Chronic Fatigue Syndrome Clinical Trial
Official title:
Effectiveness of Acupressure Treatment in Pain Management and Fatigue Relief for Gulf War Veterans
Verified date | October 2017 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will provide symptomatic veterans with acupressure treatment and determine its
effectiveness in fatigue relief and pain management for Gulf War Illness (GWI). Investigators
plan to recruit patients reporting symptoms of GWI through the Department of Veterans Affairs
(VA), and randomize them into acupressure group (to receive acupressure treatment) and
control group (to receive Reiki treatment). The acupressure treatment, twice per week for 6
weeks, will be offered by a licensed acupressure practitioner. Evaluations will be made
before and after treatment (at 6 weeks). Clinical outcomes will be compared between groups
(acupressure group vs. control group) and between different timepoints (before treatment vs.
after treatment) within the same group.
The results of this study may provide useful information to develop more effective treatment
for veterans with GWI disease. Since acupressure treatment is of Asian origin and has shown
excellent promise within its Eastern traditions, if successful, this study has the potential
to produce a paradigm shift in clinical practice to more effectively relieve the symptoms of
veterans with GWI disease. Meanwhile, as a non-invasive therapeutic massage, acupressure may
lend to better patient acceptance and ultimately, greater clinical accessibility.
Hypotheses
1. Acupressure besides routine clinical care will produce a more complete fatigue relief
and pain alleviation in veterans with GWI versus routine clinical care plus reiki
treatment.
2. EEG measures will exhibit a positive change when fatigue is relieved and pain is
alleviated for symptomatic veterans after effective treatment.
Status | Completed |
Enrollment | 7 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Veterans with Gulf War Illness for more than 6 months - Over 18 years old (male or female) - Additional inclusion criteria: - A score of 5 and above for severity and 5 and above for interference by BPI. - A score of 3 and above by revised Piper Fatigue Scale. Exclusion Criteria: - Pregnant woman; - fatigue can be explained by existing causes (i.e., eating disorder); - previous neuromuscular or mood disorders (i.e., bipolar disorder); - previous cognitive problems (i.e., schizophrenia, dementia, delusional disorder); - significant cardiovascular problems; - under other rehabilitation treatment that can significantly differentiate the subject from others. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Medical Outcome Study Short Form 36 | Ware and Sherbourne. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473-83. This tool is used to assess quality of life. | Change from baseline score will be assessed at 6 weeks. | |
Primary | Piper Fatigue Scale | Piper et al., The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum 1998 25(4):677-84. This scale is used to assess fatigue levels in patients. | Change from baseline score will be assessed at 6 weeks. | |
Secondary | Changes in corticomuscular coherence | Changes in the relation between brain (EEG) and muscle (EMG) surface signals will be analyzed. This is a non-invasive procedure. | Change from baseline score will be assessed at 6 weeks. |
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