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## Complete Summary

#### GUIDELINE TITLE

Treatment of primary headache: episodic tension-type headache. Standards
of care for headache diagnosis and treatment.

#### BIBLIOGRAPHIC SOURCE(S)

Ruoff G, Urban G. Treatment of primary headache: episodic tension-type
headache. In: Standards of care for headache diagnosis and treatment.
Chicago (IL): National Headache Foundation; 2004. p. 53-8. \[6
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory information
has been released.

-   [June 15, 2005, COX-2 Selective (includes Bextra, Celebrex, and
    Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs
    (NSAIDs)](http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#NSAID):
    Labeling revised to include a boxed warning and a Medication Guide,
    highlighting the potential for increased risk of cardiovascular (CV)
    events and life-threatening gastrointestinal (GI) bleeding.

-   [April 7, 2005, Bextra (valdecoxib), Cox-2 inhibitors, Celebrex
    (celecoxib), Non-steroidal anti-inflammatory drugs (NSAIDS)
    (prescription and OTC, including ibuprofen and
    naproxen](http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#BEXTRA):
    Bextra (valdecoxib) withdrawn from the market and labels for other
    Cox-2 inhibitors and NSAIDS revised to include a boxed warning and a
    Medication Guide, highlighting the potential for increased risk of
    cardiovascular (CV) events and life-threatening gastrointestinal
    (GI) bleeding.

**Additional Notice**

-   [April 11, 2007, Zanaflex (tizanidine
    hydrochloride)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zanaflex):
    Changes to the product labeling for Zanaflex, a drug used to treat
    spasticity, to warn against its hypotensive and sedative effects
    when administered with fluvoxamine or ciprofloxacin (CYP1A2
    inhibitors).

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Episodic tension-type headache (TTH)

#### GUIDELINE CATEGORY

Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Neurology

#### INTENDED USERS

Health Care Providers\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To improve the medical treatment of headache

-   To help physicians and other health care professionals to design a
    treatment plan, combining nonpharmacologic with pharmacologic
    approaches as necessary to:

    -   Minimize symptomatology

    -   Reduce disability

    -   Improve quality of life

-   To make practicing physicians aware of the existence of tension-type
    headache (TTH), as well as general treatment strategies for it,
    including both drug and nondrug approaches

#### TARGET POPULATION

Patients with episodic tension-type headache (TTH)

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Drug Treatment**

**Simple Over-the-Counter Analgesics**

1.  Aspirin

2.  Acetaminophen

3.  Nonsteroidal anti-inflammatory drugs (NSAIDs)

    -   Acetylsalicylic acid

    -   Ibuprofen

    -   Naproxen sodium

**Over-the-Counter Combination Analgesics**

1.  Aspirin/caffeine

2.  Acetaminophen/caffeine

3.  Aspirin/acetaminophen/caffeine

**Prescription Medications**

1.  NSAIDs

    -   Celecoxib

    -   Diclofenac

    -   Diflunisal

    -   Etodolac

    -   Fenoprofen

    -   Flurbiprofen

    -   Ibuprofen

    -   Indomethacin

    -   Ketoprofen

    -   Ketorolac

    -   Meclofenamate

    -   Mefenamic acid

    -   Meloxicam

    -   Nabumetone

    -   Naproxen

    -   Naproxen sodium

    -   Rofecoxib

    -   Salsalate

    -   Tolmetin

    -   Valdecoxib

2.  Muscle relaxants, alone or combination

    -   Baclofen

    -   Carisoprodol

    -   Carisoprodol/aspirin

    -   Chlorzoxazone

    -   Cyclobenzaprine

    -   Metaxalone

    -   Methocarbamol

    -   Orphenadrine citrate

    -   Orphenadrine citrate/aspirin/caffeine

    -   Tizanidine

3.  Barbiturate-containing analgesics

    -   Butalbital/aspirin/caffeine

    -   Butalbital/acetaminophen/caffeine

    -   Butalbital/acetaminophen

4.  Other

    -   Isometheptene mucate/dichloralphenazone/acetaminophen

**Nondrug Treatments**

1.  Relaxation techniques

2.  Proper sleep and diet habits

3.  Exercise

4.  Avoidance of behaviors or situations that may trigger an attack

5.  Biofeedback

6.  Physical interventions

    -   Acupuncture and acupressure

    -   Heat or cold applications

#### MAJOR OUTCOMES CONSIDERED

Not stated

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The guidelines presented in this monograph represent the consensus of an
advisory panel of practitioners chosen by the National Headache
Foundation (NHF) for their expertise. In addition to incorporating the
US Headache Consortium\'s recommendations, their conclusions reflect
clinical experience and the most recent medical literature.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Not stated

