Recruiting
Phase 2
Phase 3

Manual Therapy

Sponsor:

Canandaigua VA Medical Center

Code:

NCT04386590

Conditions

Chronic Obstructive Pulmonary Disease Moderate

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Interventions

Manual Therapy Plus Pulmonary Rehabilitation

Sham Intervention

Study Details

Brief summary:

The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.

Conditions

Chronic Obstructive Pulmonary Disease Moderate

Study ID

NCT04386590

Start date

Jun 15, 2022

Status verified date

Mar, 2022

Completion date

Nov 2, 2023

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Sex: Male and Female
  • Age range: 50-70 years
  • Disease status: Moderate COPD (FEV1% predicted: moderate 50-80% (GOLD 2018))
  • Concomitant disease status: Stable COPD (no exacerbations in preceding 6 months) Non-smoking (for preceding 6 months)
  • Willingness to give written informed consent.
  • Willingness to participate in and comply with the study requirements.

Exclusion Criteria:

  • Inability to complete 6-minute walking test unassisted
  • Contra-indicated to thoracic spinal manipulation

  • Thoracic joint instability
  • Acute pain on thoracic joint range of motion testing
  • High level of anxiety related to receiving thoracic spinal manipulation
  • Inability to understand English
  • People with a cognitive impairment, an intellectual disability or a mental illness
  • Completed a pulmonary rehabilitation program in the previous 12 months

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: 'Sham' manual therapy plus Pulmonary Rehabilitation (PR)

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

experimental: Manual therapy plus Pulmonary Rehabilitation (CMT+

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.

Interventions

Manual Therapy Plus Pulmonary Rehabilitation

Manual therapy combined with Pulmonary Rehabilitation

Sham Intervention

Detuned US plus Pulmonary Rehabilitation

Primary outcome measure

  • Spirometry [ Time Frame: Change from Baseline to Post Intervention (4 weeks post baseline) ]

Central Contacts and Locations

Central contacts

Paul E Dougherty, DC

315-945-7381paul.dougherty@va.gov

Emily McCormick, BS

315-425-4400emily.mccormick@va.gov

Locations

Syracuse VA Medical Center

Recruiting

Syracuse, New York, United States, 13210

Contacts

Emily McCormick, BA

315-425-4400emily.mccormick@va.gov

Lori Gould, BA

315-425-4400lori.gould@va.gov

More Information

Sponsor

Canandaigua VA Medical Center

Last update posted

Mar 31, 2022

Last verified

Mar, 2022

Keywords

  • manual therapy
  • respiratory therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canandaigua VA Medical Center on 2022-03-31.