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Study of the Safety of PM Tendon Rescue for cases of Medial and Lateral Epicondylitis (Tennis and Golf Elbow): a randomized, double-blinded, placebo-controlled trial

Breeana K. Saffell, Steven R. Frank, Mark J. McNamara, Rosia Warner, and Gary B. Clark, MD

Abstract:

Background: Medial and lateral epicondylitis are generally referred to as golfer’s and tennis elbows respectively. They are usually the results of a repetitive stress injury and many treatment options are available. However, the condition tends to be a chronic problem that can affect people for a lifetime.

Methods: Subjects were randomly selected to use either the test or the placebo for a three week assessment phase during which they completed daily side effect assessments.

Results: Only one placebo subject reported any kind of side effect during the assessment phase of the trial. The placebo subject reported red bumps present on the skin where the gel was being applied during the second week of assessment. The side effect was no longer reported by the third week of assessment.

Conclusion: The results suggest that the test gel was safer than the placebo gel and that Peaceful Mountain Tendon Rescue could be a safe topical therapy for epicondylitis.

Background:

Tendonopathy, otherwise known as tendonitis, is one of the most common diagnoses in both occupational and sports-related injuries. Chronic injuries, such as tendonitis, account for about 48% of reported occupational illnesses and 30-50% of sports-related injuries1. Tendonopathy is most commonly the result of repetitive movement and the overuse of a tendon. Tendonopathy collectively describes tendonitis, which is inflammation of the tendon, and tendonosis, which is a slow-healing series of micro-tears to the tendon. Following an injury of the tendon, both tendonitis and tendonosis may occur, causing general pain, tenderness, and swelling in the area of the injury2.

The common treatment for tendonopathy is rest of the injured area, the application of ice to reduce swelling, and anti-inflammatory pain relievers. Anti-inflammatory agents such as corticosteroids and NSAIDs (non-steroidal anti-inflammatory drugs), which include ibuprofen, ketoprofen, and Aleve, are commonly recommended for treatment of tendonopathy3, 4, 5. However, these treatments do not promote the healing process of the tendon, and research has failed to show these methods as effective in the long-term. Physical therapy is another method commonly used to conservatively treat tendonopathy5. Adherence to a treatment regimen, however, can be difficult for many subjects, and compliance is often not adequate to maintain remission. The most beneficial treatment of tendonopathy is one that includes not only anti-inflammatory, and analgesic agents, but also connective tissue-regenerating agents that will treat the symptoms of both tendonitis and tendonosis. If the inflammation is reduced, the body’s natural mechanism to facilitate repair of the damaged collagen fiber is thwarted. Weakness of the tendon then results from the micro-tears that remain. As the tendon is continuously used, rupture of the tendon may occur.

Epicondylitis, tendonopathy of the medial and/or lateral epicondyle regions of the arm and the common wrist extensors and flexors, is caused most commonly by repeated pronation and supination, or extension and flexion of the forearm. Typically, repeated extension of the forearm can lead to lateral epicondylitis and repeated flexion of the forearm can lead to medial epicondylitis6, 7. Although the incidence of elbow tendonitis is 40% in tennis players1, less than 1 in 10 cases are diagnoses in tennis players8. Overall, the incidence of lateral epicondylitis alone has been estimated at 4-7 per 1000 patients per year in general practice, and between 1% and 3% of adults in the general population are affected annually9.

The product to be tested, Peaceful Mountain Tendon Rescue, is administered topically in gel form according to a specified protocol. The solution is an herbal gel that contains agents with analgesic, blood-flow enhancing, and tissue-regenerating properties.

Methods:

Subjects were recruited from local advertisements such as flyers and newspapers and study visits were held at the Klearsen Corporation clinical research department. Subjects were required to have a history of medial and/or lateral epicondylitis unilaterally or bilaterally, and to be at least 18 years of age. Subjects were not allowed to use anti-inflammatory medications or any other medications during the trial period. If a subject presented with bilateral epicondylitis, only one elbow was assessed.

Following a comprehensive screening questionnaire and upon consented enrollment, subjects were randomly assigned to either the placebo or the test groups. Subjects were required to attend weekly visits at the clinic to complete weekly side effect surveys and to have the gel tube weight assessed. At the first clinic visit, each subject completed a side effect survey and was instructed complete daily surveys for the duration of the trial. During the first week of the trial, the subject did not apply any gel, therefore, this is referred to as the Baseline Phase. The three-week Assessment Phase began following the second visit where the subjects were given the gel tube that had been randomly assigned to them. They were instructed to liberally apply the gel to the affected elbow 3 times daily. At the fifth visit, the subjects were instructed to discontinue the use of the gel and to continue completing daily side effect surveys for the last week, the Return to Baseline Phase, of the study. At the sixth and final visit, the subjects completed a final weekly side effect survey and were informed of whether they had been given the test or the placebo.

Variable

Test (n=15)

Placebo (n=14)

Period of symptoms in months — median (range)

18 (1-48)

21 (2-48)

No. women (%)

6 (40)

9 (64)

Tendon affected

Lateral No. (%)

7 (47)

7 (50)

Medial No. (%)

2 (13)

2 (14)

Lateral and Medial No. (%)

6 (40)

5 (36)

Table 1 Baseline characteristics of the test and placebo groups. Values are averages (+/- standard deviation) unless otherwise stated.

Results:

Outcome

No test subjects reported any side effects with the application of the gel. One placebo subject reported red bumps where the gel was applied during the second week of application. No side effects were reported when the gel was no longer being used.

Discussion:

The results suggest that the test gel was safer than a placebo gel. One placebo subject out of 14 reported red bumps on a patch of skin where the gel was being applied during the second week of assessment only. This was 7% of the placebo population. No test subjects reported any type of side effect during or after assessment. This suggests that Peaceful Mountain Tendon Rescue is a safe topical therapy.

References:

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