Trigger Point Therapy in Cervicogenic Headache

Cervicogenic Headache Clinical Trial

Official title:

MANUAL TREATMENT OF ACTIVE TRIGGER POINTS IN THE STERNOCLEIDOMASTOID MUSCLE IN PATIENTS WITH CERVICOGENIC HEADACHE: A PILOT RANDOMIZED CLINICAL TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790074
• Other study ID #: HPA 2010
• Status: Completed
• Phase: N/A
• First received: February 9, 2013
• Last updated: February 12, 2013
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

It is a pilot randomized controlled trial comparing real and simulated manual treatment of trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the current randomized clinical pilot trial was to determine the preliminary effects of TrP manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as compared to manual contact over the muscle tissues.

Description:

CeH pain has been mostly related to joint, disk and ligament pain from the upper cervical spine; however, clinicians should consider that the upper cervical spine also receives afferent inputs from muscles. In fact, the role of referred pain to the head elicited by muscle TrPs has received particular interest in recent years. No study has investigated the effectiveness of TrP manual therapy in patients with CeH exhibiting active TrPs. Investigators hypothesized that patients receiving a real TrP treatment will exhibit a greater reduction in pain, sensitivity, cervical range of motion and neck endurance than those receiving a manual control non-therapeutic intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• unilateral pain starting in the neck and radiating to the frontal-temporal region

• pain aggravated by neck movement

• restricted cervical range of motion

• joint tenderness in at least one of the joints of the upper cervical spine (C1-C3)

• headache frequency of at least one per week over a period greater than 3 months

• active TrPs in the sternocleidomastoid muscle

Exclusion Criteria:

• other primary headaches (i.e., migraine, tension type-headache)

• bilateral headaches

• had received treatment for neck or head pain in the previous year

• presented any contraindications to manual therapy

• had pending legal action regarding their neck and head pain.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Other:
• TrP therapy
TrP manual therapy comprises different manual approaches, e.g., compression, stretching, or transverse friction massage applied over active TrPs in the sternocleidomastoid muscle
• TrP manual control therapy
The treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure.

Locations

Country	Name	City	State
Spain	University of Alcala	Alcala de Henares	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
César Fernández-de-las-Peñas	University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in headache intensity from baseline to one week after treatment	The intensity of head and neck pain was separately assessed with an 11-point numerical pain rate scale (NPRS, 0: no current pain, 10: maximum pain). It was recorded as a mean based on headaches experienced in the preceding week.	Baseline and one week after the intervention	No
Secondary	Change in cervical range of motion from baseline to one week after treatment	Cervical range of motion was measured using a cervical range of motion (CROM) device. Subjects were asked to move their head as far as they could without pain in a stan¬dardized sequence: flexion, extension, affected/non-affected lateral flexion, and affected/non-affected rotation.	Baseline and one week after the intervention	No
Secondary	Change in pressure pain sensitivity from baseline to one week after treatment	Pressure pain thresholds (PPT), i.e., the amount of pressure where a sensation of pressure first changes to pain was assessed with an analogical algometer over C0-C1, C1-C2 and C2-C3 zygapophyseal joints on the symptomatic side.	Baseline and one week after the intervention	No
Secondary	Change in deep cervical flexors motor performance from baseline to one week after treatment	The motor performance of the deep cervical flexor muscles was tested in all patients by using the cervical flexor test (CCFT).	Baseline and one week after the intervention	No