Treatment methods for rehabilitation of fibromyalgia

A systematic review

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SBU Assessment

Presents a comprehensive, systematic assessment of available scientific evidence for effects on health, social welfare or disability. Full assessments include economic, social and ethical impact analyses. Assessment teams include professional practitioners and academics. Before publication the report is reviewed by external experts, and scientific conclusions approved by the SBU Board of Directors.

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Published: Report no: 340 Registration no: SBU 2019/500 ISBN: 978-91-88437-83-9 https://int.sbu.se/340e

Conclusions

  • Few high-quality studies of treatments for fibromyalgia study long-term effects on health. We identified some studies of psychological therapies, psycho-educative interventions, interventions that promote physical activity and acupuncture. However, the studies identified were too few and too small to allow us to reliably judge the health effects of the interventions.
  • Results for two pharmacological substances, Duloxetine and Pregabalin show that, when measured three months after initiated treatment, patients assess themselves as improved (low certainty of evidence); that Duloxetine can reduce pain interference and depressive symptoms (low certainty of evidence); and that Pregabalin can reduce symptoms of fibromyalgia and pain intensity, and improve sleep quality (low certainty of evidence)..

Comment

Participants in the included studies may differ somewhat from fibromyalgia patients in the clinic today. A majority of the studies established a diagnosis of fibromyalgia using the 1990 criteria from American College of Rheumatology (ACR-1990). The criteria have been revised since and differences between the earlier and later versions of the ACR-criteria affect who gets diagnosed. Moreover, in the clinic patients often have comorbid conditions in addition to fibromyalgia.

The differences between fibromyalgia patients diagnosed with fibromyalgia before and after the criteria changed, as well as the presence of comorbid conditions, may affect both the need for, and the effects of treatments. Investigations of treatment effects in such subgroups of fibromyalgia patients are needed.

Background

Fibromyalgia is characterized by widespread musculoskeletal pain. In addition, people with fibromyalgia often experience sleep problems and fatigue. Comorbidity with depression and anxiety is common. There is no cure for fibromyalgia, rather the goal of treatment is to improve health and to restore function and quality of life.

Aim

The aim of the review is to present the current evidence for long-term effects on health of treatments used for rehabilitation of people with fibromyalgia, measured as quality of life, physical, psychological and social function, and pain.

The review did not include multimodal or multidisciplinary forms of rehabilitation which are instead covered in www.sbu.se/341e

Method

A systematic review was conducted in accordance with the PRISMA statement. The protocol is registered in Prospero. The certainty of evidence was assessed with GRADE.

Inclusion criteria

The review was limited to treatments of relevance for Swedish healthcare and to treatments used for long-term improvement of fibromyalgia. Studies had to fulfil the following criteria for inclusion in the review:

  • Population – adults (≥18 years) diagnosed with fibromyalgia.
  • Intervention – treatments aimed at improving fibromyalgia or consequences of the condition
  • Control – other relevant treatments, no treatment, or treatment as usual.
  • Outcomes – effects on health:pain, quality of life, and mental, physical or social function
  • Study design – prospective and controlled clinical trials, with or without randomised allocation
  • Length of follow-up – at least three months after initiated treatment. In addition, temporary interventions, i.e. all treatments except continuous pharmacological therapies, must report a follow-up directly after termination of treatment
  • Language – English, Swedish, Danish or Norwegian

Exclusion criteria

We chose not to include:

  • Studies that allowed participants with other primary conditions, apart from fibromyalgia
  • Studies with fewer than 20 participants per comparison group

Search period: From 2000 to 2021. Final search February, 2021.

Databases searched: Cochrane (Wiley), Embase (Elsevier), Medline (OvidSP), PsycINFO (Ebsco), Scopus (Elsevier) and CINAHL (Ebsco).

Risk of bias

All relevant studies were assessed for risk of bias. Studies with results assessed as of low or moderate risk of bias were included in analyses. Studies with results assessed as of high risk of bias were not included.

Client/patient involvement: No

Results

A total of 34 studies are included in the assessments of health effects of different treatments:

  • Pharmacological substances: 6 studies
  • Psychological therapies: 15 studies
  • Physical activity and acupuncture: 9 studies
  • Psychoeducation: 4 studies

Interventions investigated in at least two studies are included in the assessments of health effects. We also identified interventions for which we only could include a single study. They were not assessed but we report them for information. Studies which investigated effects of multimodal treatments are reported in [länk till eng. sammanfattning av rapporten om multimodal behandling].

Pharmacological treatments

We evaluated the effects of two different substances for long-term improvement of fibromyalgia symptoms: duloxetine and pregabalin. For both substances the assessments included three original studies.