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Episodic Tension-Type Headache (TTH)**

**Drug Treatment**

Once a more serious underlying condition has been ruled out, the goal of
TTH therapy is acute intervention with the simplest, most effective, and
best-tolerated agent (see figure 5.1 of the original guideline
document). Selection of an appropriate therapeutic approach is based on
a thorough history, including the patient\'s response to previous
treatments and an assessment of the impact of the attacks on the
patient\'s quality of life. Physicians should specifically inquire about
over-the-counter (OTC) medications, as few patients recognize how
differences in this class of analgesics can affect subsequent treatment
(see table 5.1 of the original guideline document for guidelines for use
of selected abortive therapies in the treatment of TTH).

**Simple OTC Analgesics**

Unless the patient has already tried simple analgesics without success,
treatment of TTH should begin with a nonprescription aspirin,
acetaminophen, or nonsteroidal anti-inflammatory drug (NSAID) such as
ibuprofen, naproxen sodium, or ketoprofen. In general, recommend a
relatively high dose and stress the importance of early intervention to
maximize effectiveness.

**OTC Combination Analgesics**

If simple analgesics fail, consider recommending a nonprescription
medication that contains aspirin and/or acetaminophen with the addition
of caffeine. Caffeine is an adjunct that provides mild vasoconstrictive,
psychomimetic, and pain-enhancing action as well as a gastrokinetic
effect.

**Prescription Medications**

If OTC analgesics are unsuccessful, prescription medications are the
next appropriate step, including NSAIDs and barbiturate-containing
medications (see table below). Keep in mind that the response to NSAIDs
is highly individual, and failure of one agent should not preclude the
use of another for future attacks. Further, prescribe
barbiturate-containing products only with extreme caution, as they have
a strong tendency to induce analgesic rebound, which often leads to
their overuse.

+--------------------------+-------------------------------------------+
| **Prescription NSAIDs    |                                           |
| and                      |                                           |
| Barbiturate-Containing   |                                           |
| Analgesics**             |                                           |
+==========================+===========================================+
| **NSAIDs**               | **Barbiturate-Containing Analgesics**     |
+--------------------------+-------------------------------------------+
| -   Celecoxib            | -   Butalbital/aspirin/caffeine           |
|                          |                                           |
| -   Diclofenac           | -   Butalbital/acetaminophen/caffeine     |
|                          |                                           |
| -   Etodolac             | -   Butalbital/acetaminophen              |
|                          |                                           |
| -   Fenoprofen           |                                           |
|                          |                                           |
| -   Flurbiprofen         |                                           |
|                          |                                           |
| -   Indomethacin         |                                           |
|                          |                                           |
| -   Ibuprofen            |                                           |
|                          |                                           |
| -   Ketoprofen           |                                           |
|                          |                                           |
| -   Ketorolac            |                                           |
|                          |                                           |
| -   Mefenamic acid       |                                           |
|                          |                                           |
| -   Meloxicam            |                                           |
|                          |                                           |
| -   Nabumetone           |                                           |
|                          |                                           |
| -   Naproxen             |                                           |
|                          |                                           |
| -   Naproxen sodium      |                                           |
|                          |                                           |
| -   Rofecoxib\*          |                                           |
|                          |                                           |
| -   Salsalate            |                                           |
|                          |                                           |
| -   Valdecoxib\*\*       |                                           |
+--------------------------+-------------------------------------------+

\*On September 30, 2004, Vioxx (rofecoxib) was withdrawn from the U.S.
and worldwide market due to safety concerns of an increased risk of
cardiovascular events. See the [U.S. Food and Drug Administration (FDA)
Web site](http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx)
for more information.

