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FibromyalgiaNCT06713278

Tension-Type Headache and Masseter Thickness in Fibromyalgia

An observational study of Fibromyalgia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
What is being tested?
masseter muscle thickness measurement and scales
How many people
94 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2024to 2 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: female 18-65 years

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Çorum Hitit University Erol Olçok Training and Research Hospital

    Çorum, Çorum, 19040

Other trials in Turkey (Türkiye)

About this study

Official title: Association Between Tension-Type Headache and Masseter Muscle Thickness in Women With Fibromyalgia

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?

Read the detailed description

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
Fibromyalgia
Being tested
masseter muscle thickness measurement, scales
Keywords
tension type headache, masseter muscle
Medical subject headings
Fibromyalgia, Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • masseter muscle thickness measurementOther

    masseter muscle thickness measurement with ultrasonography

  • scalesOther

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

Study groups in NCT06713278
Study groupRoleWhat they receive
fibromyalgia with tension type headachefibromyalgia with tension type headache
Receives: Other: masseter muscle thickness measurement; Other: scales
fibromyalgia without tension type headachefibromyalgia without tension type headache
Receives: Other: masseter muscle thickness measurement; Other: scales
control groupcontrol group
Receives: Other: masseter muscle thickness measurement; Other: scales

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Masseter muscle thickness

    Measurement of masseter muscle thickness by ultrasonography

    Measured: 1 day

Secondary outcomes (5)

  1. HIT-6 (Headache Impact Test-6)

    HIT-6 (Headache Impact Test-6):The HIT-6 (Headache Impact Test-6) consists of 6 questions, each evaluated using a 5-point Likert scale. The scale assigns the following scores: 6 points for "never," 8 points for "rarely," 10 points for "sometimes," 11 points for "very often," and 13 points for "always." The total score ranges from 36 to 78. The severity of the headache's impact is categorized as follows:

    60-78: Severe impact 56-59: Substantial impact 50-55: Moderate impact <49: Little to no impact Higher scores indicate worse outcomes.

    Measured: 1 day

  2. FIQ (Fibromyalgia Impact Questionnaire)

    FIQ (Fibromyalgia Impact Questionnaire):The Fibromyalgia Impact Questionnaire (FIQ) is a validated and reliable tool in Turkish that measures the impact of fibromyalgia on daily life. It consists of 10 main items covering various aspects of daily life, including physical functionality, ability to perform tasks, sleep quality, emotional well-being, and pain. The total FIQ score is categorized as follows:

    0-38: Mild impact 39-58: Moderate impact 59-100: Severe impact Higher scores indicate worse outcomes.

    Measured: 1 day

  3. Fibromyalgia Total Score

    The Fibromyalgia Total Score assesses the severity and impact of fibromyalgia symptoms. It is typically calculated as the sum of two components: the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS).

    Calculation Widespread Pain Index (WPI):Evaluates the number of body regions experiencing pain, ranging from 0 to 19.

    Symptom Severity Scale (SSS):Assesses the severity of fatigue, unrefreshed sleep, and cognitive difficulties, along with the presence of other somatic symptoms, ranging from 0 to 12.

    Total Score:The Fibromyalgia Total Score ranges from 0 to 31. Higher scores indicate more severe symptoms and a greater impact of fibromyalgia. Higher scores indicate worse outcomes.

    This score is used to aid in diagnosing fibromyalgia and evaluating its severity.

    Measured: 1 day

  4. Widespread Pain Index (WPI)

    The Widespread Pain Score (WPI) is a measure included in the 2016 ACR fibromyalgia diagnostic criteria. It consists of 19 body regions. Participants indicate the areas where they experience pain, receiving 1 point for each marked region. The WPI is scored on a scale of 0 to 19. Higher scores indicate worse outcomes.

    Measured: 1 day

  5. Symptom Severity Scale (SSS)

    The Symptom Severity Scale (SSS) is a measure included in the 2016 ACR fibromyalgia diagnostic criteria.

    First Section: Evaluates fatigue, waking unrefreshed, and cognitive symptoms, scored as follows:0 (none), 1 (mild), 2 (moderate), 3 (severe).

    Second Section: Assesses the presence of headaches, lower abdominal pain, and depression, scored as:0 (absent), 1 (present).

    The total SSS score ranges from 0 to 12. Higher scores indicate worse outcomes.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start15 May 2024
  3. Primary completion2 Dec 2024
  4. Study completion2 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06713278
Sponsor's protocol ID
CORUM-PMR-DRHENY-01
Status last verified
Dec 2024
First submitted
24 Nov 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25329141

  • 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.

    PubMed 32133042

  • 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.

    PubMed 37789886

  • 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.

    PubMed 22364327

  • 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.

    PubMed 34946366

  • 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.

    PubMed 38434992

  • 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.

    PubMed 25955963

  • 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.

    PubMed 28775915

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

    PubMed 29789115

  • 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.

    PubMed 20961685

  • 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.

    PubMed 17602994

  • 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.

    PubMed 33918736

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Masseter muscle thickness (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06713278, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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