Trial Outcomes & Findings for Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia (NCT NCT00142597)

Results Overview

Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

46 participants

Primary outcome timeframe

measured from baseline to week 5

Results posted on

2015-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Traditional Acupuncture Acupuncture sites will be used for active intervention. Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.	Sham Treatment Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.
Overall Study STARTED	23	23
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traditional Acupuncture n=23 Participants Acupuncture sites will be used for active intervention. Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.	Sham Treatment n=23 Participants Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.	Total n=46 Participants Total of all reporting groups
Age, Continuous	48.52 years STANDARD_DEVIATION 12.85 • n=5 Participants	44.87 years STANDARD_DEVIATION 15.03 • n=7 Participants	46.70 years STANDARD_DEVIATION 13.95 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: measured from baseline to week 5

Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.

Outcome measures

Outcome measures
Measure	Traditional Acupuncture n=10 Participants Acupuncture sites will be used for active intervention. Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.	Sham Treatment n=10 Participants Sham acupuncture is used. Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.
Change in Mu-opioid Receptor Occupancy	0.2352 Unitless: binding potential is Bmax/Kd Standard Deviation 0.1911	.0015 Unitless: binding potential is Bmax/Kd Standard Deviation .1197

Adverse Events

Traditional Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Treatment

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

Richard E. Harris

University of Michigan

Phone: 734-998-6996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place