Evaluating BFA for Pain Management
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
NA · Bnai Zion Medical Center · NCT05969353
This study tests whether a new non-drug treatment called BFA can help hospitalized patients with moderate to severe pain feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bnai Zion Medical Center (other gov) |
| Locations | 1 site (Haifa) |
| Trial ID | NCT05969353 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of BFA, a non-pharmacologic pain management intervention, in patients hospitalized with pain levels of 4 or higher. Participants will be randomly assigned to receive either BFA or a sham treatment, with pain assessments conducted before and after treatment. If pain does not improve significantly within 24 hours, additional acupuncture will be administered. The study aims to provide insights into alternative pain management strategies for hospitalized patients.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients experiencing musculoskeletal or orthopedic pain with a pain score of 4 or higher.
Not a fit: Patients with non-muscular pain syndromes or those scheduled for an MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could offer a new, effective method for managing pain without the use of medications.
How similar studies have performed: Previous studies on acupuncture and similar non-pharmacologic interventions have shown promising results, suggesting potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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 -
Where this trial is running
Haifa
- BnaiZion MC — Haifa, Israel (RECRUITING)
Study contacts
- Principal investigator: shira ginsberg, MD — BnaiZion MC
- Study coordinator: Julia Sterlin
- Email: JULIA.STERLIN@GMAIL.COM
- Phone: 0528976129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.