Clinical trial NCT04947800: Acupuncture to Enhance for Pulmonary Rehab
Official title: Exploring the Dose-Response Effect of Adjunctive Acupuncture on Pulmonary Rehabilitation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: American Academy of Medical Acupuncture
First posted: 2021-07-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator is investigating if acupuncture may improve pulmonary function, exercise tolerance, stress and modulate the inflammatory effects of chronic obstructive pulmonary disease (COPD). The investigator would like to measure the effect of the combination of acupuncture with standard pulmonary rehab in patients with COPD.

Detailed description: Participation in this study may last 3 months. The experimental intervention is electro-acupuncture. Electro-acupuncture is similar to Transcutaneous Electrical Nerve Stimulation (TENS) where a very small current of electricity is applied, in this case to specific acupuncture points. The intervention will be applied by a trained physician-acupuncturist. The treatment itself would be applied for 20 minutes prior to regularly scheduled pulmonary rehab session. All participants will receive electro-acupuncture for the duration of the study. Because the investigators are interested in the effect of dose, participants will be randomized to 4, 8 or 12 weeks of "active pulmonary" acupuncture versus "control" acupuncture. One third of the participants will be asked to undergo the intervention for 4 weeks, one third will be asked to undergo the intervention for 8 weeks and one third will be asked to undergo the intervention for 12 weeks. Intervention acupuncture needles will be placed on what are thought to be active points for helping lung function, control acupuncture needles will be placed in neutral locations. Participants will not be told which weeks they are receiving the active acupuncture versus the control. Information relating to pulmonary and physical function, standard blood markers of inflammation, and survey responses at the beginning, during and after the intervention will be collected. During the experimental period participants will be asked to fill out surveys on quality of life, pulmonary function and physical function.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older
* Qualify to participate in the pulmonary rehab program at DHMC

Exclusion Criteria:

* Severe cognitive impairment
* Active pulmonary exacerbation
* Unstable cardiopulmonary disease

Primary outcomes:
measure: Change in Forced expiratory volume in one second (FEV1)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in Forced vital capacity (FVC)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in number of eosinophils
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in number of neutrophil
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in number of C reactive protein
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Quality of life relating to Dyspnea as measured by Borg scales
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in health related quality of life as measured by the St. George's Respiratory Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in health related quality of life as measure by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in 6-minute walk distance
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Incidence of Acute Exacerbations (AE)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James E Stahl, MD, CM, MPH
role: PRINCIPAL_INVESTIGATOR
References: