An observational study in Head and Neck Lymphedema, sponsored by Tactile Medical. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by Tactile Medical · Observational
The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.
560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.
This study's enrollment of 18 is below the median of 106 across 144 observational studies indexed under Lymphedema.
Browse Lymphedema studies →Tactile Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment
Exclusion Criteria:
Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed
Symptom/Problem Improvement From Baseline to 6 Months
To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Function (Range of Motion) Improvement From Baseline to 6 Months
To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Health-related Quality of Life From Baseline to 6 Months
Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months
Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Pain From Baseline to 6 Months
Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Change in Swelling From Baseline to 6 Months
Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Ease of Use/Satisfaction
Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.
Time frame: Assessed at 6 months
Participants were recruited among therapists and physicians across 4 US sites between September 2018 and March 2020. The first subject was enrolled on September 14, 2018.
| Milestone | Intervention |
|---|---|
| Started | 18 |
| Completed | 8 |
| Not completed | 10 |
| Withdrew: Study early termination | 10 |
To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
| percent change in score | Intervention |
|---|---|
| Have you had pain in your mouth? | 14.3 |
| Have you had pain in your jaw? | 30.0 |
| Have you had soreness in your mouth? | 17.4 |
| Have you had a painful throat? | 35.3 |
| Have you had problems swallowing liquids? | 23.5 |
| Have you had problems swallowing pureed food? | 53.8 |
| Have you had problems swallowing solid food? | -7.7 |
| Have you choked when swallowing? | -20.0 |
| Have you had problems with your teeth? | 30.0 |
| Have you had problems opening your mouth wide? | 13.0 |
| Have you had a dry mouth? | 0.0 |
| Have you had sticky saliva? | 4.3 |
| Have you had problems with you sense of smell? | -5.0 |
| Have you had problems with your sense of taste? | 3.4 |
| Have you coughed? | -4.2 |
| Have you been hoarse? | 0.0 |
| Have you felt ill? | 0.0 |
| Has your appearance bothered you? | -20.8 |
| Have you had trouble eating? | 0.0 |
| Have you had trouble eating in front of family? | 17.6 |
| Have you had trouble eating in front of people? | -22.2 |
| Have you had trouble enjoying your meals? | 3.8 |
| Have you had trouble talking to other people? | -4.8 |
| Have you had trouble talking on the telephone? | -17.4 |
| Have you had trouble social contact with family? | -29.4 |
| Have you had trouble social contact with friends? | -19.0 |
| Have you had trouble going out in public? | -23.8 |
| Have you had trouble having physical contact? | -35.3 |
| Have you felt less interest in sex? | 0.0 |
| Have you felt less sexual enjoyment? | -14.8 |
| Have you used pain killers? | 28.6 |
| Have you taken any nutritional supplements? | 50.0 |
| Have you used a feeding tube? | -50.0 |
| Have you lost weight? | -20.0 |
| Have you gained weight? | 57.1 |
To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline.
