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Trigger Point Therapy in Cervicogenic Headache

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TrP therapy
TrP manual control therapy
Sponsored by
César Fernández-de-las-Peñas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring cervicogenic headache, trigger point, sternocleidomastoid, manual therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alcala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TrP therapy

TrP manual control therapy

Arm Description

TrP manual therapy comprises different manual approaches, e.g., compression, stretching, or transverse friction massage applied over active TrPs in the sternocleidomastoid muscle

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
February 9, 2013
Last Updated
February 12, 2013
Sponsor
César Fernández-de-las-Peñas
Collaborators
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT01790074
Brief Title
Trigger Point Therapy in Cervicogenic Headache
Official Title
MANUAL TREATMENT OF ACTIVE TRIGGER POINTS IN THE STERNOCLEIDOMASTOID MUSCLE IN PATIENTS WITH CERVICOGENIC HEADACHE: A PILOT RANDOMIZED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
César Fernández-de-las-Peñas
Collaborators
University of Alcala

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
cervicogenic headache, trigger point, sternocleidomastoid, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TrP therapy
Arm Type
Experimental
Arm Description
TrP manual therapy comprises different manual approaches, e.g., compression, stretching, or transverse friction massage applied over active TrPs in the sternocleidomastoid muscle
Arm Title
TrP manual control therapy
Arm Type
Placebo Comparator
Arm Description
The treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure.
Intervention Type
Other
Intervention Name(s)
TrP therapy
Intervention Description
TrP manual therapy comprises different manual approaches, e.g., compression, stretching, or transverse friction massage applied over active TrPs in the sternocleidomastoid muscle
Intervention Type
Other
Intervention Name(s)
TrP manual control therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in headache intensity from baseline to one week after treatment
Description
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.
Time Frame
Baseline and one week after the intervention
Secondary Outcome Measure Information:
Title
Change in cervical range of motion from baseline to one week after treatment
Description
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.
Time Frame
Baseline and one week after the intervention
Title
Change in pressure pain sensitivity from baseline to one week after treatment
Description
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.
Time Frame
Baseline and one week after the intervention
Title
Change in deep cervical flexors motor performance from baseline to one week after treatment
Description
The motor performance of the deep cervical flexor muscles was tested in all patients by using the cervical flexor test (CCFT).
Time Frame
Baseline and one week after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Fernández-de-las-Peñas, PhD, DMSc
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alcala
City
Alcala de Henares
State/Province
Madrid
Country
Spain

12. IPD Sharing Statement

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Trigger Point Therapy in Cervicogenic Headache

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