\*\*Subsequently, on April 7, 2005, after concluding that the overall
risk versus benefit profile is unfavorable, the FDA requested that
Pfizer, Inc voluntarily withdraw Bextra (valdecoxib) from the market.
The FDA also asked manufacturers of all marketed prescription
nonsteroidal anti-inflammatory drugs (NSAIDs), including Celebrex
(celecoxib), a COX-2 selective NSAID, to revise the labeling (package
insert) for their products to include a boxed warning and a Medication
Guide. Finally, FDA asked manufacturers of non-prescription (over the
counter \[OTC\]) NSAIDs to revise their labeling to include more
specific information about the potential gastrointestinal (GI) and
cardiovascular (CV) risks, and information to assist consumers in the
safe use of the drug. See the [FDA Web
site](http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Bextra) for
more information.

**Additional Prescribing Considerations**

Preventive therapy is not required unless the number of TTH attacks
exceeds 15 per month. Muscle relaxants with or without analgesics may be
used effectively, if the attacks are associated with the pericranial
muscles (see table below). In rare cases, depression, anxiety, or both
may be associated with TTH and should be treated as appropriate.

+-----------------------------------------------------------------------+
| **Muscle Relaxants with/without Analgesics**                          |
+=======================================================================+
| -   Baclofen                                                          |
|                                                                       |
| -   Carisoprodol                                                      |
|                                                                       |
| -   Carisoprodol/aspirin                                              |
|                                                                       |
| -   Chlorzoxazone                                                     |
|                                                                       |
| -   Cyclobenzaprine                                                   |
|                                                                       |
| -   Metaxalone                                                        |
|                                                                       |
| -   Methocarbamol                                                     |
|                                                                       |
| -   Orphenadrine                                                      |
|                                                                       |
| -   Orphenadrine/aspirin/caffeine                                     |
|                                                                       |
| -   Tizanidine                                                        |
|                                                                       |
| -   Isometheptene/dichloralphenazone/acetaminophen                    |
+-----------------------------------------------------------------------+

**Safety Issues**

Physicians should be aware of, and should thoroughly explain to the
patient, any potential side effects associated with treatments for TTH.
For example, prolonged use or abuse of analgesics may lead to
gastrointestinal irritation, impair platelet function, and cause renal
or hepatic complications. Barbiturate-containing analgesics may cause
drowsiness, analgesic rebound headache, and habituation.

Patients should always be reminded to follow precisely the recommended
usage for any acute headache medication. For example, patients who
medicate their attacks on a daily or near-daily basis may be susceptible
to the rebound phenomenon. Although the medication initially relieves
the pain, response may gradually decrease over time, prompting the
gradual use of additional medication. As this cycle continues - and
worsens - the patient may ultimately develop chronic TTH or daily
headache. Reminding patients to limit their use of acute medications to
a single dose (with one repeat dose if pain persists) may help to avoid
a serious problem before it begins.

**Nondrug Treatments**

Nondrug treatments can be an effective approach to TTH treatment,
especially when used in conjunction with medication. Strategies include
relaxation techniques, proper sleep and diet habits, exercise, and
avoidance of behaviors or situations that may trigger an attack.
Biofeedback has been used successfully in practice, but clinical studies
on its effectiveness have been inconclusive. Physical interventions,
such as acupuncture and acupressure, as well as simple heat or cold
applications may also be useful.

#### CLINICAL ALGORITHM(S)

A clinical algorithm is provided for the pharmacologic approach to
tension-type headache (TTH)

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically
stated.

In addition to incorporating the US Headache Consortium\'s
recommendations, the conclusions reflect clinical experience and the
most recent medical literature.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate treatment of episodic tension-type headache (TTH)

#### POTENTIAL HARMS

-   Prolonged use or abuse of analgesics may lead to gastrointestinal
    irritation, impair platelet function, and cause renal or hepatic
    complications.

-   Barbiturate-containing analgesics may cause drowsiness, analgesic
    rebound headache, and habituation.

