NCT01305811

Brief Summary

This unblinded Phase II clinical trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2009

Typical duration for phase_1

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

Study Start

First participant enrolled

July 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 21, 2015

Completed
Last Updated

June 15, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

February 24, 2011

Results QC Date

September 29, 2014

Last Update Submit

May 20, 2015

Conditions

Persian Gulf Syndrome

Keywords

Complex Medical IllnessGulf War IllnessVeteran

Outcome Measures

Primary Outcomes (1)

  • SF-36P

    Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.

    6 months

Other Outcomes (1)

  • SF-36P

    2 months

Study Arms (2)

Bi-weekly acupuncture treatment

EXPERIMENTAL

Bi-weekly acupuncture treatment

Device: Acupuncture

Wait list

ACTIVE COMPARATOR

Wait list for 2 months followed by weekly acupuncture for 4 months

Device: Acupuncture

Interventions

AcupunctureDEVICE

Sterile insertive needles are applied by licensed, experienced practitioners.

Bi-weekly acupuncture treatmentWait list

Eligibility Criteria

Age39 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • deployed to the "Gulf Theater of operations, as defined by 38 CFR 3.317, includes Iraq, Kuwait, Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above all of these locations" between August 1990 and the present date,
  • they have at least 2 of the following symptoms from the 3 CDC clusters of symptom that have lasted for more than 6 months. Each symptom cluster must be characterized as "mild-moderate" or "severe" with at least one symptom in each cluster required to be severe. The clusters are:
  • A-Fatigability
  • fatigue 24 hours or more after exertion B-Mood and Cognition
  • feeling depressed or
  • feeling irritable or
  • difficulty thinking or concentrating or
  • feeling worried, tense, anxious or
  • problems finding words or
  • problems getting to sleep C-Musculoskeletal
  • joint pain or muscle pain

You may not qualify if:

  • Currently enrolled in another clinical trial
  • Have another disease that likely could account for the symptoms, as determined by our Medical Monitor
  • Severe psychiatric illness (in the last 2 years psychiatric hospitalization, suicidal attempt, alcohol or substance abuse, use of antipsychotic medication) as measured by the Primary Care Evaluation of Mental Disorder (Prime MD).
  • Unable to complete the protocol on based on the evaluation of the Medical Monitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England School of Acupuncture

Newton, Massachusetts, 02458, United States

Location

Related Publications (1)

  • Conboy L, Gerke T, Hsu KY, St John M, Goldstein M, Schnyer R. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial. PLoS One. 2016 Mar 31;11(3):e0149161. doi: 10.1371/journal.pone.0149161. eCollection 2016.

    PMID: 27031099DERIVED

MeSH Terms

Conditions

Persian Gulf Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Occupational DiseasesWar-Related InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Lisa Conboy
Organization
New England School of Acupuncture
lconboy@nesa.edu
6175581788

Study Officials

  • Lisa A Conboy, ScD

    New England School of Acupuncture

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

February 24, 2011

First Posted

March 1, 2011

Study Start

July 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 15, 2015

Results First Posted

May 21, 2015

Record last verified: 2015-05

Locations

US(1)