Tension-type HeadacheMTvsFR-TTHNCT03591601
Effectiveness of Manual Therapy vs Exercises With Foam Rolling for Tension Headache
A study testing Manual Therapy protocol and Foam Rolling protocol in people with Tension-type Headache, run by University of Valencia at 2 sites in Spain.
Trial summary
Tension headache (CT) is the most frequent problem within the group of headaches, with a prevalence of 30-78% of the population throughout its life. Regarding this pathology, treatment with manual therapy has been studied a lot, observing the benefits of different techniques separately in elements such as disability… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tension-type Headache
- What is being tested?
- Manual Therapy protocol and Foam Rolling protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Aug 2018to 15 Dec 2018
- 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
- Be between 20 and 55 years old.
- CT medical diagnosis.
- Evolution of, at least, 3 months of the CT.
- Suffer, at least, 1 crisis a week.
- Meet, at least, 2 of the following IHS criteria:
- Bilateral location.
Show all 12Show fewer
- Pressure pain, not pulsating pain.
- Having a mild-moderate pain intensity.
- Pain that is not aggravated by physical activity.
- Minimum duration of 30 'of the TC.
- Accompanied by some associated symptom:
- or Photophobia. or Fonofobia. or mild nausea.
Who cannot join
- Have less than 20 years or more than 55.
- Cervical trauma.
- Musculoskeletal problems that may be aggravated by movement.
- Klein test positive.
- Contraindications to receive manual therapy.
- Musculoskeletal problems that may give another type of headache.
- Problems of dizziness.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Faculty of Physiotherapy
Valencia, 46010
Gemma V Espí López
Valencia, 46010
About this study
Official title: Effectiveness of a Global Manual Therapy Protocol vs Exercises With Foam Rolling for Tension Headache
Tension headache (CT) is the most frequent problem within the group of headaches, with a prevalence of 30-78% of the population throughout its life. Regarding this pathology, treatment with manual therapy has been studied a lot, observing the benefits of different techniques separately in elements such as disability, impact or depression.
The "Foam Rolling" (FR) is an element widely used in sport that has been studied its applications in terms of hip and knee flexibility after application in muscles such as the quadriceps or hamstrings.
Read more
In this study the investigators recruited randomized subjects in three groups, one of exercises with RF, another of a protocol of manual therapy (TM) techniques and one control (CTR) with a placebo treatment. There will be 4 treatments, 1 per week, and the data will be collected in 3 moments, pre-treatment, post-treatment and one month after treatment.
The investigators will evaluate aspects such as the average pain of headaches, the impact, disability, quality of life, self-satisfaction and pain at the pressure of painful points of the trapezius and suboccipital muscles.
Read the detailed description
Introduction Primary headaches occupy an important field in neurology consultations. Both migraines and tension headaches are often self-treated by the patients themselves and for some patients, headache is a true disease, constituting a symptomatology that can have various etiologies, from severe to functional organics. Headache, when it becomes chronic, becomes a serious problem for the patient with important repercussions on their quality of life.
Objective. To evaluate the effectiveness of the application of the treatment by means of manual therapy in patients with tension headache and to compare it with the application of massage by means of a roll of foam manufactured for this purpose.
Methodology The study will be carried out in the Faculty of Physiotherapy of the Universitat de València. An experimental, longitudinal and prospective design, controlled, randomized, with 3 groups will be carried out.
Population. The sample will be formed by participants diagnosed with tension headache, following the criteria established by the IHS.
Subjects with headache less than 15 days per month and other types of primary headache, as well as those associated with drug abuse and those who do not meet the criteria established by the IHS, will be excluded from the study.
Experimental treatment The patients will be randomly assigned to 3 different groups (one group of treatment with manual therapy, one group that will receive massage and another group of placebo control).
The treatment will last for 8 weeks (4 weeks of treatment and 4 weeks of follow-up). The 2 groups will be evaluated before treatment, at the end of this and in the follow-up (30 days after treatment).
Evaluations
For the collection of data, a clinical interview with data referring to headache was designed and the following evaluation instruments are included:
- Scale disability due to HDI Headache
- Impact of pain HIT-6
- Quality of life SF-36
- Visual Analog Scale (EVA)
- Algometry. Measurement of pain at pressure on spinous and transverse processes
- CROM. Cervical range
- QS. Body satisfaction questionnaire
- Conditions
- Tension-type Headache
- Being tested
- Manual Therapy protocol, Foam Rolling protocol, Placebo control
- Keywords
- Tension-type headache, Pain
- Medical subject headings
- Tension-Type Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy protocolOther
Treatment based on manual therapy with proven evidence.
