ClinicalTrials.gg
RecruitingNCT04609709Updated May 18, 2025

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

An interventional study of Thrust Manipulation, Electric Dry Needling and Exercise and Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS in Tension-Type Headache, sponsored by Alabama Physical Therapy & Acupuncture. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

Read the 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

02

Conditions studied

  • Tension-Type Headache

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03

In context

Tension-Type Headache

143 studies on the registry are indexed under Tension-Type Headache; 42 are open to participants now.

This study's planned enrollment of 110 is above the median of 60 across 108 interventional studies indexed under Tension-Type Headache.

Browse Tension-Type Headache studies →

Lead sponsor

Alabama Physical Therapy & Acupuncture is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

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, , 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    thrust manipulation, electric dry needling and exercise

    thrust manipulation, electric dry needling and exercise

    Other: Thrust Manipulation, Electric Dry Needling and Exercise

  • Active comparator
    non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS

    non-thrust mobilization, soft-tissue mobilization, exercise and TENS

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

Interventions

  • OtherThrust Manipulation, Electric Dry Needling and Exercise

    Thrust Manipulation, Electric Dry Needling

  • OtherNon-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS

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

06

What researchers measure

Primary outcomes

  1. Change in Headache Intensity (NPRS)

    Average Numeric Pain Rating Score. Higher score means greater pain

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

Secondary outcomes

  1. Change in Headache Disability Inventory

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

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

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

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

    Time frame: 8 Weeks, 12 weeks

  3. Change in Headache Frequency

    Number of days patient has a headache during last time period

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

  4. Change in Headache Duration

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

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

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

    Frequency of medication intake during last time period

    Time frame: Baseline, 3-months

07

Study locations

1 of 1 sites recruiting
  • Maller and Swoverland Orthopedic PT
    Fort Wayne, Indiana 46804, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04609709
Lead sponsor
Alabama Physical Therapy & Acupuncture
Responsible party
James Dunning, DPT, MSc, FAAOMPT (DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture) — Principal investigator
First posted
Oct 30, 2020
Start date
Oct 31, 2020
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
May 18, 2025

Study contacts

James Dunning, DPT PhD
Contact
jamesdunning@hotmail.com
801-707-9056
Raymond Butts, DPT PhD
Contact
fellowship@spinalmanipulation.org
803-422-3954
James Dunning, DPT PhD
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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