RecruitingNot ApplicableNCT04609709

HVLAT, Electric DN, Exercise Vs. Mobilization, STM, Exercise, TENS for Tension Type Headaches

Thrust Manipulation, Electric Dry Needling and Exercise Vs. Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS for Tension Type Headache Sufferers

Sponsor

Alabama Physical Therapy & Acupuncture

Enrollment

110 participants

Start Date

Oct 31, 2020

Study Type

INTERVENTIONAL

Conditions

Tension-type headache

Summary

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. Physical therapists commonly use all of these techniques to treat tension-type headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria29

Patient must be between 18 and 65 years old and report ALL YES under one of the Tension-type Headaches described below:
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 >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
2.1 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.
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
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 Criteria22

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 face, altered taste, presence of pathological 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 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