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NOT YET RECRUITING
NCT07865169
NA

Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome

Sponsor: Hong Kong Baptist University

View on ClinicalTrials.gov

Summary

Background: With the rising popularity of long-distance running in Hong Kong, running-related injuries have become more common, particularly patellofemoral pain syndrome (PFPS), which is one of the most prevalent conditions among endurance runners. PFPS can negatively affect training consistency, race performance, and long-term participation. While exercise therapy is the primary intervention, patient adherence and long-term outcomes remain limited. Traditional Chinese Medicine ointment (TCMO, Ng's formula) has shown anti-inflammatory and tissue-repairing properties, making it a promising adjunct therapy for PFPS. Objective: 1. To evaluate the efficacy and safety of selected topical agents used in Traditional Chinese Medicine on PFPS in long-distance runners. 2. To assess the impact of these topical agents on running performance in PFPS patients. Methods: A randomized, controlled, parallel-group, single-blinded trial will be conducted with 50 participants. Group A will receive TCMO combined with exercise therapy, while Group B will receive exercise therapy alone. The intervention lasts four weeks, with weekly follow-ups to monitor adherence. Primary outcomes include Kujala Scale (AKPS), eccentric step-down test, and fastest finishing time of recorded race distances. Safety will be monitored through participant reports and exclusion of individuals with contraindications.

Official title: 外敷中藥(吳氏處方)治療長跑手膝痛的臨床研究 Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09-15

Completion Date

2026-12-31

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

OTHER

TCM ointment

Group A's TCMO intervention is a four-week topical therapy applied directly to the knee. Each participant receives one jar per week and applies the ointment once nightly on non-training days, and twice daily-before training and before sleep-on training days. A thin layer is spread slightly beyond the painful area to ensure coverage. Patients keep a logbook of applications, and researchers supervise the first use, provide instructions, and check technique during weekly visits. Safety is monitored through exclusion criteria and weekly follow-ups. This routine is designed to prevent pain during activity and aid recovery overnight, offering both immediate relief and long-term support.

OTHER

Exercise therapy

The exercise therapy intervention in the protocol is a structured four-week program designed to strengthen hip and quadriceps muscles while improving flexibility. Participants complete 12 supervised sessions (three per week), each consisting of three sets of 10 repetitions performed at 60% of their 10-repetition maximum. The first two weeks focus on hip strengthening through abduction and external rotation exercises with sandbag resistance, while the following two weeks target quadriceps with straight leg raises and end-range knee extensions. Stretching routines for hamstrings, quadriceps, iliotibial band, and gastrocnemius are included, each held for 30 seconds and repeated three times. Weekly follow-ups ensure proper technique, adherence, and progression, with therapists reviewing exercise logs and adjusting resistance as needed. This intervention emphasizes muscle balance, pain reduction, and functional recovery, serving as the control arm against topical therapy in the trial.

Locations (1)

Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok

Hong Kong, Hong Kong