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The purpose of this study is to compare two kinds of self-administered acupressure (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue and pain in low back pain patients.
Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue and sleep quality, pain, and physical function compared to stimulating acupressure and usual care.
Acupressure is a Traditional Chinese Medicine (TCM) technique based on a philosophy similar to that of acupuncture. It involves the application of physical pressure on different acupuncture points (acupoints). One advantage of acupressure is the ability to self-administer the treatment. Acupressure is also a viable alternative to acupuncture in situations where patients: (1) cannot come to the clinic to receive an acupuncture treatment; (2) when a more frequent intervention is needed; or (3) where needle phobia or safety concerns are an issue.
The objective of this study is to evaluate the validity and feasibility of teaching acupressure interventions using an acupressure educator for the management of symptoms related to low back pain.
Specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxation acupressure | Experimental |
| |
| Stimulating acupressure | Active Comparator |
| |
| Wait-list control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation acupressure | Behavioral | The relaxation acupressure protocol will use a set of nine fixed acupoints: forehead, twixt the eyebrows (unilateral); posterior neck, behind the ears (bilateral); palmer side of hand at wrist (bilateral); inside of lower leg (bilateral); top of foot (bilateral). A trained acupressure educator will meet with each participant and demonstrate the sites and techniques for self-administered acupressure. Additionally, each participant will receive a demonstration DVD and a laminated handout detailing the locations of each acupoint. Participants will be asked to perform daily acupressure sessions using the assigned sites. Each site is stimulated for 3 minutes, and the entire session can be completed in approximately 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue severity and interference in daily activities | Fatigue severity and interference in daily activities will be measured using the Brief Fatigue Inventory. Subjects will answer the BFI at both baseline and follow-up. To investigate a change from baseline in fatigue, the difference between the post-assessment outcomes and baseline measures will be calculated. Analyses on these differences will be performed using independent samples t-tests between treatment groups. We will also evaluate all continuous outcomes by ANCOVA, adjusting for baseline value and treatment group. | Week 0 (baseline) and approximately 9 weeks (follow-up) |
| Sleep quality via objectively measured sleep efficiency | We will use wrist-worn accelerometry to assess sleep efficiency. Subjects will wear a wrist-worn accelerometer for 7 consecutive days (at baseline and follow-up) that collects in vivo sleep quality data; an accompanying logbook will be used to enhance objective data. To investigate a change from baseline in sleep efficiency, the difference between the post-assessment outcomes and baseline measures will be calculated. Analyses on these differences will be performed using independent samples t-tests between treatment groups. We will also evaluate all continuous outcomes by ANCOVA, adjusting for baseline value and treatment group. | Week 0 (baseline) and approximately 9 weeks (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity and interference in daily activities | Pain severity and interference in daily activities will be measured using the Brief Pain Inventory. Subjects will answer the BPI at both baseline and follow-up. To investigate a change from baseline in pain, the difference between the post-assessment outcomes and baseline measures will be calculated. Analyses on these differences will be performed using independent samples t-tests between treatment groups. We will also evaluate all continuous outcomes by ANCOVA, adjusting for baseline value and treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan L Murphy, ScD, OTR | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31237610 | Derived | Murphy SL, Harris RE, Keshavarzi NR, Zick SM. Self-Administered Acupressure for Chronic Low Back Pain: A Randomized Controlled Pilot Trial. Pain Med. 2019 Dec 1;20(12):2588-2597. doi: 10.1093/pm/pnz138. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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|
| Stimulating acupressure | Behavioral | The stimulating acupressure protocol will use a set of ten fixed acupoints: top of the head (unilateral); below the navel (unilateral); back of the hand (bilateral); outside of lower leg (bilateral); inside of lower leg (bilateral); inside of ankle (bilateral). A trained acupressure educator will meet with each participant and demonstrate the sites and techniques for self-administered acupressure. Additionally, each participant will receive a demonstration DVD and a laminated handout detailing the locations of each acupoint. Participants will be asked to perform daily acupressure sessions using the assigned sites. Each site is stimulated for 3 minutes, and the entire session can be completed in approximately 30 minutes. |
|
| Week 0 (baseline) and approximately 9 weeks (follow-up) |
| Level of physical functioning as measured by the Roland-Morris Disability Questionnaire. | Subjects will answer the Roland-Morris Disability Questionnaire at both baseline and follow-up. To investigate a change from baseline in physical function, the difference between the post-assessment outcomes and baseline measures will be calculated. Analyses on these differences will be performed using independent samples t-tests between treatment groups. We will also evaluate all continuous outcomes by ANCOVA, adjusting for baseline value and treatment group. | Week 0 (baseline) and approximately 9 weeks (follow-up) |