Clinical trial NCT02106741: Acupressure for Fatigue and Low Back Pain
Official title: Randomized Pilot Study of Self-Administered Acupressure for Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Chronic Low Back Pain
Keywords: Pain
Acupressure
Symptoms
Fatigue
Self-administered
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue severity and interference in daily activities
timeFrame: Week 0 (baseline) and approximately 9 weeks (follow-up)
measure: Sleep quality via objectively measured sleep efficiency
timeFrame: Week 0 (baseline) and approximately 9 weeks (follow-up)
Secondary outcomes:
measure: Pain severity and interference in daily activities
timeFrame: Week 0 (baseline) and approximately 9 weeks (follow-up)
measure: Level of physical functioning as measured by the Roland-Morris Disability Questionnaire.
timeFrame: Week 0 (baseline) and approximately 9 weeks (follow-up)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Susan L Murphy, ScD, OTR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.