One Needle Hand Acupuncture for MSK Disorders

NCT ID: NCT04048941

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2025-12-01

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.

Conditions

Acupuncture; Pain; Range of Motion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Verum Acupuncture with Movement

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

Group Type: EXPERIMENTAL

One Needle Hand Acupuncture with Movement

Intervention Type: 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 without Movement

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

Group Type: ACTIVE_COMPARATOR

One Needle Hand Acupuncture without Movement

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

Control Acupuncture with Movement

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tonia Thompson

Role: STUDY_DIRECTOR

Washington University School of Medicine

Locations

Washington University Orthopedic Center

Chesterfield, Missouri, United States

Countries

United States

Other Identifiers

201904173

Identifier Type: -

Identifier Source: org_study_id