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No effect of approved fibromyalgia drugs on the social pain (invalidation) contrary to physical pain: an open-label short-term randomized clinical trial

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Abstract

Objectives

The social pain or invalidation denoting painful feeling following social conflicts or misunderstanding about illness legitimacy has been proposed as a salient disabling symptom besides physical pain or non-pain symptoms in fibromyalgia (FM). We sought to evaluate the effect of 1-month administration of duloxetine or pregabalin on the invalidation dimensions in FM patients with respect to the comparison of these two drugs on this issue.

Method

This open-label randomized clinical trial study was performed on FM patients whose diagnoses were confirmed by a rheumatologist based on the 2016 American College of Rheumatology (ACR). Primary outcome measure (Illness Invalidation Inventory (3*I)) and secondary outcome measures (Beck Depression Inventory-II (BDI-II), widespread pain index (WPI), and polysymptomatic distress scale (PSD)) were compared before and after treatment, using paired t test or Wilcoxon signed test.

Results

Of 81 eligible FM patients, 44 patients in the duloxetine arm and 27 patients in the pregabalin arm completed the study protocol. Overall, no significant improvement was seen in 3*I scores after treatment with either duloxetine or pregabalin, except in the lack of understanding of medical professionals which improved after treatment with pregabalin (2.43 ± 1.38 to 1.79 ± 0.94, p value: 0.01). There were no intragroup and intergroup differences in the effects of duloxetine and pregabalin on 3*I scores when adjusted with the cofounders. Both duloxetine and pregabalin improved WPI, BDI-II, and PSD scores significantly.

Conclusions

Short-term FM pharmacological treatment had no effect on social pain. This finding was regardless of drug type, improvement of physical pain, and depression.

Key Points

• Social pain may behave as an independent but influential factor in FM rather than physical pain and depression.

• Approved FM medications do not seem to change predictably the invalidation perception, which is a crucial factor in chronicity and maintaining of FM symptoms.

• Dedicated approach to social pain seems necessary for the depiction of future successful therapeutic plan in FM.

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Data availability

Data associated with the paper is available and will be provided if requested under reasonable conditions.

Code availability

Not applicable.

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Acknowledgements

The authors thank all the colleagues at the Guilan University of Medical Sciences, Rasht, Iran, who contributed to this research.

Funding

The source of funding was the Guilan University of Medical Sciences.

Author information

Author notes

  1. Banafsheh Ghavidel-Parsa and Ali Bidari contributed equally to this work

Authors and Affiliations

  1. School of Medicine, Rheumatology Research Center, Razi Hospital, Guilan University of Medical Science, Rasht, Guilan, Iran

    Banafsheh Ghavidel-Parsa

  2. Department of Rheumatology, Iran University of Medical Sciences, Tehran, Iran

    Ali Bidari

  3. Student Research Committee, Faculty of Medicine, Guilan University of Medical Sciences, Rasht, Guilan, Iran

    Ashkan Rahimi & Faeze Gharibpoor

  4. Gastrointestinal and Liver Disease Research Center, Guilan University of Medical Sciences, Rasht, Iran

    Mohammad-Javad Khosousi

Authors
  1. Banafsheh Ghavidel-Parsa
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  2. Ali Bidari
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  4. Faeze Gharibpoor
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  5. Mohammad-Javad Khosousi
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Contributions

B.G.H. and A.B. contributed equally to the design of the work; all the authors made substantial contributions to the acquisition, analysis, interpretation of data, and first draft of the article. All the authors read and approved the final manuscript. They agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Banafsheh Ghavidel-Parsa.

Ethics declarations

Ethics approval

The study protocol was approved by the ethics committee of Guilan University of Medical Sciences (IR.GUMS.REC.1398.208) in accordance with the World Medical Association’s code of ethics (Declaration of Helsinki, revised in Brazil 2013) and registered at an ICMJE-recognized registry of clinical trials (IRCT20181113041646N1; www.irct.ir).

Consent to participate

All participants were clearly informed about the study design and written informed consent was obtained from all volunteers.

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All participants gave their written consent on the publication of their clinical data. They were assured that their names will not be revealed.

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Cite this article

Ghavidel-Parsa, B., Bidari, A., Rahimi, A. et al. No effect of approved fibromyalgia drugs on the social pain (invalidation) contrary to physical pain: an open-label short-term randomized clinical trial. Clin Rheumatol 41, 245–254 (2022). https://doi.org/10.1007/s10067-021-05890-6

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  • DOI: https://doi.org/10.1007/s10067-021-05890-6

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