Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic Surgery
To evaluate the effectiveness of a protocolized physical therapy program in reducing postoperative chest and abdominal wall pain after minimally invasive thoracic surgery. To characterize neuropathic and nociceptive components of post-thoracotomy pain using the Perioperative Neuropathic Pain Assessment Form
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Luismiguel Cotamo, Research Assistant
- Telefonnummer: 305-689-3366
- E-mail: lxc332@miami.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Are ≥18 years old
- Undergo minimally invasive lung surgery including Video assisted thoracic surgery (VAST) and Robotic assisted thoracic surgery (RATS)
- Wedge resection
- Segmentectomy
- Lobectomy
- Pneumonectomy
- Present to the 2-week postoperative clinic visit
- Report pain score ≥4 on the Numeric Rating Scale
- Can participate in physical therapy at the University of Miami (UM) downtown facility
Exclusion Criteria:
- Undergo esophagectomy
- Undergo mediastinal or thymic resection procedures
- Are unable to participate in physical therapy due to severe medical comorbidities or geographical limitations
- Have cognitive impairment preventing participation in assessments
- Decline participation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Physical Therapy + Standard of Care Analgesia Therapy Group
Participants will receive standard postoperative analgesic therapy per routine clinical care throughout the study period. In addition, participants will complete protocolized physical therapy consisting of 1 session per week for 4 weeks, beginning at postoperative week 4. Total participation in this arm is approximately 6 months |
Protocolized physical therapy administered once weekly for 4 weeks beginning at postoperative week 4. Therapy includes chest wall strengthening, shoulder girdle mobilization, postural training, abdominal strengthening, inspiratory muscle training, and pain management modalities (cryotherapy, moist heat, ultrasound). Postoperative analgesic therapy administered as part of routine clinical standard of care and determined by the treating physician. Medications may include acetaminophen (Tylenol), celecoxib (Celebrex), ibuprofen (Advil), ketorolac (Toradol), gabapentin (Neurontin), and oxycodone (OxyContin). Dosing, frequency, and duration will be individualized based on patient need and determined by the treating clinician. |
|
Aktiv komparator: Standard Care Analgesia Therapy Group
Participants will receive standard postoperative analgesic therapy per routine clinical care throughout the study period. Total participation in this arm is approximately 6 months. |
Postoperative analgesic therapy administered as part of routine clinical standard of care and determined by the treating physician. Medications may include acetaminophen (Tylenol), celecoxib (Celebrex), ibuprofen (Advil), ketorolac (Toradol), gabapentin (Neurontin), and oxycodone (OxyContin). Dosing, frequency, and duration will be individualized based on patient need and determined by the treating clinician. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Postoperative Pain Intensity
Tidsramme: Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
Pain intensity will be measured using the Numeric Rating Scale (NRS), a patient-reported scale ranging from 0 (no pain) to 10 (worst possible pain). Time Frame: Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively |
Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
|
Change in Neuropathic Pain Score
Tidsramme: Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
Neuropathic pain will be measured using the DN4 (Douleur Neuropathique en 4 Questions) questionnaire, with total scores ranging from 0 to 10. A score of ≥4 indicates the presence of neuropathic pain. |
Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative Opioid Exposure
Tidsramme: 8 weeks, and 6 months postoperatively
|
Cumulative opioid exposure, calculated as the total morphine milligram equivalents (MME) of opioid medications used during the assessment periods |
8 weeks, and 6 months postoperatively
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Diego Avella-Patino, MD, University of Miami
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20260414
Plan for individuelle deltagerdata (IPD)
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