Clinical trial NCT04609709: HVLAT, Electric DN, Exercise Vs. Mobilization, STM, Exercise, TENS for Tension Type Headaches
Official title: Thrust Manipulation, Electric Dry Needling and Exercise Vs. Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS for Tension Type Headache Sufferers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2020-10-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patient will tension-type headaches will be randomized to receive 2 sessions per week for 6 weeks (up to 8-12 sessions total) of either: 1. thrust Manipulation, electric dry Needling and exercise or 2. non-thrust mobilization, soft-tissue mobilization, exercise and TENS

Eligibility criteria: Inclusion 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, 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.

1. At least 10 episodes of headache occurring on 1- 14 days per month on average for \>3 months (12 and \<180 days per year)
2. Headache lasting from 30 minutes to 7 days
3. Patient has headaches that have at least two of the following four characteristics:

   1. Bilateral location
   2. Pressing or tightening (non-pulsating) quality
   3. Mild or moderate intensity
   4. Not aggravated by routine physical activity such as walking or climbing stairs
4. Both of the following are true:

   1. No nausea or vomiting
   2. No more than one of photophobia or phonophobia

2.2.1 Frequent Episodic Tension-type Headache associated with pericranial tenderness

1. Episodes fulfilling criteria for Frequent episodic tension-type headache (See 2.2 above)
2. 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.

1. Headache occurring on 15 days per month on average for \>3 months (180 days per year)
2. Headache lasting hours to days, or unremitting
3. At least two of the following four characteristics

   1. Bilateral location
   2. Pressing or tightening (non-pulsating) quality
   3. Mild or moderate intensity
   4. Not aggravated by routine physical activity such as walking of climbing stairs
4. Both of the following:

   1. No more than one of the photophobia, phonophonbia, or mild nausea
   2. Neither moderate or severe nausea nor vomiting

2.3.1 Chronic Tension-type Headache associated with pericranial tenderness

1. Headache fulfilling criteria for 2.3 Chronic tension- type headache
2. Increased pericranial tenderness on manual palpation.

Exclusion Criteria:

Exclusion Criteria: Must all be NO to be eligible

1. Patient presents with other primary and/or secondary headache
2. Patient presents with Medication Overuse Headache defined as:

   1. Headache occurring on 15 days per month in a patient with a pre-existing headache disorder
   2. Regular overuse for \>3 months of one of more drug that can be taken for acute and/or symptomatic treatment of headache
   3. Not better accounted for by another headache diagnosis
3. History of head/neck trauma (to include whiplash)
4. History of Cervical Stenosis
5. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
6. 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.
7. Bilateral upper extremity symptoms
8. 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).
9. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:

   1. Muscle weakness involving a major muscle group of the upper extremity.
   2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
   3. Diminished or absent sensation to pinprick in any UE dermatome.
10. Prior surgery to neck of thoracic spine
11. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
12. Diagnosis of fibromyalgia syndrome
13. Received anesthetic blocks or botulinum toxin within the previous 6 months
14. Received physical treatment in the neck and head the previous 6 months
15. Any condition that might contraindicate spinal manipulative therapy
16. Pregnancy

Primary outcomes:
measure: Change in Headache Intensity (NPRS)
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks
Secondary outcomes:
measure: Change in Headache Disability Inventory
timeFrame: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks
measure: Change in GROC (Global Rating of Change score)
timeFrame: 8 Weeks, 12 weeks
measure: Change in Headache Frequency
timeFrame: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks
measure: Change in Headache Duration
timeFrame: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks
measure: Change in Medication Intake (Frequency of medication intake during last time period)
timeFrame: Baseline, 3-months
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Maller and Swoverland Orthopedic PT
state: Indiana
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT PhD
role: PRINCIPAL_INVESTIGATOR
References: