Phase 2
Completed N=20
Cranial Electrotherapy Stimulation in Burned Patients
Post Traumatic Stress Disorders · Burns
Source: ClinicalTrials.gov NCT00723008 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score — 53.8; 56.7; 48.8; 50.4 Score
Summary
To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to some or all of those symptoms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score |
53.8; 56.7; 48.8; 50.4; 55.5; 44.7 | — |
| PRIMARY Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score |
28.8; 30.6; 27.5; 24.5; 36.3; 21.7 | — |
| PRIMARY Mean Brief Profile of Mood States (BPOMS) Score |
50.2; 55.9; 42.3; 50.3; 51.0; 41.0 | — |
| PRIMARY Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). |
3.7; 3.3; 3.9; 4.2; 2.9; 2.3 | — |
| PRIMARY Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). |
3.6; 3.2; 3.3; 3.3; 2.6; 2.1 | — |
| PRIMARY Mean General Sleep Disturbance Scale (GSDS) Score |
76.3; 90.8; 80.6; 83.3; 67.8; 56.3 | — |
Eligibility Criteria
Inclusion Criteria
- burned patients requiring outpatient physical or occupational therapy in the USAISR Burn Rehabilitation Gym or Center for the Intrepid
- Able to read and speak English
- Between ages of 18-65 years
- Screen positive (score greater than 44) on the PCL-M/C instruments
Exclusion Criteria
- pregnant patients
- patients with implantable pacemakers or electronic stimulators
- patients scoring below 44 on the PCL-M/C instrument
- patients who previously used CES therapy
Data sourced from ClinicalTrials.gov (NCT00723008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.