One Needle Hand Acupuncture for MSK Disorders

The Washington University

Status: Active, not recruiting

Conditions: Range of Motion; Acupuncture; Pain

Treatments: Procedure: One Needle Hand Acupuncture with Movement; Procedure: Control Acupuncture with Movement; Procedure: One Needle Hand Acupuncture without Movement

Study type: Interventional

Funder types: Other

Identifiers

NCT04048941

201904173

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary pain localized to neck, shoulder, low back, hip.
• Pain >=4 on Numeric Pain Rating Scale with one of predetermined motions.
• Willing to participate in study and fill out questionnaires.

Exclusion criteria

• Fracture, malignancy
• Condition that requires urgent treatment (e.g. cervical myelopathy)
• Contraindications to needling (e.g. pregnancy, active infection)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Verum Acupuncture with Movement

Experimental group

Description:

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

Treatment:

Procedure: One Needle Hand Acupuncture with Movement

Verum Acupuncture without Movement

Active Comparator group

Description:

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

Treatment:

Procedure: One Needle Hand Acupuncture without Movement

Control Acupuncture with Movement

Sham Comparator group

Description:

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

Treatment:

Procedure: Control Acupuncture with Movement