Table 1 Pharmacological therapies compared to placebo: effects during treatment.
FIQ = Fibromyalgia Impact Questionnaire, QoL = Quality of Life

* Results from the review:
↑ = Better effect;
↓ = Less effect;
↔ = No detectable effect (statistical test result of p >0.05 for a difference in effect between comparison groups).

** Evaluation of the strength of evidence of a result according to GRADE:
⊕⊕⊕⊕ = High;
⊕⊕⊕◯ = Moderate;
⊕⊕◯◯ = Low;
⊕◯◯◯ = Very low (meaning that the trustworthiness of the result is very low and can’t be used to evaluate the true effect – even if a statistical test reached p <0.05).
Outcome   Duloxetine
3 months after initiation of treatment		 Pregabalin
3 months after initiation of treatment
Fibromyalgia symptoms FIQ ↑* ⊕◯◯◯** ↑* ⊕⊕◯◯**
Quality of Life Mental QoL ↑ ⊕⊕◯◯ ↔ ⊕◯◯◯
  Physical QoL ↔ ⊕◯◯◯ ↔ ⊕◯◯◯
  Global change ↑ ⊕◯◯◯ ↑ ⊕⊕◯◯
Body Functions          
Pain Pain intensity ↔ ⊕◯◯◯ ↑ ⊕⊕◯◯
  Pain interference ↑ ⊕⊕◯◯    
Psychological symptoms Depression ↑ ⊕⊕◯◯ ↔ ⊕◯◯◯
  Anxiety ↔ ⊕◯◯◯ ↑ ⊕◯◯◯
  Sleep Quality     ↑ ⊕⊕◯◯
  Fatigue ↑ ⊕◯◯◯ ↔ ⊕◯◯◯
Mental and physical Function Cognitive och Physical function ↔ ⊕◯◯◯    

Psychological treatments

We evaluated the effects of Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT) and Mindfulness Based Stress Reduction (MBSR). The assessment of CBT, ACT, and MBSR included eight, two, and five studies respectively.

Table 2 Psychological therapies compared to treatment as usual or waiting list: effects after end of treatment.
FIQ = Fibromyalgia Impact Questionnaire; QoL = Quality of Life

* Results from the review:
↑ = Better effect;
↓ = Less effect;
↔ = No detectable effect (statistical test result of p >0.05 for a difference in effect between comparison groups).

** Evaluation of the strength of evidence of a result according to GRADE:
⊕⊕⊕⊕ = High;
⊕⊕⊕◯ = Moderate;
⊕⊕◯◯ = Low;
⊕◯◯◯ = Very low (meaning that the trustworthiness of the result is very low and can’t be used to evaluate the true effect – even if a statistical test reached p <0.05).
Outcome   CBT
3–6 months after end of treatment		 ACT
3 months after end of treatment		 MBSR
2–10 months after end of treatment
Fibromyalgia symptoms FIQ ↔* ⊕◯◯◯** ↑* ⊕◯◯◯** ↑* ⊕◯◯◯**
Quality of Life Global QoL     ↔ ⊕◯◯◯ ↓ ⊕◯◯◯
  Mental QoL ↔ ⊕◯◯◯        
  Physical QoL ↔ ⊕◯◯◯        
Body Functions              
Pain Pain Intensity ↔ ⊕◯◯◯ ↔ ⊕◯◯◯ ↔ ⊕◯◯◯
  Pain Interference         ↔ ⊕◯◯◯
Psychological symptoms Depression ↔ ⊕◯◯◯ ↑ ⊕◯◯◯ ↔ ⊕◯◯◯
  Anxiety ↔ ⊕◯◯◯     ↔ ⊕◯◯◯
  Stress/Distress         ↑ ⊕◯◯◯
  Catastrophising ↔ ⊕◯◯◯ ↔ ⊕◯◯◯ ↑ ⊕◯◯◯
  Sleep problems ↑ ⊕◯◯◯ ↔ ⊕◯◯◯ ↔ ⊕◯◯◯
Activities and Participation              
Impairment Physical         ↔ ⊕◯◯◯
  Cognitive         ↑ ⊕◯◯◯
Personal Factors              
Coping Self efficacy ↑ ⊕◯◯◯        
  Coping with sleep ↓ ⊕◯◯◯        
  Acceptance ↑ ⊕◯◯◯ ↑ ⊕◯◯◯    

Physical activity and Acupuncture

We evaluated the effects of guided physical activity (physical activity under guidance from a physiotherapist or other therapist) and of Acupuncture. The assessment of guided physical activity included nine studies, and the assessment of acupuncture included three studies.

Table 3 Guided Physical Activity compared to less active interventions for physical activity, treatment as usual or waiting list and Acupuncture compared to sham-treatment: effects after end of treatment.
FIQ = Fibromyalgia Impact Questionnaire; QoLADL = Activities of Daily Life

* Results from the review:
↑ = Better effect;
↓ = Less effect;
↔ = No detectable effect (statistical test result of p >0.05 for a difference in effect between comparison groups).

