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| Name | Class |
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| Hill-Rom | INDUSTRY |
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Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.
Patients with cystic fibrosis (CF) perform daily airway clearance therapy to facilitate removal of secretions from their airways. Many different techniques are available to achieve this and there is currently no consensus as to which form of therapy is most effective. High frequency chest wall oscillation (HFCWO) is used by CF patients throughout the United States and abroad. To perform this therapy, the patient wears a vest which fits over the entire torso and is connected to an air compressor. The compressor generates oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The most commonly used device is The Vest™ Airway Clearance System, (Hill-Rom Inc, St Paul, MN). Adjustment of the inflation pressure and frequency of oscillations affects the volume of displaced air and flow of air measured at the mouth of the patient. Previous studies indicate this form of therapy is as effective as more traditional and cumbersome forms of therapy. However, it is unclear which inflation pressures and oscillator frequencies provide optimal airway clearance. Some studies of sine waveform HFCWO reported the largest volume of air displacement and highest air flow measured at the mouth when using a combination of high inflation pressures with either low (7 - 10 Hz) or high frequencies (18 - 20 Hz), but most CF centers in the United States use HFCWO with lower pressures combined with mid-range frequencies (10 - 14 Hz). Furthermore, there are no previous studies assessing the affect of sine waveform HFCWO settings on sputum production. As a result, there is no consensus on which pressure and frequency settings are most efficacious for CF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFCWC with higher pressure/variable frequency settings | Active Comparator | Half patients randomly assigned to perform HFCWC therapy first with a higher pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period |
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| HFCWC with lower pressure/mid-frequency settings | Active Comparator | lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFCWC with higher pressure/variable-frequency settings | Device | Randomized crossover trial of airway clearance therapy comparing sine wave HFCWO with high pressures and variable frequency (pressure 10, frequencies 8,9,10 and pressure 6, frequencies 18,19,20) to low pressure and mid frequency (pressure 5, frequency 12). Subjects will have 2-day washout between airway clearance sessions. All sputum collected during sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Wet and Dry Weight | All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum "wet weight" was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum "dry weight" was calculated after re-weighing the container. | Produced during each airway clearance therapy session on days 1 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pre vs. Post Therapy Spirometry | Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards. | Prior to and following each airway clearance therapy session on days 1 and 4 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R Kempainen, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20507651 | Result | Kempainen RR, Milla C, Dunitz J, Savik K, Hazelwood A, Williams C, Rubin BK, Billings JL. Comparison of settings used for high-frequency chest-wall compression in cystic fibrosis. Respir Care. 2010 Jun;55(6):695-701. |
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Potentially eligible patients were identified by query of the Minnesota CF database based on age and FEV1. This list was then reviewed and patients who met additional eligibility requirements were contacted by phone or recruited during a clinic visit by one of the study investigators. Enrollment was completed between 6/1/08 and 10/31/08.
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| ID | Title | Description |
|---|---|---|
| FG000 | Higher Pressure/Variable-freq, Then Lower Pressure/Mid-freq | HFCWC therapy first with a higher pressure/variable frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol (2nd Intervention). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: First Intervention: 30 Minutes |
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| HFCWC with lower pressure/mid-frequency settings | Device | Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects will complete a questionnaire addressing the comfort of therapy upon completion of the session. |
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| Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. | Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4 |
| Patients' Perceived Comfort Using the Different Settings for the Vest Device | Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled "Post-Therapy Questionnaire". Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable). Scale range for how "effective" the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective). | Immediately following each airway clearance therapy on day 1 and day 4 |
| Lower Pressure/Mid-freq, Then Higher Pressure/Variable-freq |
HFCWC therapy first with a lower pressure/mid-frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the higher-pressure/variable frequency HFCWC protocol (2nd Intervention). |
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| Period 2: 2-day Washout |
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| Period 3: 2nd Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Half patients randomly assigned to HFCWC therapy first with a higher-pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period VEST Airway Clearance System, Model 205 : Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Sputum Wet and Dry Weight | All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum "wet weight" was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum "dry weight" was calculated after re-weighing the container. | In a previous study with similar design,21 the standard deviation for the difference in the mean sputum wet weight between treatment arms was 4.6 g. Assuming the same standard deviation for the current study, enrollment of 16 subjects provided an 80% chance of detecting a 3.5-g difference in the sputum wet weights at a significance level of .05. | Posted | Median | Full Range | grams | Produced during each airway clearance therapy session on days 1 and 4 |
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| Secondary | Pre vs. Post Therapy Spirometry | Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards. | Power calculation not performed for secondary outcomes. | Posted | Mean | Standard Deviation | ml | Prior to and following each airway clearance therapy session on days 1 and 4 |
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| Secondary | Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. | power calculation not performed for secondary outcomes | Posted | Median | Full Range | dynes/cm^2 | Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4 |
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| Secondary | Patients' Perceived Comfort Using the Different Settings for the Vest Device | Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled "Post-Therapy Questionnaire". Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable). Scale range for how "effective" the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective). | power calculation not performed for secondary outcomes | Posted | Median | Full Range | units on a scale | Immediately following each airway clearance therapy on day 1 and day 4 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lower Pressure/Mid-frequency | 0 | 17 | 0 | 17 | |||
| EG001 | Higher Pressure/Variable Frequency | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Kempainen | University of Minnesota School of Medicine | 612-873-6413 | kempa001@umn.edu |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D035641 | Chest Wall Oscillation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum "dry weight" was calculated after re-weighing the container. |
Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards. |
| OG003 | Change in FVC Pre vs Post Lower Pressure/Mid-frequency | Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards. |
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| OG001 | G' Storage Modulus at 1 Rad/Sec Lower Pressure/Mid-frequency | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
| OG002 | G' Storage Modulus 100 Rad/Sec Higher Pressure/Variable Freq | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
| OG003 | G' Storage Modulus 100 Rad/Sec Lower Pressure/Mid-frequency | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
| OG004 | G" Loss Modulus 1 Rad/Sec Higher Pressure/Variable Frequency | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
| OG005 | G" Loss Modulus 1 Rad/Sec Lower Pressure/Mid-frequency | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
| OG006 | G" Loss Modulus 100 Rad/Sec Higher Pressure/Variable Frequency | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
| OG007 | G" Loss Modulus 100 Rad/Sec Lower Pressure/Mid-frequency | Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G") were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G" is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids. |
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| OG002 | Perceived Effectiveness Higher Pressure/Variable Frequency | Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled "Post-Therapy Questionnaire". Scale range for how "effective" the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective). |
| OG003 | Perceived Effectiveness Lower Pressure/Mid-frequency | Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled "Post-Therapy Questionnaire". Scale range for how "effective" the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective). |
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