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NCT Number: NCT03589703

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

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.

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Key information

Conditions

Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target ear points related to chronic low back pain (T-APA)

Other

Light touch using vaccaria seeds on specific points of the ear.

Non-Target ear Points not related to chronic low back pain (NT-APA)

Other

Light touch using vaccaria seeds on different points of the ear (compared to the APA group).

Enhanced Educational Control Group (CG-2)

Other

No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.

Primary outcomes

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

    Time frame: 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")

  2. 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")

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

    Time frame: 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").

  4. 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").

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

    Time frame: 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).

  6. 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).

Secondary outcomes

  1. Number of Participants Who Use Opioids

    Time frame: Baseline

  2. Number of Participants Who Use Opioids

    Time frame: 1 month post completion of the treatment (2 months after baseline)

  3. APA Treatment Satisfaction as Assessed by Satisfaction Survey

    Time frame: immediately post intervention (1 month after baseline)

    Satisfaction is assessed using a 5-point numeric rating scale:

    • - Completely satisfied
    • - Somewhat satisfied
    • - Neither satisfied nor dissatisfied
    • - Somewhat dissatisfied
    • - Very dissatisfied

  4. APA Treatment Satisfaction as Assessed by Satisfaction Survey

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    Satisfaction is assessed using a 5-point numeric rating scale:

    • - Completely satisfied
    • - Somewhat satisfied
    • - Neither satisfied nor dissatisfied
    • - Somewhat dissatisfied
    • - Very dissatisfied

  5. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety

    Time frame: Baseline

    The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits.

  6. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits.

  7. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression

    Time frame: Baseline

    The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits.

  8. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits.

  9. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance

    Time frame: Baseline

    The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits.

  10. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits.

  11. Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)

    Time frame: Baseline

    The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale where 0 = completely disagree and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs.

  12. Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale where 0 = completely disagree and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs.

  13. Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)

    Time frame: Baseline

    The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain. This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," with higher scores indicate stronger catastrophizing.

  14. Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain. This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," with higher scores indicate stronger catastrophizing.

  15. Memory as Assessed by the Stroop Test

    Time frame: Baseline

    T-score will be reported, with a range of 0-100, with a higher score indicating better memory.

  16. Memory as Assessed by the Stroop Test

    Time frame: 1 month post completion of the treatment (2 months after baseline)

    T-score will be reported, with a range of 0-100, with a higher score indicating better memory.

  17. Relaxation as Assessed by Relaxation Response

    Time frame: Baseline

  18. Relaxation as Assessed by Relaxation Response

    Time frame: 1 month post completion of the treatment (2 months after baseline)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 18, 2018
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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