NCT01060553

Brief Summary

The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study will also examine the degree of veteran acceptance for acupuncture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 19, 2014

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

January 29, 2010

Results QC Date

October 15, 2014

Last Update Submit

April 6, 2015

Conditions

Post-traumatic Stress Disorders

Keywords

Post-traumatic stress disordersAcupunctureQuality of lifesleep disorder

Outcome Measures

Primary Outcomes (1)

  • SF-36

    global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.

    baseline, 6 or 12 weeks (latest available is used)

Secondary Outcomes (1)

  • Pittsburgh Sleep Index

    baseline, 6 or 12 weeks (latest available is used)

Study Arms (2)

Arm 1

EXPERIMENTAL

The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen

Other: Acupuncture treatment

wait list control

NO INTERVENTION

subjects were put on a wait list control. due to small numbers completing in both groups, the data from the wait list who completed acupuncture are combined with the experimental treatment group for analysis.

Interventions

Acupuncture treatmentOTHER

This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment. Due to the very small number of subjects in the wait list control, the ones who completed 6 or 12 weeks of acupuncture after the wait list were combined with the few who completed the initial acupuncture for a pre-post single group analysis. for those who completed both the 6 and 12 week measures, the latest one was selected for analysis

Arm 1

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis or positive screen test for PTSD.
  • Combat veterans of Operation Iraqi Freedom or Operation Enduring Freedom conflicts.

You may not qualify if:

  • Unable to travel to East Orange VA for 12 consecutive weeks, biweekly for treatment.
  • Does not speak English.
  • Acupuncture or CBT treatment within the previous six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSleep Wake Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Limitations and Caveats

very small numbers of subjects due to dropout and loss to followup. data from the wait list subjects who completed the intervention were combined with those initially assigned to treatment for a pre/post single group analysis

Results Point of Contact

Title
Thomas W. Findley, MD, PhD
Organization
Veteran Affairs New Jersey Health Care System
thomas.findley@va.gov
973-676-1000

Study Officials

  • Thomas W Findley, MD PhD

    East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 28, 2015

Results First Posted

November 19, 2014

Record last verified: 2014-08

Locations

US(1)