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NCT Number: NCT04609709

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maller and Swoverland Orthopedic PT

Fort Wayne, Indiana, 46804, United States

Location status: Recruiting

Location contact

Ben England, DPT

CONTACT

[email protected]

740-403-9133

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • 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 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 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-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

Treatment and study plan

Thrust Manipulation, Electric Dry Needling and Exercise

Other

Thrust Manipulation, Electric Dry Needling

Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS

Other

Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS

Primary outcomes

  1. Change in Headache Intensity (NPRS)

    Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks

    Average Numeric Pain Rating Score. Higher score means greater pain

Secondary outcomes

  1. Change in Headache Disability Inventory

    Time frame: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks

    25 questions each worth 0-4 points with maximum score of 100 points possible. Greater scores indicate increased disability.

  2. Change in GROC (Global Rating of Change score)

    Time frame: 8 Weeks, 12 weeks

    GROC (ranges from -7 to +7). Global Rating of Change score.

  3. Change in Headache Frequency

    Time frame: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks

    Number of days patient has a headache during last time period

  4. Change in Headache Duration

    Time frame: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks

    Average number of hours/day that the patient had a headache during last time period

  5. Change in Medication Intake (Frequency of medication intake during last time period)

    Time frame: Baseline, 3-months

    Frequency of medication intake during last time period

Study contacts

Contact information is provided by the study sponsor or research team.

James Dunning, DPT PhD

CONTACT

[email protected]

801-707-9056

Raymond Butts, DPT PhD

CONTACT

[email protected]

803-422-3954

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2020
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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