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Not yet recruitingNCT07934160Updated Nov 12, 2026

Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic Surgery

A Phase 4 interventional study of Physical Therapy and Standard of Care Analgesic Therapy in Post Operative Pain, sponsored by University of Miami. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Miami · Phase 4, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Post Operative Pain

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03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 150 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University of Miami is the lead sponsor of 842 studies on the registry; 166 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: Physical Therapy · Drug: Standard of Care Analgesic Therapy

  • Active comparator
    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.

    Drug: Standard of Care Analgesic Therapy

Interventions

  • BehavioralPhysical Therapy

    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).

  • DrugStandard of Care Analgesic Therapy

    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.

06

What researchers measure

Primary outcomes

  1. Change in Postoperative Pain Intensity

    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

    Time frame: Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively

  2. Change in Neuropathic Pain Score

    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.

    Time frame: Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively

Secondary outcomes

  1. Cumulative Opioid Exposure

    Cumulative opioid exposure, calculated as the total morphine milligram equivalents (MME) of opioid medications used during the assessment periods

    Time frame: 8 weeks, and 6 months postoperatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.

Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 12 months is below that.

Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07934160
Responsible party
Diego Avella-Patino (Assistant Professor, University of Miami) — Principal investigator
First posted
Nov 12, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Luismiguel Cotamo, Research Assistant
Contact
lxc332@miami.edu
305-689-3366
Diego Avella-Patino, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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