BridgeMD
New treatment option for Tension-Type Headache
Official title HVLAT, Electric DN, Exercise Vs. Mobilization, STM, Exercise, TENS for Tension Type Headaches
ClinicalTrials.gov ID: NCT04609709
What this study is testing
- What it's testing
- The purpose of this research is to compare two different approaches for treating patients with tension-type headaches: thrust Manipulation, electric dry Needling and exercise Vs. non-thrust mobilization, soft-tissue mobilization, exercise and TENS.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patient must be between 18 and 65 years old and report ALL YES under one of the Tension-type Headaches described below: 2.2 Frequent Episodic...
- At least 10 episodes of headache occurring on 1- 14 days per month on average for \>3 months (12 and \<180 days per year)
- Headache lasting from 30 minutes to 7 days
- Patient has headaches that have at least two of the following four characteristics:
- Bilateral location
You likely can't join if
- Exclusion Criteria: Must all be NO to be eligible
- Patient presents with other primary and/or secondary headache
- Patient presents with Medication Overuse Headache defined as:
- Headache occurring on 15 days per month in a patient with a pre-existing headache disorder
- Regular overuse for \>3 months of one of more drug that can be taken for acute and/or symptomatic treatment of headache
- Not better accounted for by another headache diagnosis
See the full eligibility criteria
- Patient must be between 18 and 65 years old and report ALL YES under one of the Tension-type Headaches described below: 2.2 Frequent Episodic Tension-type Headaches: Frequent episodes of headache, typically bilateral...
- At least 10 episodes of headache occurring on 1- 14 days per month on average for \>3 months (12 and \<180 days per year)
- Headache lasting from 30 minutes to 7 days
- Patient has headaches that have at least two of the following four characteristics:
- Bilateral location
- Pressing or tightening (non-pulsating) quality
- Mild or moderate intensity
- Not aggravated by routine physical activity such as walking or climbing stairs
- Both of the following are true:
- No nausea or vomiting
- No more than one of photophobia or phonophobia 2.2.1 Frequent Episodic Tension-type Headache associated with pericranial tenderness
- Episodes fulfilling criteria for Frequent episodic tension-type headache (See 2.2 above)
- Increased pericranial tenderness on manual palpation. 2.3 Chronic Tension-type Headaches: A disorder evolving from frequent episodic tension-type headache, with daily or very frequent episodes of headache, typically...
- Headache occurring on 15 days per month on average for \>3 months (180 days per year)
- Headache lasting hours to days, or unremitting
- At least two of the following four characteristics
- Bilateral location
- Pressing or tightening (non-pulsating) quality
- Mild or moderate intensity
- Not aggravated by routine physical activity such as walking of climbing stairs
- Both of the following:
- No more than one of the photophobia, phonophonbia, or mild nausea
- Neither moderate or severe nausea nor vomiting 2.3.1 Chronic Tension-type Headache associated with pericranial tenderness
- Headache fulfilling criteria for 2.3 Chronic tension- type headache
- Increased pericranial tenderness on manual palpation.
- Exclusion Criteria: Must all be NO to be eligible
- Patient presents with other primary and/or secondary headache
- Patient presents with Medication Overuse Headache defined as:
- Headache occurring on 15 days per month in a patient with a pre-existing headache disorder
- Regular overuse for \>3 months of one of more drug that can be taken for acute and/or symptomatic treatment of headache
- Not better accounted for by another headache diagnosis
- History of head/neck trauma (to include whiplash)
- History of Cervical Stenosis
- Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
- Bilateral upper extremity symptoms
- Evidence of CNS involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the...
- Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:
- Muscle weakness involving a major muscle group of the upper extremity.
- Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
- Diminished or absent sensation to pinprick in any UE dermatome.
- Prior surgery to neck of thoracic spine
- Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
- Diagnosis of fibromyalgia syndrome
- Received anesthetic blocks or botulinum toxin within the previous 6 months
- Received physical treatment in the neck and head the previous 6 months
- Any condition that might contraindicate spinal manipulative therapy
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Fort Wayne, Indiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Wayne, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.