One Needle Hand Acupuncture for MSK Disorders

NCT04048941 | Unknown

• 1 other identifier: 201904173
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Pain; Range of Motion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in Total Arc of Motion

  Pre-Acupuncture, post-acupuncture + 10 minutes

Other Outcomes (5)

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

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

• Presence of Deqi response

  During Acupuncture treatment

• Presence of Local twitch response

  During Acupuncture treatment

Study Arms (3)

Verum Acupuncture with Movement

EXPERIMENTAL

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

Procedure: One Needle Hand Acupuncture with Movement

Verum Acupuncture without Movement

ACTIVE COMPARATOR

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

Procedure: One Needle Hand Acupuncture without Movement

Control Acupuncture with Movement

SHAM COMPARATOR

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

Procedure: Control Acupuncture with Movement

Interventions

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.

Verum Acupuncture with Movement

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.

Verum Acupuncture without Movement

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.

Control Acupuncture with Movement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University Orthopedic Center

Chesterfield, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Movement

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tonia Thompson

  Washington University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: August 7, 2019
• Study Start: October 8, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)