Hand Acupuncture for Pain

Overseen By Melissa Armbrecht

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Fracture, Malignancy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a unique acupuncture method, using just one needle on the hand, to treat pain in various body parts. Researchers aim to assess the effectiveness of this approach in both the short term and long term, and its potential to alter the course of a patient's condition. Participants will be divided into groups to test acupuncture with and without movement, alongside a control group receiving a sham treatment. This trial suits individuals experiencing significant pain in the neck, shoulder, lower back, or hip, who also find certain movements painful. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method of acupuncture is safe for treating pain?

Research has shown that acupuncture is generally safe, especially when performed by trained professionals. Studies have found One Needle Hand Acupuncture without movement effective for long-term pain relief. Most people tolerate it well, experiencing only minor issues like slight bleeding or temporary pain.

For One Needle Hand Acupuncture with movement, similar studies suggest it is also safe and effective. Again, only minor side effects, such as temporary discomfort, are common. Overall, acupuncture appears well-tolerated, which is encouraging for anyone considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hand acupuncture for pain because it explores a non-drug approach that could offer relief without the side effects of medications like opioids or NSAIDs. Current pain treatments often rely on these medications, which can have unwanted side effects and risks. The trial is investigating two unique acupuncture methods: one involves active movement during the treatment, which might enhance pain relief by promoting blood flow and flexibility, while the other uses a static approach, providing a comparison to understand the role of movement. This study could reveal new insights into how acupuncture and movement work together to manage pain, offering an alternative solution for those seeking non-pharmaceutical options.

What evidence suggests that this trial's acupuncture methods could be effective for pain?

Research shows that acupuncture can reduce pain in conditions like chronic low back pain and osteoarthritis. Studies have found that real acupuncture is more effective at reducing pain than sham acupuncture. In this trial, participants will receive either One Needle Hand Acupuncture with or without movement, or Control Acupuncture with Movement. One Needle Hand Acupuncture, in particular, has shown promise in managing pain. Even for those who might move during treatment, acupuncture has improved pain and movement, especially for muscle and joint pain. Although some research did not find it significantly better than other methods, acupuncture overall has a strong record in pain management. ^{5 6 7 8 9}

Who Is on the Research Team?

Tonia Thompson

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with primary pain in the neck, shoulder, low back, or hip rated at least 4 on a pain scale during certain movements. Participants must be willing to engage in the study and complete questionnaires.

Inclusion Criteria

My pain level is 4 or higher when I move in certain ways.

My main pain is in my neck, shoulder, lower back, or hip.

I am willing to join the study and complete questionnaires.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either verum hand acupuncture or control acupuncture, with or without movement, for 10 minutes

1 session

1 visit (in-person)

Follow-up

Participants complete PROMIS measures and are monitored for changes in pain and range of motion

8 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Control Acupuncture with Movement
• One Needle Hand Acupuncture with Movement
• One Needle Hand Acupuncture without Movement

Trial Overview The study tests one needle hand acupuncture's effectiveness for treating musculoskeletal disorders. It compares three methods: control acupuncture with movement, one needle without movement, and one needle with movement over time.

How Is the Trial Designed?

Group I: Verum Acupuncture with Movement Experimental Treatment 1 Intervention

Verum acupuncture along radial side of 2nd metacarpal, following by active movement of previously painful body part x 10 minutes.

Group II: Verum Acupuncture without Movement Active Control 1 Intervention

Verum acupuncture along radial side of 2nd metacarpal, following by laying on examination table x 10 minutes.

Group III: Control Acupuncture with Movement Placebo Group 1 Intervention

Sham/control acupuncture at acupoint LI4, following by active movement of previously painful body part x 10 minutes.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

In a survey of 37,490 acupuncture treatments conducted by 222 Korean Medicine Doctors, adverse events (AEs) were reported at a frequency of 1,205 per 10,000 treatments, with common AEs including bleeding, needle site pain, and bruising.

