Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia

NCT02846194 | Completed

• 1 other identifier: 0015-16COM2
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect that the Brief Guided Imagery (BGI) technique has on fibromyalgia patients suffering from chronic pain in regards to their sense of pain, wellbeing and quality of life. This study will explore whether daily training of one to two minutes exercises in Brief Guided Imagery can reduce chronic pain and improve the quality of life of patients by studying specifically patients suffering from fibromyalgia. Chronic pain is a common condition which affects person's physical and mental health. It occurs in between 10% to 40% of the population, depending on the exact research and chosen sample. In 2010 Manchikant et al. found an effect chronic pain has on human functioning and quality of life. A research from 2007 defined chronic pain as pain that lasts more than three months. Being long lasting by its nature, chronic pain has an ongoing effect on deteriorating the quality of life. In this regards, quality of life is scientifically determined by five modes: i. Physical wellbeing. ii. Mental wellbeing. iii. Social wellbeing. iv. Emotional wellbeing, and v. sense of development and self-realization. Chronic pain damages daily ongoing functions and is also related to sleep disturbances, stress and unemployment. A direct correlation was also found between chronic pain and psycho-social . One of the many results of chronic pain is the huge impact on the economy, such as absence from work due to sick leaves. The overall cost of chronic pain was found to be one percent of the total expense on health. The frequency and impact of chronic pain is such that some professionals define it as an epidemic. In many cases, chronic pain occurs with patients suffering from a wide spectrum of medical disorders. In 2007 Tunks et al. demonstrated that chronic pain often accompanies an illness that involves also a psychological aspect. Both Baird et al. in 2004 and Menzies et al. in 2012 found a significant positive effect daily guided imagery exercises have on chronic pain. The study proposes to research the specific technique of Brief Guided Imagery on chronic pain, and will focus on patients suffering from fibromyalgia. Fibromyalgia is a syndrome where a patient suffers from both chronic pain and a fatigue. The pain of fibromyalgia is characterized as abstract and non-localized, while the fatigue appears in a varying range of intensity. These symptoms are often accompanied by exhaustion, lack of energy, somatic disorders and psychologic symptoms such as depression. The ongoing pain, fatigue and depression cause fibromyalgia patients to further suffer from sleep disorders and diminishing ability to function. Menzies et al. studied in 2012 the effect of guided imagery exercises on the stress level, pain, fatigue and depression. The study also examined different physiologic blood markers (such as proteins, cytokines and C reactive. Menzies found a positive and significantly large improvement in the ability to control both stress and pain levels, and treat the depression of the participants. However, no significant changes were observed in the blood tests monitoring the levels of physiologic markers in the blood.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Fibromyalgia; Guided Imagery; chronic pain

Outcome Measures

Primary Outcomes (1)

• Changes in Pain

  pain will be measure by BPI questionnaire

  Week 0 , Week 6

Secondary Outcomes (1)

• Changes in Quality of Life

  week 0, Week 6

Study Arms (2)

brief guided imagery

EXPERIMENTAL

The study group of our research will go through six Brief Guided Imagery sessions. These sessions will be completed within two months and will last one hour each.

Behavioral: brief guided imagery

control group

NO INTERVENTION

Interventions

brief guided imagery BEHAVIORAL

brief guided imagery

Eligibility Criteria

• Age: 22 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with Fibromyalgia that suffers from pain at least for 3 months

You may not qualify if:

• lliterates

Sponsors & Collaborators

• Pablo Roitman: lead

Study Sites (1)

Ramat Eshkol Clalit health services

Jerusalem, Israel

Location

Related Publications (13)

• Baird CL, Sands L. A pilot study of the effectiveness of guided imagery with progressive muscle relaxation to reduce chronic pain and mobility difficulties of osteoarthritis. Pain Manag Nurs. 2004 Sep;5(3):97-104. doi: 10.1016/j.pmn.2004.01.003.

  PMID: 15359221 BACKGROUND

• Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.

  PMID: 16095934 BACKGROUND

• Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

  PMID: 6602967 BACKGROUND

• Chandra A, Ozturk A. Quality of life issues and assessment tools as they relate to patients with chronic nonmalignant pain. Hosp Top. 2005 Winter;83(1):33-7. doi: 10.3200/htps.83.1.33-37. No abstract available.

  PMID: 16092637 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Felce D, Perry J. Quality of life: its definition and measurement. Res Dev Disabil. 1995 Jan-Feb;16(1):51-74. doi: 10.1016/0891-4222(94)00028-8.

  PMID: 7701092 BACKGROUND

• Richter K, Egger R, Negri L, Corsi R, Severini C, Kreil G. cDNAs encoding [D-Ala2]deltorphin precursors from skin of Phyllomedusa bicolor also contain genetic information for three dermorphin-related opioid peptides. Proc Natl Acad Sci U S A. 1990 Jun;87(12):4836-9. doi: 10.1073/pnas.87.12.4836.

  PMID: 2352951 BACKGROUND

• Jain S, McMahon GF, Hasen P, Kozub MP, Porter V, King R, Guarneri EM. Healing Touch with Guided Imagery for PTSD in returning active duty military: a randomized controlled trial. Mil Med. 2012 Sep;177(9):1015-21. doi: 10.7205/milmed-d-11-00290.

  PMID: 23025129 BACKGROUND

• Twycross A. Nurses' views about the barriers and facilitators to effective management of pediatric pain. Pain Manag Nurs. 2013 Dec;14(4):e164-e172. doi: 10.1016/j.pmn.2011.10.007. Epub 2011 Dec 14.

  PMID: 24315269 BACKGROUND

• Lahmann C, Nickel M, Schuster T, Sauer N, Ronel J, Noll-Hussong M, Tritt K, Nowak D, Rohricht F, Loew T. Functional relaxation and guided imagery as complementary therapy in asthma: a randomized controlled clinical trial. Psychother Psychosom. 2009;78(4):233-9. doi: 10.1159/000214445. Epub 2009 Apr 28.

  PMID: 19401624 BACKGROUND

• Lyon D, McCain N, Elswick RK, Sturgill J, Ameringer S, Jallo N, Menzies V, Robins J, Starkweather A, Walter J, Grap MJ. Biobehavioral examination of fatigue across populations: report from a P30 Center of Excellence. Nurs Outlook. 2014 Sep-Oct;62(5):322-31. doi: 10.1016/j.outlook.2014.06.008. Epub 2014 Jul 18.

  PMID: 25218081 BACKGROUND

• D'Antoni ML, Harvey PL, Fried MP. Alternative medicine: does it play a role in the management of voice disorders? J Voice. 1995 Sep;9(3):308-11. doi: 10.1016/s0892-1997(05)80239-5.

  PMID: 8541975 BACKGROUND

• McHorney CA, Haley SM, Ware JE Jr. Evaluation of the MOS SF-36 Physical Functioning Scale (PF-10): II. Comparison of relative precision using Likert and Rasch scoring methods. J Clin Epidemiol. 1997 Apr;50(4):451-61. doi: 10.1016/s0895-4356(96)00424-6.

  PMID: 9179104 BACKGROUND

Related Links

• Prediction of function in daily life following multidisciplinary rehabilitation for individuals with chronic musculoskeletal pain; a prospective study

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anat Kaplun

  Ministry of Health, Israel

  STUDY DIRECTOR

• Pablo Roitman, MD

  Clalit Heath Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

IL (1)