Acupuncture to Enhance for Pulmonary Rehab

COPD Clinical Trial

Official title:

Exploring the Dose-Response Effect of Adjunctive Acupuncture on Pulmonary Rehabilitation: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947800
• Other study ID #: STUDY02000887
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: James E Stahl, MD, CM, MPH
• Phone: 603 650-8529
• Email: james.e.stahl[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points
• Pulmonary rehabilitation program + Lv7/Gb26
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	American Academy of Medical Acupuncture

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Forced expiratory volume in one second (FEV1)	Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in Forced vital capacity (FVC)	Change in Forced vital capacity (FVC) as measures by spirometry test	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in number of eosinophils	Change in number of eosinophils as measured in blood samples	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in number of neutrophil	Change in number of neutrophil as measured in blood samples	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in number of C reactive protein	Change in number of C reactive protein as measured in blood samples	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Quality of life relating to Dyspnea as measured by Borg scales	The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in health related quality of life as measured by the St. George's Respiratory Questionnaire	The St. George's Respiratory Questionnaire scores range from 0 to 100, with higher scores indicating more limitations. The 50-item questionnaire was developed to measure health status (quality of life) in patients with diseases of airways obstruction.	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in health related quality of life as measure by the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire-9 scale questionnaire measures the level of depression. Score range is 0 to 27 points. Higher scores mean more severe depression.	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Change in 6-minute walk distance	Change in maximum distance walked in 6 minutes	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Primary	Incidence of Acute Exacerbations (AE)	Throughout the course of the study acute exacerbations will be recorded and tallied.	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks