Postural; DefectNCT05964517
Fascial Distortion Model in Tension Type Headache
A study testing Fascial Distortion Model in people with Postural; Defect and Tension-Type Headache, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Postural; Defect, Tension-Type Headache, Pain, Neck
- What is being tested?
- Fascial Distortion Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2023to 31 Oct 2023
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tuba Maden
Gaziantep, Sahinbey
Tuba Maden, PhD, 05319340249, tuba.kmaden@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postural; Defect, Tension-Type Headache, Pain, Neck, Craniovertebral; Syndrome, Proprioceptive Disorders
- Being tested
- Fascial Distortion Model
- Medical subject headings
- Tension-Type Headache, Neck Pain, Syndrome, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Distortion ModelOther
Also called Manual therapy
Facial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fascial Distortion Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from posture at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start7 Aug 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural; DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogr Uyesi Tuba MADEN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964517
- Sponsor's protocol ID
- 2022/392
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Fascial Distortion Model on Pain Intensity, Cervical Posture, and Joint Position Sense in Patients With Tension-type Headache.
- ClinicalTrials.gov ID
- NCT05964517
- Acronym / sponsor ID
- 2022/392
- Conditions
- Postural; Defect, Tension-Type Headache, Pain, Neck, Craniovertebral; Syndrome, Proprioceptive Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 7 Aug 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Fascial Distortion ModelPatients with tension-type headache in the study group are treated. Evaluations are made before and after treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial Distortion ModelAlso: Manual therapyFacial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue. | Other | Study Group |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Distortion Model in people with Postural; Defect and Tension-Type Headache, run by University of Gaziantep 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuba Maden (05319340249, tuba.kmaden@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Evaluation (time frame: Change from McGill scale at one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2023.