Cervical Stabilization Training on Individuals With Headache

NCT05839496 | Completed

• 1 other identifier: 730
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. The effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.

Conditions

Headache

Keywords

Headache; Neck pain; Exercise

Outcome Measures

Primary Outcomes (5)

• Pain intensity assessed by the VAS

  The average headache severity and neck pain severity in the last month was also assessed by using the Visual Analogue Scale (VAS). A Visual Analogue Scale (VAS) is one of the pain rating scales. A VAS consists of a line, often 10 cm long, with verbal anchors at either end (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

  Eight weeks

• Forward head posture assessed by the craniovertebral angle

  To evaluate the cervical posture, pictures were taken from the side to objectively measure the forward head posture. Patients were asked to stand straight and then relax while the camera was placed at shoulder level. After printing the pictures, the craniovertebral angle was measured to represent the degree of forward head posture. This angle was calculated by measuring the angle between a horizontal line drawn through the 7th cervical vertebra and a line connecting the tragus of the ear and C7 spinous process.

  Eight weeks

• Deep cervical flexor muscles strength assessed by the stabilizer pressure biofeedback

  Cranio-Cervical Flexion Test : To begin the test, the patient is lying on a table in a supine position with their neck in a neutral position. A biofeedback stabilizer device is then placed under the patient's neck to rest against the occiput and inflated to a baseline pressure of 20 mmHg. During the test, the patient is asked to close their mouth with a slight gap between their jaws and place their tongue on the upper palate. They are then instructed to nod their head as if saying "yes." In the first stage of the test, the patient is asked to increase the pressure by 2 mmHg and maintain this position at 22 mmHg for 10 seconds. The patient is then asked to relax. In subsequent stages of the test, the pressure is reset to the initial pressure of 20 mmHg, and the patient is asked to perform the same head movement for 10 repetitions to create a pressure of 4, 6, 8, and 10 mmHg, respectively, and maintain the pressure for 10 seconds in each movement.

  Eight weeks

• Endurance of cervical muscles assessed by the chronometer

  During the endurance test of cervical flexors, the patient is lying supıne position with the therapist's hand placed under their head. They are then asked to bring their chin closer to their chest, lifting their head about 2.5 cm and holding that position. The time they are able to maintain the position is recorded in seconds. During the endurance test of cervical extensors, the patient is lying down with their heads bent downwards and their heads and chest hanging over the bed, with a 2-kg sandbag placed on the back of their necks. They are then asked to lift their heads to a neutral position and hold their position. The time they are able to maintain the position is recorded in seconds.

  Eight weeks

• Cervical joint range of motion assessed by the cervical range of motion instrument

  The cervical joint range of motion was evaluated with a cervical joint range of motion measuring device. Active range of motion was measured in cervical flexion, extension, right rotation, left rotation, right lateral flexion, and left lateral flexion. Joint range of motion measurements were measured while the patient was sitting normally in an armless chair with a backrest.

  Eight weeks

Secondary Outcomes (5)

• Disability level (headache) assessed by migraine disability rating scale

  Eight weeks

• Disability level (neck pain) assessed by the neck disability index

  Eight weeks

• Health-related quality of life assessed by the short form 36 quality of life scale

  Eight weeks

• Sleep quality assessed by the Pittsburgh sleep quality index

  Eight weeks

• Mood assessed by the Beck depression inventory

  Eight weeks

Study Arms (2)

Cervical Stabilization Training Group

EXPERIMENTAL

The Cervical Stabilization Training Group applied cervical stabilization training three times a week for 8 weeks. Each session was completed in 45 minutes.

Other: Cervical stabilization exercises

Control Group

NO INTERVENTION

Control Group continued their medical treatment and they did not participate in any treatment for eight weeks.

Interventions

Cervical stabilization exercises OTHER

Patients learned the activation of deep cervical flexor and extensor muscles. Then, during the activity of deep cervical muscles, superficial cervical muscles and upper extremity muscles were also strengthened. Thus, it was aimed to strengthen all neck muscles and upper extremity muscles in different positions synchronously and to increase their endurance.

Cervical Stabilization Training Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• a clinical diagnosis of migraine, tension-type headache (TTH), and cervicogenic headache (CGH)
• age between 18 and 55 years
• being female
• frequency of headaches at least once a week or more in the last year

You may not qualify if:

• having a neurological and orthopedic disease such as Parkinson's, stroke, cognitive disorders, and temporomandibular joint dysfunction,
• having any contraindication for exercise,
• having any serious head and/or neck trauma,
• being with menopause,
• being included in a physiotherapy program for head and neck pain in the last 12 months.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• Fernandez-de-Las-Penas C, Florencio LL, Plaza-Manzano G, Arias-Buria JL. Clinical Reasoning Behind Non-Pharmacological Interventions for the Management of Headaches: A Narrative Literature Review. Int J Environ Res Public Health. 2020 Jun 9;17(11):4126. doi: 10.3390/ijerph17114126.

  PMID: 32527071 BACKGROUND

• Castien R, De Hertogh W. A Neuroscience Perspective of Physical Treatment of Headache and Neck Pain. Front Neurol. 2019 Mar 26;10:276. doi: 10.3389/fneur.2019.00276. eCollection 2019.

  PMID: 30972008 BACKGROUND

• Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.

  PMID: 24853166 BACKGROUND

• Edmondston SJ, Wallumrod ME, Macleid F, Kvamme LS, Joebges S, Brabham GC. Reliability of isometric muscle endurance tests in subjects with postural neck pain. J Manipulative Physiol Ther. 2008 Jun;31(5):348-54. doi: 10.1016/j.jmpt.2008.04.010.

  PMID: 18558277 BACKGROUND

• Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.

  PMID: 32051295 BACKGROUND

MeSH Terms

Conditions

Headache; Neck Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Arzu Guclu-Gunduz, Prof

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: January 2, 2019
• Primary Completion: January 2, 2021
• Study Completion: February 2, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)