FatigueNCT02106741
Acupressure for Fatigue and Low Back Pain
A study testing Relaxation acupressure and Stimulating acupressure in people with Fatigue and Chronic Low Back Pain, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue, Chronic Low Back Pain
- What is being tested?
- Relaxation acupressure and Stimulating acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Pilot Study of Self-Administered Acupressure for Patients With Low Back Pain
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.
Read the 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.
- Conditions
- Fatigue, Chronic Low Back Pain
- Being tested
- Relaxation acupressure, Stimulating acupressure
- Keywords
- Pain, Acupressure, Symptoms, Fatigue, Self-administered
- Medical subject headings
- Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation acupressureBehavioural
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.
Stimulating acupressureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation acupressure | Experimental | Not described Receives: Behavioral: Relaxation acupressure |
| Stimulating acupressure | Active comparator | Not described Receives: Behavioral: Stimulating acupressure |
| Wait-list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 0 (baseline) and approximately 9 weeks (follow-up)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 0 (baseline) and approximately 9 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan L Murphy, ScD, OTR, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106741
- Sponsor's protocol ID
- BAK
- Status last verified
- Aug 2015
- First submitted
- 31 Mar 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31237610
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study of Self-Administered Acupressure for Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02106741
- Acronym / sponsor ID
- BAK
- Conditions
- Fatigue, Chronic Low Back Pain
- Keywords
- Pain, Acupressure, Symptoms, Fatigue, Self-administered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Relaxation acupressure | Experimental | Behavioral: Relaxation acupressure |
| Stimulating acupressure | Active comparator | Behavioral: Stimulating acupressure |
| Wait-list control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation acupressureThe 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. | Behavioural | Relaxation acupressure |
| Stimulating acupressureThe 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. | Behavioural | Stimulating acupressure |
Primary outcome
Fatigue severity and interference in daily activities
Time frame: 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
Time frame: 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.
2 secondary outcomes
Pain severity and interference in daily activities
Time frame: Week 0 (baseline) and approximately 9 weeks (follow-up)
Level of physical functioning as measured by the Roland-Morris Disability Questionnaire.
Time frame: Week 0 (baseline) and approximately 9 weeks (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 31237610Murphy 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.
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L Murphy, ScD, OTR principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation acupressure and Stimulating acupressure in people with Fatigue and Chronic Low Back Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity and interference in daily activities (time frame: Week 0 (baseline) and approximately 9 weeks (follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02106741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.