Fascial Distortion Model in Tension Type Headache

Sponsor
University of Gaziantep (Other)
Overall Status
Recruiting
CT.gov ID
NCT05964517
Collaborator
(none)
30
1
2
2.8
10.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fascial Distortion Model
N/A

Detailed Description

This study was planned as a randomized controlled trial to investigate the effect of fascial distortion model on pain severity, cervical posture and joint position sense in patients with tension headache. Individuals with tension-type headache will be divided into control (n=15) and study group (n=15) by simple random method. Fascial distortion modeling will be applied to the study group for a total of 4 weeks, one session a week for 30 minutes. No application was made to the control group. Evaluations will made for all individuals twice, at baseline and after 4 weeks. Pain severity of individuals was evaluated with VAS and McGill-Melzack Pain Scale, cervical posture with Posturescreen Mobile application, joint position sense with laser cursor-assisted angle repetition test.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
Participants dont know in which group enrolled.
Primary Purpose:
Treatment
Official Title:
The Effects of the Fascial Distortion Model on Pain Intensity, Cervical Posture, and Joint Position Sense in Patients With Tension-type Headache.
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

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

Active Comparator: Study Group

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

Other: Fascial Distortion Model
Facial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue.
Other Names:
  • Manual therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Pain Evaluation [Change from McGill scale at one month]

      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.

    2. Pain Intensity [Change from VAS at one month]

      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.

    3. Cervical Joint Position sense [Change from joint position sense at one month]

      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.

    4. Posture analysis [Change from posture at one month]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tuba Maden Gaziantep Sahinbey Turkey

    Sponsors and Collaborators

    • University of Gaziantep

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ogr Uyesi Tuba MADEN, Assisstanf Profesor, University of Gaziantep
    ClinicalTrials.gov Identifier:
    NCT05964517
    Other Study ID Numbers:
    • 2022/392
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 2, 2023