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Effectiveness of Topical Chinese Medicine Ointment Therapy (TCMO) (Ng's Prescription) Eccentric Exercise for Tennis Elbow as Control: a Randomized Controlled Trial.

Sponsor: Hong Kong Baptist University

Summary

B. Introduction Tennis elbow, medically termed lateral epicondylitis (LE), is a prevalent musculoskeletal disorder characterized by pain and tenderness over the lateral epicondyle of the humerus. Excessive mechanical stress on the elbow tendons, often caused by repetitive movements or manual labor, contributes to microtrauma and cumulative strain of the forearm and elbow musculature. Clinically, the site of maximal tenderness is situated just anterior and distal to the lateral epicondyle itself. Moreover, studies have demonstrated that pain intensity and grip strength are closely associated with manual test outcomes in chronic tennis elbow, further supporting the functional relevance of these diagnostic measures. Although historically associated with racquet sports, contemporary evidence indicates that the condition is more frequently linked to occupational and daily activities such as typing, carpentry, and healthcare work.Epidemiological studies estimate an annual prevalence of approximately 1.3% and an incidence of 3.4 per 1,000 individuals, making it one of the most common causes of elbow pain in adults aged 30-60 years. The disorder exerts a considerable impact on modern life. Participants often experience reduced grip strength and functional limitations that interfere with essential tasks such as lifting, writing, or using tools. This functional impairment contributes to work productivity loss and increased healthcare utilization, resulting in substantial economic burden. Moreover, lifestyle factors such as smoking and repetitive manual work has been shown to negatively influence prognosis, with a subset of participants requiring surgical intervention after six months of unsuccessful conservative treatment. Collectively, these findings underscore that tennis elbow is not merely a sports-related injury but a significant occupational health issue, affecting individual well-being and societal efficiency in today's workforce. A pilot randomize controlled cross-over trial of TCMO (Ng's prescription) in 2024 has significant efficacy on LE and can effectively improve the pain symptoms of participants (95%CI: -22.4 to -5.28, p: 0.0032). Modern drug treatments for tennis elbow mainly focus on reducing pain and inflammation. While this can provide short-term relief and help participants tolerate daily activities or rehabilitation, it often does not address the underlying tendon degeneration and impaired healing. C. Trial Objective 1. Primary objective: To evaluate the efficacy of TCMO (Ng's prescription) in reducing pain intensity of LE through randomized controlled trial (RCT). 2. Secondary objective: To evaluate safety of TCMO (Ng's prescription) of LE through randomized controlled trial (RCT). To assess functional improvement of TCMO (Ng's prescription) (PRTEE). Randomization and allocation concealment To minimize research bias, 48 participants will be assigned to two treatment groups and a control group in a 1:1 ratio. Block randomization via Sealed Envelope tool, with gender as the stratification criterion. Sealed opaque envelopes and password-protected file. RA generates sequence; Research Assistant II (RAII) blinded. To further minimize potential bias, evaluators and data analysts involved in the study will be blinded to treatment assignments. RAII will manage and analyze collected data. The PI will assess participant outcomes and oversee the entire study process. Group A: receive Topical Chinese Medicine Ointment (TCMO)（Ng's prescription）and eccentric exercise Group B: receive eccentric exercise only

Official title: 外敷中藥（吳氏處方）治療網球肘的臨床研究 Effectiveness of Topical Chinese Medicine Ointment Therapy (TCMO) (Ng's Prescription) Eccentric Exercise for Tennis Elbow as Control: a Randomized Controlled Trial.

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