Most reported AEs were mild and transient, with only two life-threatening cases that resolved without lasting effects, suggesting that acupuncture performed by qualified practitioners is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. Won, J., Lee, JH., Bang, H., et al.[2022]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

A review of 23 observational studies on acupuncture-related adverse events revealed that many did not provide sufficient information to determine the cause of complications, highlighting a gap in reporting quality.

The study emphasizes the need for better involvement of acupuncture experts in reporting adverse events to improve the understanding and safety of acupuncture practices, particularly regarding infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. Kim, TH., Kang, JW., Park, WS.[2022]

In a study involving 78 acupuncturists and 31,822 consultations, the incidence of adverse events was found to be 684 per 10,000 consultations, indicating that while acupuncture does have risks, they are relatively low when performed by trained professionals.

The most common minor adverse events included bleeding and needling pain, with 70% of symptom aggravations resolving afterward, and only 14 significant adverse events reported, suggesting that acupuncture is generally safe in skilled hands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of adverse events following acupuncture (SAFA): a prospective study of 32,000 consultations. White, A., Hayhoe, S., Hart, A., et al.[2022]

A systematic review of 115 Chinese-language articles identified 479 cases of adverse events related to acupuncture, with 14 reported deaths, highlighting significant safety concerns.

The most common adverse events included pneumothorax and infections, primarily resulting from improper techniques, indicating a need for improved monitoring and risk management in acupuncture practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. Zhang, J., Shang, H., Gao, X., et al.[2022]

A review of 8 hand acupuncture schools revealed inconsistencies in positioning methods and needling techniques, as well as a lack of clarity on the specific diseases treated, highlighting the need for standardization.

Future research should focus on optimizing hand acupuncture practices, developing quantitative standards, and promoting integration among different acupuncture schools to enhance the effectiveness and application of hand acupuncture therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of different schools of hand acupuncture therapies]. Wang, RQ., Zhang, ZD., Liu, JX., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9502036/

Acupuncture as Part of Multimodal Analgesia for Chronic Pain Real acupuncture reduced chronic low back pain bothersomeness and pain intensity better than sham acupuncture. Adverse effects were minor, such ...

2. withpower.com withpower.com/trial/phase-9-2019-a392e

Hand Acupuncture for Pain · Info for Participants Acupuncture has been shown to be effective for pain relief in conditions like osteoarthritis and chronic pain, suggesting it might help with pain management in ...

3. liebertpub.com liebertpub.com/doi/abs/10.1177/19336586251361296

Immediate Results Following Novel Single-Point Hand ... There was no statistically significant mean difference between the single-point hand acupuncture with movement and the other two techniques.

4. integrmed.org integrmed.org/journal/view.php?number=16

A Scoping Review of Clinical Research on Motion Style ... The study participants were patients with musculoskeletal pain, and many studies reported significant improvements in pain and functional disability outcomes ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811822

Acupuncture vs Massage for Pain in Patients Living With ... In this randomized clinical trial that included 298 patients with advanced cancer, both acupuncture and massage were associated with long-term pain reduction.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10671479/

Effectiveness and Safety of Progressive Loading–Motion Style ... This two-armed, parallel, assessor-blinded, randomized controlled trial evaluated the effectiveness and safety of progressive loading–motion style acupuncture ...

7. nccih.nih.gov nccih.nih.gov/health/acupuncture-effectiveness-and-safety

Acupuncture: Effectiveness and Safety - nccIH.nih.gov In a 2018 review, data from 12 studies (8,003 participants) showed acupuncture was more effective than no treatment for back or neck pain, and data from 10 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1526590017307800

Acupuncture for Chronic Pain: Update of an Individual ... We conclude that acupuncture is effective for the treatment of chronic pain, with treatment effects persisting over time.

9. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03570-6

Efficacy and safety of acupuncture for hand osteoarthritis Acupuncture is well known for analgesia and has been proved effective in treating basal thumb joint arthritis. This study aims to clarify the ...