PainNCT01678586

Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

A study testing Acupuncture and Gabapentin 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.

Official record

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Trial summary

In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized clinical trial to compare the clinical effectiveness of radicular pain relief by either acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative Sensory Testing (QST). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain
What is being tested?: Acupuncture and Gabapentin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited States
Study dates: Dec 2012to 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject will be between ages 18 to 75 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.

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 pregnant.
Subject tests positive for illicit drugs.
Subject has a pacemaker.
Subject is currently taking gabapentin.

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

Conditions: Pain
Being tested: Acupuncture, Sham Acupuncture, Gabapentin, Sham Gabapentin
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
In true acupuncture the needles penetrate the skin.
Sham AcupunctureOther
In sham acupuncture the needles do not penetrate the skin.
GabapentinDrug
Also called Neurontin
Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
Sham GabapentinDrug
Also called Benadryl, diphenhydramine
Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)

Study groups in NCT01678586
Study group	Role	What they receive
True Acupuncture	Active comparator	Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. Receives: Other: Acupuncture
Sham Acupuncture	Sham comparator	Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments. Receives: Other: Sham Acupuncture
Gabapentin	Active comparator	Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Receives: Drug: Gabapentin
Sham Gabapentin	Sham comparator	Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Receives: Drug: Sham Gabapentin

What is being measured

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

Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.
Measured: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.
Measured: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.

Timeline

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

Dec 2012Dec 2021

First posted5 Sep 2012 (estimated)
Study startDec 2012
Primary completionDec 2021
Study completionDec 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.
Publications (1)Papers the sponsor has linked to this study.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01678586
Sponsor's protocol ID: 2012P-001795
Other IDs: 5R01AT005819-04
Status last verified: Apr 2024
First submitted: 31 Aug 2012
Last updated: 23 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chen L, Deng H, Houle T, Zhang Y, Ahmed S, Zhang W, Sullivan S, Opalacz A, Roth S, Filatava EJ, Stabach K, Vo T, Malarick C, Kim H, You Z, Shen S, Mao J. Comparison between acupuncture therapy and gabapentin for chronic pain: a pilot study. Acupunct Med. 2021 Dec;39(6):619-628. doi: 10.1177/09645284211026683. Epub 2021 Jul 29.
PubMed 34325532

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
ClinicalTrials.gov ID: NCT01678586
Acronym / sponsor ID: 2012P-001795
Conditions: Pain
Keywords: Pain, Pain management
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Dec 2012 (actual)
Primary completion: Dec 2021 (actual)
Study completion: Dec 2021 (actual)
First posted: 5 Sep 2012 (estimated)
Results: Posted 23 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
True Acupuncture	Active comparator	Other: AcupuncturePain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Sham Acupuncture	Sham comparator	Other: Sham AcupuncturePain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Gabapentin	Active comparator	Drug: GabapentinPain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin	Sham comparator	Drug: Sham GabapentinPain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject will be between ages 18 to 75 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.

Key exclusion criteria (6 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 pregnant.
Subject tests positive for illicit drugs.
Subject has a pacemaker.

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
AcupunctureIn true acupuncture the needles penetrate the skin.	Other	True Acupuncture
Sham AcupunctureIn sham acupuncture the needles do not penetrate the skin.	Other	Sham Acupuncture
GabapentinAlso: NeurontinGabapentin is a commonly prescribed drug used to treat neuropathic pain.	Drug	Gabapentin
Sham GabapentinAlso: Benadryl, diphenhydramineBenadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)	Drug	Sham Gabapentin

Primary outcome

Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)
Time frame: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.
Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)
Time frame: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.
Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant.

