Health Condition 1: F454- Pain disorders related to psychological factors
Conditions
Interventions
Intervention1: repetitive Transcranial Magnetic Stimulation (rTMS): Target: Right medial prefrontal cortex (identified using the International 10-20 EEG system)
Frequency: 10 Hz
Intensity: 100% of res
Sponsors
Kalinga Institute of Medical Science
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 60 years, any gender 2.Diagnosis of persistent somatoform pain disorder according to DSM V criteria using SCID-5 RV for at least 6 months 3.Moderate to severe pain intensity (VAS score equal to or grater than score of 4) 4.Stable medication regimen for at least 4 weeks prior to enrollment 5.Willing and able to provide written informed consent 6.Able to comply with study procedures and follow-up visits
Exclusion criteria
Exclusion criteria: 1.Presence of diagnosable physical illness that could explain the pain symptoms 2.Severe psychiatric comorbidities (e.g., psychosis, bipolar disorder, substance dependence, severe major depressive disorder with suicidal ideation) 3.Pregnancy or lactation 4.Recent changes in psychotropic medications (less than 4 weeks)- Shall be put on waitlist 5.Neurological disorders (e.g., epilepsy, cerebrovascular disease, traumatic brain injury, dementia) 6.Contraindications to rTMS: Ferromagnetic metallic implants in the head/neck region Implanted medical devices (e.g., cardiac pacemakers, cochlear implants) History of seizures or epilepsy Increased intracranial pressure 7.Current participation in another clinical trial 8.Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity from baseline to end of treatment (after 2 weeks- completion of 10 sessions ,5 sessions per week) as measured by the Visual Analog Scale (VAS- defined as greater than or equal to 50 percent reduction in Visual analog score (VAS) score)Timepoint: Before starting treatment (Week 0): Participants will be checked to see if they are eligible for the study. If they agree, we will take their consent, collect basic personal and medical details, and measure their symptoms. Mid-treatment (Week 1, after 5 sessions): We will check the participant s pain levels, physical symptoms, anxiety, depression, and overall health condition. End of treatment (Week 2, after 10 sessions): We will again assess pain, physical symptoms, anxiety, depression, and other health-related measures. Follow-up (Week 6, 4 weeks after last session): A final check of all health measures will be done to see how the participant is doing after the treatment has ended. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in somatic symptom burden as measured by the Somatic Symptom Scale-8 (SSS-8) 2.Change in quality of life as measured by the WHO Quality of Life Scale (WHOQOL-BREF) 3.Change in anxiety symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A) 4.Change in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) 5.Remission rate (defined as VAS score less than 3) 6.Incidence and severity of adverse events Timepoint: Before starting treatment (Week 0): Participants will be checked to see if they are eligible for the study. If they agree, we will take their consent, collect basic personal and medical details, and measure their symptoms. Mid-treatment (Week 1, after 5 sessions): We will check the participant s pain levels, physical symptoms, anxiety, depression, and overall health condition. End of treatment (Week 2, after 10 sessions): We will again assess pain, physical symptoms, anxiety, depression, and other health-related measures. Follow-up (Week 6, 4 weeks after last session): A final check of all health measures will be done to see how the participant is doing after the treatment has ended. | — |
Countries
India
Contacts
Public ContactRam Chandra Das
Kalinga Instituste od Medical Science
Outcome results
None listed