Migraine Relief – Clinical Study

Headache Classification, Information, Treatment and I.C.E. DOWN's clinical study for migraine pain relief.


MIGRAINE, TENSION, & CLUSTER headaches are the three most common varieties and the following is a brief description of these three types of headaches and the treatments available to relieve pain.


In a "classical" migraine, which affects about 15% of migraine sufferers, or migraineurs, the headache is heralded by an aura, a distortion of vision that can be hallucinatory in nature. In a classical and common migraine the throbbing pain generally attacks only one side of the head; victims often feel nauseated and vomit, and they may be exquisitely sensitive to light and sound.

Over 15% of the population or 45 million Americans get chronic, recurring headaches. Of these approximately 29 million suffer from migraines annually. 70% of all migraine suffers are women. Approximately 65% of the female migraine suffers complain of headaches immediately before, during or immediately after menstruation.

Migraine is found to have a hereditary influence in about 70% of suffers. Infants and children can have migraine headaches.


Cluster headaches produce some of the most severe pain that a headache sufferer can feel. No cause has been determined, but most can be controlled with adequate treatment. Over 1 million individuals in the United States suffer from cluster headache. Approximately 10% are afflicted with chronic cluster and primarily it affects men.

TENSION (Muscle Contraction)

Approximately 90% of all headaches are classified as muscle contraction/tension headache. The pain is typically generalized all over the head. There are two types of muscle contraction (tension) headache: those that occur on an episodic basis and those that occur daily.

There are two types of muscle contraction (tension) headache: those that occur on an episodic basis and those that occur daily. The daily muscle contraction headache is often caused by depression or other emotional problems. Suffers usually awaken in the morning with the headache and frequently have an accompanying sleep disorder.


Children do experience headache, even children as young as 2 years of age have been known to suffer from headaches. Both parents and pediatricians alike have neglected the problem of headaches in children. This is a problem that may not be as widespread as it is in adults, but headaches in children are quite frequent and deserve more attention than they have received. Most are due to migraine or emotional problems. 90% of children with migraine headaches have a family history of this disorder.


TMJ disorders are most commonly identified by headaches with the feeling of pressure around the head, and can be either tension or migraine-like. Vertigo, dizziness, loss of equilibrium, ringing in the ears, and pain of varying degrees with any amount of jaw movement are other frequent complaints of persons suffering from this disorder.

* Information supplied by the National Headache Foundation HYPERLINK "http://www.headaches.org/" http://www.headaches.org/


The standard regimens of treatment for headache pain suffers are as follows:

  • Drugs
  • Biofeedback
  • Diet, Exercise and relaxation

Treatment for TMJ could include any of the above or other types of treatments as may be recommend by a physician.

By far, drugs are the most widely prescribed form of treatment for headaches. Preventative medication is recommended for patients getting two or more disabling attacks per month that are severe enough to curtail their normal work or social activities.

Below is a list of the types of drugs prescribed for the treatment of headache and their side effects and/or contraindications. Most of the drugs used in the treatment of headaches were originally developed for other uses such as arthritis, hypertension and

OTC Drugs

Brand Name - Generic active ingredient
  • ASPRIN® (acetaminophen)
  • EXCEDRIN® (acetaminophen, asprin, caffeine)
  • TYLENOL® (acetaminophen)
  • ADVIL® (ibuprofen)
  • MOTRIN® (ibuprofen)
Prescription Rx Drugs
  • Brand Name Generic active ingredient
  • DEPAKOTE® (divalproex sodium)
  • ZOMIG® (zolmitriptan)
  • IMITREX® (sumatriptan succinate)
  • SEDAPAP® (acepaminophen and butalbital)
  • FIORICET® (acepaminophen butalbital and caffeine)
  • AXERT® (almotriptan malate)
  • ESGIC® (acepaminophen Butalbital Caffeine)

Side effects

As shown in their respective clinical studies the following are side effects caused by one or more of the preceding list of drugs.

Nausea (31%), dyspepsia (13%), diarrhea 12%, vomoiting (11%) abdominal pain, nervous system (asthenia 20%), somnolence (17%), edema, increased appetite (6%), weight gain (8%), rash, tooth disorder, respiratory disorder and alopecia-hair loss (7%). Anorexia, gum hemorrhage, mouth ulceration, fecal incontience, gastroenteritis, back pain, dry eye, insomnia, hallucinations, irritability, liver function abnormality and thirst, tongue swelling, fever, miscarriage, leg cramps, arthritis, asthenia, twitching, voice alteration, ear pain, bronchitis, urinary urgency and frequency, chest-pain, chest-pressure, neck/throat/jaw-pain/tightness/pressure, dizziness, heaviness, disorder of breasts, influenza, colitis, myoclonia, serious cardiac events, coronary artery vasospasm, transient myocardial ischemia, angina pectoris, and myocardial infarction, uncontrolled sensitive to light or sound, stinging sensations, stress, difficulty in walking, lower respiratory tract infection, herpes and peeling of the skin and analgesic.

