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

NCT04609709 | Recruiting

• 1 other identifier: AAMT51
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

• Change in Headache Intensity (NPRS)

  Average Numeric Pain Rating Score. Higher score means greater pain

  Baseline, 4-weeks, 8-weeks, 12-weeks

Secondary Outcomes (5)

• Change in Headache Disability Inventory

  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)

  8 Weeks, 12 weeks

• Change in Headache Frequency

  Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks

• Change in Headache Duration

  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)

  Baseline, 3-months

Study Arms (2)

thrust manipulation, electric dry needling and exercise

EXPERIMENTAL

thrust manipulation, electric dry needling and exercise

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

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

Interventions

Thrust Manipulation, Electric Dry Needling and Exercise OTHER

Thrust Manipulation, Electric Dry Needling

thrust manipulation, electric dry needling and exercise

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

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be between 18 and 65 years old and report ALL YES under one of the Tension-type Headaches described below:
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Maller and Swoverland Orthopedic PT

Fort Wayne, Indiana, 46804, United States

RECRUITING

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• James Dunning, DPT PhD

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Dunning, DPT PhD

CONTACT

801-707-9056; jamesdunning@hotmail.com

Raymond Butts, DPT PhD

CONTACT

803-422-3954; fellowship@spinalmanipulation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DPT, MSc, FAAOMPT

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: October 31, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)