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Evidence-Based Osteopathy for Tension-Type Headache (EBOTTH) (EBOTTH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Tremolizzo Lucio, University of Milano Bicocca.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02592850
First Posted: October 30, 2015
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Italian School of Osteopathy and Manual Therapies
Alpha Search Milano
Information provided by (Responsible Party):
Tremolizzo Lucio, University of Milano Bicocca
  Purpose

Tension-type headache (TTH) is a very common primary headache disorder, with important costs for both patients and society. Often these patients are not willing to take prophylactic medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT) is an interesting option in such field, since it is characterized by a low profile of side effects.

In this study the investigators will assess the efficacy of OMT (semi-structured evaluation and "black box" treatment) in frequent Episodic TTH (ETTH) in an outpatient setting. Preliminary data for power calculation are already available (Rolle et al. 2014), and the investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind, sham-controlled design.


Condition Intervention
Tension-Type Headache Other: osteopathic manipulative treatment Other: sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Osteopathic Manipulative Treatment in Frequent Episodic Tension-type Headache: the EBOTTH Multicentric Study

Resource links provided by NLM:


Further study details as provided by Tremolizzo Lucio, University of Milano Bicocca:

Primary Outcome Measures:
  • Headache frequency [ Time Frame: 4 months ]
    average reduction of headache frequency between the two arms and/or over time obtained from the headache diary (n/month)


Secondary Outcome Measures:
  • Headache intensity [ Time Frame: 4 months ]
    average reduction of headache intensity between the two arms and/or over time obtained from the headache diary (average value; scale 0-5)

  • Symptomatic Drugs [ Time Frame: 4 months ]
    average modification of symptomatic drug use between the two arms and/or over time obtained from the headache diary (n/month)

  • Headache Disability Inventory (HDI) [ Time Frame: 4 months ]
    average modification of HDI scores between the two arms and/or over time

  • Headache Impact Test-6 (HIT-6) [ Time Frame: 4 months ]
    average modification of HIT-6 scores between the two arms and/or over time

  • Side effects [ Time Frame: 4 months ]
    any type of adverse event


Other Outcome Measures:
  • Goal Attainment Scale (GAS) for osteopathic dysfunction [ Time Frame: 4 months ]
    any modification of any osteopathic dysfunction found at study entry between the two arms and/or over time (score between -2 and +2)


Estimated Enrollment: 264
Study Start Date: January 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteopathic Manipulative Treatment
Active manipulative treatment.
Other: osteopathic manipulative treatment

This intervention will not be protocol-based but the treating D.O. will compulsory have to include the evaluation (and possible treatment) of temporo-mandibular joint disorders and cervical dysfunctions (semi-structured treatment). Specifically, OMT will focus on correcting those osteopathic dysfunctions found during the initial evaluation; both structural (including myofascial release and HVLA), visceral and craniosacral techniques will be administered as appropriate.

Duration: 45 minutes. Administered once a week for four weeks.

Other Name: OMT
Sham Comparator: Sham Osteopathic Manipulative Treatment
Sham manipulative treatment.
Other: sham

In this intervention, the operator will be restricted to the assessment of the cranial rhythmic impulse (CRI), temporo-mandibular joint disorders and cervical dysfunctions, spending a similar amount of time to that being spent on OMT-treated patients. Any found osteopathic dysfunction will not be corrected.

Duration: 45 minutes. Administered once a week for four weeks.

Other Name: SHAM-OMT

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥18 and ≤65 years-old,
  • diagnosis of frequent episodic tension-type headache according to the International Headache Society guidelines,
  • frequency of attacks ≥3/month,
  • willing to adhere to study procedures,
  • signed informed consent

Exclusion Criteria:

  • age <18 or >65 years-old,
  • headache duration less than one year,
  • history of: major psychiatric disorders, relevant cognitive deficits, chronic pain other than headache, secondary headaches,
  • any type of headache prophylactic treatment ongoing or started during the study,
  • hormonal therapy started or modified during the study,
  • participating to other clinical trials,
  • not willing to sign informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592850


Contacts
Contact: Lucio Tremolizzo, MD, PhD +39.02.6448 ext 8167 lucio.tremolizzo@unimib.it
Contact: Guido Rolle, DO, MD +39.02.6448 ext 8128 guidorolle@libero.it

Sponsors and Collaborators
University of Milano Bicocca
Italian School of Osteopathy and Manual Therapies
Alpha Search Milano
Investigators
Principal Investigator: Lucio Tremolizzo, MD, PhD University of Milano-Bicocca, Italy
Study Director: Guido Rolle, DO, MD Italian School of Osteopathy and Manual Therapies
  More Information

Additional Information:
Publications:

Responsible Party: Tremolizzo Lucio, Assistant Professor of Neurology, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT02592850     History of Changes
Other Study ID Numbers: EBOTTH-1
203 ( Registry Identifier: UNIMIB Ethic Commettee )
First Submitted: October 29, 2015
First Posted: October 30, 2015
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Tremolizzo Lucio, University of Milano Bicocca:
Osteopathic manipulative treatment
Frequent Episodic Tension-Type Headache
Randomized Controlled Trial

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases