EFFECTIVENESS OF MAGNETIC STIMULATION OF BRAIN AS SUPPORTING TREATMENT IN OUTCOME PROFILE OF PATIENTS WITH PERSISTENT SOMATOFORM PAIN DISORDER
Not Applicable
- Conditions
- Health Condition 1: F450- Somatization disorder
- Registration Number
- CTRI/2022/12/047819
- Lead Sponsor
- SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HELATH SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient with persistent somatoform pain disorder as per ICD - 10 DCR (Diagnostic criteria of research)
Right-handed, Normotensive patients
Exclusion Criteria
Neurodegenerative disorder (like, Spinal muscular atrophy, Sclerosis etc.) or history of seizures
History suggestive of brain injury or surgery
Any significant brain malfunction or neoplasm
Exposure to Electroconvulsive therapy (ECT) in last 6 months
Any metal part in the body like cardiac pacemaker, stents in the neck or brain, bullet fragments or shrapnel near the head, aneurysm clips or coils etc.
Diagnosis of mental and behavioral disorder due to harmful use of psychoactive substances or their dependence (other than nicotine and caffeine).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess and compare change in severity of symptoms in patients after active and placebo treatment by using Brief Pain Inventory (BPI), Visual Analog Scale(VAS), Global Pain Scale (GPS).Timepoint: BPI, VAS AND GPS will be applied in the beginning of the treatment, after completion of 10 sessions and 2 weeks post completion of treatment.
- Secondary Outcome Measures
Name Time Method Post treatment, to assess and compare change in symptoms of 1) Depression using Beck Depression Inventory (BDI - II) and Montgomery- Asberg Depression Rating Scale (MADRS) <br/ ><br>2) Anxiety using Hamilton Anxiety Rating Scale (HAM - A) <br/ ><br>3)Quality of life using World Health Organization Quality of Life Scale (WHOQOLS) <br/ ><br>4) Mental and Psychological Well Being using Warwick - Edinburg Mental Well - Being Scale (WEMWBS) <br/ ><br>5) Sleep Quality using Pittsburg Sleep Quality Index (PSQI) <br/ ><br>6) Sexual Functioning using Changes in Sexual Functioning Questionnaire (CSFQ - F- C)Timepoint: BDI - II, MADRS, HAM - A, WHOQOLS, WEMWBS, PSQI and CSFQ - F - C will be applied in the beginning of the treatment, after completion of 10 sessions and 2 weeks post completion of treatment.