Fibromyalgia Clinical Trial
Official title:
The Effects of Training and Relaxation on Fibromyalgia.
Verified date | October 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.
Status | Completed |
Enrollment | 240 |
Est. completion date | October 2020 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: ACR 1990 criteria for fibromyalgia - Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise - |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Sweden | Linkopings University Hospital | Linkoping | |
Sweden | Karolinska Institute | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping |
Sweden,
Bjersing JL, Larsson A, Palstam A, Ernberg M, Bileviciute-Ljungar I, Löfgren M, Gerdle B, Kosek E, Mannerkorpi K. Benefits of resistance exercise in lean women with fibromyalgia: involvement of IGF-1 and leptin. BMC Musculoskelet Disord. 2017 Mar 14;18(1):106. doi: 10.1186/s12891-017-1477-5. — View Citation
Christidis N, Ghafouri B, Larsson A, Palstam A, Mannerkorpi K, Bileviciute-Ljungar I, Löfgren M, Bjersing J, Kosek E, Gerdle B, Ernberg M. Comparison of the Levels of Pro-Inflammatory Cytokines Released in the Vastus Lateralis Muscle of Patients with Fibromyalgia and Healthy Controls during Contractions of the Quadriceps Muscle--A Microdialysis Study. PLoS One. 2015 Dec 1;10(12):e0143856. doi: 10.1371/journal.pone.0143856. eCollection 2015. — View Citation
Ericsson A, Palstam A, Larsson A, Löfgren M, Bileviciute-Ljungar I, Bjersing J, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves physical fatigue in women with fibromyalgia: a randomized controlled trial. Arthritis Res Ther. 2016 Jul 30;18:176. doi: 10.1186/s13075-016-1073-3. — View Citation
Ernberg M, Christidis N, Ghafouri B, Bileviciute-Ljungar I, Löfgren M, Bjersing J, Palstam A, Larsson A, Mannerkorpi K, Gerdle B, Kosek E. Plasma Cytokine Levels in Fibromyalgia and Their Response to 15 Weeks of Progressive Resistance Exercise or Relaxation Therapy. Mediators Inflamm. 2018 Apr 18;2018:3985154. doi: 10.1155/2018/3985154. eCollection 2018. — View Citation
Ernberg M, Christidis N, Ghafouri B, Bileviciute-Ljungar I, Löfgren M, Larsson A, Palstam A, Bjersing J, Mannerkorpi K, Kosek E, Gerdle B. Effects of 15 weeks of resistance exercise on pro-inflammatory cytokine levels in the vastus lateralis muscle of patients with fibromyalgia. Arthritis Res Ther. 2016 Jun 13;18(1):137. doi: 10.1186/s13075-016-1041-y. — View Citation
Flodin P, Martinsen S, Löfgren M, Bileviciute-Ljungar I, Kosek E, Fransson P. Fibromyalgia is associated with decreased connectivity between pain- and sensorimotor brain areas. Brain Connect. 2014 Oct;4(8):587-94. doi: 10.1089/brain.2014.0274. Epub 2014 Aug 7. — View Citation
Flodin P, Martinsen S, Mannerkorpi K, Löfgren M, Bileviciute-Ljungar I, Kosek E, Fransson P. Normalization of aberrant resting state functional connectivity in fibromyalgia patients following a three month physical exercise therapy. Neuroimage Clin. 2015 Aug 18;9:134-9. doi: 10.1016/j.nicl.2015.08.004. eCollection 2015. — View Citation
Gerdle B, Ernberg M, Mannerkorpi K, Larsson B, Kosek E, Christidis N, Ghafouri B. Increased Interstitial Concentrations of Glutamate and Pyruvate in Vastus Lateralis of Women with Fibromyalgia Syndrome Are Normalized after an Exercise Intervention - A Case-Control Study. PLoS One. 2016 Oct 3;11(10):e0162010. doi: 10.1371/journal.pone.0162010. eCollection 2016. — View Citation
Jablochkova A, Bäckryd E, Kosek E, Mannerkorpi K, Ernberg M, Gerdle B, Ghafouri B. Unaltered low nerve growth factor and high brain-derived neurotrophic factor levels in plasma from patients with fibromyalgia after a 15-week progressive resistance exercise. J Rehabil Med. 2019 Oct 29;51(10):779-787. doi: 10.2340/16501977-2593. — View Citation
Kosek E, Martinsen S, Gerdle B, Mannerkorpi K, Löfgren M, Bileviciute-Ljungar I, Fransson P, Schalling M, Ingvar M, Ernberg M, Jensen KB. The translocator protein gene is associated with symptom severity and cerebral pain processing in fibromyalgia. Brain Behav Immun. 2016 Nov;58:218-227. doi: 10.1016/j.bbi.2016.07.150. Epub 2016 Jul 20. — View Citation