Foam Rolling protocolOther
Treatment based on massage with a Foam Rolling
Placebo controlOther
Placebo treatment based on the placement of the hands on the head without intention to treat.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy protocol | Active comparator | Treatment based on manual therapy with proven evidence. Receives: Other: Manual Therapy protocol |
| Foam Rolling protocol | Experimental | Treatment based on massage with a Foam Rolling Receives: Other: Foam Rolling protocol |
| Placebo Control | Placebo comparator | Placebo treatment based on the placement of the hands on the head without intention to treat. Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Visual Analog Scale. The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.
Measured: 8 weeks
Secondary outcomes (6)
Disability headache
Headache Disability Index (HDI). Questionnaire developed by G.P. Jacobson et al. to quantify the impact of disability due to headache in daily life. The objective is to identify the difficulties that the patient experiences due to headaches. It consists of two questions: 1) intensity of pain (mild, moderate and severe), and 2) frequency (once a month, more than 1 and less than 4 times a month, and once a week). In addition, it includes 25 items with two subscales, one emotional (13 items) and another functional (12 items) with three possible answers ("no" 0 points, "sometimes" 2 points, "yes" 4 points). The maximum score is 100 points, with 0 "no disability" and 100 "maximum disability".
Measured: 8 weeks
Impact of headache
Headache Impact Test (HIT-6). Published by Ware et al. To measure the impact of headache. The score is calculated as follows: never (6 points), few times (8 points), sometimes (10 points), very often (11 points) and always (13 points). With a total of 49 or less points is considered "little or no impact", between 50-55 "some impact", between 56-59 "significant impact" and 60 or more "very severe impact".
Measured: 8 weeks
Pressure pain threshold
Algometer. To assess the pain threshold at the pressure of the different muscles, a mechanical pressure algometer (Wagner Instruments FDK 20) will be used. The pressure pain threshold is the minimum pressure that is needed to cause pain or discomfort at a certain point. In obtaining the result, the average of the 3 scores obtained from each point was made. The reliability of this procedure is high in healthy subjects [BCI = 0.91 (95% confidence interval: 0.82-0.97)] 28.31. In patients with TMD, reliability is moderate (ICC = 0.64)
Measured: 8 weeks
Cervical range movment
Goniometry. The range of joint movement of the neck is measured by the use of a goniometer. Flexion, extension, lateral tilt and cervical rotation are assessed. To be able to perform the measurement, the patient is asked to remain in a sitting position keeping his back at 90 degrees and his head in a neutral position. The physiotherapist instructs the patients to perform the previously explained movements, until reaching the maximum range of movement or in the presence of pain. We proceed to evaluate mobility in the 3 planes: sagittal plane, frontal plane and transverse plane. 3 measurements of each movement are made, and the final measurement obtained is the average of each previous result.
Measured: 8 weeks
Body satisfaction
Body satisfaction questionnaire. It contains 10 positive and 10 negative adjectives about the participant's body sensation with alternative answers ranging from 1 = Excellent to 5 = Poor. Each question is scored independently.
Measured: 8 weeks
Health Status
SF-36 questionnaire. It consists of 36 items with the following scales: Physical function (items 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j), Physical role (items 4a, 4b, 4c, 4d), Corporal pain ( items 7, 8), General Health (items 1, 11a, 11b, 11c, 11d), Vitality (items 9a, 9e, 9g, 9i), Social function (items 6, 10), Emotional role (items 5a, 5b, 5c) and Mental Health (items 9b, 9c, 9d, 9f, 9h). Includes an item on the change in the general health status with respect to the previous year (item 2). To calculate the score, we must first homogenize the address of the answers by re-coding the items that require it, so that "the higher the score, the better the health condition", then the calculation of the sum of the items of each scale and, finally, the linear transformation of raw scores on a scale of 0 (worst health status for that dimension) to 100 (the best health status).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Aug 2018
- Primary completion15 Nov 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591601
- Sponsor's protocol ID
- ID0021
- Acronym
- MTvsFR-TTH
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Global Manual Therapy Protocol vs Exercises With Foam Rolling for Tension Headache
- ClinicalTrials.gov ID
- NCT03591601
- Acronym / sponsor ID
- MTvsFR-TTH / ID0021
- Conditions
- Tension-type Headache
- Keywords
- Tension-type headache, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 19 Jul 2018 (actual)
- 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.
