Tension-type HeadacheMANIHDI-IINCT02450955
Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients?
A study testing Massage and Occiput-Atlas-Axis Technique in people with Tension-type Headache, run by University of Valencia.
Trial summary
Objective. To compare the benefits of spinal manipulation combined with massage therapy versus massage alone in patients with tension-type headache (TTH) on the frequency, intensity and disability caused by headache and on cervical range of motion. Method. 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?
- Massage and Occiput-Atlas-Axis Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Dec 2014
- 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
- Subjects aged between 18 and 65 years
- Diagnosis of frequent ETTH and CTTH
- Having headache episodes on more than 4 days per month
- Headache episodes lasting from 30 minutes to 7 days
- Headaches having at least 2 of the following characteristics:
- Bilateral location of pain
Show all 13Show fewer
- Pressing non pulsating quality
- Mild or moderate intensity
- Not aggravated by physical activity
- Sufferers may present photophobia, phonophobia, nausea or vomiting
- Headache may be associated with pericranial tenderness
- Suffering from TTH for over 3 months
- Subjects being under pharmacological control
Who cannot join
- • Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.
- Headache that is aggravated by head movements.
- Metabolic or musculoskeletal disorders with symptoms similar to headache (rheumatoid arthritis)
- Previous neck trauma
- Vertigo, dizziness, arterial hypertension.
- Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
Show all 17Show fewer
- Patients with heart devices
- Patients in process of pharmacological adaptation
- Excessive emotional tension
- Neurological disorders
- Laxity of neck soft tissues
- Radiological alterations
- General hypermobility or hyperlaxity
- Joint instability
- Pregnancy
- Received physical therapy treatment for headache or neck pain in the previous 3 months
- Suspicion of malignancy
About this study
Official title: Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients? A Randomized Controlled Clinical Trial
Objective. To compare the benefits of spinal manipulation combined with massage therapy versus massage alone in patients with tension-type headache (TTH) on the frequency, intensity and disability caused by headache and on cervical range of motion.
Method. A factorial, randomized, double-blinded, placebo-controlled clinical trial was conducted with a sample of 105 subjects diagnosed with TTH, divided into two groups: a) the treatment group received a manipulative technique followed by massage of the cervical and suboccipital region; a) the control group received massage alone. Four sessions (once per week) were applied over four weeks. The Headache Disability Inventory (HDI) was used to evaluate changes in the frequency and severity of headache and functional and emotional aspects of headache. Range of upper cervical and cervical flexion and extension were evaluated. Measures were conducted at baseline, immediately after the intervention (week 4) and at a follow up 8 weeks after completion of the intervention.
Read the detailed description
MATERIALS AND METHODS Participants The sample consisted of 105 people diagnosed with frequent (47.6%) and chronic (52.4%) TTH derived from two primary care centres, selected according to the criteria of IHS3,4, and suffering from headache for more than three months. Participants were aged between 18 and 65 years (mean ± SD: 38.9 ± 10.9 years), which included 23 men (21.9%) and 82 women (78.1%). Patients were excluded if they had suspected malignant disease, rheumatoid arthritis, pregnancy, vertigo, continuous intake of prescribed medication or those who received physical therapy in the past 3 months for headache or neck pain. Finally, 102 subjects completed the study (2 from the treatment group dropped out due to work problems and one from the control due to lack of improvement).
The software G*power14 was to calculate the required sample size, using data from previous studies to estimate the effect sizes to be expected. Our review of the extant literature showed that across studies, the mean N was 44.28 and in general large effect sizes were found (Cohen's d = .40).15-19 We accepted a 5% alpha risk (α = .05) and 10% beta risk (β = .1) as study parameters which showed that 51 subjects were required in each group to achieve a medium-to-large effect size (f = .35). We predicted a 5% dropout rate in the follow-up period.
Study design The study was a factorial, randomized, double-blinded, placebo-controlled clinical trial. It was conducted from January to November, 2014. After the initial clinical interview, the allocation of patients to control or treatment groups was randomized by an external assistant using a specific software (name) who monitored the sequence and documentation at all times. Both the external assistant and the therapist and examiner were blinded to the study objective.
Patients were randomly assigned into 2 groups (treatment and control). The treatment group received occiput-atlas-axis manipulation (OAA) and soft tissue treatment by massage. The control group received massage only. Thus both groups received the same duration of massage therapy and the exposure times were the same, however the difference between groups lay in the manipulative OAA technique which only the treatment group received. Four sessions were conducted (once per week) and the assessment was carried out in 3 stages: at baseline, end of treatment (at 4 weeks) and follow-up at 8 weeks following completion of treatment. All patients in both groups were assessed under the same conditions before and after the treatment by an examiner blinded to the group allocation.
The study was conducted at the University of Valencia (Spain) from January 2014 to November 2014. Prior to data collection, informed written consent was obtained from all patients, and all procedures were conducted according to the Declaration of Helsinki.
