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临床试验/NCT03589703
NCT03589703已完成不适用

Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure

The University of Texas Health Science Center, Houston4 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
4
主要终点
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)

研究概览

简要总结

Almost one-third (30%) of persons 60 years and older suffer from cLBP and cause a significant negative impact on individuals and society in the U.S. The goal of managing cLBP is decreased pain and disability.To accomplish this, cLBP sufferers often use analgesics including opioids to decrease pain and facilitate activity, but the side effects caused by these medications are problematic. A better pain management strategy clearly needs to be developed.

The investigators propose to test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and an innovative solution for chronic low back pain (cLBP) in older adults. APA involves an acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and index finger, three times a day (morning, noon, and evening) for three minutes each session to achieve pain relief. The investigators have developed a detailed APA protocol to teach health-care providers without experience in acupuncture and traditional Chinese Medicine that investigators can learn about APA in brief educational seminars as a treatment including the systematic identification of ear points (called auricular diagnosis). The investigators teach methods that enable patients to continue using APA to self-manage participants' pain.

Brain imaging studies in acupuncture indicate that acupuncture can restore normal functional connectivity related to pain reduction. Studies suggest that stimulation of ear points (1) excites the somatotopic reflex system in the brain and that pathological brain patterns are electrically reset to stop the unwanted activation of spinal pain pathways, explaining the possible immediate pain relief that patients feel after APA and (2) cause a broad spectrum of systemic effects, such as vasodilation, by releasing endorphin to elicit short-term analgesic effects or neuropeptide-induced anti-inflammatory cytokines, which may explain long-term effects.

The Ecological Momentary Assessment (EMA) smart phone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. Neuro-transmitters is measured by inflammatory biomarkers. Blood samples will be collected for serum collection and a multiplex bead-based immunofluorescence assay performed to check for serum levels. Mini-Mental State Examination will be used to screen for cognitive function, also HRQoL, satisfaction, treatment beliefs and expectations, sleep, relaxation effects, catastrophizing and fear/avoidance, and placebo effects will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 60 years or older
  • Able to read and write English
  • cLBP that has persisted at least 3 months and has pain on at least half of the days for the previous 6 months
  • Average intensity of pain ≥ 4 on a 11-point numerical pain scale in the previous week
  • Have intact cognition (Mini-Mental State Examination (MMSE) > 24)
  • Willing to commit to up to 13-17 months as a study participant, depending on which group the participant is placed in
  • Able to apply pressure to the seeds with tapes on their ears

排除标准

  • Malignant or autoimmune diseases (e.g., rheumatoid arthritis), in which the pain from the disease cannot be separated from the low back pain by the participant
  • Known acute compression fractures caused by osteoporosis, spinal stenosis, spondylolysis, or spondylolisthesis because these conditions may confound treatment effects or the interpretation of results
  • Sciatica with leg pain greater than back pain
  • Allergy to the tape
  • Use of some types of hearing aids (size may obstruct the placement of seeds)
  • Pain in other parts of the body that is more severe than the cLBP and which occurs daily or almost every day with at least moderate intensity or acute pain
  • Neurological disorders that could interfere with pain reporting or confound performance on the other outcomes, cerebral tumor, Alzheimer's disease (or other cognitive illnesses), prior stroke, or multiple sclerosis

结局指标

主要结局

Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)

时间窗: 1 month post completion of the treatment (2 months after baseline)

The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability).

Pain Intensity as Assessed by the Numeric Rating Scale (NRS)

时间窗: 1 month post completion of the treatment (2 months after baseline)

Pain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable")

Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale

时间窗: 1 month post completion of the treatment (2 months after baseline)

Pain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0 = "does not interfere" and 10 = "completely interferes").

次要结局

  • Number of Participants Who Use Opioids(1 month post completion of the treatment (2 months after baseline))
  • Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression(1 month post completion of the treatment (2 months after baseline))
  • Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance(1 month post completion of the treatment (2 months after baseline))
  • Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety(1 month post completion of the treatment (2 months after baseline))
  • Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)(1 month post completion of the treatment (2 months after baseline))
  • Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)(1 month post completion of the treatment (2 months after baseline))
  • Relaxation as Assessed by Relaxation Response(1 month post completion of the treatment (2 months after baseline))
  • Memory as Assessed by the Stroop Test(1 month post completion of the treatment (2 months after baseline))
  • APA Treatment Satisfaction as Assessed by Satisfaction Survey(1 month post completion of the treatment (2 months after baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Constance Johnson

Professor

The University of Texas Health Science Center, Houston

研究点 (4)

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