Low Back Pain in Patients Living in the Pinheiro-MA Microregion: a randomized clinical trial comparing non-invasive treatment and a low-cost minimally invasive intervention

Low back pain in patients living in the microregion of Pinheiro-MA: a randomized clinical study comparing a non-invasive therapy (TENS) and a low-cost minimally invasive therapy (Neurolysis with glucose 75%)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-543c9q9

Enrollment

Unknown

Registered

2021-05-10

Start date

2020-01-01

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

From the selected sample (n=50), two groups, with 25 patients each, will appear according to the proposed interventions and randomization. The first group, will be treated with TENS (transcutaneous ne

the second group will be treated with facet denervation using hypertonic glucose (75%) associated with blocking with 0.5 ml of 2% Lidocaine. Patients will provide written consent prior to participatin

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Eligibility

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 80 years with chronic low back pain (over 12 weeks) non-traumatic and unresponsive to at least one month of physical therapy, with physical and imaging exams (computed tomography) suggestive of facet degeneration and presenting pain improvement above 80% within two hours after facet block with 0.5ml of 2% Lidocaine.

Exclusion criteria

Exclusion criteria: Individuals between 18 and 80 years old will be excluded from the study if they have the following symptoms: radicular pain, evidence of radiculopathy or neurological deficit on physical examination; as well as individuals who, do not show 80% improvement in painwithin two hours after performing facet block with 0.5 ml of 2% Lidocaine

Design outcomes

Primary

Measure	Time frame
All patients will receive a pain diary and will be followed up in a return visit 15 days, 1, 3 and 6 months and after 1 year for pain assessment through questionnaires and validated pain scales (Numeric and Analog Visual Scale, Rolland Morris Disability Questionnaire, Oswestry Disability Index and SF36 Quality of Life Scale). With the intervention compared by the evaluated parameters, it is expected to find a reduction in back pain and an improvement in functional capacity.	—

Measure

Time frame

All patients will receive a pain diary and will be followed up in a return visit 15 days, 1, 3 and 6 months and after 1 year for pain assessment through questionnaires and validated pain scales (Numeric and Analog Visual Scale, Rolland Morris Disability Questionnaire, Oswestry Disability Index and SF36 Quality of Life Scale). With the intervention compared by the evaluated parameters, it is expected to find a reduction in back pain and an improvement in functional capacity.

—

Secondary

Measure	Time frame
No secondary outcomes expected	—

Countries

Brazil

Contacts

Public ContactJosé Alberto Pires

Universidade Federal do Maranhão

medalbertopires@uol.com.br55 98 92401999

Outcome results

None listed

Source: REBEC (via WHO ICTRP)