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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04609709
Enrollment
110
Registered
2020-10-30
Start date
2020-10-31
Completion date
2026-05-01
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-Type Headache

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

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

Sponsors

Universidad Rey Juan Carlos
CollaboratorOTHER
Alabama Physical Therapy & Acupuncture
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Headache Intensity (NPRS)Baseline, 4-weeks, 8-weeks, 12-weeksAverage Numeric Pain Rating Score. Higher score means greater pain

Secondary

MeasureTime frameDescription
Change in Headache Disability InventoryBaseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks25 questions each worth 0-4 points with maximum score of 100 points possible. Greater scores indicate increased disability.
Change in GROC (Global Rating of Change score)8 Weeks, 12 weeksGROC (ranges from -7 to +7). Global Rating of Change score.
Change in Headache FrequencyBaseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeksNumber of days patient has a headache during last time period
Change in Headache DurationBaseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeksAverage number of hours/day that the patient had a headache during last time period
Change in Medication Intake (Frequency of medication intake during last time period)Baseline, 3-monthsFrequency of medication intake during last time period

Countries

United States

Contacts

Primary ContactJames Dunning, DPT PhD
jamesdunning@hotmail.com801-707-9056
Backup ContactRaymond Butts, DPT PhD
fellowship@spinalmanipulation.org803-422-3954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026