-   Patients who medicate their attacks on a daily or near-daily basis
    may be susceptible to the rebound phenomenon. Although the
    medication initially relieves the pain, response may gradually
    decrease over time, prompting the gradual use of additional
    medication. As this cycle continues - and worsens - the patient may
    ultimately develop chronic TTH or daily headache.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Drug therapy is constantly evolving as new research, clinical trials,
case reports, and opinions are published. Many of the drugs recommended
in these guidelines are not approved by the US Food and Drug
Administration (FDA) for treatment of headache, nor are they necessarily
the same as those therapies recommended by the manufacturer for labeled
indications. Their use in headache, however, may be supported by the
scientific literature and by the authors\' clinical experiences. While
efforts have been made to ensure accuracy, the authors and publisher do
not assume responsibility for the consistent updating of available
information for these guidelines, nor for any errors or omissions, nor
for any consequences thereof. The onus is on the practitioner to
evaluate recommendations in light of the clinical condition of the
patient and recent medical literature. The authors advise the
practitioner to consult other sources, especially the manufacturers\'
warnings and precautions, before prescribing any drug with which they
are unfamiliar. Practitioners are also advised that while these
guidelines will address the needs of many patients, there will be
circumstances calling for exceptions to these recommendations.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Clinical Algorithm\
Foreign Language Translations\
Patient Resources\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Ruoff G, Urban G. Treatment of primary headache: episodic tension-type
headache. In: Standards of care for headache diagnosis and treatment.
Chicago (IL): National Headache Foundation; 2004. p. 53-8. \[6
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2004

#### GUIDELINE DEVELOPER(S)

National Headache Foundation - Private Nonprofit Organization

#### SOURCE(S) OF FUNDING

National Headache Foundation

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Gary Ruoff, MD, and George Urban, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: None available

Print copies: Available from the National Headache Foundation, 820 N.
Orleans, Suite 218, Chicago, IL 60610; Phone: (888) NHF-5552; Web
address: [www.headaches.org](http://www.headaches.org/)

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   The complete headache chart. Chicago (IL): National Headache
    Foundation (NHF); 2 p. Electronic copies available in Portable
    Document Format (PDF) from the [National Headache Foundation Web
    site](http://www.headaches.org/consumer/presskit/hachart.pdf)

-   National Headache Foundation fact sheet. Chicago (IL): National
    Headache Foundation (NHF); 2004 Oct. 2 p. Electronic copies
    available in Portable Document Format (PDF) from the [National
    Headache Foundation Web
    site](http://www.headaches.org/consumer/presskit/factsheet.pdf).

Print copies: Available from the National Headache Foundation, 820 N.
Orleans, Suite 218, Chicago, IL 60610; Phone: (888) NHF-5552; Web
address: [www.headaches.org](http://www.headaches.org/)

#### PATIENT RESOURCES

The National Headache Foundation (NHF) has created a variety of
educational resources for patients, including informative brochures, a
patient diary for migraines, Power Point presentations, and patient
guides; many of these resources are available in both Spanish and
English. Some of these items are available as print copies for purchase
through the [NHF online
store](http://www.headaches.org/consumer/storeindex.jsp). Electronic
versions of other resources are available through the consumer education
section of the [NHF Web
site](http://www.headaches.org/consumer/educationindex.html).

Print copies: Available from the National Headache Foundation, 820 N.
Orleans, Suite 218, Chicago, IL 60610; Phone: (888) NHF-5552; Web
address: [www.headaches.org](http://www.headaches.org/).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on April 11, 2005. The
information was verified by the guideline developer on April 26, 2005.
This summary was updated by ECRI on June 16, 2005, following the U.S.
Food and Drug Administration advisory on COX-2 selective and
non-selective non-steroidal anti-inflammatory drugs (NSAIDs). This
summary was updated by ECRI Institute on May 8, 2007, following the U.S.
Food and Drug Administration advisory on Zanaflex (tizanidine
hydrochloride).

#### COPYRIGHT STATEMENT

These guidelines are for reference purposes only and are not to be mass
produced. This information is copyrighted by the National Headache
Foundation, 2005.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008