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Completed

NCT Number: NCT01790074

Trigger Point Therapy in Cervicogenic Headache

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.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alcala

Alcalá de Henares, Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TrP therapy

Other

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

Other

The treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure.

Primary outcomes

  1. Change in headache intensity from baseline to one week after treatment

    Time frame: Baseline and one week after the intervention

    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.

Secondary outcomes

  1. Change in cervical range of motion from baseline to one week after treatment

    Time frame: Baseline and one week after the intervention

    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.

  2. Change in pressure pain sensitivity from baseline to one week after treatment

    Time frame: Baseline and one week after the intervention

    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.

  3. Change in deep cervical flexors motor performance from baseline to one week after treatment

    Time frame: Baseline and one week after the intervention

    The motor performance of the deep cervical flexor muscles was tested in all patients by using the cervical flexor test (CCFT).

Sponsors and collaborators

Lead sponsor

César Fernández-de-las-Peñas

Other

Collaborators

  • University of Alcala

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 13, 2013
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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