Baltimore, Maryland 21205

  • Chronic Low Back Pain

Purpose:

Almost one-third (30%) of persons 65 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) smartphone 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.


Criteria:

Inclusion Criteria: - Age 65 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 months49 - The 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 4-weekly study visits and up to 12-months follow-up. - Able to apply pressure to the seeds with tapes on their ears. Exclusion Criteria: - Malignant or autoimmune diseases (e.g., rheumatoid arthritis). - 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.


Study is Available At:


Original ID:

IRB00175409


NCT ID:

NCT03589703


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

270


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Chao Hsing Yeh, PhD
Principal Investigator
Johns Hopkins University
Primary Contact:Chao Hsing H Yeh, PhD
6672087637
cyeh13@jhu.edu
Backup Contact:Chao Hsing H Yeh, MS
6672087637
cyeh13@jhu.edu

Study Dates

Start Date:March 1, 2019
Completion Date:January 1, 2023
Completion Type:Anticipated
Primary Completion Date:January 1, 2023
Primary Completion Type:Anticipated
Verification Date:March 2021
Last Changed Date:March 19, 2021
First Received Date:May 22, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pain and Catastrophizing Scale (PCS)
Time Frame:Day 28
Safety Issues:False
Description:The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of 13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptom
Outcome Type:Secondary Outcome
Measure:Placebo effect
Time Frame:Baseline
Safety Issues:False
Description:Treatment and nonspecific psychological placebo effects will be measured via HEAL treatment expectation and HEAL provider connection questionnaires. The participants will be asked few questions about their; confidence in treatment, treatment expectations,
Outcome Type:Secondary Outcome
Measure:Fear-Avoidance
Time Frame:Day 28
Safety Issues:False
Description:It is measured by Fear-avoidance beliefs questionnaire (FABQ) that focuses on participants 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 statem
Outcome Type:Secondary Outcome
Measure:Treatment Satisfaction
Time Frame:Day 28
Safety Issues:False
Description:The participants will be assessed using a 12-item scale, each item with score between 0-5 with 5 being most satisfied with treatment progress. Highest score of 60 (maximum satisfaction) and lowest score of 0 (least satisfaction)
Outcome Type:Secondary Outcome
Measure:Health Related Quality of Life (HRQoL)
Time Frame:Day 28
Safety Issues:False
Description:The WHO Quality of Life-BREF (WHOQOL-BREF), used to measure quality of life. The WHOQOL-BREF, is self-administered, and measures the following broad domains: physical health, psychological health, social relationships, and environment. Each individual ite
Outcome Type:Primary Outcome
Measure:Physical Function
Time Frame:1 month post completion of the treatment
Safety Issues:False
Description:The Oswestry Disability Index (ODI) was used to measure a participants impairment and quality of life on 10 items with 0-5 point scales [37]. The score ranges from 0-100%; a lower score indicates less disability.
Outcome Type:Primary Outcome
Measure:Pain Interference
Time Frame:1 month post completion of the treatment
Safety Issues:False
Description:The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, was used to assess the impact of back pain on their daily functioning. The score ranged from 0 (no disability) to 24 (maximum disability).
Outcome Type:Primary Outcome
Measure:Pain intensity
Time Frame:1 month post completion of the treatment
Safety Issues:False
Description:The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference wit

Study Interventions

Intervention Type:Other
Name:APA
Description:Light touch using vaccaria seeds on specific points of the ear.
Arm Name:APA
Intervention Type:Other
Name:Comparison Group (CG-1)
Description:Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
Arm Name:Comparison Group (CG-1)
Intervention Type:Other
Name:Enhanced Educational Control Group (CG-2)
Description:No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
Arm Name:Enhanced Educational Control Group (CG-2)

Study Arms

Study Arm Type:Other
Arm Name:Enhanced Educational Control Group (CG-2)
Description:Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.
Study Arm Type:Sham Comparator
Arm Name:Comparison Group (CG-1)
Description:The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the sham APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA trea
Study Arm Type:Active Comparator
Arm Name:APA
Description:Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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