Chronic Pain Clinical Trial
Official title:
Personalized Neuromodulation for Treating Post-surgical Pain
NCT number | NCT03994991 |
Other study ID # | 201906717 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2021 |
Est. completion date | May 19, 2021 |
Verified date | May 2021 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with high severity of post-surgical pain scores will be randomized to transcranial magnetic stimulation (TMS) vs sham TMS groups. Both group of patients will have 10 TMS sessions during 5 days. Our hypothesis is that, the reduction in the severity of pain scores will be greater among those patients who are randomized to active TMS group compared to sham TMS group. The investigators will explore how improvements in pain correlate with changes in brain network connectivity.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 19, 2021 |
Est. primary completion date | May 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - English speaking - 18 to 80 years old - scheduled thoracic surgery w/one of the following procedures: thoracotomy, pneumonectomy, removal of lung other than bilobectomy, pneumonectomy, completion pneumonectomy, sleeve lobectomy, segmentectomy, single or multiple wedge resection, or thoracoscopy with excision-plication of bullae, with lobectomy, with partial or total pulmonary decortication or with wedge resection of lung. - Post-surgery pain equal or greater 4 at phone screen Exclusion Criteria: - limitations of self-expression or visual dysfunction (as assessed by research team member during inpatient screen) - having emergency surgery - bipolar, schizophrenia or other psychotic disorders - Alzheimer's, dementia, epilepsy, traumatic brain injury or other similarly impacting neurological issues - pregnancy - incarceration - pain in thoracic region for last two or more months - additional MRI/TMS exclusions: (implants, stents, neurostimulators, metal, claustrophobia, certain medications) |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Emine Bayman |
United States,
Bayman EO, Brennan TJ. Incidence and severity of chronic pain at 3 and 6 months after thoracotomy: meta-analysis. J Pain. 2014 Sep;15(9):887-97. doi: 10.1016/j.jpain.2014.06.005. Epub 2014 Jun 23. Review. — View Citation
Bayman EO, Parekh KR, Keech J, Larson N, Vander Weg M, Brennan TJ. Preoperative Patient Expectations of Postoperative Pain Are Associated with Moderate to Severe Acute Pain After VATS. Pain Med. 2019 Mar 1;20(3):543-554. doi: 10.1093/pm/pny096. — View Citation
Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in the severity of pain score after 5 days of active vs sham TMS. | The change in pain score will be calculated based on the following 2 pain scores:
Day 1 NRS is the severity of pain collected at the beginning of the first study visit before the TMS and MRI sessions. Day 5 NRS is the severity of pain collected at the end of the 5th study visit, after the second TMS and the MRI session. The change in pain score is the difference between the day 5 NRS and the day 1 NRS. |
5 days | |
Secondary | The presence of thoracic surgery related chronic pain at 6 months after surgery. | Pain assessments at 6 months aftger surgery will be made with phone interview. Patients will be asked if they still have pain related to their thoracic surgery ('Do you currently have pain related to your thoracic surgery? [yes/ no]') | 6 months after thoracic surgery |
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