FibromyalgiaNCT02846194
Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia
A study testing brief guided imagery in people with Fibromyalgia and Chronic Pain, run by Pablo Roitman at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 72 years
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- brief guided imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with Fibromyalgia that suffers from pain at least for 3 months
Who cannot join
- lliterates
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Hypothesis Chronic pain imposes great suffering on patients as well as a heavy extra expenditure on the healthcare system . In addition, it many patients of chronic pain were found to also suffer from depression .
Guided imagery was found to be an effective technique to reduce chronic pain deriving from muscle or skeletal pain and from fibromyalgia. Guided imagery treatment carries low therapeutic costs and is noninvasive. It also puts the main emphasis of the process on the patient's satisfaction .Furthermore, a quantitative study by Kaplan et al. in 2014 found that daily exercises of guided imagery improved the sense of wellbeing among university students.
However, the improvement in the sense of wellbeing due to the practice of daily guided imagery was not tested empirically. Therefore, the investigators suggested research will look into the empirical effect of Brief Guided Imagery on chronic pain. The investigators will study the Colette technique for Brief Guided Imagery using short one to two minutes guided imagery exercises to try and determine the empiric effect brief exercises have on pain sensation and quality of life when performed by fibromyalgia patients with chronic pain.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- brief guided imagery
- Keywords
- Fibromyalgia, Guided Imagery, chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief guided imageryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: brief guided imagery |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain
pain will be measure by BPI questionnaire
Measured: Week 0 , Week 6
Secondary outcomes (1)
Changes in Quality of Life
Quality of Life will be measure by SF36 questionnaire
Measured: week 0, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pablo Roitman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pablo Roitman, Clalit Health Services
- Investigators
- Anat Kaplun, Study director, Ministry of Health, IsraelPablo Roitman, MD, Principal investigator, Clalit Heath Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846194
- Sponsor's protocol ID
- 0015-16COM2
- Status last verified
- Feb 2021
- First submitted
- 19 Jul 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15359221Breivik 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.
PubMed 16095934Carlsson 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.
PubMed 6602967Chandra 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.
PubMed 16092637Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Felce 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.
PubMed 7701092Richter 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.
PubMed 2352951Jain 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.
PubMed 23025129Twycross 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.
PubMed 24315269Lahmann 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.
PubMed 19401624Lyon 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.
PubMed 25218081D'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.
PubMed 8541975McHorney 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.
PubMed 9179104
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brief Guided Imagery for Chronic Pain in Patients Diagnosed With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02846194
- Acronym / sponsor ID
- 0015-16COM2
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Fibromyalgia, Guided Imagery, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Pablo RoitmanUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis Chronic pain imposes great suffering on patients as well as a heavy extra expenditure on the healthcare system . In addition, it many patients of chronic pain were found to also suffer from depression .
Guided imagery was found to be an effective technique to reduce chronic pain deriving from muscle or skeletal pain and from fibromyalgia. Guided imagery treatment carries low therapeutic costs and is noninvasive. It also puts the main emphasis of the process on the patient's satisfaction .Furthermore, a quantitative study by Kaplan et al. in 2014 found that daily exercises of guided imagery improved the sense of wellbeing among university students.
However, the improvement in the sense of wellbeing due to the practice of daily guided imagery was not tested empirically. Therefore, the investigators suggested research will look into the empirical effect of Brief Guided Imagery on chronic pain. The investigators will study the Colette technique for Brief Guided Imagery using short one to two minutes guided imagery exercises to try and determine the empiric effect brief exercises have on pain sensation and quality of life when performed by fibromyalgia patients with chronic pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brief guided imagery | Experimental | Behavioral: brief guided imageryThe 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. |
| control group | No intervention | – |
Who may qualify
- Ages
- 22 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with Fibromyalgia that suffers from pain at least for 3 months
Key exclusion criteria (1 listed)
- lliterates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief guided imagery | Behavioural | brief guided imagery |
Primary outcome
Changes in Pain
Time frame: Week 0 , Week 6
pain will be measure by BPI questionnaire
1 secondary outcome
Changes in Quality of Life
Time frame: week 0, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 15359221Baird 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.
- Background: PubMed 16095934Breivik 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.
- Background: PubMed 6602967Carlsson 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.
- Background: PubMed 16092637Chandra 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.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 7701092Felce 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.
- Background: PubMed 2352951Richter 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.
- Background: PubMed 23025129Jain 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.
- Background: PubMed 24315269Twycross 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.
- Background: PubMed 19401624Lahmann 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.
- Background: PubMed 25218081Lyon 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.
- Background: PubMed 8541975D'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.
- Prediction of function in daily life following multidisciplinary rehabilitation for individuals with chronic musculoskeletal pain; a prospective studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anat Kaplun study director
Ministry of Health, Israel
Pablo Roitman, MD principal investigator
Clalit Heath Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief guided imagery in people with Fibromyalgia and Chronic Pain, run by Pablo Roitman at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain (time frame: Week 0 , Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846194, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.