Trial Outcomes & Findings for An Acupuncture Functional Magnetic Resonance Imaging (fMRI) Study on Chronic Pain: Response Reliability and Dose Effect (NCT NCT01079390)

Results Overview

The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

One post-treatment measurement 5-7 weeks after baseline

Results posted on

2017-08-10

Participant Flow

Forty-four acupuncture naïve patients aged 43-70 with a diagnosis of chronic osteoarthritis in the right and/or left knee participated in the study. 30 (13 females) completed all study procedures. Fourteen subjects did not complete the study. All subjects were recruited form the Boston area over the course of the past 3 years.

Fourteen subjects did not complete the study due to problems with scheduling (6), ineligibility at screening (3), disinterest (2), claustrophobia (1), or inability to adhere to study requirements in scanner (2). Of the 14 subjects who dropped, four dropped out after randomization.

Participant milestones

Participant milestones
Measure	High Dose Acupuncture six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Low Dose Acupuncture two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Placebo Acupuncture sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.
Overall Study STARTED	15	15	14
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	5	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Acupuncture Functional Magnetic Resonance Imaging (fMRI) Study on Chronic Pain: Response Reliability and Dose Effect

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose Acupuncture n=15 Participants six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Low Dose Acupuncture n=15 Participants two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Placebo Acupuncture n=14 Participants sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	44 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	60 years STANDARD_DEVIATION 9 • n=5 Participants	58 years STANDARD_DEVIATION 8 • n=7 Participants	54 years STANDARD_DEVIATION 7 • n=5 Participants	58 years STANDARD_DEVIATION 8 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	14 participants n=5 Participants	44 participants n=4 Participants

PRIMARY outcome

Timeframe: One post-treatment measurement 5-7 weeks after baseline

The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.

Outcome measures

Outcome measures
Measure	High Dose Acupuncture n=10 Participants six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Low Dose Acupuncture n=10 Participants two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Placebo Acupuncture n=10 Participants sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.
Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment	59 units on KOOS scale Standard Deviation 13	53 units on KOOS scale Standard Deviation 9	56 units on KOOS scale Standard Deviation 19

PRIMARY outcome

Timeframe: 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline

Population: We combined low and high dose acupuncture into one group because we found there were not clinical differences between the two group.

All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software.

Outcome measures

Outcome measures
Measure	High Dose Acupuncture n=20 Participants six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Low Dose Acupuncture n=10 Participants two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.	Placebo Acupuncture sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.
Cortical Thickness Changes at 5-7 Weeks Post-Treatment	2.9 millimeters Standard Deviation 0.15	3.13 millimeters Standard Deviation 0.28	—

Adverse Events

High Dose Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jian Kong

Mass General Hospital

Phone: 617-726-7893

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place