NCT04213989

An Investigator-initiated Study Assessing the Effect of Intermittent Pneumatic Compression (IPC) on Symptoms and Quality of Life in Women With Lipo-lymphedema (Lipedema With Swelling)

Extracted Fields (from Registry)
Protocol IDNCT04213989
Registration Date2019-12-30
Statuscompleted
SponsorThomas Wright, MD
CountryUnited States
Industryindustry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2020-01-31
Last Patient Out2021-11-24
Publicationy
Gender %FEMALE
Mean Age18 Years - 70 Years
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
9262ms / 9689 tok 		CLAUDE
claude-sonnet-4-20250514
4659ms / 11023 tok 		OPENAI
gpt-4o
3248ms / 9522 tok 		Review
rct_type parallel RCT parallel RCT parallel RCT OK
cancer_status non-cancer non-cancer non-cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient outpatient outpatient OK
setting_place home care home care → home care
shaky reasoning
✓ Unanimous Initial: home care Requery: home care — The intervention involves an in-home advanced pneumatic compression device used daily for 1 hour to provide manual lymphatic drainage therapy over a 3-4 week period.
 home care other → home care
shaky reasoning
✓ Unanimous Initial: other Requery: home care — The intervention involves a Flexitouch Plus device that provides in-home manual lymphatic drainage therapy for approximately 1 hour daily, clearly indicating home-based treatment delivery.
 home care other → home care
shaky reasoning
✓ Unanimous Initial: other Requery: home care — The intervention involves the use of in-home manual lymphatic drainage therapy devices (Flexitouch Plus) for treating lipo-lymphedema, indicating delivery at the patient's own home.
 OK
feasibility feasibility RCT feasibility RCT → feasibility RCT
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — The trial is a randomized interventional study with a small enrollment of 36 participants (n≤30 threshold for pilot/feasibility) and primary outcomes focused on clinical effectiveness measures (symptoms, quality of life, pain) without explicit pilot/feasibility labeling, but the small sample size suggests it is likely a feasibility or pilot study.
 feasibility RCT feasibility RCT → feasibility RCT
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — With only 36 participants enrolled, this appears to be a small-scale study designed to assess whether IPC treatment shows promise for symptom relief and quality of life improvements in lipo-lymphedema patients, rather than a fully powered efficacy trial.
 feasibility RCT fully powered RCT → feasibility RCT
shaky reasoning
✓ Unanimous Initial: fully powered RCT Requery: feasibility RCT — The study has a relatively small sample size of 36 and focuses on evaluating symptoms and quality of life, which suggests it may be a preliminary or feasibility study.
 OK
intervention_pharmacologic no no no OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device yes yes yes OK
intervention_psychological no no no OK
intervention_complex no no no OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no yes
shaky reasoning
✓ Unanimous Initial: yes
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — This study tests an intermittent pneumatic compression device for symptom management in women with lipo-lymphedema, not palliative care consultation or services as the intervention.
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The study tests the effect of intermittent pneumatic compression on symptoms and quality of life, not palliative care as an intervention.
 OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom yes yes yes OK
outcome_qol yes yes yes OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub N/A N/A N/A OK
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