Pain
Conditions
Keywords
Pain, Pain management
Brief 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.
Interventions
OTHERAcupuncture
Subjects receive 6 acupuncture treatments for neck or back pain.
OTHERSham Acupuncture
Subjects receive 6 sham acupuncture treatments for neck or back pain.
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited. 2. 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. 3. Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain). 4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome. 5. For controls, healthy subjects without radicular pain for at least three months will be recruited. \*We are no longer accepting healthy volunteers.\*
Exclusion criteria
1. 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. 2. Subject has scar tissue, infection, or acute injury at the site of QST. 3. Subject is on anticoagulation therapy. 4. Subject is pregnant. 5. Subject is tested positive on illicit drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
254 participants were enrolled in the study and were randomly assigned to one of the 6 study arms at Visit 1. 6 participants were later found to be ineligible to continue to participate (e.g. drug screen, medical history, no longer interested) further in Visit 1 and they did not recieve study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Healthy - True Acupuncture 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). | 39 |
| Healthy - Sham Acupuncture 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). | 39 |
| Healthy - No Treatment Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | 34 |
| Pain - True Acupuncture 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). | 56 |
| Pain - Sham Acupuncture 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). | 42 |
| Pain - No Treatment Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | 38 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Healthy Subject Had Pain | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Hypertension | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 2 | 1 | 4 |
| Overall Study | Low Visual Analog Scale (VAS) Score | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Noncompliance With Study Schedule | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Positive Drug Screen | 2 | 2 | 1 | 1 | 3 | 2 |
| Overall Study | Recent Interventional Injection | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Sensory Deficit at Site of QST | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Unable to Complete Questionnaires | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 1 | 5 | 5 | 0 |
| Overall Study | Wrong Pain Condition | 0 | 0 | 0 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Healthy - True Acupuncture | Healthy - Sham Acupuncture | Healthy - No Treatment | Pain - True Acupuncture | Pain - Sham Acupuncture | Pain - No Treatment | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants | 34 Participants | 55 Participants | 42 Participants | 38 Participants | 247 Participants |
| Region of Enrollment United States | 39 participants | 39 participants | 34 participants | 56 participants | 42 participants | 38 participants | 248 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 14 Participants | 23 Participants | 31 Participants | 24 Participants | 133 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 20 Participants | 33 Participants | 11 Participants | 14 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 39 | 0 / 39 | 0 / 34 | 0 / 56 | 0 / 42 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 34 | 0 / 56 | 0 / 42 | 0 / 38 |
Outcome results
Primary
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.
Time frame: Start of Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - True Acupuncture | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | 1.2 Degrees Celcius | Standard Deviation 3 |
| Healthy - Sham Acupuncture | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | 0.5 Degrees Celcius | Standard Deviation 1 |
| Healthy - No Treatment | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2.1 Degrees Celcius | Standard Deviation 5 |
| Pain - True Acupuncture | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2.5 Degrees Celcius | Standard Deviation 5.5 |
| Pain - Sham Acupuncture | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2.8 Degrees Celcius | Standard Deviation 6.1 |
| Pain - No Treatment | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | 1.1 Degrees Celcius | Standard Deviation 3.5 |
Primary
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.
Time frame: End of Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - True Acupuncture | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | 1.7 Degrees Celcius | Standard Deviation 4.1 |
| Healthy - Sham Acupuncture | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | 0.3 Degrees Celcius | Standard Deviation 1.3 |
| Healthy - No Treatment | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | 1.9 Degrees Celcius | Standard Deviation 3.9 |
| Pain - True Acupuncture | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2.2 Degrees Celcius | Standard Deviation 5.6 |
| Pain - Sham Acupuncture | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2.8 Degrees Celcius | Standard Deviation 5.8 |
| Pain - No Treatment | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2.4 Degrees Celcius | Standard Deviation 6.1 |
Primary
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.
Time frame: End of Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - True Acupuncture | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | 1.8 Degrees Celcius | Standard Deviation 4.2 |
| Healthy - Sham Acupuncture | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | 0.1 Degrees Celcius | Standard Deviation 0.3 |
| Healthy - No Treatment | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | 2 Degrees Celcius | Standard Deviation 4.5 |
| Pain - True Acupuncture | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | 3.7 Degrees Celcius | Standard Deviation 7.4 |
| Pain - Sham Acupuncture | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | 3.3 Degrees Celcius | Standard Deviation 7.1 |
| Pain - No Treatment | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | 1.9 Degrees Celcius | Standard Deviation 5.7 |
Primary
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.
Time frame: Start of Week 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - True Acupuncture | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.9 Degrees Celcius | Standard Deviation 1.7 |
| Healthy - Sham Acupuncture | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.5 Degrees Celcius | Standard Deviation 1.3 |
| Healthy - No Treatment | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.9 Degrees Celcius | Standard Deviation 1.7 |
| Pain - True Acupuncture | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.5 Degrees Celcius | Standard Deviation 2.4 |
| Pain - Sham Acupuncture | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.7 Degrees Celcius | Standard Deviation 2.2 |
| Pain - No Treatment | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.1 Degrees Celcius | Standard Deviation 2 |
Primary
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.
Time frame: End of Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - True Acupuncture | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.8 Degrees Celcius | Standard Deviation 1.6 |
| Healthy - Sham Acupuncture | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.3 Degrees Celcius | Standard Deviation 1.6 |
| Healthy - No Treatment | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.2 Degrees Celcius | Standard Deviation 1.6 |
| Pain - True Acupuncture | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.6 Degrees Celcius | Standard Deviation 2.8 |
| Pain - Sham Acupuncture | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.3 Degrees Celcius | Standard Deviation 2.1 |
| Pain - No Treatment | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.0 Degrees Celcius | Standard Deviation 2.1 |
Primary
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.
Time frame: End of Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - True Acupuncture | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.9 Degrees Celcius | Standard Deviation 1.6 |
| Healthy - Sham Acupuncture | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.3 Degrees Celcius | Standard Deviation 1.7 |
| Healthy - No Treatment | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.1 Degrees Celcius | Standard Deviation 1.3 |
| Pain - True Acupuncture | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | 50.1 Degrees Celcius | Standard Deviation 1.9 |
| Pain - Sham Acupuncture | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.8 Degrees Celcius | Standard Deviation 2.9 |
| Pain - No Treatment | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | 49.2 Degrees Celcius | Standard Deviation 3.5 |