Implementing Group Battlefield Acupuncture in CCRCs for the Treatment of Chronic Lower Back Pain

NCT06128538 | Completed FDA Device

• 1 other identifier: 202305425
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Lower back pain (LBP) is one of the most common causes of disability, with 68% of adults over 60 years of age suffering from chronic Lower Back Pain (cLBP). In addition to the exacerbation of physical, social and emotional health issues, LBP has a staggeringly high US economic burden. Community-dwelling older adults experience a significant amount of chronic pain and treatments that are effective in their younger adult counterparts (e.g., pain medications, exercise) are often not safe or feasible. Our long-term goal is to decrease cLBP and improve function in older adults residing in continuing care retirement communities (CCRC). Battlefield Acupuncture (BFA), a promising treatment for cLBP, is an auricular (ear-based) treatment intended to compliment traditional allopathic medical treatments for acute and chronic pain. Auricular acupuncture has been implemented and used widely in the US military. Despite emerging evidence supporting the use of BFA in chronic pain, BFA has not been used to treat older adults with cLBP residing in CCRC. To this end, we propose an adapted group BFA protocol for CCRC residents. We will determine the feasibility and acceptability of implementing group BFA for cLBP at the University of Iowa (UI) Family Medicine-affiliated CCRCs by evaluating patient participation rates and retention, comfort with the protocol and satisfaction with the sessions, protocol delivery and ease of use. We will also determine treatment effectiveness by evaluating pain scales in cLBP, pain medication use, mobility, and falls. Data obtained from this study will inform the design of a future clinical trial testing group BFA for the management of cLBP in older adults.

Conditions

Pain, Back

Outcome Measures

Primary Outcomes (1)

• Pain Scale after acupuncture sessions

  The investigators will evaluate the reduction in pain using the Visual Analog Pain Scale between baseline and 24 weeks. The average pain, using the pain scale, will be compared between the 12 week period prior to acupuncture (baseline measures) and the following 12 weeks which contains the 6 sessions of auricular acupuncture (24 weeks at end of study).

  Baseline to 24 weeks

Study Arms (1)

Acupuncture Arm

EXPERIMENTAL

No control

Device: Auricular acupuncture; Behavioral: Visual Analog Scale for Pain; Behavioral: Roland-Morris Disability Questionnaire

Interventions

Auricular acupuncture DEVICE

we will implement 12 weeks of BFA. These sessions will be done every other week (total of 6 sessions over 12 weeks). During these sessions, Dr. Quinlan (Co-I) and another BFA-trained provider (Dr. Wilbur or Dr. Butler; also research team members) will perform the group BFA protocol with all 20 participants. During this 12-week acupuncture phase, participants will receive the same SMS messages twice a week to collect pain intensity scores. The group BFA protocol involves taking vitals for all patients (similar to a regular medical visit) and placing all 10 acupuncture needles (5 in each ear) while the patient remains seated in a chair. Once the acupuncture needles are placed, the patient will be asked to move around and remain in the room for 30 minutes (for any questions or medical concerns.

Acupuncture Arm

Visual Analog Scale for Pain BEHAVIORAL

During the first 12 weeks of the trial, the research manager will collect weekly pain scores using the visual analog scale (pain scale 1-10). During the second 12 week phase of the trial, which includes the acupuncture sessions, the research manager will collect pain scores using the visual analog scale at each acupuncture session immediately before and 30 minutes after the acupuncture protocol by the research team, and then twice a week thereafter.

Acupuncture Arm

Roland-Morris Disability Questionnaire BEHAVIORAL

During the first 12 weeks of the trial, the research manager will collect weekly Roland -Morris Disability questionnaire data. During the second 12 week phase of the trial, which includes the acupuncture sessions, the research manager will collect disability scores using the Roland-Morris Disability Questionnaire at each acupuncture session (6 sessions in total).

Acupuncture Arm

Eligibility Criteria

• Age: 18 Years - 115 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults \>65 years residing at the Oaknoll Community Center
• Chronic lower back pain musculo-skeletal diagnosis
• UIHC patient
• Some mobility needed (independent or assisted living care levels).

You may not qualify if:

• Prior BFA acupuncture treatment
• Documented dementia diagnosis

Sponsors & Collaborators

• Korey Kennelty: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: October 30, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)