Phase
Condition
Pain (Pediatric)
Pain
Chronic Pain
Treatment
Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
Thrust Manipulation, Electric Dry Needling and Exercise
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient must be between 18 and 65 years old and report ALL YES under one of theTension-type Headaches described below:
2.2 Frequent Episodic Tension-type Headaches: Frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting minutes to days. The pain does not worsen with routine physical activity and is not associated with nausea, but photophobia or phonophobia may be present.
At least 10 episodes of headache occurring on 1- 14 days per month on average for >3months (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 2.2above)
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 bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting hours to days, or unremitting. The pain does not worsen with routine physical activity, but may be associated with mild nausea, photophobia or phonophobia.
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
Exclusion Criteria:
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-existingheadache disorder
Regular overuse for >3 months of one of more drug that can be taken for acuteand/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 vasculardisease, 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 thehand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus,loss of visual acuity, impaired sensation of the face, altered taste, presence ofpathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
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 orsuperficial 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/orheadaches
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
Study Design
Study Description
Connect with a study center
Maller and Swoverland Orthopedic PT
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
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