Trigger Point Therapy in Cervicogenic Headache

NCT01790074 | Completed DMC

• 1 other identifier: HPA 2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervicogenic Headache

Keywords

cervicogenic headache; trigger point; sternocleidomastoid; manual therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline and one week after the intervention

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

  Baseline and one week after the intervention

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

  Baseline and one week after the intervention

Study Arms (2)

TrP therapy

EXPERIMENTAL

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 control therapy

PLACEBO COMPARATOR

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

Interventions

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 therapy

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.

TrP manual control therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• César Fernández-de-las-Peñas: lead
• University of Alcala: collaborator

Study Sites (1)

University of Alcala

Alcalá de Henares, Madrid, Spain

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• César Fernández-de-las-Peñas, PhD, DMSc

  Universidad Rey Juan Carlos

  STUDY CHAIR

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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2013
• First Posted: February 13, 2013
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

ES (1)