Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery
- Conditions
- Post Thoracotomy Pain Syndrome (PTPS)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2020-003300-14-DK
- Lead Sponsor
- Department of Cardiothoracic Surgery, Aalborg Universityhospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Primary end point(s): 1. Recruitment of 30 test subjects.<br>2. Half of the first half of included test subject must complete the treatment.<br>3. Half of test subjects in total mus complete the treatment.;Timepoint(s) of evaluation of this end point: 1. One year.<br>2. At the treatment session.<br>3. End of trial after last follow-up (15 Months).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Pain at rest, coughing and when active<br>Numerical rating score (NRS) for presence of pain before and after treatment and course of pain symptoms.<br>2. General Health<br>Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100.<br>3. Neuropathic Pain Symptoms Inventory (NPSI)<br>NRS<br>4. Activities of daily life<br>Impact and intensity of pain categorically in 16 situations of daily life.<br>5. Patient's Global Impression of Change (PGIC)<br>Rating of global change perceived by the test subject from More Worse to Much better and a scale from 0 to 10.<br><br>;Timepoint(s) of evaluation of this end point: 1. Weekly after treatment for 3 months.<br>2-4 Baseline, 1month and 3 months after treatment.<br>5. One and 3 months after treatment. <br>