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Evaluation of the use of Laser-ILIB to improve pain and change in sensitivity in patients with Diabetic Neuropathy

Evaluation of the effectiveness of the Laser- ILIB in the control of pain and sensory changes associated with Diabetic Neuropath - ILIB Intravascular Laser Irradiation of Blood

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3bth6y2
Enrollment
Unknown
Registered
2022-08-30
Start date
2021-10-11
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

Diabetic neuropathy

Interventions

This is a two-arm, randomized controlled, single-blind study. Experimental group:26 participants with diabetic neuropathy will receive 10 sessions of ILIB low-level laser therapy on the wrist (radial
E02.774.500

Sponsors

Faculdade de Farmácia da Universidade Federal da Bahia
Lead Sponsor
Faculdade de Farmácia da Universidade Federal da Bahia
Collaborator

Eligibility

Age
20 Years to 79 Years

Inclusion criteria

Inclusion criteria: Volunteers with diabetic neuropathy; both genders; age between 20 and 79 years; pain for more than 6 months with an intensity greater than 4 on the VAS scale (Visual Analogue Scale)

Exclusion criteria

Exclusion criteria: Cognitive impairment; chronic pain of another origin; invasive procedures less than 2 months; use of pain staging medication for less than 30 days

Design outcomes

Primary

MeasureTime frame
Evaluate the change in pain intensity on the VAS scale (visual analogue scale), comparing pre-treatment (baseline) and post-treatment values, verified through the t-student test, with a significance level (p) set at 5%. To identify the existence of significant differences between pain intensity on the VAS scale, before and after treatment, the t-student test for paired samples will be used. To verify this significant difference between the control and intervention groups, the t-student test will be used. Expect to find a change of at least 30% in intensity.—

Secondary

MeasureTime frame
To evaluate the change in the scores of the SF-36 (Short Form Health Survey) and HAD questionnaires (hospital anxiety and depression scale) and the sensory parameters of the QST (Quantitative Sensory Testing) comparing pre-treatment (baseline) and post-treatment values. The analysis will be performed using the t-student test, with a significance level (p) set at 5%. To identify the existence of significant differences between pain intensity on the VAS scale (visual analogue scale), before and after treatment, the t-student test for paired samples will be used. To verify this significant difference between the control and intervention groups, the t-student test will be used.—

Countries

Brazil

Contacts

Public ContactCristiane Villarreal

Faculdade de Farmácia da Universidade Federal da Bahia

cfv@ufba.br+55 (71) 32836933

Outcome results

None listed

Source: REBEC (via WHO ICTRP)