Tension headache (CT) is the most frequent problem within the group of headaches, with a prevalence of 30-78% of the population throughout its life. Regarding this pathology, treatment with manual therapy has been studied a lot, observing the benefits of different techniques separately in elements such as disability, impact or depression.
The "Foam Rolling" (FR) is an element widely used in sport that has been studied its applications in terms of hip and knee flexibility after application in muscles such as the quadriceps or hamstrings.
In this study the investigators recruited randomized subjects in three groups, one of exercises with RF, another of a protocol of manual therapy (TM) techniques and one control (CTR) with a placebo treatment. There will be 4 treatments, 1 per week, and the data will be collected in 3 moments, pre-treatment, post-treatment and one month after treatment.
The investigators will evaluate aspects such as the average pain of headaches, the impact, disability, quality of life, self-satisfaction and pain at the pressure of painful points of the trapezius and suboccipital muscles.
Detailed description
Introduction Primary headaches occupy an important field in neurology consultations. Both migraines and tension headaches are often self-treated by the patients themselves and for some patients, headache is a true disease, constituting a symptomatology that can have various etiologies, from severe to functional organics. Headache, when it becomes chronic, becomes a serious problem for the patient with important repercussions on their quality of life.
Objective. To evaluate the effectiveness of the application of the treatment by means of manual therapy in patients with tension headache and to compare it with the application of massage by means of a roll of foam manufactured for this purpose.
Methodology The study will be carried out in the Faculty of Physiotherapy of the Universitat de València. An experimental, longitudinal and prospective design, controlled, randomized, with 3 groups will be carried out.
Population. The sample will be formed by participants diagnosed with tension headache, following the criteria established by the IHS.
Subjects with headache less than 15 days per month and other types of primary headache, as well as those associated with drug abuse and those who do not meet the criteria established by the IHS, will be excluded from the study.
Experimental treatment The patients will be randomly assigned to 3 different groups (one group of treatment with manual therapy, one group that will receive massage and another group of placebo control).
The treatment will last for 8 weeks (4 weeks of treatment and 4 weeks of follow-up). The 2 groups will be evaluated before treatment, at the end of this and in the follow-up (30 days after treatment).
Evaluations
For the collection of data, a clinical interview with data referring to headache was designed and the following evaluation instruments are included:
- Scale disability due to HDI Headache
- Impact of pain HIT-6
- Quality of life SF-36
- Visual Analog Scale (EVA)
- Algometry. Measurement of pain at pressure on spinous and transverse processes
- CROM. Cervical range
- QS. Body satisfaction questionnaire
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual therapy protocol | Active comparator | Other: Manual Therapy protocolTreatment based on manual therapy with proven evidence. |
| Foam Rolling protocol | Experimental | Other: Foam Rolling protocolTreatment based on massage with a Foam Rolling |
| Placebo Control | Placebo comparator | Other: Placebo controlPlacebo treatment based on the placement of the hands on the head without intention to treat. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Be between 20 and 55 years old.
- CT medical diagnosis.
- Evolution of, at least, 3 months of the CT.
- Suffer, at least, 1 crisis a week.
- Meet, at least, 2 of the following IHS criteria:
Key exclusion criteria (7 listed)
- Have less than 20 years or more than 55.
- Cervical trauma.
- Musculoskeletal problems that may be aggravated by movement.
- Klein test positive.
- Contraindications to receive manual therapy.
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 Therapy protocolTreatment based on manual therapy with proven evidence. | Other | Manual therapy protocol |
| Foam Rolling protocolTreatment based on massage with a Foam Rolling | Other | Foam Rolling protocol |
| Placebo controlPlacebo treatment based on the placement of the hands on the head without intention to treat. | Other | Placebo Control |
Primary outcome
Intensity of pain
Time frame: 8 weeks
Visual Analog Scale. The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.
6 secondary outcomes
Disability headache
Time frame: 8 weeks
Impact of headache
Time frame: 8 weeks
Pressure pain threshold
Time frame: 8 weeks
Cervical range movment
Time frame: 8 weeks
Body satisfaction
Time frame: 8 weeks
Health Status
Time frame: 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 20 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy protocol and Foam Rolling protocol in people with Tension-type Headache, run by University of Valencia at 2 sites 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 12 inclusion and 7 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intensity of pain (time frame: 8 weeks). 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 20 Feb 2020.