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Tension-Type Headache and Masseter Thickness in Fibromyalgia

NCT ID: NCT06713278

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-12-02

Brief Summary

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This study aims to investigate the relationship between tension-type headaches and masseter muscle thickness in women with fibromyalgia syndrome (FMS) and to explore the potential for new therapeutic approaches in the treatment of both headaches and FMS. Additionally, the study seeks to evaluate the impact of headaches on the quality of life in individuals with FMS.

Does tension-type headache associate with increased masseter muscle thickness in women with fibromyalgia syndrome (FMS)? Does tension-type headache negatively impact the quality of life in women with FMS?

Detailed Description

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Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, fatigue, cognitive dysfunction, and tenderness, affecting approximately 5% of the global population, predominantly women. Central sensitization plays a key role in its pathophysiology. Tension-type headaches, the most common in FMS (59.01%), are associated with pericranial muscle sensitivity, anxiety, and reduced quality of life. Increased masseter muscle activity has been observed in tension-type headaches, but its relationship with FMS remains unexplored.

Conditions

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Fibromyalgia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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fibromyalgia with tension type headache

fibromyalgia with tension type headache

masseter muscle thickness measurement

Intervention Type OTHER

masseter muscle thickness measurement with ultrasonography

scales

Intervention Type OTHER

headache impact scale (HIT-6) Short SF-36 fibromyalgia total score widespread pain index symptom severity scale fibromyalgia impact questionnaire (FIQ)

fibromyalgia without tension type headache

fibromyalgia without tension type headache

masseter muscle thickness measurement

Intervention Type OTHER

masseter muscle thickness measurement with ultrasonography

scales

Intervention Type OTHER

headache impact scale (HIT-6) Short SF-36 fibromyalgia total score widespread pain index symptom severity scale fibromyalgia impact questionnaire (FIQ)

control group

control group

masseter muscle thickness measurement

Intervention Type OTHER

masseter muscle thickness measurement with ultrasonography

scales

Intervention Type OTHER

headache impact scale (HIT-6) Short SF-36 fibromyalgia total score widespread pain index symptom severity scale fibromyalgia impact questionnaire (FIQ)

Interventions

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masseter muscle thickness measurement

masseter muscle thickness measurement with ultrasonography

Intervention Type OTHER

scales

headache impact scale (HIT-6) Short SF-36 fibromyalgia total score widespread pain index symptom severity scale fibromyalgia impact questionnaire (FIQ)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women aged 18-65 years.
* Diagnosed with fibromyalgia syndrome (FMS) according to the 2016 American College of Rheumatology (ACR) diagnostic criteria.
* At least one year since the FMS diagnosis.
* Chronic tension-type headache lasting for at least six months.
* Diagnosed with tension-type headache by a neurologist based on the International Classification of Headache Disorders (ICHD-3) criteria.

Exclusion Criteria

* Patients with neurological or psychiatric disorders.
* Patients using medications related to the central nervous system.
* Those with temporomandibular dysfunction.
* Patients with rheumatologic diseases.
* Individuals undergoing dental treatment or using dental prostheses.
* Those with facial tumors or a history of facial surgery.
* Pregnant women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Handan Elif Nur BAYRAKTAR

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Çorum Hitit University Erol Olçok Training and Research Hospital

Çorum, Çorum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Moraska AF, Stenerson L, Butryn N, Krutsch JP, Schmiege SJ, Mann JD. Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: a randomized, placebo-controlled clinical trial. Clin J Pain. 2015 Feb;31(2):159-68. doi: 10.1097/AJP.0000000000000091.

Reference Type BACKGROUND
PMID: 25329141 (View on PubMed)

Shields G, Smith JM. Remedial Massage Therapy Interventions Including and Excluding Sternocleidomastoid, Scalene, Temporalis, and Masseter Muscles for Chronic Tension Type Headaches: a Case Series. Int J Ther Massage Bodywork. 2020 Feb 26;13(1):22-31. eCollection 2020 Mar.

Reference Type BACKGROUND
PMID: 32133042 (View on PubMed)

Martin-Vera D, Sanchez-Sierra A, Gonzalez-de-la-Flor A, Garcia-Perez-de-Sevilla G, Dominguez-Balmaseda D, Del-Blanco-Muniz JA. Efficacy of a strength-based exercise program in patients with chronic tension type headache: a randomized controlled trial. Front Neurol. 2023 Sep 18;14:1256303. doi: 10.3389/fneur.2023.1256303. eCollection 2023.

Reference Type BACKGROUND
PMID: 37789886 (View on PubMed)

de Tommaso M. Prevalence, clinical features and potential therapies for fibromyalgia in primary headaches. Expert Rev Neurother. 2012 Mar;12(3):287-95; quiz 296. doi: 10.1586/ern.11.190.

Reference Type BACKGROUND
PMID: 22364327 (View on PubMed)

Lee K, Chon S. Assessments of Muscle Thickness and Tonicity of the Masseter and Sternocleidomastoid Muscles and Maximum Mouth Opening in Patients with Temporomandibular Disorder. Healthcare (Basel). 2021 Nov 26;9(12):1640. doi: 10.3390/healthcare9121640.

Reference Type BACKGROUND
PMID: 34946366 (View on PubMed)

Kobayashi R, Haga S, Umehara A, Takakaze M, Akatsuka K, Nakano H. Quantitative and qualitative evaluation of the masseter muscle by ultrasonography and correlation with whole body health status. J Phys Ther Sci. 2024 Mar;36(3):136-141. doi: 10.1589/jpts.36.136. Epub 2024 Mar 1.

Reference Type BACKGROUND
PMID: 38434992 (View on PubMed)

Andersen S, Petersen MW, Svendsen AS, Gazerani P. Pressure pain thresholds assessed over temporalis, masseter, and frontalis muscles in healthy individuals, patients with tension-type headache, and those with migraine--a systematic review. Pain. 2015 Aug;156(8):1409-1423. doi: 10.1097/j.pain.0000000000000219.

Reference Type BACKGROUND
PMID: 25955963 (View on PubMed)

Alizadeh Savareh B, Ghanjal A, Bashiri A, Motaqi M, Hatef B. The power features of Masseter muscle activity in tension-type and migraine without aura headache during open-close clench cycles. PeerJ. 2017 Jul 25;5:e3556. doi: 10.7717/peerj.3556. eCollection 2017.

Reference Type BACKGROUND
PMID: 28775915 (View on PubMed)

May A. Hints on Diagnosing and Treating Headache. Dtsch Arztebl Int. 2018 Apr 27;115(17):299-308. doi: 10.3238/arztebl.2018.0299.

Reference Type BACKGROUND
PMID: 29789115 (View on PubMed)

Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.

Reference Type BACKGROUND
PMID: 20961685 (View on PubMed)

Nielsen LA, Henriksson KG. Pathophysiological mechanisms in chronic musculoskeletal pain (fibromyalgia): the role of central and peripheral sensitization and pain disinhibition. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):465-80. doi: 10.1016/j.berh.2007.03.007.

Reference Type BACKGROUND
PMID: 17602994 (View on PubMed)

Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.

Reference Type BACKGROUND
PMID: 33918736 (View on PubMed)

Other Identifiers

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CORUM-PMR-DRHENY-01

Identifier Type: -

Identifier Source: org_study_id