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Analysis of anti-inflammatory and anti-pain effects of Black Sesame Oil on performance of day-to-day functions and pain intensity in adults with Low Back Pain

Analysis of anti-inflammatory and antinociceptive effects of Subcritical Extract of Black Sesame (Sesamum Indicum L.) on functional performance and pain intensity in adults with Low Back Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4h3chsp
Enrollment
Unknown
Registered
2023-01-20
Start date
2023-04-01
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

The aim will be to investigate the anti-inflammatory and antinociceptive effects of subcritical black sesame extract (Sesamum indicum L.) on functional performance and pain intensity in adults with lo
D10.212.302.380.775

Sponsors

Universidade Federal do Oeste do Pará
Lead Sponsor
Universidade Federal do Oeste do Pará
Collaborator

Eligibility

Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Adults of both sexes; be in the age group between 18 and 55 years; peoples confirmed with the presence of low back pain; present functional impairment and limiting pain due to low back pain; staying one day prior to the start of the study intervention without performing any type of treatment for low back pain; have consent, voluntarily, through the Free and Informed Consent Term (ICF)

Exclusion criteria

Exclusion criteria: Presence of neoplastic, infectious, neurological, severe progressive orthopedic, rheumatic or autoimmune conditions; fibromyalgia diagnosis; presence of decompensated metabolic and/or cardiorespiratory disorders; pregnancy status; obesity; compression fracture of the spine; candidates for neurosurgery or orthopedic surgery; use of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, analgesics, muscle relaxants, psychotropic drugs and/or some other specific treatment for low back pain during the study intervention; previous surgery on the lumbar spine; to present changes in cognitive functions that make it impossible to proceed with the study treatment

Design outcomes

Primary

MeasureTime frame
It is expected that the topical application of subcritical black sesame extract (Sesamum indicum L.) will have an effect on possible inflammatory foci and, thus, reduce the intensity of pain in people with low back pain when compared with the application of an innocuous oil (mineral oil ), verified through algometry, in which the participant will indicate the onset of pain (pain threshold) to the pressure applied by the algometer tip in the region of the lumbar spine and the value obtained will be recorded, with the international unit: kilogram per square centimeter ( Kg/cm²) and by thermography with analysis of the lumbar spine, checking the temperature points to be compared and determining whether there is a difference in the measurement of the temperature delta between the pre- and post-intervention examination according to the parameters of the ICF (International Classification Functionality).;It is expected that the topical application of subcritical black sesame extract (Sesamum indicum L.) will reduce pain intensity and thus improve functional performance of day-to-day aspects in people with low back pain when compared to application of an innocuous oil (mineral oil), verified through the brief pain inventory that contains a scale of 0-10 to grade the items: intensity, interference of pain in the ability to walk, general activity, at work, social activities, mood and sleep. The item named treatment or use of pain medications will be used to assess therapy with subcritical black sesame extract or mineral oil.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactMarina Souza

Universidade Federal do Oeste do Pará

marinasouza185@gmail.com+55 (93) 2101 4911

Outcome results

None listed

Source: REBEC (via WHO ICTRP)