Tension-type HeadacheNCT01550276
Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy
A study testing Manual Therapy in people with Tension-type Headache, run by University of Valencia at 1 site in Spain.
Trial summary
Background. Headache is one of the most common causes of consultation in primary health care and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain. Objective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-type Headache
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years, episodes of headaches lasting from 30 minutes to 7 days, headache having at least two of the following characteristics: *bilateral location
- pressing non-pulsating quality
- mild or moderate intensity
- not aggravated by routine physical activity.
- Participants may present photophobia or phonophobia, nausea or vomiting, pericranial tenderness, with evolution of more than three months, and they must be under pharmacological control.
Who cannot join
- Patients with other types of headache
- Headache that is aggravated by head movements
- Metabolic disorders or musculoskeletal complaints previous neck trauma
- Vertigo
- Dizziness
- Arterial hypertension
Show all 12Show fewer
- Advanced degenerative osteoarthritis
- Neck joint stiffness
- Signs of malignancy
- Pregnancy
- Patients with cardiac devices
- Patients in process of pharmacological adaptation, and excessive emotional tension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Background. Headache is one of the most common causes of consultation in primary health care and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain.
Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type headache.
Read more
Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a combination of both techniques. Outcome measures were: impact of headache, disability caused by headache, ranges of motion of the craniocervical junction, frequency and intensity of headache, and associated headache symptoms.
Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01), disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to large.
Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than suboccipital soft tissue inhibition for tension-type headache. The treatment with suboccipital soft tissue inhibition, despite producing less significant results, also has positive effects on different aspects of headache.
- Conditions
- Tension-type Headache
- Being tested
- Manual Therapy, Placebo control
- Keywords
- Effectiveness, Tension-type headache, Manual therapy
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
The SI treatment aims to release the suboccipital muscle spasm10 that maintains the occiput-atlas-axis joint dysfunction. This technique, which was administered for 10 minutes, uses a deep and progressive gliding pressure applied with the fingertips towards the posterior arch of atlas.
Manual TherapyOther
All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
The OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex. It is a structural technique performed on a vertical line along the odontoid process of axis; neither flexion nor extension is used, and lateroflexion is minimal.
Manual TherapyOther
All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
The combination of both treatments aims to determine whether this combination has greater effects than the separate application of each treatment. After receiving the treatment, the subjects in the experimental groups stayed for five minutes in the supine resting position, in neutral ranges of cervical flexion, extension, lateral flexion and rotation.
Placebo controlOther
All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
The control group received four sessions of placebo treatment, followed by ten minutes of resting position.
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital soft tissue inhibition | Experimental | The SI treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction. Receives: Other: Manual Therapy |
| Occiput-atlas-axis global manipulation | Experimental | The OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex Receives: Other: Manual Therapy |
| The combination of both treatments | Experimental | Not described Receives: Other: Manual Therapy |
| control group | Placebo comparator | Not described Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firstly, an individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)
This interview gathers information about age, sex, intensity and frequency of headache (with a Visual Analog Scale from 0 to 10), severity of pain (low, moderate, high), qualities of pain (Bilateral location of pain, Pulsating pressure, Not aggravated by physical activity, Photofobia/Phonofobia, Nausea/Vomiting, Pericranial tenderness), cranial location of pain, family history of headache, triggers, aggravating and pain-relieving factors, as well as any previous physiotherapy treatment for headache relief.
Measured: up to 4 weeks
Secondary outcomes (5)
Impact of headache on daily life(HIT-6)
It consists of 6 items each with 4 response options ranging from "never" (6 points) to "always" (13 points), and has shown high reliability in previous studies (alpha 0.87).
Measured: up to 8 weeks
Headache Disability Inventory (HDI)
Two first items concerning the frequency and intensity of headaches and a questionnaire of 25 items assessing emotional and functional aspects with 4 possible response options, with an alpha reliability of 0.76-0.83
Measured: up to 8 weeks
Headache pain intensity
rated daily by the patient on the 0-10 Visual Analogue Scale (VAS) (0 = no pain, 10 = most severe pain).
Measured: up to 8 weeks
Ranges of motion of the craniocervical junction
measured with the CROM-device. This instrument has demonstrated a good intra-tester reliability for the movements of cervical flexion, extension, lateral flexion and rotation (ICC > 0.80) (ICC>0.80). However, not having found any previous studies about its reliability for the craniocervical junction (upper cervical joint), we performed -before using this device in our study- an inter-tester reliability analysis with our two examiners and 10 patients not participating in this study, which showed a Pearson's correlation of 0.98
Measured: up to 8 weeks
Headache diary
During the four-week treatment period and in the follow-up phase, patients recorded on a daily basis the characteristics of headache with data regarding headache frequency and intensity, associated headache symptoms of photophobia or phonophobia, nausea or vomiting, and pericranial tenderness, completing a total of 7 weekly records.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tension-type HeadacheStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma Victoria Espí López, PhD, Principal investigator, Physiotherapy Department. University of Valencia. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550276
- Sponsor's protocol ID
- UVT001
- Status last verified
- Mar 2012
- First submitted
- 15 Feb 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011 Jan;31(2):133-43. doi: 10.1177/0333102410377362. Epub 2010 Jul 20.
