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Clinical Trials/NCT03589703
NCT03589703
Completed
Not Applicable

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

The University of Texas Health Science Center, Houston2 sites in 1 country272 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
272
Locations
2
Primary Endpoint
Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
January 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Constance Johnson

Professor

The University of Texas Health Science Center, Houston

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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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

Time Frame: 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").

Secondary Outcomes

  • Number of Participants Who Use Opioids(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))
  • 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))

Study Sites (2)

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