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EFFECTIVENESS OF MAGNETIC STIMULATION OF BRAIN AS SUPPORTING TREATMENT IN OUTCOME PROFILE OF PATIENTS WITH PERSISTENT SOMATOFORM PAIN DISORDER

EFFICACY IN OUTCOME PROFILE OF ADJUNCTIVE INTERMITTENT THETA BURST STIMULATION (iTBS) IN PERSISTENT SOMATOFORM PAIN DISORDER - A RANDOMIZED SHAM CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047819
Enrollment
60
Registered
2022-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F450- Somatization disorder

Interventions

Intervention1: INTERMITTENT THETA BURST TRANSCRANIAL MAGNETIC STIMULATION: First session of Intermittent theta burst transcranial magnetic stimulation on left motor cortex and second session (half an

Sponsors

SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HELATH SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient with persistent somatoform pain disorder as per ICD - 10 DCR (Diagnostic criteria of research) Right-handed, Normotensive patients

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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) 2) Anxiety using Hamilton Anxiety Rating Scale (HAM - A) 3)Quality of life using World Health Organization Quality of Life Scale (WHOQOLS) 4) Mental and Psychological Well Being using Warwick - Edinburg Mental Well - Being Scale (WEMWBS) 5) Sleep Quality using Pittsburg Sleep Quality Index (PSQI) 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.—

Countries

India

Contacts

Public ContactSHAILJA JOSHI

SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HELATH SCIENCES

shobit.garg@gmail.com8958534261

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026