Clinical trial NCT03589703: Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
Official title: Management of Chronic Low Back Pain in Older Adults Using Auricular Point Acupressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic Low Back Pain
cLBP
pain
acupressure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Johns Hopkins University
First posted: 2018-07-18
Enrollment: 272
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Intensity as Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline
measure: Pain Intensity as Assessed by the Numeric Rating Scale (NRS)
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale
timeFrame: Baseline
measure: Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline
measure: Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 1 month post completion of the treatment (2 months after baseline)
Secondary outcomes:
measure: Number of Participants Who Use Opioids
timeFrame: Baseline
measure: Number of Participants Who Use Opioids
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: APA Treatment Satisfaction as Assessed by Satisfaction Survey
timeFrame: immediately post intervention (1 month after baseline)
measure: APA Treatment Satisfaction as Assessed by Satisfaction Survey
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety
timeFrame: Baseline
measure: Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
timeFrame: Baseline
measure: Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
timeFrame: Baseline
measure: Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline
measure: Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Memory as Assessed by the Stroop Test
timeFrame: Baseline
measure: Memory as Assessed by the Stroop Test
timeFrame: 1 month post completion of the treatment (2 months after baseline)
measure: Relaxation as Assessed by Relaxation Response
timeFrame: Baseline
measure: Relaxation as Assessed by Relaxation Response
timeFrame: 1 month post completion of the treatment (2 months after baseline)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Constance Johnson, PhD, MS, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Nada Lukkahatai, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeh CH, Li C, Glick R, Schlenk EA, Albers K, Suen LK, Lukkahatai N, Salen N, Pandiri S, Ma W, Perrin N, Morone NE, Christo PJ. A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol. Trials. 2020 Jan 20;21(1):99. doi: 10.1186/s13063-019-4016-x.