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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589703
• Other study ID #: HSC-SN-21-1059
• Secondary ID: 1R01AG056587-01A
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: January 1, 2023
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Target ear points related to chronic low back pain (T-APA)
Light touch using vaccaria seeds on specific points of the ear.
• Non-Target ear Points not related to chronic low back pain (NT-APA)
Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
• Enhanced Educational Control Group (CG-2)
No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Johns Hopkins University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity as Assessed by the Numeric Rating Scale (NRS)	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")	Baseline
Primary	Pain Intensity as Assessed by the Numeric Rating Scale (NRS)	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")	1 month post completion of the treatment (2 months after baseline)
Primary	Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale	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").	Baseline
Primary	Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale	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").	1 month post completion of the treatment (2 months after baseline)
Primary	Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)	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).	Baseline
Primary	Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ)	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).	1 month post completion of the treatment (2 months after baseline)
Secondary	Number of Participants Who Use Opioids		Baseline
Secondary	Number of Participants Who Use Opioids		1 month post completion of the treatment (2 months after baseline)
Secondary	APA Treatment Satisfaction as Assessed by Satisfaction Survey	Satisfaction is assessed using a 5-point numeric rating scale: - Completely satisfied; - Somewhat satisfied; - Neither satisfied nor dissatisfied; - Somewhat dissatisfied; - Very dissatisfied	immediately post intervention (1 month after baseline)
Secondary	APA Treatment Satisfaction as Assessed by Satisfaction Survey	Satisfaction is assessed using a 5-point numeric rating scale: - Completely satisfied; - Somewhat satisfied; - Neither satisfied nor dissatisfied; - Somewhat dissatisfied; - Very dissatisfied	1 month post completion of the treatment (2 months after baseline)
Secondary	Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety	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.	Baseline
Secondary	Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety	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.	1 month post completion of the treatment (2 months after baseline)
Secondary	Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression	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.	Baseline
Secondary	Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression	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.	1 month post completion of the treatment (2 months after baseline)
Secondary	Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance	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.	Baseline
Secondary	Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance	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.	1 month post completion of the treatment (2 months after baseline)
Secondary	Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)	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.	Baseline
Secondary	Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ)	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.	1 month post completion of the treatment (2 months after baseline)
Secondary	Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)	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.	Baseline
Secondary	Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)	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.	1 month post completion of the treatment (2 months after baseline)
Secondary	Memory as Assessed by the Stroop Test	T-score will be reported, with a range of 0-100, with a higher score indicating better memory.	Baseline
Secondary	Memory as Assessed by the Stroop Test	T-score will be reported, with a range of 0-100, with a higher score indicating better memory.	1 month post completion of the treatment (2 months after baseline)
Secondary	Relaxation as Assessed by Relaxation Response		Baseline
Secondary	Relaxation as Assessed by Relaxation Response		1 month post completion of the treatment (2 months after baseline)