- Conditions
- Tension-type Headache
- Being tested
- Massage, Occiput-Atlas-Axis Technique
- Keywords
- Tension-type headache, manual therapy, disability, spinal manipulation
- 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.
MassageOther
Also called Active Comparator
A superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading, five minutes prone and five minutes supine with a focus on cervical and suboccipital muscles in order to induce a global relaxation of the cervical and suboccipital region. Resting position. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.
Occiput-Atlas-Axis TechniqueOther
Also called Experimental
This technique was applied as described previously and is used with the aim of restoring joint mobility between the occiput, atlas and axis. It is a structural technique applied bilaterally, performed on a vertical axis passing through the dens process of the axis without extension or flexion and very little side-bending. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Active comparator | A superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading. Receives: Other: Massage |
| Occiput-Atlas-Axis Technique | Experimental | The technique is applied in two stages: in the first stage, a light core decompression is performed and then small circumductions are made with the aim of increasing viscoelasticity of tissues. Subsequently the appropriate joint barrier is sought by selective tension and high-velocity rotation manipulation is performed in a cranial helical motion without raising the subjects head. Receives: Other: Occiput-Atlas-Axis Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Disability Inventory (HDI).
An inventory of disability caused by headaches developed by Jacobson et al. and Gary et al. was used. The purpose of the scale is to identify the difficulties the patient may experience due to headache. It includes 2 items: headache severity (mild, moderate and severe) and frequency (once a month, more than once and less than 4 times a month, and once a week) and 25 items that assess two subscales (E = Emotional with 13 items and F = Functional, with 12 items). Subjects answer each question (yes = 4 points, sometimes = 2 points or no = 0 points). The maximum disability score in this inventory is 100 points. The Spanish adaptation was performed by Rodríguez et al. in 2000, and provides a good index of internal consistency (Cronbach 0.94).
Measured: 8 weeks
Secondary outcomes (1)
Cervical range of motion
A cervical range of motion (CROM) device was used to assess range of motion of the cervical spine. Higher inter-tester reliability for the CROM is reported for measures of the upper cervical spine ICC> = 0.89. To assess upper cervical flexion and extension, the patient was standing with the back against the wall, looking forward horizontally and performed upper cervical flexion and extension guided by the examiner. For the assessment of cervical flexion and extension, the patient was seated and performed the movements whilst the examiner placed one hand on the sternum and the other over the upper thoracic region to minimise compensatory movements.
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 posted21 May 2015 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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, Investigator, Outcomes assessor
- Enrolment
- 105 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
- NCT02450955
- Sponsor's protocol ID
- ID006
- Acronym
- MANIHDI-II
- Status last verified
- May 2015
- First submitted
- 17 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Victoria Espi-Lopez G, Arnal-Gomez A, Arbos-Berenguer T, Gonzalez AAL, Vicente-Herrero T. Effectiveness of Physical Therapy in Patients with Tension-type Headache: Literature Review. J Jpn Phys Ther Assoc. 2014;17(1):31-38. doi: 10.1298/jjpta.Vol17_005.
PubMed 25792906Espi-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 25440210Espi-Lopez GV, Gomez-Conesa A. Efficacy of manual and manipulative therapy in the perception of pain and cervical motion in patients with tension-type headache: a randomized, controlled clinical trial. J Chiropr Med. 2014 Mar;13(1):4-13. doi: 10.1016/j.jcm.2014.01.004.
PubMed 24711779Espi-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 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Manipulation Provide Added Benefit to Massage Therapy for Tension-type Headache Patients? A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02450955
- Acronym / sponsor ID
- MANIHDI-II / ID006
- Conditions
- Tension-type Headache
- Keywords
- Tension-type headache, manual therapy, disability, spinal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 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.
Objective. To compare the benefits of spinal manipulation combined with massage therapy versus massage alone in patients with tension-type headache (TTH) on the frequency, intensity and disability caused by headache and on cervical range of motion.
Method. A factorial, randomized, double-blinded, placebo-controlled clinical trial was conducted with a sample of 105 subjects diagnosed with TTH, divided into two groups: a) the treatment group received a manipulative technique followed by massage of the cervical and suboccipital region; a) the control group received massage alone. Four sessions (once per week) were applied over four weeks. The Headache Disability Inventory (HDI) was used to evaluate changes in the frequency and severity of headache and functional and emotional aspects of headache. Range of upper cervical and cervical flexion and extension were evaluated. Measures were conducted at baseline, immediately after the intervention (week 4) and at a follow up 8 weeks after completion of the intervention.
Detailed description
MATERIALS AND METHODS Participants The sample consisted of 105 people diagnosed with frequent (47.6%) and chronic (52.4%) TTH derived from two primary care centres, selected according to the criteria of IHS3,4, and suffering from headache for more than three months. Participants were aged between 18 and 65 years (mean ± SD: 38.9 ± 10.9 years), which included 23 men (21.9%) and 82 women (78.1%). Patients were excluded if they had suspected malignant disease, rheumatoid arthritis, pregnancy, vertigo, continuous intake of prescribed medication or those who received physical therapy in the past 3 months for headache or neck pain. Finally, 102 subjects completed the study (2 from the treatment group dropped out due to work problems and one from the control due to lack of improvement).
