Fascial Distortion Model in Tension Type Headache

July 31, 2023 updated by: Ogr Uyesi Tuba MADEN, University of Gaziantep

The Effects of the Fascial Distortion Model on Pain Intensity, Cervical Posture, and Joint Position Sense in Patients With Tension-type Headache.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Sahinbey
      • Gaziantep, Sahinbey, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Evaluation
Time Frame: 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.
Change from McGill scale at one month
Pain Intensity
Time Frame: 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.
Change from VAS at one month
Cervical Joint Position sense
Time Frame: 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.
Change from joint position sense at one month
Posture analysis
Time Frame: 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.
Change from posture at one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 7, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/392

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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