Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Rey Juan Carlos | OTHER |
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thrust manipulation, electric dry needling and exercise | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrust Manipulation, Electric Dry Needling and Exercise | Other | Thrust Manipulation, Electric Dry Needling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Headache Intensity (NPRS) | Average Numeric Pain Rating Score. Higher score means greater pain | Baseline, 4-weeks, 8-weeks, 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Headache Disability Inventory | 25 questions each worth 0-4 points with maximum score of 100 points possible. Greater scores indicate increased disability. | 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) |
Not provided
Inclusion Criteria:
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:
Both of the following are true:
2.2.1 Frequent Episodic Tension-type Headache associated with pericranial tenderness
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
Both of the following:
2.3.1 Chronic Tension-type Headache associated with pericranial tenderness
Exclusion Criteria:
Exclusion Criteria: Must all be NO to be eligible
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
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:
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
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Dunning, DPT PhD | Contact | 801-707-9056 | jamesdunning@hotmail.com | |
| Raymond Butts, DPT PhD | Contact | 803-422-3954 | fellowship@spinalmanipulation.org |
| Name | Affiliation | Role |
|---|---|---|
| James Dunning, DPT PhD | American Academy of Manipulative Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maller and Swoverland Orthopedic PT | Recruiting | Fort Wayne | Indiana | 46804 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS | Other | Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS |
|
GROC (ranges from -7 to +7). Global Rating of Change score. |
| 8 Weeks, 12 weeks |
| Change in Headache Frequency | Number of days patient has a headache during last time period | 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 | 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 | Baseline, 3-months |
| ID | Term |
|---|---|
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided