Acupuncture, Pain, Range of Motion
Conditions
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.
Interventions
PROCEDUREOne 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.
PROCEDUREOne 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.
PROCEDUREControl 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Pain Rating Scale (NPRS) | 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. |
| Percentage Change in Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Arc of Motion | 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. |
Countries
United States
Contacts
STUDY_DIRECTORTonia Thompson
Washington University School of Medicine
Outcome results
None listed