Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans

NCT02075489 | Completed

• 1 other identifier: W81XWH1210567
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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. 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. 2.EEG measures will exhibit a positive change when fatigue is relieved and pain is alleviated for symptomatic veterans after effective treatment.

Conditions

Persian Gulf Syndrome; Chronic Fatigue Syndrome

Keywords

Acupressure; Reiki; EEG; EMG; fatigue relief; veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in corticomuscular coherence

  Change from baseline score will be assessed at 6 weeks.

Other Outcomes (1)

• Medical Outcome Study Short Form 36

  Change from baseline score will be assessed at 6 weeks.

Study Arms (2)

Acupressure

EXPERIMENTAL

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).

Other: Acupressure treatment.

Reiki

ACTIVE COMPARATOR

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).

Other: Reiki

Interventions

Acupressure treatment. OTHER

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.

Acupressure

Reiki OTHER

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.

Reiki

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with Gulf War Illness for more than 6 months
• Over 18 years old (male or female)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Persian Gulf Syndrome; Fatigue Syndrome, Chronic

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Vernon W Lin, MD PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: September 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)