Clinical trial NCT04048941: One Needle Hand Acupuncture for MSK Disorders
Official title: One Needle Hand Acupuncture (Combined) With Movement for Treatment of Musculoskeletal Disorders: A Blinded Randomized Controlled Trial Involving 3 Groups
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acupuncture
Pain
Range of Motion
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: Pre-acupuncture, post-acupuncture + 10 minutes
measure: Percentage Change in Pain
timeFrame: Immediately post-acupuncture, post-acupuncture + 10 minutes
Secondary outcomes:
measure: Change in Total Arc of Motion
timeFrame: Pre-Acupuncture, post-acupuncture + 10 minutes
Other outcomes:
measure: Change in Patient-Reported Outcome Measurement Information Systems (PROMIS)
timeFrame: Pre-Acupuncture, 1 week post-acupuncture, 2 weeks post-acupuncture, 4 weeks post-acupuncture, 8 weeks post-acupuncture
measure: Presence of Deqi response
timeFrame: During Acupuncture treatment
measure: Presence of Local twitch response
timeFrame: During Acupuncture treatment
measure: Structural diagnosis
timeFrame: Pre-acupuncture
measure: Change in RAND 12 score
timeFrame: Pre-acupuncture, 4 weeks post-acupuncture
Locations:
city: Chesterfield
country: United States
facility: Washington University Orthopedic Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tonia Thompson
role: STUDY_DIRECTOR
References: