NCT06632808

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

October 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

October 7, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

Tension-type headachePainPosturesensory sensitivity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Two months

Study Arms (2)

deep cervical flexor muscle exercises

EXPERIMENTAL

deep cervical flexor muscle exercises program

Other: Exercise

Control

NO INTERVENTION

no intervention

Interventions

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.

deep cervical flexor muscle exercises

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being diagnosed with tension-type headache

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tension-Type HeadachePain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 9, 2024

Study Start

November 18, 2024

Primary Completion

January 24, 2025

Study Completion

January 31, 2025

Last Updated

October 9, 2024

Record last verified: 2024-07