Post Thoracotomy Pain Syndrome (PTPS)
Conditions
Interventions
Trade Name: BOTOX 100 Allergan-enheder
Product Name: BOTOX
Pharmaceutical Form: Powder for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo:
Sponsors
Department of Cardiothoracic Surgery, Aalborg Universityhospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of 18 years of age or above. 2. Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies. 3. Patients who are radically treated for pulmonary malignancy 4. Patients who suffers from chronic pain or unpleasant sensations at the site of scar at least six months after surgery with fully healed surgical wounds. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patients who cannot understand oral and written information. 2. Patients who were not radically operated. 3. Patients with other concomitant or other active cancer diseases. 4. Patients with chronic pain in the chest wall prior to surgery. 5. Pregnant women or women planning to get pregnant in the study period. 6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy. 7. Patients with intolerance or allergy to BOTOX®. 8. Patients who are at present treated with Onabotulinum toxin A or similar neuromuscular blocking drug or have received such in the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine recruitment potential among cured lung cancer patients with chronic pain following lung surgery for an RCT and if our method of Onabotulinum toxin A administration is feasible and acceptable to the test subjects.;Secondary Objective: Early stage testing of the hypothesis that chronic pain following thoracic surgery can be treated using method. ;Primary end point(s): 1. Recruitment of 30 test subjects. 2. Half of the first half of included test subject must complete the treatment. 3. Half of test subjects in total mus complete the treatment.;Timepoint(s) of evaluation of this end point: 1. One year. 2. At the treatment session. 3. End of trial after last follow-up (15 Months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pain at rest, coughing and when active Numerical rating score (NRS) for presence of pain before and after treatment and course of pain symptoms. 2. General Health Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100. 3. Neuropathic Pain Symptoms Inventory (NPSI) NRS 4. Activities of daily life Impact and intensity of pain categorically in 16 situations of daily life. 5. Patient's Global Impression of Change (PGIC) Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10. ;Timepoint(s) of evaluation of this end point: 1. Weekly after treatment for 3 months. 2-4 Baseline, 1month and 3 months after treatment. 5. One and 3 months after treatment. | — |
Countries
Denmark
Contacts
Public ContactHjerte-lungekirurgisk afdeling,
Aalborg Universitetshospital
Outcome results
None listed