Larsson A, Palstam A, Bjersing J, Löfgren M, Ernberg M, Kosek E, Gerdle B, Mannerkorpi K. Controlled, cross-sectional, multi-center study of physical capacity and associated factors in women with fibromyalgia. BMC Musculoskelet Disord. 2018 Apr 19;19(1):121. doi: 10.1186/s12891-018-2047-1. — View Citation
Larsson A, Palstam A, Löfgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Pain and fear avoidance partially mediate change in muscle strength during resistance exercise in women with fibromyalgia. J Rehabil Med. 2017 Nov 21;49(9):744-750. doi: 10.2340/16501977-2278. — View Citation
Larsson A, Palstam A, Löfgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17:161. doi: 10.1186/s13075-015-0679-1. — View Citation
Martinsen S, Flodin P, Berrebi J, Löfgren M, Bileviciute-Ljungar I, Ingvar M, Fransson P, Kosek E. Fibromyalgia patients had normal distraction related pain inhibition but cognitive impairment reflected in caudate nucleus and hippocampus during the Stroop Color Word Test. PLoS One. 2014 Oct 2;9(9):e108637. doi: 10.1371/journal.pone.0108637. eCollection 2014. — View Citation
Martinsen S, Flodin P, Berrebi J, Löfgren M, Bileviciute-Ljungar I, Mannerkorpi K, Ingvar M, Fransson P, Kosek E. The role of long-term physical exercise on performance and brain activation during the Stroop colour word task in fibromyalgia patients. Clin Physiol Funct Imaging. 2018 May;38(3):508-516. doi: 10.1111/cpf.12449. Epub 2017 Jun 18. — View Citation
Palstam A, Larsson A, Bjersing J, Löfgren M, Ernberg M, Bileviciute-Ljungar I, Ghafouri B, Sjörs A, Larsson B, Gerdle B, Kosek E, Mannerkorpi K. Perceived exertion at work in women with fibromyalgia: explanatory factors and comparison with healthy women. J Rehabil Med. 2014 Sep;46(8):773-80. doi: 10.2340/16501977-1843. — View Citation
Palstam A, Larsson A, Löfgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Decrease of fear avoidance beliefs following person-centered progressive resistance exercise contributes to reduced pain disability in women with fibromyalgia: secondary exploratory analyses from a randomized controlled trial. Arthritis Res Ther. 2016 May 21;18(1):116. doi: 10.1186/s13075-016-1007-0. — View Citation
Stensson N, Gerdle B, Ernberg M, Mannerkorpi K, Kosek E, Ghafouri B. Increased Anandamide and Decreased Pain and Depression after Exercise in Fibromyalgia. Med Sci Sports Exerc. 2020 Jul;52(7):1617-1628. doi: 10.1249/MSS.0000000000002293. — View Citation
Stensson N, Ghafouri N, Ernberg M, Mannerkorpi K, Kosek E, Gerdle B, Ghafouri B. The Relationship of Endocannabinoidome Lipid Mediators With Pain and Psychological Stress in Women With Fibromyalgia: A Case-Control Study. J Pain. 2018 Nov;19(11):1318-1328. doi: 10.1016/j.jpain.2018.05.008. Epub 2018 Jun 7. — View Citation
Tour J, Löfgren M, Mannerkorpi K, Gerdle B, Larsson A, Palstam A, Bileviciute-Ljungar I, Bjersing J, Martin I, Ernberg M, Schalling M, Kosek E. Gene-to-gene interactions regulate endogenous pain modulation in fibromyalgia patients and healthy controls-antagonistic effects between opioid and serotonin-related genes. Pain. 2017 Jul;158(7):1194-1203. doi: 10.1097/j.pain.0000000000000896. — View Citation
Wåhlén K, Ernberg M, Kosek E, Mannerkorpi K, Gerdle B, Ghafouri B. Significant correlation between plasma proteome profile and pain intensity, sensitivity, and psychological distress in women with fibromyalgia. Sci Rep. 2020 Jul 27;10(1):12508. doi: 10.1038/s41598-020-69422-z. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle function | isometric knee-extension force (Steve StrongĀ®) | 2010-2013 | |
Secondary | Fibromyalgia impact questionnaire | Ratings on FIQ, total score | 2010-2013 | |
Secondary | VAS pain | Pain intensity ratings on VAS | 2010-2013 |
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