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

Last updated: May 14, 2025
Sponsor: Alabama Physical Therapy & Acupuncture
Overall Status: Active - Recruiting

Phase

N/A

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

NCT04609709
AAMT51
  • Ages 18-65
  • All Genders

Study 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 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.

  1. At least 10 episodes of headache occurring on 1- 14 days per month on average for >3months (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:

  4. Bilateral location

  5. Pressing or tightening (non-pulsating) quality

  6. Mild or moderate intensity

  7. Not aggravated by routine physical activity such as walking or climbing stairs

  8. Both of the following are true:

  9. No nausea or vomiting

  10. 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 2.2above)

  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

  4. Bilateral location

  5. Pressing or tightening (non-pulsating) quality

  6. Mild or moderate intensity

  7. Not aggravated by routine physical activity such as walking of climbing stairs

  8. Both of the following:

  9. No more than one of the photophobia, phonophonbia, or mild nausea

  10. 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

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:

  3. Headache occurring on 15 days per month in a patient with a pre-existingheadache disorder

  4. Regular overuse for >3 months of one of more drug that can be taken for acuteand/or symptomatic treatment of headache

  5. Not better accounted for by another headache diagnosis

  6. History of head/neck trauma (to include whiplash)

  7. History of Cervical Stenosis

  8. Presence of any of the following atherosclerotic risk factors: hypertension,diabetes, heart disease, stroke, transient ischemic attack, peripheral vasculardisease, smoking, hypercholesterolemia or hyperlipidemia

  9. 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.

  10. Bilateral upper extremity symptoms

  11. 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).

  12. Two or more positive neurologic signs consistent with nerve root compression,including any 2 of the following:

  13. Muscle weakness involving a major muscle group of the upper extremity.

  14. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps orsuperficial flexors

  15. Diminished or absent sensation to pinprick in any UE dermatome.

  16. Prior surgery to neck of thoracic spine

  17. Involvement in litigation or worker's compensation regarding their neck pain and/orheadaches

  18. Diagnosis of fibromyalgia syndrome

  19. Received anesthetic blocks or botulinum toxin within the previous 6 months

  20. Received physical treatment in the neck and head the previous 6 months

  21. Any condition that might contraindicate spinal manipulative therapy

  22. Pregnancy

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
Phase:
Study Start date:
October 31, 2020
Estimated Completion Date:
May 01, 2026

Study 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

Connect with a study center

  • Maller and Swoverland Orthopedic PT

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

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