Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans
Primary Purpose
Persian Gulf Syndrome, Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupressure treatment.
Reiki
Sponsored by
About this trial
This is an interventional treatment trial for Persian Gulf Syndrome focused on measuring Acupressure, Reiki, EEG, EMG, fatigue relief, veterans
Eligibility Criteria
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.
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupressure
Reiki
Arm Description
This group of patients will serve as the experimental group and receive acupressure treatment in addition to routine clinical care. Acupressure will be provided 40 mins/day, 2 days/week for 6 weeks (total of 12 sessions).
This group of participants will serve as control group and receive Reiki treatment in addition to routine clinical care. Reiki will be provided 40 mins/day, 2 days/week for 6 weeks (total of 12 sessions).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02075489
First Posted
February 26, 2014
Last Updated
October 9, 2017
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02075489
Brief Title
Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans
Official Title
Effectiveness of Acupressure Treatment in Pain Management and Fatigue Relief for Gulf War Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
EEG measures will exhibit a positive change when fatigue is relieved and pain is alleviated for symptomatic veterans after effective treatment.
Detailed Description
Symptomatic veterans will receive standardized acupressure treatment, first with one-thumb pressing applied to the head at acupoints of GV-20 (Bai Hui), EX-HN-3 (Yin Tang), Du-24 (Shen Ting), ST-8 (Tou Wei), EX-HN-5 (Tai Yang). B-2 (Zan Zhu), M-HN-6 (Yu Yao), and SJ-23 (Si Zhu Kong) for ~5 s on each acupoint until the subject gets the sense of soreness and numbness, and the procedure will be repeated three times. The frequency of one-thumb pressing is 120±10 times per minute and the force is 10±2 Newtons. Kneading massage will be applied around eyes and forehead, and face will be swabbed by palm for ~ 5 min. Manipulation of these acupoints is aimed at helping to calm and ease the subject, lighten headache and migraine, relieve fatigue, and alleviate insomnia. Finally, LI- 4 (He Gu), LI-11 (Qu Chi), HT-7(Shen Men), ST-32 (Fu Tu), SP-10 (Xue Hai), ST-36 (Zu San Li), and KI-3 (Tai Xi) acupoints will be one-thumb pressed for 10 min. Manipulations on these acupoints and meridians located on the limbs is to relax muscles, alleviate muscle and joint pain, and improve mobility. This protocol is based on our consultant's previous acupressure research and clinical practice, our pilot case study for CFS patient, and the basic rationale in traditional Chinese acupressure medicine (Yan, 2003; Cao, 2006).
A matter of great concern in investigating oriental alternative and complementary interventions is standardizability and repeatability of experiments. In this proposed study the process of identifying the location of acupoints and underlying meridians for each subject will be carried out using Western anatomy and the World Health Organization's Standard Acupuncture Point Locations (Lim, 2009). The level of manipulation (force and frequency of pressing and kneading) will be monitored by the TN-II manipulation radiometer (Shangxin Medical Science & Technology Co. Ltd, Shanghai, China), which has been successfully used to normalize acupressure manipulation in previous research (Ma et al., 2006). In this manner, the whole treatment design would be standardized as much as possible and could be repeated in the future by our own and other groups.
Reiki: Veterans in the control group will receive reiki treatment with the same dosage (40 min/session, 12 sessions in 6 wks). The practitioner will place the hands on the recipient in various positions covering head, the back of the torso, and the 4 limbs with fixed set of 12 hand positions. These covered areas will then be tapped and stroked, and practitioner will focus his/her gaze on these areas for 2-3 min, through which the healing energy is transferred to the subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persian Gulf Syndrome, Chronic Fatigue Syndrome
Keywords
Acupressure, Reiki, EEG, EMG, fatigue relief, veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupressure
Arm Type
Experimental
Arm Description
This group of patients will serve as the experimental group and receive acupressure treatment in addition to routine clinical care. Acupressure will be provided 40 mins/day, 2 days/week for 6 weeks (total of 12 sessions).
Arm Title
Reiki
Arm Type
Active Comparator
Arm Description
This group of participants will serve as control group and receive Reiki treatment in addition to routine clinical care. Reiki will be provided 40 mins/day, 2 days/week for 6 weeks (total of 12 sessions).
Intervention Type
Other
Intervention Name(s)
Acupressure treatment.
Intervention Description
Acupressure will be provided 40 min/day, 2 days/week for 6 weeks (total of 12 sessions). Symptomatic veterans will receive standardized acupressure treatment for ~5 s on each acupoint until the subject gets the sense of soreness and numbness, and the procedure will be repeated three times. Kneading massage will be applied around eyes and forehead, and face will be swabbed by palm for ~ 5 min. Manipulation of these acupoints is aimed at helping to calm and ease the subject, lighten headache and migraine, relieve fatigue, and alleviate insomnia.
Intervention Type
Other
Intervention Name(s)
Reiki
Intervention Description
Veterans in the control group will receive reiki treatment with the same dosage (40 min/session, 12 sessions in 6 wks). The practitioner will place his/her hands on the recipient in various positions covering head, the back of the torso, and the 4 limbs with fixed set of 12 hand positions. These covered areas will then be tapped and stroked, and practitioner will focus his/her gaze on these areas for 2-3 min, through which the healing energy is transferred to the subjects. In a format similar to acupressure treatment, it will be used as an inert control treatment to balance additional care the experimental group will receive.
Primary Outcome Measure Information:
Title
Piper Fatigue Scale
Description
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.
Time Frame
Change from baseline score will be assessed at 6 weeks.
Secondary Outcome Measure Information:
Title
Changes in corticomuscular coherence
Description
Changes in the relation between brain (EEG) and muscle (EMG) surface signals will be analyzed. This is a non-invasive procedure.
Time Frame
Change from baseline score will be assessed at 6 weeks.
Other Pre-specified Outcome Measures:
Title
Medical Outcome Study Short Form 36
Description
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.
Time Frame
Change from baseline score will be assessed at 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vernon W Lin, MD PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans
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