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
Men and women aged 18 to 65 who are able to give written informed consent
Meet the diagnostic criteria of the LE
Lateral elbow pain duration more than 3 weeks
No history of allergic reactions to Chinese medicine ointment
Absolute contraindications exist for the use of traditional Chinese Medicine ointment
Participants are in pregnancy or lactation
Use of non-steroidal anti-inflammatory drugs during the previous weeks
Receipt of corticosteroid injection within the past two months
Crossover
TCM ointment
Other interventionGroup A gets both Prof. Ng's Traditional Chinese Medicine ointment (TCMO, Ng'sPrescription) and eccentric exercise. The ointment is made from herbal powders and minerals, stored in small 0.5-ounce (14.17 g) jars, with one jar given each week. Patients apply it twice a day, at daytime and again before sleep. Apply the ointment within a 1-cm radius around the most prominent point of the lateral epicondyle. On the same time all the participants will receive an eccentric exercise, the participants need to follow the schedule and finish the group of exercise daily
Control exercises
Other interventionStretching exercise To perform this exercise, extend the affected arm straight out in front of the participants, keeping the elbow fully extended and avoiding any bending. Keep their palm facing down. Next, grasp the back of the affected hand with your other hand and gently press to move the palm inward and downward, thereby increasing the stretch in the forearm Start with a sitting position, participants should feel a distinct stretch in the outer area of the forearm. Perform three sets daily, with 15-30 seconds per set. Avoid causing pain-the goal is to achieve a tolerable tightness or stretching sensation. Loading exercise Initial resistance is standardized at 1 kg for female participants and 2kg for male participants. first flexing the wrist of the affected side to lower the weight, then using the unaffected arm to lift the weight back to its original position. Perform three sets daily, with 15 repetitions per set, totaling 45 wrist lowering movement.
Patient-Reported Tennis Elbow Evaluation Questionnaire (PRTEE)
The Patient-Reported Tennis Elbow Evaluation Questionnaire (PRTEE) provides a concise, efficient, and reliable tool for assessing arm pain and functional status in patients with lateral collateral ligament inflammation. To facilitate communication with Chinese-speaking participants, this study will use the English version of the PRTEE (Table 2.) as a template for translation. Participants will complete the questionnaire independently with assistance from research assistants.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) has been used as the measurement of the pain intensity. Pain intensity was measured using the Visual Analogue Scale (VAS), with 0 defined as no pain and 10 defined as the worst imaginable pain. During assessment, no verbal prompts or guidance were given by nurses or physicians, and the scores were recorded solely based on patient self-report.
Wrist and Elbow Range of Motion
In addition to pain metrics, wrist and elbow range of motion will be utilized as a reference data point in this study. Given that lateral epicondylitis can significantly affect wrist and elbow mobility, the flexion and extension angles for each participant will be measured using a universal goniometer 20 both prior to and following the treatment intervention.
Handgrip Strength (HGS)
A weak handgrip strength (HGS) is a significant predictor of mortality in patients with established coronary artery disease (CAD), with weaker individuals facing nearly double the risk of death21 . Therefore, includes HGS as one of the outcomes to provide participants with a health reference. HGS will test by a handgrip dynamometer and take the average of three times griping. Participants should be seated with the shoulder adducted and neutrally rotated, the elbow extended and the forearm and wrist keep in neutral position. Both affected and normal side will be asked to grip the handgrip dynamometer and recorded in week 0 and the assessment will repeat every weeks.
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