Abstract

Experimental Group Based Study of topical oil treatment with substance: ZX-2549 ( Renamed to NAT-U-Von Rx Oil) Author Dr. med. Dirk Wiedbrauck, Gran Canaria, Spain

Introduction

Pain reducing medications such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and COX-2 inhibitors have been common treatments for osteoarthritis in the growing elderly population. However, these medications often have painful side effects or do not react well with other medications. Accordingly, there is a need for alternative treatments for the osteoarthritis patient.

Today, patients have a variety of treatment options for managing their pain. Topical pain relief products are not only gaining in popularity, but medical science is discovering innovative ways to broaden their use. Scientists from the University of Strathclyde and University of Glasgow stated.

Study Design

Double blind randomized trial

Randomized selected patients from a holistic orientated outpatient clinic for rehabilitation, specialized in chronic pain relief. (Primarily: Physiotherapy, Osteopathy, Acupuncture, Electrotherapy, Neural Therapy, Carbon Dioxide Therapy and Chiropractics.) The study consisted of a block of 8 weeks. Subjects were reassessed after one, two, four, six and eight weeks. The assessments were done consistently by the same study consultant, including goniometer measurements, pain questionnaire evaluation and treatment response with the Lanier Scale. Treatment

Topical ZX-2549 oils were supplied to the test group and placebo oil to the control group, who were instructed by a blinded consultant (nurse) as to appropriate use. Instructions included applications three times a day on the pain region and surrounding trigger points. Placebo oils, identical in smell and appearance to the active oils were supplied to the control group. If subjects encountered any side effects while using the product, they were instructed to notify the study personal immediately.

Methodology

All subjects were required to complete a pain questionnaire and a numerical rating scale for pain. Measurements included goniometer measurements for epicondylitis, knee arthritis and achilles tendon pain. Subjects also rated their response to treatment using the seven points Lanier scale.

Numeric Pain Assessment Scale

On a scale of 0 to 10 (0=no pain, 10=most pain), my pain is:

0  1   2  3  4  5  6  7  8  9  10

Response to treatment with the Lanier Scale

1 - markedly worse

2 - moderately worse

3 - mildly worse

4 - no change

5 - mildly better

6 - moderately better

7 - markedly better

Range of Motion Measurement

Joint flexibility is defined as the range of motion (ROM) allowed at a joint. A joint's ROM is usually measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. The most common way this is done is by using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint. When anatomical landmarks are well defined, the accuracy of measurement is greater. If there is softer tissue surrounding the joint area, measurement error can be more frequent.

Test Group

Twelve patients having epicondylitis, fourteen experiencing finger polyarthritis, twenty test results were obtained for patients with knee arthritis and sixteen measurements were taken with patients diagnosed with Achilles tendon pain. Each patient received substance ZX-2549.

Control Group

Twelve patients having epicondylitis, fourteen experiencing finger polyarthritis, twenty test results were obtained for patients with knee arthritis and sixteen measurements were taken with patients diagnosed with Achilles tendon pain. Each patient received a placebo.

Results

The results of the study were based on the response of the treatment with the Lanier scale and the range of movement measurement (ROM), after eight weeks.

After the first week 54 patients reported no change of symptoms in the placebo group (87.2%), 4 patients felt worse (6.4%), 4 patients felt mildly better (6.4%).

In the treatment group 9 patients reported no change of symptoms (14.5%), 2 patients felt worse (3.2%), 11 patients were mildly better ( 17.7%) and 41 patients were moderately better (66.2%).

After eight weeks 42 patients reported no change of symptoms in the placebo group (67%), 3 patients felt worse (4.8%), 4 patients were mildly better (6.4%), 7 patients were moderately better (11.2%) and 6 patients were markedly better (9.6%).

In the treatment group 4 patients reported no change of symptoms after eight weeks (6.4%), 2 patients were worse (3.2%), 6 patients were mildly better (9.6%), 4 patients were moderately better (6.4%) and 46 patients were markedly better (74.4%).

Five post functional testing sessions were taken for all four groups, after one, two, four and six weeks. Across the four groups the test measurement revealed that the use of topical oil, applied to the trigger points in a range of three centimeters of the affected joint produced significant improvements in pain relief, range of motion, physical performance and plantar/dorsal flexion in the achilles tendon pain group.

74.4% of the treatment group were markedly better after eight weeks of treatment and only 6.4% in the placebo group were markedly better.

Conclusion

The study clearly pointed out the effectiveness of topical oil in the treatment of epicondylitis, knee arthritis, finger arthritis and achilles tendon pain.