| percent change in measurement | Intervention |
|---|---|
| Cervical: Flexion | 3.7 |
| Cervical: Extension | 28.9 |
| Cervical: Right Lateral | 1.5 |
| Cervical: Left Lateral | 15.9 |
| Cervical: Right Rotation | 28.5 |
| Cervical: Left Rotation | 7.8 |
| Shoulder: Right Flexion | -2.0 |
| Shoulder: Right Abduction | 12.6 |
| Shoulder: Left Flexion | -1.9 |
| Shoulder: Left Abduction | 2.6 |
| Mouth: Open | 0.6 |
Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
| percent change in score | Intervention |
|---|---|
| Do you have trouble doing strenuous activities? | -17.2 |
| Do you have any trouble taking a long walk? | 0.0 |
| Do you have trouble taking a short walk? | -12.5 |
| Do you need to stay in bed or a chair during day? | 0.0 |
| Do you need help eating, dressing, washing? | 40.0 |
| Were you limited in work or other day activities? | 4.3 |
| Were you limited in hobbies or leisure activities? | 8.3 |
| Were you short of breath? | 6.3 |
| Have you had pain? | 0.0 |
| Did you need to rest? | 21.1 |
| Have you had trouble sleeping? | -12.5 |
| Have you felt weak? | 0.0 |
| Have you lacked appetite? | 5.0 |
| Have you felt nauseated? | 10.0 |
| Have you vomited? | 0.0 |
| Have you been constipated? | -18.8 |
| Have you had diarrhea? | 7.1 |
| Were you tired? | 0.0 |
| Did pain interfere with daily activities? | 0.0 |
| Have you had difficulty concentrating? | -5.9 |
| Did you feel tense? | 0.0 |
| Did you worry? | 10.5 |
| Did you feel Irritable? | 0.0 |
| Did you feel depressed? | 25.0 |
| Have you had difficulty remembering things? | 0.0 |
| Has condition/treatment interfered with family? | -18.2 |
| Has condition/treatment interfered socially? | 0.0 |
| Has condition/treatment caused difficult finances? | -4.8 |
Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
| % change from baseline to 6 months | Intervention |
|---|---|
| Overall health during the past week | 4.3 |
| Overall quality of life during the past week | 0.0 |
Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
| percent change in score | Intervention |
|---|---|
| Changes in Pain From Baseline to 6 Months | 47.5 |
Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline.
| percent change in swelling measurements | Intervention |
|---|---|
| Lower Neck Circumference | -3.0 |
| Upper Neck Circumference | -2.1 |
| Ear to Ear Length | -2.6 |
Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.
| percent of participants | Intervention |
|---|---|
| Very difficult to use Flexitouch garments | 0.0 |
| Difficult to use Flexitouch garments | 0.0 |
| Neither easy nor difficult with Flexitouch garment | 14.3 |
| Easy to use Flexitouch garments | 57.1 |
| Very easy to use Flexitouch garments | 28.6 |
| Very difficult to use Flexitouch controller | 0.0 |
| Difficult to use Flexitouch controller | 0.0 |
| Neither easy nor difficult-Flexitouch controller | 0.0 |
| Easy to use Flexitouch controller | 42.9 |
| Very easy to use Flexitouch controller | 57.1 |
| Very uncomfortable treatment by Flexitouch system | 0.0 |
| Uncomfortable treatment by Flexitouch system | 0.0 |
| Neither uncomfortable nor comfortable treatment | 0.0 |
| Comfortable treatment by Flexitouch system | 57.1 |
| Very comfortable treatment by Flexitouch system | 42.9 |
| Very dissatisfied overall with Flexitouch system | 0.0 |
| Dissatisfied overall with Flexitouch system | 0.0 |
| Neither dissatisfied nor satisfied overall | 0.0 |
| Satisfied overall with Flexitouch system | 28.6 |
| Very satisfied overall with Flexitouch system | 71.4 |
| Yes, would recommend Flexitouch system to others | 100 |
| No,would not recommend Flexitouch system to others | 0.0 |
Collected over Adverse events were collected on participants who received and were trained on the device from the 2 week visit until 6 month visit or study exit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/18 (0%) | 0/18 (0%) | 3/18 (16.7%) |
| Event | Intervention |
|---|---|
| CystNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/18 |
| Dry SkinSkin and subcutaneous tissue disorders | 1/18 |
| HypotensionCardiac disorders | 1/18 |
| Lingual villosaSkin and subcutaneous tissue disorders | 1/18 |
| OsteomylelitisMusculoskeletal and connective tissue disorders | 1/18 |
| RashSkin and subcutaneous tissue disorders | 1/18 |
Baseline analysis population includes subjects who completed the screening process. This does not include screen failure subjects.
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 62.1 (43 to 74) |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 3 |
| Male | 15 |
| Race/Ethnicity, Customized(participants) | Intervention |
|---|---|
| Race : White or Caucasian | 17 |
| Race : Black or African American | 1 |
| Race : Asian | 0 |
| Race : American Indian or Alaska Native | 2 |
| Race : Native Hawaiian or Other Pacific Islander | 0 |
| Race : Other | 0 |
| Ethnicity: Hispanic or Latino | 1 |
| Ethnicity: Not Hispanic or Latino | 17 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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