Trigger Point Therapy in Cervicogenic Headache

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

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.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: TrP therapy; Other: TrP manual control therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcala de Henares, Madrid, Spain
      • University of Alcala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Placebo Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: César Fernández-de-las-Peñas
• Collaborators: University of Alcala
• Investigators: Study Chair: César Fernández-de-las-Peñas, PhD, DMSc, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 9, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: manual therapy; trigger point; cervicogenic headache; sternocleidomastoid
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: HPA 2010