PubMed 20647241Espi-Lopez GV, Gomez-Conesa A, Gomez AA, Martinez JB, Pascual-Vaca AO, Blanco CR. Treatment of tension-type headache with articulatory and suboccipital soft tissue therapy: A double-blind, randomized, placebo-controlled clinical trial. J Bodyw Mov Ther. 2014 Oct;18(4):576-85. doi: 10.1016/j.jbmt.2014.01.001. Epub 2014 Jan 10.
PubMed 25440210
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01550276
- Acronym / sponsor ID
- UVT001
- Conditions
- Tension-type Headache
- Keywords
- Effectiveness, Tension-type headache, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Mar 2012 (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.
Background. Headache is one of the most common causes of consultation in primary health care and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain.
Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type headache.
Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a combination of both techniques. Outcome measures were: impact of headache, disability caused by headache, ranges of motion of the craniocervical junction, frequency and intensity of headache, and associated headache symptoms.
Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01), disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to large.
Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than suboccipital soft tissue inhibition for tension-type headache. The treatment with suboccipital soft tissue inhibition, despite producing less significant results, also has positive effects on different aspects of headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Suboccipital soft tissue inhibition | Experimental | Other: Manual TherapyThe SI treatment aims to release the suboccipital muscle spasm that maintains the occiput-atlas-axis joint dysfunction. |
| Occiput-atlas-axis global manipulation | Experimental | Other: Manual TherapyThe OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex |
| The combination of both treatments | Experimental | Other: Manual Therapy |
| control group | Placebo comparator | Other: Placebo control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years, episodes of headaches lasting from 30 minutes to 7 days, headache having at least two of the following characteristics: *bilateral location
- Participants may present photophobia or phonophobia, nausea or vomiting, pericranial tenderness, with evolution of more than three months, and they must be under pharmacological control.
Key exclusion criteria (12 listed)
- Patients with other types of headache
- Headache that is aggravated by head movements
- Metabolic disorders or musculoskeletal complaints previous neck trauma
- Vertigo
- Dizziness
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 |
|---|---|---|
| Manual TherapyAll patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups. The SI treatment aims to release the suboccipital muscle spasm10 that maintains the occiput-atlas-axis joint dysfunction. This technique, which was administered for 10 minutes, uses a deep and progressive gliding pressure applied with the fingertips towards the posterior arch of atlas. | Other | Suboccipital soft tissue inhibition |
| Manual TherapyAll patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups. The OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex. It is a structural technique performed on a vertical line along the odontoid process of axis; neither flexion nor extension is used, and lateroflexion is minimal. | Other | Occiput-atlas-axis global manipulation |
| Manual TherapyAll patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups. The combination of both treatments aims to determine whether this combination has greater effects than the separate application of each treatment. After receiving the treatment, the subjects in the experimental groups stayed for five minutes in the supine resting position, in neutral ranges of cervical flexion, extension, lateral flexion and rotation. | Other | The combination of both treatments |
| Placebo controlAll patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups. The control group received four sessions of placebo treatment, followed by ten minutes of resting position. | Other | control group |
Primary outcome
Firstly, an individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks)
Time frame: up to 4 weeks
This interview gathers information about age, sex, intensity and frequency of headache (with a Visual Analog Scale from 0 to 10), severity of pain (low, moderate, high), qualities of pain (Bilateral location of pain, Pulsating pressure, Not aggravated by physical activity, Photofobia/Phonofobia, Nausea/Vomiting, Pericranial tenderness), cranial location of pain, family history of headache, triggers, aggravating and pain-relieving factors, as well as any previous physiotherapy treatment for headache relief.
5 secondary outcomes
Impact of headache on daily life(HIT-6)
Time frame: up to 8 weeks
Headache Disability Inventory (HDI)
Time frame: up to 8 weeks
Headache pain intensity
Time frame: up to 8 weeks
Ranges of motion of the craniocervical junction
Time frame: up to 8 weeks
Headache diary
Time frame: up to 8 weeks
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 9 Mar 2012.
- Background: PubMed 20647241Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011 Jan;31(2):133-43. doi: 10.1177/0333102410377362. Epub 2010 Jul 20.
- Derived from this study: PubMed 25440210Espi-Lopez GV, Gomez-Conesa A, Gomez AA, Martinez JB, Pascual-Vaca AO, Blanco CR. Treatment of tension-type headache with articulatory and suboccipital soft tissue therapy: A double-blind, randomized, placebo-controlled clinical trial. J Bodyw Mov Ther. 2014 Oct;18(4):576-85. doi: 10.1016/j.jbmt.2014.01.001. Epub 2014 Jan 10.
Related trials for Tension-type Headache
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 4
Treatment of Tension-type Headache by Zhixuan Analgesic Tablets
Frequent Episodic Tension-Type Headache
Not yet recruitingObservational study
Prevalence of Primary Headache in Multiple Sclerosis Patients
Multiple Sclerosis, Primary Headache Disorders
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
Recruiting
High- vs Standard-Dose Intravenous Magnesium for Acute Headache
Acute Headache, Migraine
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.
Gemma Victoria Espí López, PhD principal investigator
Physiotherapy Department. University of Valencia. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Tension-type Headache, run by University of Valencia 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 5 inclusion and 12 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 9 Mar 2012. 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?
Firstly, an individual clinical interview was conducted to collect socio-demographic data and characteristics of headache in a one-month base period (the previous 4 weeks) (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550276, which also lists 2 linked publications.
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 9 Mar 2012.