One of the most common side effects is "rebound headache" caused by overuse of OTC analgesics or regular use of prescription drugs including those listed above or a combination thereof.


Study and Research provided by - John F. Rothrock, M.D., President, San Diego Cerebrovascular Foundation, Director UCSD Stroke Center Associate Professor of Clinical Neurosciences at University of California, San Diego (UCSD) Medical Center. Study conducted at University of California, San Diego (UCSD) Medical Center.

I.C.E. DOWN or Drugs

A clinical study of I.C.E. DOWN was performed on 25 patients with migraine (common and classical) and 25 patients with muscle tension headaches, or both, were enrolled in the study. Only patients with a minimum of 10 headaches within two months preceding the study were used.

At entry each patient was evaluated as to their recent headache history, with particular attention to headache frequency, duration and intensity. All of the patients were taking some form of medication for their headaches and each agreed to stop their drug treatment for the duration of the study.

Each patient was supplied with the I.C.E.DOWN cold therapy head wrap and asked to use it in the event of a recurrence of a typical headache. Each patient was followed for a two-month period and at the end of that time an evaluation was done on each patient.

The following are the results of the study:

73% of the patients improved since beginning the use of I.C.E. DOWN

83% would prefer using I.C.E. DOWN instead of a drug.

80% would recommend I.C.E. DOWN to their friends or family.

76% stated I.C.E. DOWN reduced pain and throbbing.

66% stated I.C.E. DOWN lessened the severity of pain.

53% stated I.C.E. DOWN helped muscle spasms in the back of the neck.

Here are some of the patient's comments made during the post-study impact on headaches:

"I.C. E. DOWN relieves the pain at night, so I can sleep."

"I.C.E. DOWN is very helpful in the beginning of a headache. It gives me a very

pleasant feeling and brings relief."

"I usually wake up with a headache but not after using I.C.E. DOWN."

"I.C.E. DOWN gave me a relieving effect, sort of calming, it also helps with my

nausea feeling, doesn't stop it but it helps."

"I use two I.C.E. DOWN wraps on my head and neck together and my pain completely disappears."

"I.C.E. DOWN is very helpful when lying down to lessen headache symptoms, relaxing." "I.C.E. DOWN seems to numb the extra sore spots on my head." The leading drug prescribed for migraine headaches targets blood vessels in the brain causing them to constrict. The results of our study show that I.C.E. DOWN cold therapy wraps can provide as good as or better relief for migraine and tension headache sufferers then the top selling drugs prescribed for headache treatment, without side effects.


I.C.E. DOWN is 100% natural.

I.C.E. DOWN has no side effects.

I.C.E. DOWN will not loose its effectiveness over time

I.C.E. DOWN costs 90% less then the lowest cost migraine drug.

I.C.E. DOWN is safe and effective for children.

I.C.E. DOWN is easy to use, easy to clean and easy to store.


Q. What does I.C.E. DOWN do?

A. Once I.C.E. DOWN is applied to the head or neck, it causes a vascular constriction just like the leading drugs prescribed for migraine. It also causes a localized release of endorphins a naturally occurring opiate produced by the body.

Q. Does I.C.E. DOWN have side effects?

A. No, unlike the drugs prescribed for headaches it has no side effects and can be used as often as needed.

Q. Is I.C.E. DOWN addictive?

A. No, I.C.E. DOWN is 100% natural, unlike medication prescribed for migraine and tension headache that can and do create drug dependency.

Q. Does the effectiveness of I.C.E. DOWN cold therapy decrease with frequency of use like many of the drugs taken for migraine?

A. No, I.C.E. DOWN cold therapy wraps can be used over and over year after year or episode after episode without loosing its effectiveness.

Q. Will my medical insurance pay for I.C.E. DOWN cold therapy wraps?

A. It depends on your physician, your insurance carrier and the amount of your deductible. Ask you physician for a prescription then contact your insurance carrier.

Click here to see I.C.E. DOWN cold therapy wraps for the head.