Pain Clinical Trial - One Needle Hand Acupuncture for MSK Disorders

Status Active, not recruiting

Clinical Trial Summary

The purpose of this research study is to study the method of acupuncture called one needle hand acupuncture, where a needle is placed just in your hand, in order to treat pain in various locations. Benefits of acupuncture will be studied over time to determine short and long term effects of acupuncture, and see how acupuncture may alter or modify a patient's disease process.

Clinical Trial Description

Patients with neck, shoulder, low back, or hip pain that is exacerbated by movement will be randomized 1:1:1 to receive either verum hand acupuncture at the correct location (with or without movement) or control acupuncture at a nearby incorrect location. After needling and as part of the intervention, the movement groups will perform gentle active range of motion (ROM) exercises, while the without movement group will lay on the examination table, all for 10 minutes. Immediately pre- and post- intervention, numeric pain rating scores (NPRS) and goniometer- or inclinometer-obtained ROM measurements will be recorded for the most provocative movement plane. In the physical therapy literature, within-session improvements in pain and ROM have been shown to correlate with between-session improvements.All patients will complete PROMIS Pain Interference, Physical Function, Anxiety, and Depression measures prior to the acupuncture intervention and then 1,2, 4, and 8 weeks later. Four potential treatment response modifiers will be assessed. In Traditional Chinese Medicine (TCM), a strong needling sensation felt by the patient during an acupuncture treatment is called a "deqi" response and is thought to be a positive prognostic sign. In Western medicine, a local twitch response (LTR) observed during needling of muscle trigger points is thought to represent a polysynaptic reflex and has been linked to local pain improvements.Other potential modifiers include patients' underlying musculoskeletal structural diagnosis and the provider's experience performing acupuncture. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04048941
Study type	Interventional
Source	Washington University School of Medicine
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 8, 2019
Completion date	December 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.