NCT05964517

Brief Summary

Tension-type headache is a headache that starts from the cervical and suboccipital regions, spreads from the back of the head to the parietal, frontal and temporal regions, and is felt in the form of compression, pressure and heaviness. Increased muscle and fascia tone in the cervical and cranial region, together with active trigger points and factors that trigger pain, cause tension-type headache. Head and neck fascia serves as an important proprioceptive structure in our body. Abnormal inputs from mechanoreceptors and structures around the joint cause deterioration in joint position sense. This study was planned to investigate the effects of the new facial distortion model on pain intensity, cervical posture and joint position sense, unlike the manual techniques used in previous studies in tension-type headache.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 19, 2023

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain Evaluation

    The McGill Pain Scale will be used to assess the pain of individuals. The questionnaire consists of four different parts. In the first part, in order to determine the localization of pain. In the second part, there are 20 word groups to be marked to determine the nature of the pain. In the fourth part of the scale, the patient is asked to choose appropriate words to determine the severity of pain. The higher the score, the greater the severity of the pain.

    Change from McGill scale at one month

  • Pain Intensity

    Pain intensity will be evaluated with the Visual analog scale (VAS). VAS consists of a 10 cm long horizontal line. '0' means no pain, '10' means unbearable pain. For evaluation, the patients were asked to mark the level of pain they felt on this line, and the distance to the starting point was measured with a ruler and the severity of the pain was recorded. The higher the score, the greater the severity of the pain.

    Change from VAS at one month

  • Cervical Joint Position sense

    Laser cursor assisted angle repetition test will be used to evaluate cervical joint position sense. The patient is positioned to coincide with the origin point of the laser target table. The patient is first asked to aim at the origin of the target pane with his eyes open. The distance from the point where the patient is standing to the origin is measured in cm. As the deviation distance increases, the sense of joint position worsens.

    Change from joint position sense at one month

  • Posture analysis

    Posturescreen mobile (PostureCo Inc., Trinity, FL, USA) application will be used for cervical posture assessment. Posturescreen Mobile (PSM) is a new photographic mobile application for detecting deviations from ideal posture.The validity and reliability study of the (PSM) application was conducted (118). As a reference point, the canthus of the eye, tragus, 7th cervical vertebra, and acromion will be marked on the photograph by the physiotherapist. Craniovertebral angle and shoulder position angle obtained automatically from the application will be recorded. Forward head posture increases with decreasing craniovertebral angle. The increase in shoulder position angle shows that protraction also increases.

    Change from posture at one month

Study Arms (2)

Control Group

NO INTERVENTION

The control group refers to patients with tension-type headache who will not be treated. These patients are only evaluated during follow-up.

Study Group

ACTIVE COMPARATOR

Patients with tension-type headache in the study group are treated. Evaluations are made before and after treatment.

Other: Fascial Distortion Model

Interventions

Facial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue.

Also known as: Manual therapy
Study Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of tension-type headache,
  • the ages of 20-50 years,
  • must be headache complaint for at least 6 months,
  • Pain is at least 4 on the visual pain scale.

You may not qualify if:

  • diagnosis of ervical disc herniation,
  • diagnosis of sinusitis, migraine and vertigo,
  • diagnosis of scoliosis,
  • diagnosis of radiculopathy,
  • Having a history of surgery Tumor, cyst or similar findings, Having received any physical therapy for the cervical region before, Having any psychological disorder It is the use of any painkillers during the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuba Maden

Gaziantep, Sahinbey, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tension-Type HeadacheNeck PainSyndromeSomatosensory Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiseasePathologic ProcessesSensation Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants dont know in which group enrolled.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Control and study group Facial distortion modeling was applied to the study group for 30 minutes, once a week, for 4 weeks. The control group was followed for 4 weeks and the same evaluations were made to the patients twice.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstanf Profesor

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 28, 2023

Study Start

August 7, 2023

Primary Completion

October 1, 2023

Study Completion

October 31, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations