A Marked Decrease in Serum Cortisol and Histamine Levels Using the Lumen Therapeutic Protocols for Acute Low Back Pain

ByStan Gross, D.C., F.A.S.A.

Introduction: The Lumen Therapeutic Light System6 utilizes two specific light spectrum applications administered with a carrier frequency with the clinical objective of reducing pain and inflammation. While the initial clinical trials of this device have proven to be effective in almost every trial case, the underlying mechanism involving specific reactions has not been identified or defined. This preliminary study was designed to measure the subjective results via analog measurements using the McGill Pain Management Survey1 for both pre-treatment and post-treatment applications with patients suffering from acute lumbar pain. Concurrently, saliva samples from all test subjects were used to measure cortisol and histamine levels before treatment and again thirty minutes following treatment. The intent was to measure any physiological responses associated with pain and inflammation using the two most accepted biological markers for these parameters.

Comparative data between the control group, the sham group as compared to the primary subjects were collected over a period of nine months. Since the sampling of data was relatively small, the standard deviation of variables using p=dv/du7was applied yielding a general predictability factor of +/- 4.0%. The objective was to formulate a comparison between the observed results, the measured results and the applied variables.

The Study Basis: 223 subjects were selected over a nine month period. All of the subjects presented with acute lumbar pain (an onset of less than three days that has not resolved with rest or over-the-counter analgesics), sclerotogenous in nature (no radiculopathy present or Somatovisceral symptoms which might indicate pathologies outside of the standard lumbar spine presentations) and no other traditional medical interventions including analgesics, anti-inflammatory or other physiotherapeutic typically prescribed for lumbar pain. All subjects were voluntarily included in the study were given a brief explanation of the objectives. During participation in the study, all subjects agreed to comply with the guidelines and refrain from any additional therapies or medications during the testing periods. 114 of the subjects were female between the ages of twenty seven through fifty five with an average age of thirty three. 109 of the subjects were male between the ages of twenty three and fifty three with an average age of thirty seven. All of thesubjects reported to be in excellent general health with the exception of acute lumbar pain. 193 of the subjects related the onset of pain with a specific activity while the remainder had reported no specific incident but had suffered a previous injury similar in nature. All of the subjects deny any previous medical history which would implicate other underlying pathologies.

The study was broken down into three separate groups:
1. 72 were subjected to standard, conservative chiropractic management for acute low back pain following the Mercy Guidelines for Lumbar Pain Management.
2. 74 were subjected to the Lumen Therapeutic Light System using the NICO Setting for the prescribed period following manufacturers guideline.
3. 77 had the Lumen Therapeutic Light unit applied but it was not activated.
Prior to the testing, each subject was asked to complete a McGill Pain Survey, offering a subjective report of their symptoms. All subjects submitted a saliva sample which was used to measure systemic levels of cortisol and histamine using ELISA test kits4 . Each subject was assigned a specific identifier within each of the groups so that general results could be compared to the specific groups to formulate an accurate predictor against the post-treatment data. Thirty minutes following each treatment, the subjects were asked to repeat the McGill Questionnaire and submitted a second saliva sample for evaluation. The time delay following treatment followed the ELISA guidelines for any accurate physiological changes that might be measured in the post-treatment phase of the study.

The Results: Group 1, having been subjected to conservative chiropractic treatment reported the following results:
a. 57 out of the 72 subjects reported feeling less pain and more freedom of motion with one treatment. On an analog scale of one to ten (one being pain free and ten being extremely painful) all 57 subjects were able to drop their pain index from an average of seven to an average three. The remaining subjects felt little to no change in their pain or motion averaging a drop of only one to two points on the pain index.
b. Normal salivary cortisol ranges for both men and women average 1.0 to 8.0 ng/ml5 during the waking hours. The average pre-treatment results for all of the subjects in Group One were 14.9 ng/ml while the average post-treatment totaled 6.2 ng/ml.
c. Normal salivary histamine levels for both men and women average 2.5 to 10.5 ng/ml during the waking hours. The average histamine measurement for the subjects in Group One totaled 19.7 at pre-treatment. The average post-treatment measurement totaled 7.5 ng/ml.
d. While nearly 72% of the subjects reported a marked reduction in pain and an increase in motion, all of the test subjects demonstrated a marked reduction in cortisol and histamine in the post-treatment assessment.

Group Two was subjected to the Lumen Therapeutic Light Therapy only and followed the same protocol as Group One. The following results were recorded:
a. All 74 subjects reported a marked reduction in pain from an average of eight on the index to a three. All of the subjects reported feeling an increase in motion without painful restriction. Of the 74 subjects, 12 reported a total remission of pain and restriction while the remainder felt some residual pain and tenderness in motion following treatment.
b. Pre-treatment cortisol levels averaged 14.2 ng/ml for Group Two. Post-treatment levels averaged 5.2 ng/ml with the lowest reading at 1.6 ng/ml.
c. Pre-treatment histamine levels for Group Two totaled 20.2 ng/ml. Post-treatment levels totaled 5.7 ng/ml on average for Group Two.

Group Three did not receive treatment but had the unit applied to the surface of the skin without activation. The patient was in the prone position with no other therapeutic influences other than mild lumbar extension in the prone position. The following results were recorded:
a. Of the 77 subjects tested, 33 reported a marked reduction in pain and an increase in motion. The average pain index was reduced from an average of eight to an average of six with the lowest recorded number of three by two of the subjects. The remaining 44 subjects reported feeling little to no change in their symptoms or range of motion following treatment.
b. The average pre-treatment cortisol levels for Group Three totaled 22.3 ng/ml with the lowest at 10.6 ng/ml and the highest at 27.9 ng/ml. Post-treatment averages totaled 16.9 ng/ml with the lowest reading at 8.7 ng/ml.
c. The average pre-treatment levels for histamine in Group Three totaled 20.6 ng/ml. The average post-treatment histamine levels totaled 17.9 ng/ml.
d. While the placebo effect remains an important factor in the data, the closed-pack extension position during the study may also have contributed to the reduction of pain and an increase in range of motion.

Analysis: Group One demonstrated a subjective reduction of symptoms of nearly 72%. There wasa 41.6% +/- 3% reduction in cortisol levels and a 38.8% +/- 4% reduction in histamine levels. All of participants in Group Two reported a marked reduction of pain and an increase in range of motion. The average reduction in cortisol totaled 36.7% +/- 3% and an average reduction in histamine levels at 27.8% +/- 4%. Group Three reported a reduction in pain and an increase in motion in 45% of the subjects. The average reduction in cortisol levels was measured at 7.3% +/- 3% and an average reduction of histamine at 8.6% +/- 4%.
Applying the statistical analysis of the McGill Pain Management protocol, Group Two realized an effectual 93.7% reduction in symptoms while Group One totaled 65.2% and Group Three only 19%. Using the analog measurement records perceived levels of pain and dysfunction based upon the subjective findings from the subject's symptoms. The cortisol and histamine results suggest a physiological measurement of pain and inflammation which does not necessarily correlate directly with perceived levels of pain. Factors involving pain tolerance, expected levels of recovery following treatment and levels of pain at the onset contribute to the unmeasured variable of the study.

Conjecture: Pain management research has advanced the knowledge of mechanistic and physiological triggers involving specific chemoreceptors that lie just beneath the skin surface. Noceceptive or pain reactive responses are moderated and controlled by opiate receptors and inflammatory response designed to prevent further injury and stabilize the damage areas. Numerous papers have been published regarding the use of specific analgesic chemicals designed to trigger opiate responses and reduce inflammation by facilitating various forms of analgesia either systemically, via the central nervous system or applied to the site of injury. Recent interest in alternative healing arts including acupuncture have also yielded significant results involving the stimulation of endorphins and the regulation of inflammatory reaction due to injury. The use of cold laser or light therapy involving a wide array of frequencies and band widths has drawn considerable attention in recent research articles and the number of therapy units available on the market is ever increasing. While all of the light therapy units lay claim to some level of clinical success, the underlying mechanism behind the data has remained illusive.
In order to trigger a response from the opiate receptors, chemoreceptors and pain antagonists associated with analgesia, a specific stimulus is needed to saturate the receptors. This study offers some evidence that the Lumen Therapeutic Light System facilitates a reduction in cortisol and histamine levels in subjects suffering from acute lumbar spine injury. Following the principles of meridian therapy and acupuncture9, the chemoreceptors just beneath the skin in theparaspinal region are noted for the reduction in pain and inflammation. Commonly referred to as the "Associated Bladder Meridian", acupuncturists have used this region of the body to control pain and inflammation associated with lumbar spine injuries through the use of needles, moxabustion, shiatsu and various other forms of Traditional Chinese Medicine with a high level of positive clinical results. The results of this study strongly suggest the same mechanism is triggered using the Lumen Therapeutic Light system.

Conclusions: While the sampling for this study is small with a very narrow focus group, the results strongly suggest a mechanistic, cause and effect relationship between the use of the Lumen Therapeutic Light system and a marked reduction in pain and inflammation using pre-treat and post-treatment cortisol and histamine levels as physiological markers. Using comparative data of the control group to a sham and placebo model clearly indicated both subjective and objective reduction in pain and restriction. While these markers do not necessarily define the underlying mechanism, the study clearly shows the physiological response to pre-treatment and post-treatment applications.
The results of this study suggests the needed for a larger sampling of acute pain subjects utilizing additional physiological markers including interleukin 4 and 6, local and systemic endorphins and serotonin levels. Comparative studies involving common analgesics and anti-inflammatory medications could also offer interesting results for both acute and chronic pain sufferers. Further investigation is involving the treatment of various forms and causes for pain is also strongly indicated.