Self-Administered Acupressure for Chronic Back Pain

Overseen By Jennifer L Caldararo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnant, Recent back surgery, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Many Veterans experience chronic pain, with back pain the most commonly reported condition. The Veterans Health Administration (VHA) is moving from reliance on medications to an approach in which non-medication interventions, including complementary and integrative health treatments, are now a first line of care. Acupressure, a Traditional Chinese Medicine technique derived from acupuncture, is emerging as a potentially effective approach for treating several chronic pain conditions and could prove beneficial in helping Veterans manage their chronic low back pain. This study will determine the effectiveness of self-administered acupressure to treat chronic low back pain. 300 Veterans will be invited to participate in the study. All participants will be asked to attend an introduction to acupressure class and complete a survey when they join the study and again at 6 weeks and 10 weeks. The survey measures assess important outcomes, such as how pain interferes with daily function, as well as other areas that can be affected by pain such as fatigue and sleep quality. After completing the first survey, half of the participants will receive a tablet computer with an app that shows them how to self-administer acupressure for low back pain and will be asked to do daily acupressure sessions for the next 6 weeks. The other half of the participants will receive the tablet computer with the app approximately 10 weeks after completing the final survey based assessment. The investigators anticipate that outcomes will be improved after 6 weeks of acupressure practice, and these improvements will persist for the following 4 weeks.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have changed your pain medication regimen in the past 4 weeks to be eligible.

What data supports the effectiveness of the treatment Self-Administered Acupressure for Chronic Back Pain?

Research shows that acupressure, when combined with physical therapy, can significantly reduce pain and disability in people with chronic low back pain, as well as improve their ability to perform daily activities. ^{1 2 3 4 5}

Is self-administered acupressure safe for humans?

Research indicates that self-administered acupressure is generally safe for managing symptoms in various conditions, including low back pain and knee osteoarthritis, with studies specifically examining its safety and reporting no significant adverse events. ^{6 7 8 9 10}

How is self-administered acupressure different from other treatments for chronic back pain?

Self-administered acupressure is unique because it allows individuals to manage their chronic back pain at home without the need for medication or professional intervention. It is a low-risk, non-invasive treatment that can be practiced anywhere, offering a convenient and accessible option for pain relief with minimal side effects. ^{1 2 5 11 12}

Research Team

Sarah L. Krein, PhD RN

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Eligibility Criteria

This trial is for Veterans with chronic low back pain who are enrolled at VA Ann Arbor Healthcare System. They must have had a pain severity of at least 4/10 for over three months and be medically stable, without hospital stays or changes in pain meds recently. Pregnant individuals, those with recent back surgery or acupressure treatments, or cognitive impairments that affect consent ability cannot participate.

Inclusion Criteria

Veterans who are part of the VA Ann Arbor Healthcare System.

My medical records confirm I have non-specific low back pain.

I have had pain at a level of 4 out of 10 for at least 3 months.

Exclusion Criteria

I have had acupuncture or acupressure in the last 3 months.

Pregnant

I had back surgery within the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introduction

Participants attend an introductory acupressure class and complete a baseline survey

1 week

1 visit (in-person or virtual)

Treatment

Participants in the intervention group perform self-administered acupressure daily for 6 weeks

6 weeks

Daily self-administered sessions

Follow-up

Participants are monitored for persisting effects of acupressure after treatment

4 weeks

Survey assessments at 6 and 10 weeks

Treatment Details

Interventions

• Self-Administered Acupressure

Trial Overview The study tests if self-administered acupressure can help manage chronic low back pain in Veterans. Participants will learn about acupressure and use an app to guide their daily sessions over six weeks. The effectiveness will be measured through surveys assessing pain's impact on function, fatigue, and sleep quality.

Participant Groups

Group I: acupressure intervention Experimental Treatment 1 Intervention

Receives access to the acupressure intervention

Group II: wait list control Active Control 1 Intervention

No access to the acupressure intervention during the study period

Self-Administered Acupressure is already approved in United States, European Union for the following indications:

Approved in United States as Acupressure for:

• Chronic Low Back Pain
• Fatigue Reduction
• Pain Management

Approved in European Union as Acupressure for:

• Chronic Pain Symptoms
• Fatigue Reduction
• Pain Management

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study of 61 participants with chronic low back pain, those receiving real auricular point acupressure (APA) experienced a significant reduction in worst pain, with a 30% decrease after the first treatment and a 44% decrease by the end of the 4-week intervention.

Participants in the real APA group also reported lower use of analgesics compared to those in the sham group, suggesting that APA is an effective and non-invasive self-management strategy for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Day-to-Day Changes of Auricular Point Acupressure to Manage Chronic Low Back Pain: A 29-day Randomized Controlled Study. Yeh, CH., Kwai-Ping Suen, L., Chien, LC., et al.[2015]

This study will evaluate the effectiveness of auricular point acupressure (APA) as a self-management strategy for chronic low back pain (cLBP) in older adults, with a follow-up period of 12 months to assess sustained effects.

Participants will be divided into three groups to compare the effects of APA on cLBP against non-active points and an educational control, using real-time assessments and blood tests to explore the treatment's efficacy and underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol. Yeh, CH., Li, C., Glick, R., et al.[2020]

In a randomized controlled trial involving 129 patients with chronic low back pain, acupressure significantly reduced disability scores compared to physical therapy, with an 89% reduction in significant disability observed.

