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Manual Therapy in Addition to Pulmonary Rehabilitation in Moderate Chronic Obstructive Pulmonary Disease.
Phase 2 & 3
Waitlist Available
Led By Paul E Dougherty, DC
Research Sponsored by Canandaigua VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post intervention (4 weeks post baseline)
Summary
This trial will test if a combination of two different treatments can help improve COPD symptoms for Veterans.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to post intervention (4 weeks post baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post intervention (4 weeks post baseline)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Spirometry
Secondary study objectives
6 Minute Walking Test (6MWT)
Hospital Anxiety and Depression scale: HAD
St Georges Respiratory Questionnaire: SGRQ
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Manual therapy plus Pulmonary Rehabilitation (CMT+Experimental Treatment1 Intervention
Manual therapy is made up of gentle Effleurage and cross-fibre friction massage applied to the muscles of the posterior chest wall. Manual Therapy consists of two separate manipulations (Grade V mobilization). Each manipulation involves the delivery of a high-velocity low amplitude (HVLA) posterior to anterior force directed at the inter-vertebral, costo-vertebral and costo-transverse joints. The first manipulation is delivered at the level of the upper/middle thoracic spine while the second is at the level of the middle/lower thoracic spine. In addition to the MT, the participant will also undergo Pulmonary Rehab as previously described.
Group II: 'Sham' manual therapy plus Pulmonary Rehabilitation (PR)Placebo Group1 Intervention
Treadmill walking, upper body exercise machine, light weight training and bicycle. These exercises are supervised. In addition to the standard exercise therapy, all participants will undergo a 20-minute session consisting of discussion with the patient and 11 minutes of detuned ultrasound, which has been used in previous studies to account for time and attention for the patient. The detuned ultrasound procedure is to apply the ultrasound gel and turn the machine on, but set the intensity at zero (0) W/cm2
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Who is running the clinical trial?
Canandaigua VA Medical CenterLead Sponsor
12 Previous Clinical Trials
1,826 Total Patients Enrolled
Paul E Dougherty, DCPrincipal InvestigatorVA Finger Lakes Healthcare System
2 Previous Clinical Trials
66 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are very anxious about getting your back manipulated in the chest area.You experience sharp pain when moving your upper back and chest.You are unable to walk for 6 minutes without any help or assistance.You cannot receive spinal manipulation in the thoracic area due to specific reasons.You have instability in the joints of your chest area.You have a condition that affects your thinking, learning, or mental health.You have finished a program to help improve your lung function in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: 'Sham' manual therapy plus Pulmonary Rehabilitation (PR)
- Group 2: Manual therapy plus Pulmonary Rehabilitation (CMT+
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.