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Fascial Distortion Model in Tension Type Headache

Primary Purpose

Postural; Defect, Tension-Type Headache, Pain, Neck

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fascial Distortion Model
Sponsored by
University of Gaziantep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural; Defect

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tuba MadenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Study Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2023
Last Updated
July 31, 2023
Sponsor
University of Gaziantep
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1. Study Identification

Unique Protocol Identification Number
NCT05964517
Brief Title
Fascial Distortion Model in Tension Type Headache
Official Title
The Effects of the Fascial Distortion Model on Pain Intensity, Cervical Posture, and Joint Position Sense in Patients With Tension-type Headache.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural; Defect, Tension-Type Headache, Pain, Neck, Craniovertebral; Syndrome, Proprioceptive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants dont know in which group enrolled.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group refers to patients with tension-type headache who will not be treated. These patients are only evaluated during follow-up.
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
Patients with tension-type headache in the study group are treated. Evaluations are made before and after treatment.
Intervention Type
Other
Intervention Name(s)
Fascial Distortion Model
Other Intervention Name(s)
Manual therapy
Intervention Description
Facial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue.
Primary Outcome Measure Information:
Title
Pain Evaluation
Description
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.
Time Frame
Change from McGill scale at one month
Title
Pain Intensity
Description
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.
Time Frame
Change from VAS at one month
Title
Cervical Joint Position sense
Description
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.
Time Frame
Change from joint position sense at one month
Title
Posture analysis
Description
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.
Time Frame
Change from posture at one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuba Maden
Phone
05319340249
Email
tuba.kmaden@gmail.com
Facility Information:
Facility Name
Tuba Maden
City
Gaziantep
State/Province
Sahinbey
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuba Maden, PhD
Phone
05319340249
Email
tuba.kmaden@gmail.com

12. IPD Sharing Statement

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Fascial Distortion Model in Tension Type Headache

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