** Evaluation of the strength of evidence of a result according to GRADE:
⊕⊕⊕⊕ = High;
⊕⊕⊕◯ = Moderate;
⊕⊕◯◯ = Low;
⊕◯◯◯ = Very low (meaning that the trustworthiness of the result is very low and can’t be used to evaluate the true effect – even if a statistical test reached p <0.05).
Outcome   Guided Physical Activity
3–12 months after end of treatment		 Acupuncture
3–24 months after end of treatment
Fibromyalgia symptoms FIQ ↑* ⊕◯◯◯** ↑* ⊕◯◯◯**
Quality of Life Mental QoL     ↔ ⊕◯◯◯
  Physical QoL     ↔ ⊕◯◯◯
  Gobal change ↔ ⊕◯◯◯    
Body Functions          
Pain Pain intensity ↔ ⊕◯◯◯ ↔ ⊕◯◯◯
Psychological symptoms Depression ↔ ⊕◯◯◯ ↓ ⊕◯◯◯
  Anxiety ↔ ⊕◯◯◯    
  Stress/Distress ↔ ⊕◯◯◯    
  Sleep problems     ↔ ⊕◯◯◯
  Fatigue ↔ ⊕◯◯◯ ↔ ⊕◯◯◯
Activities and Participation          
Impairment ADL ↔ ⊕◯◯◯    
Personal Factors          
Coping Acceptance ↔ ⊕◯◯◯    

Psychoeducation

We evaluated the effects multimodal psychoeducation (psychoeducative interventions led by lecturers/therapists from several clinical professions). The assessment included four studies.

Table 4 Multimodal psychoeducation compared to treatment as usual: effects after end of treatment.
FIQ = Fibromyalgia Impact Questionnaire; ADL = Activities of Daily Life

* Results from the review:
↑ = Better effect;
↓ = Less effect;
↔ = No detectable effect (statistical test result of p >0.05 for a difference in effect between comparison groups).

** Evaluation of the strength of evidence of a result according to GRADE:
⊕⊕⊕⊕ = High;
⊕⊕⊕◯ = Moderate;
⊕⊕◯◯ = Low;
⊕◯◯◯ = Very low (meaning that the trustworthiness of the result is very low and can’t be used to evaluate the true effect – even if a statistical test reached p <0.05).
Outcome   Psychoeducation
6–12 months after end of treatment
Fibromyalgia symptoms FIQ ↑* ⊕◯◯◯**
Body Functions      
Pain Pain intensity ↑ ⊕◯◯◯
  Pain interference ↑ ⊕◯◯◯
Psychological symptoms Depression ↔ ⊕◯◯◯
  Anxiety ↔ ⊕◯◯◯
  Stress/Distress ↔ ⊕◯◯◯
  Catastrophising ↑ ⊕◯◯◯
Activities and Participation      
Impairment ADL ↑ ⊕◯◯◯

Other treatments

In total, 19 studies were identified which were considered single studies of an intervention: other pharmacological treatments (mirtazapin, gabapentin and pregabaline in combination with amitriptyline, venlafaxine or paroxetine); psychological therapies (CBT for insomnia and Emotional Written Exposure), psychoeducative interventions, interventions for physical activity, manual therapy (myofascial release) and nerve stimulation of the brain (rTMS). The studies are listed in the report but not included in the assessments.

Conflicts of Interest

In accordance with SBU’s requirements, the experts and scientific reviewers participating in this project have submitted statements about conflicts of interest. These documents are available at SBU’s secretariat. SBU has determined that the conditions described in the submissions are compatible with SBU’s requirements for objectivity and impartiality.

The full report in Swedish

The full report is available in Swedish

Project group

Experts

  • Monica Buhrman, Ph D., Associate Professor
  • Diana Kadetoff, Ph D.
  • Björn Äng, Ph D, Professor

From SBU

  • Anna Christensson, Project Manager
  • Martin Norman, Assistant Project Manager
  • Susanne Johansson, Assistant Project Manager (until May 2020)
  • Jessica Dagerhamn, Assistant Project Manager
  • Anna Attergren Granath, Project Administrator
  • Agneta Brolund, Information Specialist (until December 2020)
  • Carl Gornitzki, Information Specialist (from January 2021)

Scientific reviewers

  • Mari Lundberg, Ph D., Professor
  • Hans Westergren, Ph D., Associate Professor

Flow chart

Flow chart for the literature. Started with identification of 6462 records and in the end were 18 with low risk of bias, 39 with moderate risk of bias and 75 with risk of bias included

Figure 1 Flow chart.

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