One Needle Hand Acupuncture for MSK Disorders

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04048941
• Other study ID #: 201904173
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acupuncture
• Pain
• Range of Motion

Intervention

Procedure:
• One Needle Hand Acupuncture with Movement
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
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
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.

Locations

Country	Name	City	State
United States	Washington University Orthopedic Center	Chesterfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient-Reported Outcome Measurement Information Systems (PROMIS)	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.	Pre-Acupuncture, 1 week post-acupuncture, 2 weeks post-acupuncture, 4 weeks post-acupuncture, 8 weeks post-acupuncture
Other	Presence of Deqi response	Yes or No whether patient reported an ache, numbness, fullness, or electric sensation with needling.	During Acupuncture treatment
Other	Presence of Local twitch response	Yes or No whether provider observed/felt twitch in the hand with acupuncture needling.	During Acupuncture treatment
Other	Structural diagnosis	Patient's structural diagnosis given by provider.	Pre-acupuncture
Other	Change in RAND 12 score	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	Pre-acupuncture, 4 weeks post-acupuncture
Primary	Change in Numeric Pain Rating Scale (NPRS)	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.	Pre-acupuncture, post-acupuncture + 10 minutes
Primary	Percentage Change in Pain	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.	Immediately post-acupuncture, post-acupuncture + 10 minutes
Secondary	Change in Total Arc of Motion	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.	Pre-Acupuncture, post-acupuncture + 10 minutes