Cervicogenic HeadacheNCT01790074
Trigger Point Therapy in Cervicogenic Headache
A study testing TrP therapy in people with Cervicogenic Headache, run by César Fernández-de-las-Peñas at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- TrP therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- TrP therapy, TrP manual control therapy
- Keywords
- cervicogenic headache, trigger point, sternocleidomastoid, manual therapy
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrP therapyOther
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 therapyOther
The treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: TrP manual control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and one week after the intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Baseline and one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- César Fernández-de-las-Peñas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala
- Responsible party
- Sponsor-investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- César Fernández-de-las-Peñas, PhD, DMSc, Study chair, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790074
- Sponsor's protocol ID
- HPA 2010
- Status last verified
- Feb 2013
- First submitted
- 9 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANUAL TREATMENT OF ACTIVE TRIGGER POINTS IN THE STERNOCLEIDOMASTOID MUSCLE IN PATIENTS WITH CERVICOGENIC HEADACHE: A PILOT RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT01790074
- Acronym / sponsor ID
- HPA 2010
- Conditions
- Cervicogenic Headache
- Keywords
- cervicogenic headache, trigger point, sternocleidomastoid, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- César Fernández-de-las-PeñasUniversity, hospital or other
- Collaborators
- University of Alcala
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TrP therapy | Experimental | Other: TrP therapyTrP 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 | Placebo comparator | Other: TrP manual control therapyThe treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrP therapyTrP 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 therapyThe 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 |
Primary outcome
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.
3 secondary outcomes
Change in cervical range of motion from baseline to one week after treatment
Time frame: Baseline and one week after the intervention
Change in pressure pain sensitivity from baseline to one week after treatment
Time frame: Baseline and one week after the intervention
Change in deep cervical flexors motor performance from baseline to one week after treatment
Time frame: Baseline and one week after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
César Fernández-de-las-Peñas, PhD, DMSc study chair
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrP therapy in people with Cervicogenic Headache, run by César Fernández-de-las-Peñas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache intensity from baseline to one week after treatment (time frame: Baseline and one week after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.