Results and safety

Results posted to the registry on 23 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
True Acupuncture	15	14
Sham Acupuncture	16	15
Gabapentin	11	9
Sham Gabapentin	14	12

Primary outcome: Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain)

Time frame: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.. Mean (Standard Deviation). Unit: degree celsius

Measure	True Acupuncture n = 14	Sham Acupuncture n = 15	Gabapentin n = 9	Sham Gabapentin n = 12
Visit 1 Cold Sensation	26.41 (5.01)	26.54 (2.44)	27.92 (2.22)	24.25 (4.27)
Visit 1 Warm Sensation	38.43 (4.03)	39.57 (4.63)	38.49 (4.89)	39.90 (4.61)
Visit 1 Heat Pain	45.77 (5.08)	47.05 (3.55)	46.31 (4.04)	46.34 (4.33)
Visit 1 Cold pain	11.11 (11.77)	8.20 (8.76)	9.65 (10.87)	9.87 (10.53)
Visit 4 Cold Sensation	26.04 (3.99)	25.11 (6.73)	28.38 (5.78)	26.35 (3.90)
Visit 4 Warm Sensation	37.56 (3.91)	39.15 (3.65)	37.11 (3.45)	37.50 (3.40)
Visit 4 Heat Pain	46.15 (3.46)	47.51 (2.41)	45.92 (4.07)	45.34 (4.70)
Visit 4 Cold Pain	11.01 (10.22)	9.55 (9.66)	9.09 (9.89)	14.13 (10.79)

Population analysed: Enrolled participants who didn't withdraw, were not withdrawn by the investigator.

Primary outcome: Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation)

Measure	True Acupuncture n = 14	Sham Acupuncture n = 15	Gabapentin n = 9	Sham Gabapentin n = 12
visit 1 heat pain threshold	48.95 (2.86)	49.93 (2.39)	49.59 (2.49)	48.95 (4.02)
visit 1 cold pain threshold	5.16 (6.78)	4.7 (6.82)	3.89 (8.58)	6.8 (9.68)
Visit 1 tolerance to 47 celsius heat simulation	27.86 (25.39)	27.56 (24.15)	29.59 (28.43)	23.63 (24.40)
visit 4 heat pain threshold	49.53 (1.96)	50.39 (1.46)	48.71 (2.91)	48.55 (3.79)
visit 4 cold pain threshold	3.72 (6.95)	2.1 (4.43)	7.09 (8.53)	7.05 (9.45)
Visit 4 tolerance to 47 celsius heat simulation	28.36 (26.67)	29.1 (24.85)	23.69 (26.44)	25.23 (26.49)
visit 7 heat pain threshold	49.57 (2.39)	50.34 (1.56)	49.8 (2.01)	48.40 (3.74)
visit 7 cold pain threshold	2.7 (4.36)	2.38 (6.42)	8.18 (9.38)	5.7 (9.39)

Population analysed: Enrolled participants who didn't withdraw, were not withdrawn by the investigator.

Adverse events

Time frame: The PI will monitor study outcomes. A monthly study staff meeting will be held to review the study progress and discuss any adverse event during study conduction. Adverse event were monitored through study completion, an average of 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
True Acupuncture	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Sham Acupuncture	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16
Gabapentin	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Sham Gabapentin	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): A major limitation is the limited number of study participants in each group. In addition, the use of a sham needle in this pilot study may not have fully differentiated sham versus true electroacupuncture. While the use of diphenhydramine as a placebo control for gabapentin may have mimicked certain side effects of gabapentin, it may have had other confounding effects on the data interpretation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34325532Chen L, Deng H, Houle T, Zhang Y, Ahmed S, Zhang W, Sullivan S, Opalacz A, Roth S, Filatava EJ, Stabach K, Vo T, Malarick C, Kim H, You Z, Shen S, Mao J. Comparison between acupuncture therapy and gabapentin for chronic pain: a pilot study. Acupunct Med. 2021 Dec;39(6):619-628. doi: 10.1177/09645284211026683. Epub 2021 Jul 29.
Center for Translational Pain ResearchLink provided by the sponsor.

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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.

Jianren Mao, M.D., Ph.D. 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 and Gabapentin 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 4 inclusion and 6 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 23 Apr 2024. 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 23 Apr 2024). 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?

Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain) (time frame: 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups.). 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?

On the ClinicalTrials.gov record for NCT01678586, which also lists 1 linked publication.

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 23 Apr 2024.