The benefits of acupressure in improving pain and functional status were not only evident immediately after treatment but also sustained for six months, indicating its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of low back pain by acupressure and physical therapy: randomised controlled trial. Hsieh, LL., Kuo, CH., Lee, LH., et al.[2018]

Acupressure, when added to traditional physical therapy, significantly reduced chronic low back pain, as shown by a decrease in the Visual Analog Scale (VAS) score from 38.8 mm at baseline to 2.5 mm after treatment.

The integration of acupressure improved functional outcomes, with the Patient Specific Functional Scale (PSFS) score increasing from 5/10 to 9/10, and the Oswestry Disability Index (ODI) score indicating a complete resolution of disability after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupressure for chronic low back pain: a single system study. Adams, A., Eschman, J., Ge, W.[2020]

A systematic review of 6 randomized control trials involving 468 participants showed that acupressure significantly reduces chronic low back pain, with all studies reporting at least a 30% decrease in pain for treatment groups.

Acupressure also led to significant improvements in disability and sleep quality, with no reported adverse events, highlighting its safety and effectiveness as a low-cost nonpharmacologic treatment option for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of acupressure for chronic low back pain: A systematic review. Godley, E., Smith, MA.[2020]

Acupressure has been shown to be an effective treatment for low back pain (LBP), outperforming tuina massage, physical therapy, and usual care in pain reduction, based on a meta-analysis of 23 randomized controlled trials involving 2400 participants.

While acupressure demonstrated significant improvements in pain and disability scores, the evidence quality was downgraded, indicating that further research is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Safety of Acupressure on Low Back Pain: A Systematic Review and Meta-Analysis. Li, T., Li, X., Huang, F., et al.[2022]

This systematic review aims to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain, analyzing randomized controlled trials from various databases up to May 2017.

The primary outcomes will focus on pain intensity and functional status, while secondary outcomes will include overall recovery, work-related impacts, quality of life, and any adverse events, providing comprehensive evidence for the use of moxibustion in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of moxibustion treatment for non-specific lower back pain: protocol for a systematic review. Leem, J., Lee, S., Park, Y., et al.[2019]

Self-applied acupressure, when combined with usual treatment, significantly reduced cervical pain in patients, with a notable decrease in pain intensity measured on a visual analogue scale (VAS) over a 6-month period.

Patients who practiced acupressure reported a 1.6-point improvement in their quality of life after 3 months, indicating that this technique not only helps with pain relief but also enhances overall self-perceived health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of self-applied acupressure for cervical pain of benign origin (EDIDO-CUH): a randomized controlled clinical trial. Susana, CT., Maria, TML., Pilar, DS., et al.[2022]

The study successfully enrolled 150 older adults with knee osteoarthritis, with a high retention rate of 83% completing all visits, indicating good feasibility for future research on self-administered acupressure.

Participants showed high adherence to the acupressure protocol, with 94% passing fidelity checks and over 80% performing the technique as instructed, while only 10% reported any discomfort, suggesting that acupressure is a tolerable intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Randomized Controlled Trial of Self-Administered Acupressure for Symptom Management in Older Adults with Knee Osteoarthritis. Li, LW., Harris, RE., Murphy, SL., et al.[2022]

Self-administered acupressure has been shown to be effective and safe in alleviating symptoms across various health issues, including allergic diseases, cancer-related nausea, respiratory problems, dysmenorrhea, and sleep disturbances, based on a review of 10 studies involving randomized controlled trials.

The studies indicated moderate quality with a low risk of bias in many areas, suggesting that self-acupressure can significantly improve symptom scores, but further research with larger and better-designed trials is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of self-acupressure for symptom management: a systematic review. Song, HJ., Seo, HJ., Lee, H., et al.[2022]

A randomized controlled trial involving 300 Veterans aims to assess the effectiveness of a self-administered acupressure protocol for improving pain interference, fatigue, sleep quality, and disability in those with chronic low back pain.

The study will evaluate the feasibility of implementing acupressure within the Veterans Health Administration, addressing barriers to access and resources, which could enhance pain management strategies for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial. Murphy, SL., Zick, SM., Harris, RE., et al.[2023]

In a randomized pilot trial involving 67 participants, both relaxing and stimulating self-administered acupressure significantly reduced pain by 35-36% compared to usual care for chronic low back pain (CLBP).

Stimulating acupressure also showed improvements in fatigue levels compared to usual care, with minimal adverse events reported, indicating it is a low-risk treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Administered Acupressure for Chronic Low Back Pain: A Randomized Controlled Pilot Trial. Murphy, SL., Harris, RE., Keshavarzi, NR., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Day-to-Day Changes of Auricular Point Acupressure to Manage Chronic Low Back Pain: A 29-day Randomized Controlled Study. [2015]

2. England pubmed.ncbi.nlm.nih.gov

A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of low back pain by acupressure and physical therapy: randomised controlled trial. [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

Acupressure for chronic low back pain: a single system study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of acupressure for chronic low back pain: A systematic review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Safety of Acupressure on Low Back Pain: A Systematic Review and Meta-Analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of moxibustion treatment for non-specific lower back pain: protocol for a systematic review. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of self-applied acupressure for cervical pain of benign origin (EDIDO-CUH): a randomized controlled clinical trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Randomized Controlled Trial of Self-Administered Acupressure for Symptom Management in Older Adults with Knee Osteoarthritis. [2022]

10. Scotland pubmed.ncbi.nlm.nih.gov

Effect of self-acupressure for symptom management: a systematic review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Self-Administered Acupressure for Chronic Low Back Pain: A Randomized Controlled Pilot Trial. [2020]