Trial Outcomes & Findings for A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment (NCT NCT03332160)
NCT ID: NCT03332160
Last Updated: 2020-08-06
Results Overview
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
From baseline to end of treatment at 8 weeks
Results posted on
2020-08-06
Participant Flow
Participant milestones
| Measure |
Wait-list Control Group
Standard home lymphedema care: May include daily self manual lymphatic drainage (MLD), exercise, skincare, compression garments (as appropriate)
|
Interventional Group
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Wait-list Control Group
Standard home lymphedema care: May include daily self manual lymphatic drainage (MLD), exercise, skincare, compression garments (as appropriate)
|
Interventional Group
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Developed Exclusion Criteria
|
0
|
1
|
|
Overall Study
Non-adherence to treatment
|
0
|
2
|
Baseline Characteristics
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
Baseline characteristics by cohort
| Measure |
Wait-list Control Group
n=24 Participants
Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate)
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
n=5 Participants
|
61.1 years
n=7 Participants
|
62.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Education
<=High School
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Education
College
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Education
Advance Degree
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital Status
Married/Living with Partner
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Marital Status
Other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Residence
City
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Residence
Country
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Residence
Suburb
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Body Mass Index (BMI) at Enrollment
Underweight
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI) at Enrollment
Normal/Health Weight
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Body Mass Index (BMI) at Enrollment
Overweight
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Body Mass Index (BMI) at Enrollment
Obese
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Smoking history/current
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Alcohol history/current
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Tracheotomy at Enrollment
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Percutaneous Endoscopic Gastrostomy (PEG) at Enrollment
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Months since Lymphedema Diagnosis
|
5.3 months
n=5 Participants
|
5.2 months
n=7 Participants
|
5.2 months
n=5 Participants
|
|
Months since Initial Lymphedema Treatment
|
4.6 months
n=5 Participants
|
4.5 months
n=7 Participants
|
4.6 months
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatment at 8 weeksPopulation: This analysis only applies to the Interventional Group.
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.
Outcome measures
| Measure |
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 0 days
|
5 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 1 day
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 2 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 3 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 4 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 5 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 6 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 1 · 7 days
|
5 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 0 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 1 day
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 2 days
|
0 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 3 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 4 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 5 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 6 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 2 · 7 days
|
5 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 0 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 1 day
|
0 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 2 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 3 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 4 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 5 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 6 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 3 · 7 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 0 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 1 day
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 2 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 3 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 4 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 5 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 6 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 4 · 7 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 0 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 1 day
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 2 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 3 days
|
0 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 4 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 5 days
|
5 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 6 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 5 · 7 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 0 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 1 day
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 2 days
|
0 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 3 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 4 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 5 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 6 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 6 · 7 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 0 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 1 day
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 2 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 3 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 4 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 5 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 6 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 7 · 7 days
|
5 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 0 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 1 day
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 2 days
|
3 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 3 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 4 days
|
4 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 5 days
|
1 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 6 days
|
2 Participants
|
—
|
|
Fidelity/Adherence Via Subject Diary
Week 8 · 7 days
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksEvaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Adverse Events
Vascular disorders
|
3 Events
|
1 Events
|
|
Adverse Events
Cardiac disorders
|
3 Events
|
0 Events
|
|
Adverse Events
Ear and labyrinth disorders
|
1 Events
|
1 Events
|
|
Adverse Events
Endocrine disorders
|
2 Events
|
2 Events
|
|
Adverse Events
Eye disorders
|
1 Events
|
0 Events
|
|
Adverse Events
Gastrointestinal disorders
|
3 Events
|
3 Events
|
|
Adverse Events
General disorders
|
7 Events
|
2 Events
|
|
Adverse Events
Immune system disorders
|
1 Events
|
0 Events
|
|
Adverse Events
Infections and infestations
|
7 Events
|
1 Events
|
|
Adverse Events
Musculoskeletal and connective tissue disorders
|
0 Events
|
2 Events
|
|
Adverse Events
Neoplasms benign, malignant and unspecified
|
1 Events
|
0 Events
|
|
Adverse Events
Nervous system disorders
|
6 Events
|
7 Events
|
|
Adverse Events
Psychiatric disorders
|
2 Events
|
0 Events
|
|
Adverse Events
Skin and subcutaneous tissue disorders
|
5 Events
|
1 Events
|
|
Adverse Events
Surgical and medical procedures
|
1 Events
|
3 Events
|
|
Adverse Events
Respiratory, thoracic and mediastinal disorders
|
10 Events
|
5 Events
|
PRIMARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksPopulation: This only applied to participants in the interventional group who had indicated good, very good, or excellent in regards to their perceived ability to control their head and neck lymphedema.
