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Terminated

NCT Number: NCT04048941

One Needle Hand Acupuncture for MSK Disorders

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.

Why the study stopped: It was stopped because of COVID, then was never restarted.
Terminated

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Key information

Conditions

Acupuncture Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Range of Motion Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University Orthopedic Center

Chesterfield, Missouri, 63017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

One Needle Hand Acupuncture with Movement

Procedure

One needle is inserted along the radial aspect of the 2nd metacarpal which relieves pain at a distant site. Then, the subject is asked to perform a series of movements that were previously painful.

One Needle Hand Acupuncture without Movement

Procedure

One needle is inserted along the radial aspect of the 2nd metacarpal which relieves pain at a distant site. Then, the subject is asked to lay quietly on the examination table.

Control Acupuncture with Movement

Procedure

Control acupuncture at acupoint LI4 is performed, which should not have a large affect on pain at a distant site. Then, the subject is asked to perform a series of movements that were previously painful.

Primary outcomes

  1. Change in Numeric Pain Rating Scale (NPRS)

    Time frame: Pre-acupuncture, post-acupuncture + 10 minutes

    Change in Numeric Pain Rating Scale from Baseline. Range is -10 to +6 by increments of 1. NPRS of later time point minus NPRS at baseline with lower number being better.

  2. Percentage Change in Pain

    Time frame: Immediately post-acupuncture, post-acupuncture + 10 minutes

    Percentage Change in Pain after Needling Treatment. Options are 0%, 25%, 50%, 75%, 100%. Patient reported outcome at 2 time points with higher percentage indicating more improvement and being better.

Secondary outcomes

  1. Change in Total Arc of Motion

    Time frame: Pre-Acupuncture, post-acupuncture + 10 minutes

    Total Arc of Motion is defined as Painful Range of Motion + Reciprocal Range of Motion. Cervical motion include active flexion + extension, active left rotation + right rotation, active left sidebend + right sidebend. Lumbar motions include active flexion + extension, active left rotation + right rotation, active left sidebend + right sidebend. Shoulder motions include active flexion + extension, active abduction + cross arm adduction, passive external rotation with arm down at the side + internal rotation behind the back, passive external rotation with the shoulder abducted to 90 + internal rotation with the shoulder abducted to 90. Hip motions include active flexion + extension with knee straight, passive flexion and extension with the knee bent to 90, passive internal rotation with the hip flexed to 90 + external rotation with the hip flexed to 90. Measurements in degrees with range from 0 to 360, the larger the change in total arc of motion the better.

Other outcomes

  1. Change in Patient-Reported Outcome Measurement Information Systems (PROMIS)

    Time frame: Pre-Acupuncture, 1 week post-acupuncture, 2 weeks post-acupuncture, 4 weeks post-acupuncture, 8 weeks post-acupuncture

    PROMIS is a computerized adaptive testing that our institution administers that provides patient reported measures in the domains of pain interference, physical function, anxiety, and depression. PROMIS scores are normalized to the general population with a mean of 50 and a standard deviation of 10. Range is 0 - 100. A decrease in pain interference, increase in physical function, decrease in anxiety, and decrease in depression is good with larger absolute changes being better.

  2. Presence of Deqi response

    Time frame: During Acupuncture treatment

    Yes or No whether patient reported an ache, numbness, fullness, or electric sensation with needling.

  3. Presence of Local twitch response

    Time frame: During Acupuncture treatment

    Yes or No whether provider observed/felt twitch in the hand with acupuncture needling.

  4. Structural diagnosis

    Time frame: Pre-acupuncture

    Patient's structural diagnosis given by provider.

  5. Change in RAND 12 score

    Time frame: Pre-acupuncture, 4 weeks post-acupuncture

    The RAND 12 is a brief health survey comprised of 12 items that looks at general health, and is broken up into physical health summary and mental health summary; Scores are calculated via computer and compared with a large database of patients; average score for US population is 50 with a standard deviation of 10

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

One Needle Hand Acupuncture (Combined) With Movement for Treatment of Musculoskeletal Disorders: A Blinded Randomized Controlled Trial Involving 3 Groups

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2019
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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