Tension-Type HeadacheSingle-BlindNCT06632808
Effectiveness of Deep Cervical Flexor Muscle Exercises in Patients With Tension-Type Headache
A study testing Exercise in people with Tension-Type Headache, run by Muş Alparslan University.
Trial summary
The aim of this study is to evaluate the effects of deep cervical flexor muscle exercises on pain, spinal posture, and sensory sensitivity in patients with tension-type headaches. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2024to 31 Jan 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being diagnosed with tension-type headache
Who cannot join
- whiplash injury,
- significant neck trauma (caused by trauma to the neck, fracture, distortion, or violent attack that have caused the current NP),
- nerve root compression of the cervical spine,
- persistent headache attributed to traumatic injury to the head
- cluster headache,
- trigeminal neuralgia,
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- pregnancy,
- breastfeeding,
- severe physical and/or mental illness
About this study
Official title: Effects of Deep Cervical Flexor Muscle Exercises on Pain, Spinal Posture, and Sensory Sensitivity in Patients With Tension-Type Headache: A Single-Blind Randomized Controlled Trial
The aim of this study is to evaluate the effects of deep cervical flexor muscle exercises on pain, spinal posture, and sensory sensitivity in patients with tension-type headaches. Designed as a single-blind randomized controlled trial, the study will assess participants' pain levels using the Visual Analog Scale (VAS), sensory sensitivity through the Sensory Sensitivity Scale, and spinal posture via a digital inclinometer for objective measurements. This research seeks to determine the effectiveness of these exercises in managing pain, improving spinal posture, and contributing to the enhancement of sensory sensitivity.
Read the detailed description
The objective of this study is to comprehensively evaluate the impact of deep cervical flexor muscle exercises on three key outcomes in patients suffering from tension-type headaches: pain intensity, spinal posture, and sensory sensitivity. Tension-type headaches, often associated with poor posture and muscular dysfunction, can significantly affect daily functioning and quality of life. This study seeks to explore whether targeted exercises for the deep cervical flexor muscles can alleviate these symptoms.
Designed as a single-blind randomized controlled trial, this research will involve carefully selected participants who will be randomly assigned to either an intervention group or a control group. The intervention group will undergo a structured exercise regimen focusing on deep cervical flexor muscles, while the control group will not receive this specific intervention.
To measure the effectiveness of the intervention, three primary assessment tools will be employed: pain levels will be evaluated using the Visual Analog Scale (VAS), which provides a subjective yet widely accepted measure of pain intensity; sensory sensitivity will be assessed using the Sensory Sensitivity Scale, offering insight into changes in sensory perceptions related to the headache condition; and spinal posture will be objectively measured using a digital inclinometer, which quantifies postural alignment and deviations.
This research aims to contribute to the understanding of non-pharmacological interventions for tension-type headaches, providing evidence on whether deep cervical flexor exercises can reduce pain, improve spinal posture, and positively influence sensory sensitivity, potentially offering a holistic approach to managing these chronic headaches.
- Conditions
- Tension-Type Headache
- Being tested
- Exercise
- Keywords
- Tension-type headache, Pain, Posture, sensory sensitivity
- Medical subject headings
- Tension-Type Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Deep cervical flexor muscle exercises target the deep neck muscles that play a crucial role in the stabilization of the cervical spine and the maintenance of proper posture. These muscles, particularly the longus colli and longus capitis, are responsible for the correct alignment of the head and neck. The exercises typically involve gentle flexion of the neck (bringing the chin towards the chest) with low-intensity, controlled movements. The goal is to strengthen these muscles, enhance spinal stability, and alleviate symptoms such as tension-type headaches. Additionally, these exercises support postural control and can reduce excessive strain on the neck.
| Study group | Role | What they receive |
|---|---|---|
| deep cervical flexor muscle exercises | Experimental | deep cervical flexor muscle exercises program Receives: Other: Exercise |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS is used to convert some values that cannot be measured numerically into numerical values. Two extreme definitions of the severity of pain are written on both ends of a 10 cm line and the patient is asked to indicate his/her own condition by placing an X mark on the line where he/she deems appropriate.
