AcupunctureNCT04048941
One Needle Hand Acupuncture for MSK Disorders
A study testing One Needle Hand Acupuncture with Movement and One Needle Hand Acupuncture without Movement in people with Acupuncture and Pain, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acupuncture, Pain, Range of Motion
- What is being tested?
- One Needle Hand Acupuncture with Movement and One Needle Hand Acupuncture without Movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Fracture, malignancy
- Condition that requires urgent treatment (e.g. cervical myelopathy)
- Contraindications to needling (e.g. pregnancy, active infection)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Orthopedic Center
Chesterfield, Missouri, 63017
About this study
Official title: One Needle Hand Acupuncture (Combined) With Movement for Treatment of Musculoskeletal Disorders: A Blinded Randomized Controlled Trial Involving 3 Groups
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.
Read the 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
- Being tested
- One Needle Hand Acupuncture with Movement, One Needle Hand Acupuncture without Movement, Control Acupuncture with Movement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Needle Hand Acupuncture with MovementProcedure or surgery
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 MovementProcedure or surgery
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 MovementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Control Acupuncture with Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately post-acupuncture, post-acupuncture + 10 minutes
Secondary outcomes (1)
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.
Measured: Pre-Acupuncture, post-acupuncture + 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start8 Oct 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: It was stopped because of COVID, then was never restarted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tonia Thompson, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048941
- Sponsor's protocol ID
- 201904173
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2019
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Needle Hand Acupuncture (Combined) With Movement for Treatment of Musculoskeletal Disorders: A Blinded Randomized Controlled Trial Involving 3 Groups
- ClinicalTrials.gov ID
- NCT04048941
- Acronym / sponsor ID
- 201904173
- Conditions
- Acupuncture, Pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was stopped because of COVID, then was never restarted.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Verum Acupuncture with Movement | Experimental | Procedure: One Needle Hand Acupuncture with MovementVerum acupuncture along radial side of 2nd metacarpal, following by active movement of previously painful body part x 10 minutes. |
| Verum Acupuncture without Movement | Active comparator | Procedure: One Needle Hand Acupuncture without MovementVerum acupuncture along radial side of 2nd metacarpal, following by laying on examination table x 10 minutes. |
| Control Acupuncture with Movement | Sham comparator | Procedure: Control Acupuncture with MovementSham/control acupuncture at acupoint LI4, following by active movement of previously painful body part x 10 minutes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Fracture, malignancy
- Condition that requires urgent treatment (e.g. cervical myelopathy)
- Contraindications to needling (e.g. pregnancy, active infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Needle Hand Acupuncture with MovementOne 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. | Procedure or surgery | Verum Acupuncture with Movement |
| One Needle Hand Acupuncture without MovementOne 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. | Procedure or surgery | Verum Acupuncture without Movement |
| Control Acupuncture with MovementControl 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. | Procedure or surgery | Control Acupuncture with Movement |
Primary outcome
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.
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.
1 secondary outcome
Change in Total Arc of Motion
Time frame: Pre-Acupuncture, post-acupuncture + 10 minutes
Results and safety
The study was stopped early (reason given: It was stopped because of COVID, then was never restarted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonia Thompson study director
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Needle Hand Acupuncture with Movement and One Needle Hand Acupuncture without Movement in people with Acupuncture and Pain, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was stopped because of COVID, then was never restarted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (NPRS) (time frame: Pre-acupuncture, post-acupuncture + 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.