Tension-type HeadachePhase 3NCT01347684
Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
A Phase 3 study testing Behavioral therapy, splint therapy and physical therapy in people with Tension-type Headache, run by University of Minnesota at 2 sites in United States.
Trial summary
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients. 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?
- Behavioral therapy, splint therapy and physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Jul 2015
- Phase
- Phase 3
- 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
- Fifty consecutive subjects (Age 18 to 65) will be included when they fulfill the diagnostic criteria for episodic or chronic TTH with pericranial muscle tenderness3 and TMD including myofascial pain involving the temporalis muscle -
Who cannot join
- Exclusion criteria, assessed by review of medical history, include:
- systemic rheumatic disease
- widespread pain
- pregnancy
- concurrent use of tricyclic antidepressants, steroids, anti-inflammatories, muscle relaxants, or narcotics
- major psychiatric disease
- any medical contraindications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota School of Dentistry
Minneapolis, Minnesota, 55455
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.
Read the detailed description
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in TMD patients with episodic or chronic tension-type headache (TTH) with pericranial tenderness involving the temporalis muscle at reducing the intensity of TTH pain at 1 and 6 months. The hypothesis is that a team approach will reduce the intensity of headache more than usual care in this group of patients.
- Conditions
- Tension-type Headache
- Being tested
- Behavioral therapy, splint therapy and physical therapy, Standard care using current drugs
- Keywords
- headache, elavil, splints, physical therapy, behavioral therapy
- Medical subject headings
- Tension-Type Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral therapy, splint therapy and physical therapyBehavioural
Also called Medications: Amitryptoline or has unacceptable side-effects, then other tricyclics and/or muscle relaxants are allowed.1
Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.
Standard care using current drugsDrug
Standard Drug therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard care using current drugs | Active comparator | Standard care with drug intervention Receives: Drug: Standard care using current drugs |
| Behavioral therapy, splint therapy and physical therapy | Experimental | Using rehabilitation for comparing use of drug Receives: Behavioral: Behavioral therapy, splint therapy and physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of headache intensity of pain using pain scale of 1-10
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: PI left University of Minnesota
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 MinnesotaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric L Schiffman, DDS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347684
- Sponsor's protocol ID
- 1103M96812
- Status last verified
- Dec 2016
- First submitted
- 28 Apr 2011
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
- ClinicalTrials.gov ID
- NCT01347684
- Acronym / sponsor ID
- 1103M96812
- Conditions
- Tension-type Headache
- Keywords
- headache, elavil, splints, physical therapy, behavioral therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left University of Minnesota
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 May 2011 (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 primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.
Detailed description
The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in TMD patients with episodic or chronic tension-type headache (TTH) with pericranial tenderness involving the temporalis muscle at reducing the intensity of TTH pain at 1 and 6 months. The hypothesis is that a team approach will reduce the intensity of headache more than usual care in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care using current drugs | Active comparator | Drug: Standard care using current drugsStandard care with drug intervention |
| Behavioral therapy, splint therapy and physical therapy | Experimental | Behavioral: Behavioral therapy, splint therapy and physical therapyUsing rehabilitation for comparing use of drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fifty consecutive subjects (Age 18 to 65) will be included when they fulfill the diagnostic criteria for episodic or chronic TTH with pericranial muscle tenderness3 and TMD including myofascial pain involving the temporalis muscle -
Key exclusion criteria (7 listed)
- systemic rheumatic disease
- widespread pain
- pregnancy
- concurrent use of tricyclic antidepressants, steroids, anti-inflammatories, muscle relaxants, or narcotics
- major psychiatric disease
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 |
|---|---|---|
| Behavioral therapy, splint therapy and physical therapyAlso: Medications: Amitryptoline or has unacceptable side-effects, then other tricyclics and/or muscle relaxants are allowed.1Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention. | Behavioural | Behavioral therapy, splint therapy and physical therapy |
| Standard care using current drugsStandard Drug therapy | Drug | Standard care using current drugs |
Primary outcome
Change from baseline of headache intensity of pain using pain scale of 1-10
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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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.
Eric L Schiffman, DDS principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral therapy, splint therapy and physical therapy in people with Tension-type Headache, run by University of Minnesota at 2 sites in United States.
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 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: withdrawn, as of the sponsor's last update on 7 Dec 2016. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline of headache intensity of pain using pain scale of 1-10 (time frame: 3 months). 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 7 Dec 2016.