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Acupressure for Fatigue and Low Back Pain

Primary Purpose

Fatigue, Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation acupressure
Stimulating acupressure
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Pain, Acupressure, Symptoms, Fatigue, Self-administered

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Relaxation acupressure

Stimulating acupressure

Wait-list control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 31, 2014
Last Updated
October 24, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02106741
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Chronic Low Back Pain
Keywords
Pain, Acupressure, Symptoms, Fatigue, Self-administered

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation acupressure
Arm Type
Experimental
Arm Title
Stimulating acupressure
Arm Type
Active Comparator
Arm Title
Wait-list control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Relaxation acupressure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stimulating acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue severity and interference in daily activities
Description
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.
Time Frame
Week 0 (baseline) and approximately 9 weeks (follow-up)
Title
Sleep quality via objectively measured sleep efficiency
Description
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.
Time Frame
Week 0 (baseline) and approximately 9 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Pain severity and interference in daily activities
Description
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.
Time Frame
Week 0 (baseline) and approximately 9 weeks (follow-up)
Title
Level of physical functioning as measured by the Roland-Morris Disability Questionnaire.
Description
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.
Time Frame
Week 0 (baseline) and approximately 9 weeks (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Murphy, ScD, OTR
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31237610
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.
Results Reference
derived

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Acupressure for Fatigue and Low Back Pain

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