The Effects of Training and Relaxation on Fibromyalgia.

Fibromyalgia Clinical Trial

Official title:

The Effects of Training and Relaxation on Fibromyalgia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226784
• Other study ID #: RF 2010 stud GLS
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.

Description:

A multi-center trial examining the effects of progressive resistance group exercise compared with an active control group (relaxation). A person-centred model of exercise was used. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists. Secondary aims off this multi-center study was to improve the understanding of pain mechanisms in fibromyalgia and how these are affected by physical exercise. Please see references of published articles for details.

Recruitment information / eligibility

• 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 -

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Physcial activity
Strenght training Relaxation exercise

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Linkopings University Hospital	Linkoping
Sweden	Karolinska Institute	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (21)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle function	isometric knee-extension force (Steve Strong®)	2010-2013
Secondary	Fibromyalgia impact questionnaire	Ratings on FIQ, total score	2010-2013
Secondary	VAS pain	Pain intensity ratings on VAS	2010-2013