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Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study

Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study in Participants Who Hospitalized in Department of Internal Medicine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05969353
Enrollment
200
Registered
2023-08-01
Start date
2023-07-23
Completion date
2026-01-10
Last updated
2023-08-01

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

Conditions

Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study

Brief summary

This is a randomized sham controlled study that will include patients hospitalized in the internal medicine department and the orthopedics department at Bnei Zion Hospital presenting with pain from various sources with an NRS level equal to or above 4.

Detailed description

All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or BFA) one hour before and every 24 hours until discharge. If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated assessments as above.

Interventions

OTHERaccupunture

BFA

Sponsors

Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment. 3.Eligible to participate in the study according to the assessment of the investigator

Exclusion criteria

1. Pain syndromes of non-muscular bony/rheumatological/orthopedic origin 2. Planned an MRI next week 3. An infectious process in the ear planned for acupuncture or a history of sensitivity to metal 4. have any participant condition that ' according to the Investigator ' could interfere with the conduct of the trial -

Design outcomes

Primary

MeasureTime frameDescription
efficacy of BFAtwo yearsEvaluating the analgesic efficacy of BFA in addition to the standard treatment for pain - Standard of care (SOC) to reduce pain in patients hospitalized in the internal and orthopedic department who experience pain of moderate intensity and above compared to SHAM BFA.

Countries

Israel

Contacts

Primary ContactJulia Sterlin
JULIA.STERLIN@GMAIL.COM0528976129
Backup ContactShira Ginsberg, MD
shiragins@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026