Tension-Type HeadacheNCT04609709
HVLAT, Electric DN, Exercise Vs. Mobilization, STM, Exercise, TENS for Tension Type Headaches
A study testing Thrust Manipulation, Electric Dry Needling and Exercise and Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS in people with Tension-Type Headache, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Thrust Manipulation, Electric Dry Needling and Exercise and Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2020to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maller and Swoverland Orthopedic PT
Fort Wayne, Indiana, 46804
Ben England, DPT, 740-403-9133, benjaminengland1313@gmail.com
About this study
Official title: Thrust Manipulation, Electric Dry Needling and Exercise Vs. Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS for Tension Type Headache Sufferers
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
- Conditions
- Tension-Type Headache
- Being tested
- Thrust Manipulation, Electric Dry Needling and Exercise, Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrust Manipulation, Electric Dry Needling and ExerciseOther
Thrust Manipulation, Electric Dry Needling
Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENSOther
Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
| Study group | Role | What they receive |
|---|---|---|
| thrust manipulation, electric dry needling and exercise | Experimental | thrust manipulation, electric dry needling and exercise Receives: Other: Thrust Manipulation, Electric Dry Needling and Exercise |
| non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS | Active comparator | non-thrust mobilization, soft-tissue mobilization, exercise and TENS Receives: Other: Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Headache Intensity (NPRS)
Average Numeric Pain Rating Score. Higher score means greater pain
Measured: Baseline, 4-weeks, 8-weeks, 12-weeks
Secondary outcomes (5)
Change in Headache Disability Inventory
25 questions each worth 0-4 points with maximum score of 100 points possible. Greater scores indicate increased disability.
Measured: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks
Change in GROC (Global Rating of Change score)
GROC (ranges from -7 to +7). Global Rating of Change score.
Measured: 8 Weeks, 12 weeks
Change in Headache Frequency
Number of days patient has a headache during last time period
Measured: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks
Change in Headache Duration
Average number of hours/day that the patient had a headache during last time period
Measured: Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks
Change in Medication Intake (Frequency of medication intake during last time period)
Frequency of medication intake during last time period
Measured: Baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start31 Oct 2020
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT PhD, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609709
- Sponsor's protocol ID
- AAMT51
- Status last verified
- May 2025
- First submitted
- 26 Oct 2020
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrust Manipulation, Electric Dry Needling and Exercise Vs. Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS for Tension Type Headache Sufferers
- ClinicalTrials.gov ID
- NCT04609709
- Acronym / sponsor ID
- AAMT51
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thrust manipulation, electric dry needling and exercise | Experimental | Other: Thrust Manipulation, Electric Dry Needling and Exercisethrust manipulation, electric dry needling and exercise |
| non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS | Active comparator | Other: Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENSnon-thrust mobilization, soft-tissue mobilization, exercise and TENS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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:
Key exclusion criteria (22 listed)
- Patient presents with other primary and/or secondary headache
- Patient presents with Medication Overuse Headache defined as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrust Manipulation, Electric Dry Needling and ExerciseThrust Manipulation, Electric Dry Needling | Other | thrust manipulation, electric dry needling and exercise |
| Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENSNon-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS | Other | non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS |
Primary outcome
Change in Headache Intensity (NPRS)
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks
Average Numeric Pain Rating Score. Higher score means greater pain
5 secondary outcomes
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
Change in GROC (Global Rating of Change score)
Time frame: 8 Weeks, 12 weeks
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
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
Change in Medication Intake (Frequency of medication intake during last time period)
Time frame: Baseline, 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Dunning, DPT PhD principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrust Manipulation, Electric Dry Needling and Exercise and Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS in people with Tension-Type Headache, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Dunning, DPT PhD (801-707-9056, jamesdunning@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Intensity (NPRS) (time frame: Baseline, 4-weeks, 8-weeks, 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.