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

Primary Purpose

Tension-Type Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrust Manipulation, Electric Dry Needling and Exercise
Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
Sponsored by
Alabama Physical Therapy & Acupuncture
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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, transient ischemic attack, 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 steroid 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

Sites / Locations

  • Maller and Swoverland Orthopedic PTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

thrust manipulation, electric dry needling and exercise

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

Arm Description

thrust manipulation, electric dry needling and exercise

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

Outcomes

Primary Outcome Measures

Change in Headache Intensity (NPRS)
Average Numeric Pain Rating Score. Higher score means greater pain

Secondary Outcome Measures

Change in Headache Disability Inventory
25 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)
GROC (ranges from -7 to +7). Global Rating of Change score.
Change in Headache Frequency
Number of days patient has a headache during last time period
Change in Headache Duration
Average 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)
Frequency of medication intake during last time period

Full Information

First Posted
October 26, 2020
Last Updated
September 1, 2023
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT04609709
Brief Title
HVLAT, Electric DN, Exercise Vs. Mobilization, STM, Exercise, TENS for Tension Type Headaches
Official Title
Thrust Manipulation, Electric Dry Needling and Exercise Vs. Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS for Tension Type Headache Sufferers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
March 2, 2024 (Anticipated)
Study Completion Date
March 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thrust manipulation, electric dry needling and exercise
Arm Type
Experimental
Arm Description
thrust manipulation, electric dry needling and exercise
Arm Title
non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
Arm Type
Active Comparator
Arm Description
non-thrust mobilization, soft-tissue mobilization, exercise and TENS
Intervention Type
Other
Intervention Name(s)
Thrust Manipulation, Electric Dry Needling and Exercise
Intervention Description
Thrust Manipulation, Electric Dry Needling
Intervention Type
Other
Intervention Name(s)
Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
Intervention Description
Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
Primary Outcome Measure Information:
Title
Change in Headache Intensity (NPRS)
Description
Average Numeric Pain Rating Score. Higher score means greater pain
Time Frame
Baseline, 4-weeks, 8-weeks, 12-weeks
Secondary Outcome Measure Information:
Title
Change in Headache Disability Inventory
Description
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
Title
Change in GROC (Global Rating of Change score)
Description
GROC (ranges from -7 to +7). Global Rating of Change score.
Time Frame
8 Weeks, 12 weeks
Title
Change in Headache Frequency
Description
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
Title
Change in Headache Duration
Description
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
Title
Change in Medication Intake (Frequency of medication intake during last time period)
Description
Frequency of medication intake during last time period
Time Frame
Baseline, 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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 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. 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: 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Dunning, DPT PhD
Phone
801-707-9056
Email
jamesdunning@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Butts, DPT PhD
Phone
803-422-3954
Email
fellowship@spinalmanipulation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dunning, DPT PhD
Organizational Affiliation
American Academy of Manipulative Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maller and Swoverland Orthopedic PT
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben England, DPT
Phone
740-403-9133
Email
benjaminengland1313@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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