- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06632808
Effectiveness of Deep Cervical Flexor Muscle Exercises in Patients With Tension-Type Headache (Single-Blind)
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
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being diagnosed with tension-type headache
Exclusion Criteria:
- 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,
- pregnancy,
- breastfeeding,
- severe physical and/or mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
no intervention
|
|
|
Experimental: deep cervical flexor muscle exercises
deep cervical flexor muscle exercises program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Two months
|
|
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.
|
Two months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tension-Type Headache
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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