Acupressure for Fatigue and Low Back Pain

Not Applicable

Completed

Interventions: Behavioral: Stimulating acupressure
Behavioral: Relaxation acupressure

Brief Summary: 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.

Detailed Description: 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:

1. To examine the effect of 6-weeks of relaxation acupressure (RA) compared to a regime of stimulating acupressure (SA) or wait-list control (WL) on fatigue and sleep quality as assessed by Brief Fatigue Inventory and wrist-worn accelerometry (sleep efficiency).

2. To explore the effect of 6-weeks of RA compared to a regime of SA or WL on for chronic low back pain in terms of reduced pain and improved function.

Recruitment & Eligibility

Inclusion Criteria

Aged18-65 years
Non-specific low back pain (either by self-report or via ICD-9 codes 724.2, 724.5, 846.0-846.9)
Low back pain that has persisted for at least 3 months
Minimum of 3/10 on the Pain Bothersome Scale
Minimum of 3/10 fatigue severity
Ambulatory with or without assistive device
Ability to operate the accelerometer (Actiwatch-S)
Stable medication regiment for the previous 2 months
Report of a physician's visit during the previous 24 months
English-speaking

Exclusion Criteria

Medically unstable (acute conditions or acute presentations of chronic conditions)
Current pregnancy
Radiculopathy or report of low back pain radiating to below the knee
Reported history of spinal fracture, herniated lumbar disc, ankylosing spondylitis, and spinal stenosis.
Report of back surgery within the preceding 12 months
Participation in active litigation or compensation claims
Conditions that might confound treatment effects or interpretation of results (for example, rheumatoid arthritis, lupus)
Acupuncture or acupressure within the preceding 12 months
Report of sleep apnea
2nd or 3rd shift workers or other non-traditional sleep schedules
Use of anti-coagulant/platelet therapy within the preceding month

Arm && Interventions

Group	Intervention	Description
Stimulating acupressure	Stimulating acupressure	-
Relaxation acupressure	Relaxation acupressure	-

Primary Outcome Measures

Name	Time	Method
Fatigue severity and interference in daily activities	Week 0 (baseline) and approximately 9 weeks (follow-up)	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.
Sleep quality via objectively measured sleep efficiency	Week 0 (baseline) and approximately 9 weeks (follow-up)	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.

Secondary Outcome Measures

Name	Time	Method
Level of physical functioning as measured by the Roland-Morris Disability Questionnaire.	Week 0 (baseline) and approximately 9 weeks (follow-up)	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.
Pain severity and interference in daily activities	Week 0 (baseline) and approximately 9 weeks (follow-up)	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.