Tension-Type Headache and Masseter Thickness in Fibromyalgia

NCT06713278 | Completed

• 1 other identifier: CORUM-PMR-DRHENY-01
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Fibromyalgia

Keywords

tension type headache; masseter muscle

Outcome Measures

Primary Outcomes (1)

• Masseter muscle thickness

  Measurement of masseter muscle thickness by ultrasonography

  1 day

Secondary Outcomes (5)

• HIT-6 (Headache Impact Test-6)

  1 day

• FIQ (Fibromyalgia Impact Questionnaire)

  1 day

• Fibromyalgia Total Score

  1 day

• Widespread Pain Index (WPI)

  1 day

• Symptom Severity Scale (SSS)

  1 day

Study Arms (3)

fibromyalgia with tension type headache

fibromyalgia with tension type headache

Other: masseter muscle thickness measurement; Other: scales

fibromyalgia without tension type headache

fibromyalgia without tension type headache

Other: masseter muscle thickness measurement; Other: scales

control group

control group

Other: masseter muscle thickness measurement; Other: scales

Interventions

masseter muscle thickness measurement OTHER

masseter muscle thickness measurement with ultrasonography

control group; fibromyalgia with tension type headache; fibromyalgia without tension type headache

scales OTHER

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

control group; fibromyalgia with tension type headache; fibromyalgia without tension type headache

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

female 18-65 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Çorum Hitit University Erol Olçok Training and Research Hospital

Çorum, Çorum, 19040, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 25329141 BACKGROUND

• 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.

  PMID: 32133042 BACKGROUND

• 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.

  PMID: 37789886 BACKGROUND

• 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.

  PMID: 22364327 BACKGROUND

• 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.

  PMID: 34946366 BACKGROUND

• 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.

  PMID: 38434992 BACKGROUND

• 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.

  PMID: 25955963 BACKGROUND

• 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.

  PMID: 28775915 BACKGROUND

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

  PMID: 29789115 BACKGROUND

• 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.

  PMID: 20961685 BACKGROUND

• 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.

  PMID: 17602994 BACKGROUND

• 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.

  PMID: 33918736 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Tension-Type Headache

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 3, 2024
• Study Start: May 15, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

TU (1)