The software G*power14 was to calculate the required sample size, using data from previous studies to estimate the effect sizes to be expected. Our review of the extant literature showed that across studies, the mean N was 44.28 and in general large effect sizes were found (Cohen's d = .40).15-19 We accepted a 5% alpha risk (α = .05) and 10% beta risk (β = .1) as study parameters which showed that 51 subjects were required in each group to achieve a medium-to-large effect size (f = .35). We predicted a 5% dropout rate in the follow-up period.
Study design The study was a factorial, randomized, double-blinded, placebo-controlled clinical trial. It was conducted from January to November, 2014. After the initial clinical interview, the allocation of patients to control or treatment groups was randomized by an external assistant using a specific software (name) who monitored the sequence and documentation at all times. Both the external assistant and the therapist and examiner were blinded to the study objective.
Patients were randomly assigned into 2 groups (treatment and control). The treatment group received occiput-atlas-axis manipulation (OAA) and soft tissue treatment by massage. The control group received massage only. Thus both groups received the same duration of massage therapy and the exposure times were the same, however the difference between groups lay in the manipulative OAA technique which only the treatment group received. Four sessions were conducted (once per week) and the assessment was carried out in 3 stages: at baseline, end of treatment (at 4 weeks) and follow-up at 8 weeks following completion of treatment. All patients in both groups were assessed under the same conditions before and after the treatment by an examiner blinded to the group allocation.
The study was conducted at the University of Valencia (Spain) from January 2014 to November 2014. Prior to data collection, informed written consent was obtained from all patients, and all procedures were conducted according to the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Active comparator | Other: MassageA superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading. |
| Occiput-Atlas-Axis Technique | Experimental | Other: Occiput-Atlas-Axis TechniqueThe technique is applied in two stages: in the first stage, a light core decompression is performed and then small circumductions are made with the aim of increasing viscoelasticity of tissues. Subsequently the appropriate joint barrier is sought by selective tension and high-velocity rotation manipulation is performed in a cranial helical motion without raising the subjects head. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects aged between 18 and 65 years
- Diagnosis of frequent ETTH and CTTH
- Having headache episodes on more than 4 days per month
- Headache episodes lasting from 30 minutes to 7 days
- Headaches having at least 2 of the following characteristics:
Key exclusion criteria (17 listed)
- • Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.
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 |
|---|---|---|
| MassageAlso: Active ComparatorA superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading, five minutes prone and five minutes supine with a focus on cervical and suboccipital muscles in order to induce a global relaxation of the cervical and suboccipital region. Resting position. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation. | Other | Massage |
| Occiput-Atlas-Axis TechniqueAlso: ExperimentalThis technique was applied as described previously and is used with the aim of restoring joint mobility between the occiput, atlas and axis. It is a structural technique applied bilaterally, performed on a vertical axis passing through the dens process of the axis without extension or flexion and very little side-bending. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation. | Other | Occiput-Atlas-Axis Technique |
Primary outcome
Headache Disability Inventory (HDI).
Time frame: 8 weeks
An inventory of disability caused by headaches developed by Jacobson et al. and Gary et al. was used. The purpose of the scale is to identify the difficulties the patient may experience due to headache. It includes 2 items: headache severity (mild, moderate and severe) and frequency (once a month, more than once and less than 4 times a month, and once a week) and 25 items that assess two subscales (E = Emotional with 13 items and F = Functional, with 12 items). Subjects answer each question (yes = 4 points, sometimes = 2 points or no = 0 points). The maximum disability score in this inventory is 100 points. The Spanish adaptation was performed by Rodríguez et al. in 2000, and provides a good index of internal consistency (Cronbach 0.94).
1 secondary outcome
Cervical range of motion
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 21 May 2015.
- Background: PubMed 25792906Victoria Espi-Lopez G, Arnal-Gomez A, Arbos-Berenguer T, Gonzalez AAL, Vicente-Herrero T. Effectiveness of Physical Therapy in Patients with Tension-type Headache: Literature Review. J Jpn Phys Ther Assoc. 2014;17(1):31-38. doi: 10.1298/jjpta.Vol17_005.
- Background: 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.
- Background: PubMed 24711779Espi-Lopez GV, Gomez-Conesa A. Efficacy of manual and manipulative therapy in the perception of pain and cervical motion in patients with tension-type headache: a randomized, controlled clinical trial. J Chiropr Med. 2014 Mar;13(1):4-13. doi: 10.1016/j.jcm.2014.01.004.
- Results publication: 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Occiput-Atlas-Axis Technique in people with Tension-type Headache, run by University of Valencia.
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 13 inclusion and 17 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Headache Disability Inventory (HDI). (time frame: 8 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 NCT02450955, which also lists 4 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 21 May 2015.