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

B

Bnai Zion Medical Center

Status

Enrolling

Conditions

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

Treatments

Other: accupunture

Study type

Interventional

Funder types

Other

Identifiers

NCT05969353
062-23 BNZ

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

sham controlled arm
Sham Comparator group
Treatment:
Other: accupunture
battlefield acupunture
Active Comparator group
Treatment:
Other: accupunture

Trial contacts and locations

0

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Central trial contact

Julia Sterlin; Shira Ginsberg, MD

Data sourced from clinicaltrials.gov

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