Health TrialsbyHealthPanel

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

ConditionTension-Type Headache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlabama Physical Therapy & Acupuncture

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Bilateral location

Pressing or tightening (non-pulsating) quality

Disqualifiers

Patient presents with other primary and/or secondary headache

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thrust Manipulation, Electric Dry Needling and Exercise

    Other intervention

    Thrust Manipulation, Electric Dry Needling

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

    Other intervention

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: thrust manipulation, electric dry needling and exerciseExperimental treatment 1 intervention
Group B: non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENSActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alabama Physical Therapy & Acupuncture

Lead sponsor

Universidad Rey Juan Carlos

Collaborator

Source ClinicalTrials.gov
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