What side effects are associated with this type of intervention?

Thrust manipulation for tension headaches can cause mild to moderate discomfort, muscle soreness, or transient headache. Electric dry needling may result in minor bleeding, bruising, temporary pain at the needle site, and rarely, infection. Exercise typically has minimal side effects but can sometimes lead to muscle soreness or strain if not performed correctly.

What prior FDA approvals exist?

The FDA has approved various treatments for tension headaches, but specific approvals for methods like Thrust Manipulation, Electric Dry Needling, and Exercise are not well-documented. Generally, treatments for tension headaches include pharmacologic options such as NSAIDs and muscle relaxants. Non-pharmacologic treatments like physical therapy, including exercise and manual therapy, are commonly recommended but may not have specific FDA approval. Techniques like acupuncture and dry needling are used for pain relief, though their FDA approval status may vary based on the specific device or method used.

What other types of research exist?

Promising novel alternatives for treating tension headaches include non-thrust mobilization, soft-tissue mobilization, and Transcutaneous Electrical Nerve Stimulation (TENS). These methods have been used by physical therapists and have shown potential in managing tension-type headaches.

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Manipulation & Dry Needling vs. Mobilization & Massage for Tension Headaches

N/A

Recruiting

Led By James Dunning, DPT PhD

Research Sponsored by Alabama Physical Therapy & Acupuncture

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be between 18 and 65 years old

Patient must have headaches that meet the criteria for Frequent Episodic Tension-type Headaches or Chronic Tension-type Headaches as described

Must not have

Patient presents with Medication Overuse Headache as defined

History of head/neck trauma (to include whiplash)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3-months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two treatment methods for people with tension headaches. One method uses chiropractic adjustments, needling, and exercise, while the other uses gentle joint movements, massage, exercise, and electrical stimulation. The goal is to see which method works better at reducing headache pain.

Who is the study for?

This trial is for adults aged 18-65 with frequent episodic or chronic tension-type headaches and tenderness around the head. Participants must not have had recent neck/head treatments, surgery, trauma, or conditions like fibromyalgia. Pregnant individuals or those involved in related litigation are excluded.

What is being tested?

The study compares two headache treatment methods: one combines thrust manipulation, electric dry needling and exercise; the other uses non-thrust mobilization, soft-tissue work, exercise and TENS (a type of electrical nerve stimulation).

What are the potential side effects?

Potential side effects may include soreness at manipulation sites, skin irritation from dry needling or TENS pads, temporary increase in headache pain following treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have frequent or chronic tension headaches.

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I have frequent headaches with scalp tenderness.

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I have chronic headaches with tenderness around my head.

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I experience tension-type headaches.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have headaches from using too much headache medicine.

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I have had a head or neck injury, including whiplash.

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My cancer has spread to my brain or spinal cord.

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I have at least two signs of nerve damage due to pressure on my nerves.

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I have symptoms in both of my arms.

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I have had surgery on my neck or upper back.

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I have a condition that may not allow for spinal manipulation treatment.

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I have been diagnosed with fibromyalgia.

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I have a history of cervical stenosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Headache Intensity (NPRS)

Secondary study objectives

Change in GROC (Global Rating of Change score)

Change in Headache Disability Inventory

Change in Headache Duration

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: thrust manipulation, electric dry needling and exerciseExperimental Treatment1 Intervention

thrust manipulation, electric dry needling and exercise

Group II: non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENSActive Control1 Intervention

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

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Thrust manipulation, electric dry needling, and exercise are common treatments for tension headaches. Thrust manipulation uses high-velocity, low-amplitude force to improve joint function and alleviate tension in the cervical spine, potentially reducing headache frequency and intensity. Electric dry needling involves inserting needles into specific muscle points with electrical stimulation to relieve muscle tension and trigger points, reducing pain and tightness. Exercise improves muscle strength and flexibility, correcting postural imbalances and reducing headache severity. Understanding these mechanisms helps patients appreciate the importance of addressing both muscular and joint components in managing tension headaches.