PainNCT01094782

Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)

A study testing Acupuncture in people with Pain, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain
What is being tested?: Acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: 1 siteUnited States
Study dates: Jan 2010to 1 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain).
Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
For controls, healthy subjects without radicular pain for at least three months will be recruited. *We are no longer accepting healthy volunteers.*

Who cannot join

Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders.
Subject has scar tissue, infection, or acute injury at the site of QST.
Subject is on anticoagulation therapy.
Subject is pregnant.
Subject is tested positive on illicit drugs.

Trial locations and contacts

1 site in 1 country.

United States1 site

MGH Center for Translational Pain Research
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Evaluating the Effect of Acupuncture on Pain Relief Using QST

The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.

Conditions: Pain
Being tested: Acupuncture, Sham Acupuncture
Keywords: Pain, Pain management
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureOther
Subjects receive 6 acupuncture treatments for neck or back pain.
Sham AcupunctureOther
Subjects receive 6 sham acupuncture treatments for neck or back pain.

Study groups in NCT01094782
Study group	Role	What they receive
Healthy - True Acupuncture	Active comparator	Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.This group received true acupuncture treatment (the needles punctured the skin). Receives: Other: Acupuncture
Healthy - Sham Acupuncture	Sham comparator	Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). Receives: Other: Sham Acupuncture
Healthy - No Treatment	No intervention	Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
Pain - True Acupuncture	Active comparator	Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). Receives: Other: Acupuncture
Pain - Sham Acupuncture	Sham comparator	Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). Receives: Other: Sham Acupuncture
Pain - No Treatment	No intervention	Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Measured: Start of Week 1
Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.
Measured: End of Week 2
Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.
Measured: End of Week 4
Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Measured: Start of Week 1
Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.
Measured: End of Week 2
Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.
Measured: End of Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20101 Dec 2021

First posted29 Mar 2010 (estimated)
Study startJan 2010
Primary completionJun 2016
Study completion1 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01094782
Sponsor's protocol ID: 2009P 0001551
Other IDs: R01AT005819
Status last verified: Apr 2022
First submitted: 19 Mar 2010
Last updated: 2 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effect of Acupuncture on Pain Relief Using QST
ClinicalTrials.gov ID: NCT01094782
Acronym / sponsor ID: 2009P 0001551
Conditions: Pain
Keywords: Pain, Pain management
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2010 (actual)
Primary completion: Jun 2016 (actual)
Study completion: 1 Dec 2021 (actual)
First posted: 29 Mar 2010 (estimated)
Results: Posted 2 Jul 2018

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 study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Healthy - True Acupuncture	Active comparator	Other: AcupunctureHealthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.This group received true acupuncture treatment (the needles punctured the skin).
Healthy - Sham Acupuncture	Sham comparator	Other: Sham AcupunctureHealthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin).
Healthy - No Treatment	No intervention	–Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
Pain - True Acupuncture	Active comparator	Other: AcupunctureVolunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin).
Pain - Sham Acupuncture	Sham comparator	Other: Sham AcupunctureVolunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin).
Pain - No Treatment	No intervention	–Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain).
Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
For controls, healthy subjects without radicular pain for at least three months will be recruited. *We are no longer accepting healthy volunteers.*

Key exclusion criteria (5 listed)

Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders.
Subject has scar tissue, infection, or acute injury at the site of QST.
Subject is on anticoagulation therapy.
Subject is pregnant.
Subject is tested positive on illicit drugs.

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
AcupunctureSubjects receive 6 acupuncture treatments for neck or back pain.	Other	Healthy - True Acupuncture, Pain - True Acupuncture
Sham AcupunctureSubjects receive 6 sham acupuncture treatments for neck or back pain.	Other	Healthy - Sham Acupuncture, Pain - Sham Acupuncture

Primary outcome

Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants
Time frame: Start of Week 1
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants
Time frame: End of Week 2
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.
Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants
Time frame: End of Week 4
Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.
Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants
Time frame: Start of Week 1
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.
Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants
Time frame: End of Week 2
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.
Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants
Time frame: End of Week 4
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.

Results and safety

Results posted to the registry on 2 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy - True Acupuncture	39	31
Healthy - Sham Acupuncture	39	29
Healthy - No Treatment	34	31
Pain - True Acupuncture	56	45
Pain - Sham Acupuncture	42	31
Pain - No Treatment	38	30

Primary outcome: Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants

Time frame: Start of Week 1. Mean (Standard Deviation). Unit: Degrees Celcius

Measure	Healthy - True Acupuncture n = 34	Healthy - Sham Acupuncture n = 30	Healthy - No Treatment n = 31	Pain - True Acupuncture n = 46	Pain - Sham Acupuncture n = 33	Pain - No Treatment n = 30
Value	49.9 (1.7)	50.5 (1.3)	49.9 (1.7)	49.5 (2.4)	49.7 (2.2)	50.1 (2)

Population analysed: Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.

Primary outcome: Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants

Time frame: End of Week 2. Mean (Standard Deviation). Unit: Degrees Celcius

Measure	Healthy - True Acupuncture n = 34	Healthy - Sham Acupuncture n = 30	Healthy - No Treatment n = 31	Pain - True Acupuncture n = 46	Pain - Sham Acupuncture n = 33	Pain - No Treatment n = 30
Value	49.8 (1.6)	50.3 (1.6)	50.2 (1.6)	49.6 (2.8)	50.3 (2.1)	50.0 (2.1)

Primary outcome: Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants

Time frame: End of Week 4. Mean (Standard Deviation). Unit: Degrees Celcius

Measure	Healthy - True Acupuncture n = 34	Healthy - Sham Acupuncture n = 30	Healthy - No Treatment n = 31	Pain - True Acupuncture n = 46	Pain - Sham Acupuncture n = 33	Pain - No Treatment n = 30
Value	49.9 (1.6)	50.3 (1.7)	50.1 (1.3)	50.1 (1.9)	49.8 (2.9)	49.2 (3.5)

Primary outcome: Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants

Time frame: Start of Week 1. Mean (Standard Deviation). Unit: Degrees Celcius

Measure	Healthy - True Acupuncture n = 34	Healthy - Sham Acupuncture n = 30	Healthy - No Treatment n = 31	Pain - True Acupuncture n = 46	Pain - Sham Acupuncture n = 33	Pain - No Treatment n = 30
Value	1.2 (3)	0.5 (1)	2.1 (5)	2.5 (5.5)	2.8 (6.1)	1.1 (3.5)

Adverse events

Time frame: Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy - True Acupuncture	0 of 39 (0%)	1 of 39 (2.6%)	Not reported
Healthy - Sham Acupuncture	0 of 39 (0%)	0 of 39 (0%)	Not reported
Healthy - No Treatment	0 of 34 (0%)	0 of 34 (0%)	Not reported
Pain - True Acupuncture	0 of 56 (0%)	0 of 56 (0%)	Not reported
Pain - Sham Acupuncture	0 of 42 (0%)	0 of 42 (0%)	Not reported
Pain - No Treatment	0 of 38 (0%)	0 of 38 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Lucy Chen, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Pain, run by Massachusetts General Hospital 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 2 May 2022. 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?

Yes. Results are posted in the registry (first posted 2 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants (time frame: Start of Week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01094782.

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 2 May 2022.