Quality of LifeMTheadacheQLNCT02455323
The Influence of Manual Therapy in the Quality of Life in Tension-Type Headache
A study testing Suboccipital inhibitory, Spinal manipulative and Combined treatment in people with Quality of Life, run by University of Valencia at 1 site in Spain.
Trial summary
The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study design involved a factorial, randomized, double-blind, controlled study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Suboccipital inhibitory, Spinal manipulative and Combined treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Dec 2013
- 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
- diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically.
Who cannot join
- Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Spinal Manipulation and Suboccipipital Inhibition as a Complementary Therapy for Tension Headache in Quality of Life: A Randomized Controlled Trial
The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study design involved a factorial, randomized, double-blind, controlled study
Read the detailed description
Object: The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques.
Methods: The study design involved a factorial, randomized, double-blind, controlled study of 76 subjects. They were divided into 4 groups: suboccipital inhibitory pressure was applied to the first group; suboccipital spinal manipulation was applied to the second group; a combination of the two treatments was applied to the third group; and the fourth group was a control group. Quality of life was assessed using the SF-12 questionnaire (both overall and in its different dimensions) at the beginning and at the end of treatment, and after one month as a follow-up.
- Conditions
- Quality of Life
- Being tested
- Suboccipital inhibitory, Spinal manipulative, Combined treatment, Control group.
- Keywords
- Efficacy, 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.
Suboccipital inhibitoryOther
According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues. The aim is to suppress spasm of the muscles and in general of the suboccipital soft tissues which are responsible for any dysfunctional mobility of the occiput, atlas, or even the axis.
Spinal manipulativeOther
This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility
Combined treatmentOther
Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
Control group.Other
The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments).
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital inhibitory | Experimental | Suboccipital inhibitory pressure technique. According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues. Receives: Other: Suboccipital inhibitory |
| Spinal Manipulative | Experimental | Suboccipital inhibitory pressure technique. This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility. Receives: Other: Spinal manipulative |
| Combined treatment | Experimental | Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique. Receives: Other: Combined treatment |
| Control group | Placebo comparator | The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments). Receives: Other: Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of pain
These included major aspects for TTH verification, including frequency of noted pain (less than 15 days monthly = ETTH; more than 15 days monthly = CTTH) response to the classification of the IHS.
Measured: one month prior to the study
severity of pain
These included major aspects for TTH verification, including severity of pain response to the classification of the IHS.
Measured: one month prior to the study
Secondary outcomes (1)
quality of life
To assess the subject's quality of life, we applied the health status questionnaire SF-12v2 (Short Form 12 Health Survey) which has shown to be highly reliable. This questionnaire has been adapted to the Spanish context by Alonso et al. and Monteagudo et al.
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 posted27 May 2015 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 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 V Espí-López, PhD, Study director, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455323
- Sponsor's protocol ID
- ID004
- Acronym
- MTheadacheQL
- Status last verified
- May 2015
- First submitted
- 20 Mar 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Couppe C, Torelli P, Fuglsang-Frederiksen A, Andersen KV, Jensen R. Myofascial trigger points are very prevalent in patients with chronic tension-type headache: a double-blinded controlled study. Clin J Pain. 2007 Jan;23(1):23-7. doi: 10.1097/01.ajp.0000210946.34676.7d.
PubMed 17277641Toro-Velasco C, Arroyo-Morales M, Fernandez-de-Las-Penas C, Cleland JA, Barrero-Hernandez FJ. Short-term effects of manual therapy on heart rate variability, mood state, and pressure pain sensitivity in patients with chronic tension-type headache: a pilot study. J Manipulative Physiol Ther. 2009 Sep;32(7):527-35. doi: 10.1016/j.jmpt.2009.08.011.
PubMed 19748404Espi-Lopez GV, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Benitez-Martinez JC, Lluch E, Falla D. Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial. Eur J Phys Rehabil Med. 2014 Dec;50(6):641-7. Epub 2014 Apr 30.
PubMed 24785463
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Spinal Manipulation and Suboccipipital Inhibition as a Complementary Therapy for Tension Headache in Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02455323
- Acronym / sponsor ID
- MTheadacheQL / ID004
- Conditions
- Quality of Life
- Keywords
- Efficacy, Tension-type headache, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 May 2015 (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.
The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study design involved a factorial, randomized, double-blind, controlled study
Detailed description
Object: The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques.
Methods: The study design involved a factorial, randomized, double-blind, controlled study of 76 subjects. They were divided into 4 groups: suboccipital inhibitory pressure was applied to the first group; suboccipital spinal manipulation was applied to the second group; a combination of the two treatments was applied to the third group; and the fourth group was a control group. Quality of life was assessed using the SF-12 questionnaire (both overall and in its different dimensions) at the beginning and at the end of treatment, and after one month as a follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Suboccipital inhibitory | Experimental | Other: Suboccipital inhibitorySuboccipital inhibitory pressure technique. According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues. |
| Spinal Manipulative | Experimental | Other: Spinal manipulativeSuboccipital inhibitory pressure technique. This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility. |
| Combined treatment | Experimental | Other: Combined treatmentConsisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique. |
| Control group | Placebo comparator | Other: Control group.The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically.
Key exclusion criteria (1 listed)
- Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, Pregnancy.
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 |
|---|---|---|
| Suboccipital inhibitoryAccording to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues. The aim is to suppress spasm of the muscles and in general of the suboccipital soft tissues which are responsible for any dysfunctional mobility of the occiput, atlas, or even the axis. | Other | Suboccipital inhibitory |
| Spinal manipulativeThis technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility | Other | Spinal Manipulative |
| Combined treatmentConsisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique. | Other | Combined treatment |
| Control group.The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments). | Other | Control group |
Primary outcome
frequency of pain
Time frame: one month prior to the study
These included major aspects for TTH verification, including frequency of noted pain (less than 15 days monthly = ETTH; more than 15 days monthly = CTTH) response to the classification of the IHS.
severity of pain
Time frame: one month prior to the study
These included major aspects for TTH verification, including severity of pain response to the classification of the IHS.
1 secondary outcome
quality of life
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 28 May 2015.
- Background: PubMed 17277641Couppe C, Torelli P, Fuglsang-Frederiksen A, Andersen KV, Jensen R. Myofascial trigger points are very prevalent in patients with chronic tension-type headache: a double-blinded controlled study. Clin J Pain. 2007 Jan;23(1):23-7. doi: 10.1097/01.ajp.0000210946.34676.7d.
- Background: PubMed 19748404Toro-Velasco C, Arroyo-Morales M, Fernandez-de-Las-Penas C, Cleland JA, Barrero-Hernandez FJ. Short-term effects of manual therapy on heart rate variability, mood state, and pressure pain sensitivity in patients with chronic tension-type headache: a pilot study. J Manipulative Physiol Ther. 2009 Sep;32(7):527-35. doi: 10.1016/j.jmpt.2009.08.011.
- Background: PubMed 24785463Espi-Lopez GV, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Benitez-Martinez JC, Lluch E, Falla D. Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial. Eur J Phys Rehabil Med. 2014 Dec;50(6):641-7. Epub 2014 Apr 30.
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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.
Gemma V Espí-López, PhD study director
Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital inhibitory, Spinal manipulative and Combined treatment in people with Quality of Life, 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 1 inclusion and 1 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 28 May 2015. 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?
frequency of pain (time frame: one month prior to the study). The study lists 2 primary outcomes in all. 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 NCT02455323, which also lists 3 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 28 May 2015.