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring treatment satisfaction using a satisfaction survey. A survey assessed participants' perceived ability to control their head and neck lymphedema before (at baseline) and after the usage of the Flexitouch at 8 weeks. Values represent a count of participants who indicated good, very good, or excellent.
Outcome measures
| Measure |
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Treatment Satisfaction
Baseline (Good, Very Good, or Excellent)
|
5 Participants
|
—
|
|
Treatment Satisfaction
8 Weeks (Good, Very Good, or Excellent)
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe change in percent of sites with visible swelling and inflammation as assessed via endoscopy (using Modified Patterson Scale) from baseline to week 8. The range for each anatomical structure includes 1-4: Normal, Mild, Moderate, and Severe. A lower score means a better outcome. A greater negative value indicates a greater reduction in swelling. Total score range: 0-100%.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Reduction in Swelling/Inflammation - Endoscopy
|
-2.7778 Change in score
Interval -16.6667 to 5.5556
|
-11.1111 Change in score
Interval -31.3725 to 8.0882
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksPopulation: Not all participants' blood samples were analyzable.
The presence of swelling and inflammation was assessed in all participants via the change in cytokine levels of Interleukin 6 (IL-6) at baseline to week 8. A lower score means a better outcome. A greater negative value indicates a greater reduction in cytokine levels.
Outcome measures
| Measure |
Interventional Group
n=20 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=18 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Reduction in Swelling/Inflammation - Cytokine Levels
|
-836.47 fg/ml
Interval -8411.52 to 1142.85
|
-275.68 fg/ml
Interval -3772.13 to 4367.3
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe presence of swelling and inflammation was assessed in all participants by digital photography at baseline and 8 weeks. A lower value means a better outcome. A greater negative value indicates a greater reduction in swelling. Three views were scored each with 30 grids. The percentage of views with visible swelling was determined. The score ranged from 0-100%.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Reduction in Swelling/Inflammation - Digital Photography
Front View Change
|
4.924 score on a scale
Interval -11.601 to 12.064
|
-24.308 score on a scale
Interval -29.167 to -7.143
|
|
Reduction in Swelling/Inflammation - Digital Photography
Right View Change
|
-7.279 score on a scale
Interval -13.991 to 2.143
|
-22.368 score on a scale
Interval -27.273 to -14.286
|
|
Reduction in Swelling/Inflammation - Digital Photography
Left View Change
|
-4.4466 score on a scale
Interval -17.2348 to 6.8062
|
-16.5217 score on a scale
Interval -21.7391 to -2.381
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe presence of swelling and inflammation was assessed in all participants through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Assessment criteria (HNLEF) during a physical examination at baseline and 8 weeks. A total of 9 sites were evaluated for the presence of lymphedema and graded from 1 (mild) to 3 (severe) at each site. The number of sites ranged from 0-9 with a total severity score ranging from 0-27. Results are the change in a total score between baseline and 8 weeks. A lower score indicates a better outcome. A greater negative value indicates a greater reduction in swelling.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Reduction in Swelling/Inflammation - Grading of External Lymphedema
|
-0.5000 score on a scale
Interval -1.0 to 2.0
|
0.0000 score on a scale
Interval -6.0 to 2.0
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe function was assessed in all participants at baseline and week 8 through the jaw range of motion measurements using the Therabite Jaw ROM Scale. The TheraBite Jaw ROM Scale was used to measure in millimeters the jaw opening of the maximum inter-incisal distance (upper right central to lower right central incisor). The values were categorized by grade change. The change of -1 indicates the severity improved by one grade. A value of zero indicates a participant remained stable. A value of 1 indicates a patient worsened by one grade.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Function - Jaw Range of Motion
-1
|
4 Participants
|
1 Participants
|
|
Function - Jaw Range of Motion
0
|
18 Participants
|
17 Participants
|
|
Function - Jaw Range of Motion
1
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe function was assessed in all participants at baseline and week 8 by the Neck Disability Index (NDI). Values represent a change from baseline. Minimum score: 0 with a minimum disability of 0%. Maximum score: 50 with a maximal disability of 100%. 0 - 20% (minimal) - The patient can cope with most living activities. Usually, no treatment is indicated apart from advice on lifting sitting and exercise. 21 - 40% (moderate) - The patient experiences more pain and difficulty with sitting lifting and standing. Travel and social life are more difficult and they may be disabled from work. The patient can usually be managed by conservative means. 41 - 60% (severe) -Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61 - 80% (crippled) - Pain impinges on all aspects of the patient's life. Positive intervention is required. 81 - 100% (bed bound) - Need to exclude exaggeration or malingering.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Function - Neck Disability Index
|
1.00 score on a scale
Interval -4.0 to 9.5
|
0.00 score on a scale
Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe function was assessed in all participants at baseline and week 8 by the Voice Handicap Index (VHI). Values represent a change from baseline. Max / Min Total Score: 0-120. A lower score indicates a better outcome.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Function - Voice Handicap Index
|
0.50 score on a scale
Interval -1.94 to 2.75
|
0.00 score on a scale
Interval -3.0 to 3.0
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksThe function was assessed in all participants at baseline and week 8 through the cervical range of motion (CROM) and shoulder range of motion (SROM) measurements. A positive value indicates a better outcome. The greater the value, the greater the change from baseline.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Function - Cervical and Shoulder Range of Motion
SROM Abduction (Left Active)
|
5.50 Degrees
Interval -13.12 to 12.88
|
5.00 Degrees
Interval -5.5 to 15.0
|
|
Function - Cervical and Shoulder Range of Motion
CROM Forward Flexion
|
-1.00 Degrees
Interval -8.75 to 8.5
|
-2.00 Degrees
Interval -5.0 to 2.0
|
|
Function - Cervical and Shoulder Range of Motion
CROM Extension
|
4.00 Degrees
Interval -5.75 to 12.75
|
1.00 Degrees
Interval -6.0 to 6.0
|
|
Function - Cervical and Shoulder Range of Motion
CROM Left Lateral Rotation
|
-1.00 Degrees
Interval -6.5 to 3.0
|
-1.00 Degrees
Interval -6.0 to 6.0
|
|
Function - Cervical and Shoulder Range of Motion
CROM Right Lateral Rotation
|
-0.50 Degrees
Interval -7.0 to 3.5
|
1.00 Degrees
Interval -8.0 to 5.0
|
|
Function - Cervical and Shoulder Range of Motion
SROM Forward Flexion (Right Active)
|
0.00 Degrees
Interval -3.5 to 6.75
|
1.50 Degrees
Interval -1.0 to 11.0
|
|
Function - Cervical and Shoulder Range of Motion
SROM Forward Flexion (Left Active)
|
-0.75 Degrees
Interval -6.37 to 9.13
|
7.50 Degrees
Interval -1.5 to 9.5
|
|
Function - Cervical and Shoulder Range of Motion
SROM Abduction (Right Active)
|
7.00 Degrees
Interval -9.0 to 17.0
|
3.00 Degrees
Interval 0.0 to 13.0
|
|
Function - Cervical and Shoulder Range of Motion
SROM External Rotation (Right Active)
|
-1.25 Degrees
Interval -8.87 to 5.0
|
0.00 Degrees
Interval -8.0 to 4.0
|
|
Function - Cervical and Shoulder Range of Motion
SROM External Rotation (Left Active)
|
-2.25 Degrees
Interval -6.5 to 1.88
|
2.50 Degrees
Interval -1.0 to 6.5
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksPopulation: Data was not available and/or applicable to all participants in certain categories.
Symptoms were assessed in all participants at baseline and week 8 via the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey (VHNSS v2.0 plus GSS). Values represent a median score change from baseline. Score range: 0-10. A lower score indicates a better outcome. A more negative value indicates a greater change from baseline. Given this was a self-reported survey, responses were not mandatory and thus missing for some subjects.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Mouth Pain
|
0.00 score on a scale
Interval -1.29 to 0.5
|
0.00 score on a scale
Interval -1.5 to 0.0
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
General Pain
|
0.67 score on a scale
Interval -0.25 to 2.08
|
0.00 score on a scale
Interval -1.33 to 0.0
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Swallowing Solids
|
-0.06 score on a scale
Interval -1.12 to 0.73
|
-0.25 score on a scale
Interval -2.25 to 0.0
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Swallowing Liquids
|
0.00 score on a scale
Interval -1.0 to 1.0
|
0.00 score on a scale
Interval -0.12 to 0.0
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Nutrition
|
0.00 score on a scale
Interval -0.94 to 1.13
|
0.00 score on a scale
Interval -1.0 to 0.25
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Mucous
|
-0.12 score on a scale
Interval -0.75 to 0.69
|
-0.50 score on a scale
Interval -1.75 to 0.0
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Dry Mouth
|
0.20 score on a scale
Interval -0.55 to 0.9
|
0.00 score on a scale
Interval -0.2 to 0.4
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Taste/Smell
|
-0.25 score on a scale
Interval -1.83 to 0.71
|
-0.17 score on a scale
Interval -1.42 to 0.45
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Voice
|
-0.67 score on a scale
Interval -1.33 to 0.25
|
-.033 score on a scale
Interval -0.67 to 1.0
|
|
Symptoms - Vanderbilt Head and Neck Symptom Survey
Teeth
|
0.25 score on a scale
Interval 0.0 to 1.13
|
0.00 score on a scale
Interval 0.0 to 0.54
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksQuality of life was assessed in all participants at baseline and week 8 using the Linear Analog Self-Assessment. The total score for the assessment ranged from 0-50. Each category represents a change in score from the baseline visit which ranged from positive 4 to negative 4. A positive change indicates an improvement. Values represent the count of participants in each category.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Quality of Life - Linear Analog Self-Assessment
-4
|
1 Participants
|
0 Participants
|
|
Quality of Life - Linear Analog Self-Assessment
-2
|
1 Participants
|
0 Participants
|
|
Quality of Life - Linear Analog Self-Assessment
-1
|
5 Participants
|
3 Participants
|
|
Quality of Life - Linear Analog Self-Assessment
0
|
10 Participants
|
13 Participants
|
|
Quality of Life - Linear Analog Self-Assessment
1
|
4 Participants
|
2 Participants
|
|
Quality of Life - Linear Analog Self-Assessment
2
|
2 Participants
|
1 Participants
|
|
Quality of Life - Linear Analog Self-Assessment
4
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to the end of treatment at 8 weeksPopulation: Data may be missing or left blank by participant.
Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN) assessed the measurement characteristics of a symptom burden for participants with head and neck lymphedema at baseline and week 8. Each symptom was rated on intensity and distress using a 5-point scale. A maximum response for any symptom within a given cluster was used for the analysis. The total score ranged from 0-10. The values represent a change from baseline. A lower score means a better outcome.
Outcome measures
| Measure |
Interventional Group
n=24 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
Interventional Group
n=19 Participants
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Soft Tissue
|
0.00 score on a scale
Interval 0.0 to 2.0
|
-2.00 score on a scale
Interval -2.0 to 0.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Neurological
|
0.00 score on a scale
Interval 0.0 to 2.0
|
0.00 score on a scale
Interval -2.0 to 0.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Oral
|
0.00 score on a scale
Interval -1.0 to 2.0
|
0.00 score on a scale
Interval -2.0 to 0.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
BioBehavioral
|
0.00 score on a scale
Interval -1.75 to 0.75
|
0.00 score on a scale
Interval -2.0 to 1.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Resources
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 0.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Sexuality
|
0.00 score on a scale
Interval 0.0 to 2.0
|
0.00 score on a scale
Interval 0.0 to 1.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Activity
|
0.00 score on a scale
Interval -2.75 to 1.0
|
0.0 score on a scale
Interval -3.0 to 0.0
|
|
Symptoms - Lymphedema Symptom Intensity and Distress Survey
Function
|
0.00 score on a scale
Interval -0.75 to 2.0
|
0.00 score on a scale
Interval -1.0 to 1.0
|
Adverse Events
Wait-list Control Group
Serious events: 2 serious events
Other events: 20 other events
Deaths: 1 deaths
Interventional Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wait-list Control Group
n=24 participants at risk
Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).
|
Interventional Group
n=19 participants at risk
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Stroke
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
General disorders
Sudden death NOS
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
Other adverse events
| Measure |
Wait-list Control Group
n=24 participants at risk
Standard home lymphedema care: May include daily self manual lymphatic drainage, exercise, skincare, compression garments (as appropriate).
|
Interventional Group
n=19 participants at risk
Twice daily treatment with Flexitouch® pneumatic compression device and home care regimen, which may include self-MLD exercise, skincare, and wearing an appropriate compression garment, if applicable.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin infection
|
8.3%
2/24 • Number of events 2 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
3/24 • Number of events 3 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Cardiac disorders
Hypertension
|
4.2%
1/24 • Number of events 2 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
2/24 • Number of events 2 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Eye disorders
Corneal ulcer
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
General disorders
Aphonia
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
General disorders
General disorders and administration site conditions - other specify
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
General disorders
Neck pain
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
General disorders
Oral pain
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
General disorders
Pain
|
12.5%
3/24 • Number of events 3 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Immune system disorders
Allergic reaction
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Infections and infestations
Bladder infection
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Infections and infestations
Eye infection
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Infections and infestations
Middle ear inflammation
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Infections and infestations
Pneumonitis
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
2/24 • Number of events 3 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
10.5%
2/19 • Number of events 4 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Myelitis
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
2/24 • Number of events 2 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Spasiticity
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • Number of events 2 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Number of events 2 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
12.5%
3/24 • Number of events 3 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
15.8%
3/19 • Number of events 3 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
0.00%
0/19 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
4.2%
1/24 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
15.8%
3/19 • Number of events 3 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
|
Infections and infestations
Infection and infestation - Other, specify
|
0.00%
0/24 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
5.3%
1/19 • Number of events 1 • 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place