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临床试验/NCT06128538
NCT06128538已完成不适用

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

Korey Kennelty2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2024年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Pain Scale after acupuncture sessions

研究概览

简要总结

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.

详细描述

For the pilot study, enrolled patients will be assigned a random numerical identifier that will be generated for each participant and used in the SMS-based messaging system.

The investigators will work with the Mobile Tech Lab (MLT) within the ICTS to develop the framework and train the research team to use an SMS-based messaging system to collect pain intensity scores using a text message of the visual analog scale (VAS) and numerical response. Upon consenting patients to the study, enrolled patients will have their cell phone numbers entered into the developed SMS framework. The participants will be sent text message prompts using Boomerang, a bi-directional text messaging platform that uses Twilio to send and receive messages. Boomerang is hosted on a secure server in the Department of Computer Science and is managed by their staff. Only research team members will have access to the responses sent in by the participants.

In the first 12 weeks of the pilot (prior to the start of the acupuncture sessions), participants will be sent once per week, the following text message prompt: "Good morning, please rate your pain level today using the scale below" and asked to respond with a number from 1-10 with an image of the visual analog pain scale. If participants have questions or problems, they can reply 'support' to the text messages and a member of the research team will contact them and offer technical support. If a participant doesn't want to receive messages from the study anymore, they may reply 'STOP' and all messaging will stop. Subjects will receive text messages at a consistent time of day at 10am and this will remain consistent throughout the study.

The research manager will collect weekly pain scores using the visual analog scale (pain scale 1-10) and weekly disability questionnaires using the Roland-Morris Disability Questionnaire, shown to be relevant for low back pain. Data on weekly pain medicine usage (dosage and frequency) and number of falls will be extracted from the patients' electronic medical records (EMR).

After the initial 12 weeks of data collection, the investigators will implement 12 weeks of BFA. These sessions will be done every other week (total of 6 sessions over 12 weeks). During these sessions, BFA-trained providers 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 and to complete the questionnaires - VAS and Disability Questionnaire). VAS data will be collected at each BFA session immediately before and 30 minutes after the BFA protocol by the research team, and then twice a week thereafter through the SMS system. Disability questionnaire data will be collected from all participants at each BFA session by the research team. Medication usage (dose and frequency) and fall (number of falls) data will be extracted from the EMR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 115 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Anyone not meeting inclusion criteria
  • Prior BFA acupuncture treatment
  • Documented dementia diagnosis

结局指标

主要结局

Pain Scale after acupuncture sessions

时间窗: Baseline to 24 weeks

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).

次要结局

未报告次要终点

研究者

发起方
Korey Kennelty
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Korey Kennelty

Associate Professor

University of Iowa

研究点 (2)

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