NCT02106741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

August 1, 2015

Enrollment Period

3 years

First QC Date

March 31, 2014

Last Update Submit

October 24, 2016

Conditions

FatigueChronic Low Back Pain

Keywords

PainAcupressureSymptomsFatigueSelf-administered

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (2)

  • Pain severity and interference in daily activities

    Week 0 (baseline) and approximately 9 weeks (follow-up)

  • Level of physical functioning as measured by the Roland-Morris Disability Questionnaire.

    Week 0 (baseline) and approximately 9 weeks (follow-up)

Study Arms (3)

Relaxation acupressure

EXPERIMENTAL
Behavioral: Relaxation acupressure

Stimulating acupressure

ACTIVE COMPARATOR
Behavioral: Stimulating acupressure

Wait-list control

NO INTERVENTION

Interventions

Relaxation acupressureBEHAVIORAL

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.

Relaxation acupressure
Stimulating acupressureBEHAVIORAL

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.

Stimulating acupressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • nd or 3rd shift workers or other non-traditional sleep schedules
  • Use of anti-coagulant/platelet therapy within the preceding month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 31237610DERIVED

MeSH Terms

Conditions

FatiguePain

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Officials

  • Susan L Murphy, ScD, OTR

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 8, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 25, 2016

Record last verified: 2015-08

Locations

US(1)