Measured: Two months
Sensory Sensitivity Scale
Sensory Sensitivity Scale: is a tool used to diagnose sensory modulation problems clinically. The Sensory Sensitivity Scale has two parts; the first part asks the person to relate to the intensity of the responses, while the second part asks the person to relate to the frequency of the responses. The scale consists of sensory stimuli including auditory, visual, taste, smell, vestibular (kinesthesia) and somatosensory (proprioceptive and tactile) stimuli except pain.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start18 Nov 2024 (estimated)
- Primary completion24 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632808
- Sponsor's protocol ID
- Tension-Type Headache
- Acronym
- Single-Blind
- Status last verified
- Jul 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Cervical Flexor Muscle Exercises on Pain, Spinal Posture, and Sensory Sensitivity in Patients With Tension-Type Headache: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06632808
- Acronym / sponsor ID
- Single-Blind / Tension-Type Headache
- Conditions
- Tension-Type Headache
- Keywords
- Tension-type headache, Pain, Posture, sensory sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 24 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Oct 2024 (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.
The aim of this study is to evaluate the effects of deep cervical flexor muscle exercises on pain, spinal posture, and sensory sensitivity in patients with tension-type headaches. Designed as a single-blind randomized controlled trial, the study will assess participants' pain levels using the Visual Analog Scale (VAS), sensory sensitivity through the Sensory Sensitivity Scale, and spinal posture via a digital inclinometer for objective measurements. This research seeks to determine the effectiveness of these exercises in managing pain, improving spinal posture, and contributing to the enhancement of sensory sensitivity.
Detailed description
The objective of this study is to comprehensively evaluate the impact of deep cervical flexor muscle exercises on three key outcomes in patients suffering from tension-type headaches: pain intensity, spinal posture, and sensory sensitivity. Tension-type headaches, often associated with poor posture and muscular dysfunction, can significantly affect daily functioning and quality of life. This study seeks to explore whether targeted exercises for the deep cervical flexor muscles can alleviate these symptoms.
Designed as a single-blind randomized controlled trial, this research will involve carefully selected participants who will be randomly assigned to either an intervention group or a control group. The intervention group will undergo a structured exercise regimen focusing on deep cervical flexor muscles, while the control group will not receive this specific intervention.
To measure the effectiveness of the intervention, three primary assessment tools will be employed: pain levels will be evaluated using the Visual Analog Scale (VAS), which provides a subjective yet widely accepted measure of pain intensity; sensory sensitivity will be assessed using the Sensory Sensitivity Scale, offering insight into changes in sensory perceptions related to the headache condition; and spinal posture will be objectively measured using a digital inclinometer, which quantifies postural alignment and deviations.
This research aims to contribute to the understanding of non-pharmacological interventions for tension-type headaches, providing evidence on whether deep cervical flexor exercises can reduce pain, improve spinal posture, and positively influence sensory sensitivity, potentially offering a holistic approach to managing these chronic headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep cervical flexor muscle exercises | Experimental | Other: Exercisedeep cervical flexor muscle exercises program |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- being diagnosed with tension-type headache
Key exclusion criteria (9 listed)
- whiplash injury,
- significant neck trauma (caused by trauma to the neck, fracture, distortion, or violent attack that have caused the current NP),
- nerve root compression of the cervical spine,
- persistent headache attributed to traumatic injury to the head
- cluster headache,
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 |
|---|---|---|
| ExerciseDeep cervical flexor muscle exercises target the deep neck muscles that play a crucial role in the stabilization of the cervical spine and the maintenance of proper posture. These muscles, particularly the longus colli and longus capitis, are responsible for the correct alignment of the head and neck. The exercises typically involve gentle flexion of the neck (bringing the chin towards the chest) with low-intensity, controlled movements. The goal is to strengthen these muscles, enhance spinal stability, and alleviate symptoms such as tension-type headaches. Additionally, these exercises support postural control and can reduce excessive strain on the neck. | Other | deep cervical flexor muscle exercises |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Two months
VAS is used to convert some values that cannot be measured numerically into numerical values. Two extreme definitions of the severity of pain are written on both ends of a 10 cm line and the patient is asked to indicate his/her own condition by placing an X mark on the line where he/she deems appropriate.
Sensory Sensitivity Scale
Time frame: Two months
Sensory Sensitivity Scale: is a tool used to diagnose sensory modulation problems clinically. The Sensory Sensitivity Scale has two parts; the first part asks the person to relate to the intensity of the responses, while the second part asks the person to relate to the frequency of the responses. The scale consists of sensory stimuli including auditory, visual, taste, smell, vestibular (kinesthesia) and somatosensory (proprioceptive and tactile) stimuli except pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Tension-Type Headache, run by Muş Alparslan University.
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 1 inclusion and 9 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Two months). The study lists 2 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 9 Oct 2024.