
Registered
2024-04-22
Start date
2023-04-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Interventions

Patients will be divided into two groups, totaling 60 patients
of both sexes
randomized controlled and blind trials, according to the draw carried out previously: where 30 patients will receive the true shock waves (“active” TOC) and 30 patients will undergo the use of the dev
G01.750.770.776.891.500

Sponsors

Departamento de Anestsiologia da Faculdade de Medicina de Botucatu
Lead Sponsor
Clinica Ortofisio Ltda
Collaborator
Faculdade de Medicina de Botucatu
Collaborator

Eligibility

Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age group between 30 and 80 years old; of both genders; diagnosed with musculoskeletal chronic low back pain for more than one year, without improvement with conservative treatment, and scores of pain intensity in , at least 20%, considering the Oswestry Disability Index (ODI), and pain intensity >5, considering the Numerical Visual Scale (VSN); all patients must be on stable doses (at least 10 days) of medications used to treat their low back pain at the time of enrollment in the study

Exclusion criteria

Exclusion criteria: Patients who present easily identifiable cognitive alterations; as well as those undergoing psychiatric treatment in which their illness is not in remission; individuals who have an indication for surgery or who have previously undergone surgery on the lumbar spine; pregnancy; coagulopathy and/or use of anticoagulants; systemic infections; presence of skin ulcers; presence of vessels at the treatment site; malignant neoplasms; cardiac arrhythmias and/or use of pacemakers; and epilepsy; patients with a diagnosis of fibromyalgia and a neuropathic component in their low back pain, diagnosed by DN4

Design outcomes

Primary

MeasureTime frame
To measure the improvement of patients submitted to shockwave therapy using the focal method for the treatment of low back pain and promote comparison with the control group. This comparison will be made through the application of visual numeric scale (VS) and Oswestry Disability Index (ODI) questionnaires—

Secondary

MeasureTime frame
No secondary outcomes are expected—

Countries

Brazil

Contacts

Public ContactGuilherme Antonio Barros

Faculdade de Medicina de Botucatu

guilherme.am.barros@unesp.br+55 (14) 3880-1608

Outcome results

None listed

Source: REBEC (via WHO ICTRP)