Clinical trial NCT02075489: 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
Overall status: COMPLETED
Phase: NA
Conditions: Persian Gulf Syndrome
Chronic Fatigue Syndrome
Keywords: Acupressure
Reiki
EEG
EMG
fatigue relief
veterans
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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.

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.

Primary outcomes:
measure: Piper Fatigue Scale
timeFrame: Change from baseline score will be assessed at 6 weeks.
Secondary outcomes:
measure: Changes in corticomuscular coherence
timeFrame: Change from baseline score will be assessed at 6 weeks.
Other outcomes:
measure: Medical Outcome Study Short Form 36
timeFrame: Change from baseline score will be assessed at 6 weeks.
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Vernon W Lin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: