Effectiveness of Deep Cervical Flexor Muscle Exercises in Patients With Tension-Type Headache (Single-Blind)

October 7, 2024 updated by: Muş Alparlan University

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

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

Yes

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

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: 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

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

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)

November 18, 2024

Primary Completion (Estimated)

January 24, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

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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