[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657796":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":20,"armGroups":32,"interventions":44,"overallOfficials":20,"centralContacts":51,"locations":57,"responsibleParty":72,"collaborators":20,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":20,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":20,"overallStatus":95,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Hong Kong Baptist University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Patient Related Tennis Elbow Evaluation (PRTEE)","PTREE involved 15 items which is self-reported by the patient, in order to measure their perceived pain and disability. There are three aspects in the questionnaire, including pain with 5 items, difficulty in performing usual activities with 6 items and difficulties in performing specific activities with 4 items. For each item, a scale of 1 to 10 can be chosen, hence the total score has a range of 1 to 100. Higher score indicates higher level of disability. Other than the English version of PRTEE, a recognized Chinese translated version will also be used to facilitate the responds of Chinese-speaking participants.","Baseline, week 4",[14,17],{"measure":15,"description":16,"timeFrame":12},"Range of Motion measurement","ROM of forearm and wrist will be measured with a universal goniometer. A. Degree of forearm supination and pronation is tested. The patient is positioned with elbow flexion of 90∘, keeping the forearm next to the trunk, while the forearm should be unsupported. The goniometer will be positioned parallel to the humerus. The patients is then be asked to perform forearm supination and pronation as much as they could. The range of supination or pronation will be recorded.\n\nB. Degree of wrist flexion and extension will be tested. The patient is positioned with elbow flexion of 90∘ and forearm pronation. The goniometer is placed with the distal arm along the lateral side of the fifth metacarpal and the proximal arm placed along the lateral side of the triquetrum of forearm. The ROM will be recorded at the lateral view.",{"measure":18,"description":19,"timeFrame":12},"Pain Free Grip Force (PFGS) measurement","PFGS will be measured with a handgrip dynamometer. PFGS refers to the maximum amount of force generated by the patient before any pain is felt. The patient is positioned with elbow extension, forearm pronation and slight wrist extension. The patient will do 3 gripping with the dynamometer in total and the mean of the three trials will be used.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"TRIPLE",[28,29,30],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","1. Trial objectives\n\n   This randomized control trial has one main objective, as shown below:\n\n   To evaluate the efficacy and safety of selected TCM elbow manipulation in treating LE.\n2. Plan of investigation 2.1 Study Design A randomized, controlled, single-blinded and parallel-group design will be used in this study. A total of 40 eligible patients will be recruited immediately after screening. They will be hence allocated into Group A and Group B randomly. The allocation ratio of Group A: Group B is 1:1 respectively. Figure 1 shows the flow chart of this design. Right after the screening, eligible patients was assigned at random to groups A or B in a 1:1 ratio, where they receive exercise with Mill's manipulation or exercise with selected TCM manipulation for 4 weeks. Patient Related Tennis Elbow Evaluation (PRTEE), ROM of wrist and forearm, and pain free grip strength (PFGS) of the affected elbow will be evaluated at the beginning and after the last of intervention in this clinical trial.\n\n   2.1.1 Randomization and concealment An allocation of 1:1 will be used in this study in respective of the treatment and control group. Sealed Envelope, an online software which is specifically made for patient randomization of clinical trials, will be used. A blocked randomization list will be generated, separating patients into either the intervention or the control group. The hard copy of the list will be securely sealed inside oblique envelopes, while the soft copy will be protected with password.\n\n   2.1.2 Blindness This study adopted double-blinding method. Participants are blinded with allocation concealment to minimize selection bias. All participants will receive a package of exercise and treatment, either Mill's manipulation or selected TCM manipulation, as their intervention. Principal investigator (PI) will illustrate the study procedures and briefly explain the usage of the manipulations without disclosing any treatment information to the participants. To further access the effectiveness of blinding, James and Bang blinding index will be used, which are standard measures to evaluate blinding in randomized control trials. To minimize any potential bias, the outcome assessor and data analyst will be blinded to the allocation list.\n\n   2.2 Participants This study recruits patients at Lui Seng Chun, one of the outpatient clinics of Hong Kong Baptist University. Patient recruitment would be conducted through social media and posters. In-person consultation, which explains the objectives, procedures, nature, advantages and potential adverse consequences of the trial, will be carried out at Lui Seng Chun by the PI. After confirming their eligibility, each of the patients are required to sign a written consent if they agree to participate in the study. They will be informed that their participation is completely voluntary, meaning that they have the right to leave the trial any moment.\n\n   2.2.1 Diagnostic Criteria\n\n   Diagnosis will be carried out face-to-face at Lui Seng Chun by the PI. The diagnostic criteria were made based on the established Clinical Practice Guideline of Lateral Elbow Pain and Muscle Function Impairments and Medical Treatment Guidelines Elbow Injuries. All eligible participants meeting all the below criteria is diagnosed with LE:\n\n   A. Tenderness was elicited over the lateral epicondyle, extending 2-3 centimeters distal to it over the ECRB and extensor digitorum tendons.\n\n   B. Pain in lateral elbow with resisted extension of wrist and middle finger C. Pain in lateral elbow with forceful grasp D. Normal ROM of elbow E. Pain reproduced with resisted isometric contraction of wrist extensors during loaded test F. Absence of numbness and tingling at forearm, hand and fingers G. Absence of neck pain and stiffness\n\n   2.2.2 Inclusion and exclusion criteria\n\n   Patient will be included in study if they fulfil all inclusion criteria below:\n\n   A. Meet the diagnostic criteria in Section 3.2.1 B. Age 18 to 65 C. Pain duration of more than 4 weeks with local tenderness near the lateral epicondyle D. Obtain a positive result in either Cozens Test or Mills' Test.\n\n   Patients will be excluded if one or more of the following criteria is satisfied:\n\n   A. Patients that are pregnant and lactating B. Had any form of administration of non-steroidal inflammatory drugs during the past two weeks C. Had received steroid injections during the past two months D. Patients with severe comorbidities, for example, poorly regulated Diabetes Mellitus, coagulopathy, goiter, liver-kidney disease, acute-chronic inflammation and any malignancies E. Infected or ulcerated skin around the lateral epicondylitis F. Had received any physical therapy treatment during the past two months G. Had received acupuncture during the past two weeks H. History of elbow surgery, fracture (distal humerus fracture, olecranon fractures and radial head and neck fractures), dislocation, infection, inflammation, tumor, rapidly progressive neurological deficit, neurovascular compromised and compartment syndrome I. Presence of osteoporosis The differential diagnosis for LE will be done by a registered Traditional Chinese Medicine Practitioner, Dr Chow Chi Ho.\n\n   2.3. Intervention 2.3.1 Exercise program for both groups Eccentric exercises has been proved to have short term pain relieve and muscles strengthening effect targeting LE. The eccentric exercise will be performed along with intervention each week. The program consist of two exercise sessions: static stretching of the ECRB followed by eccentric strengthening of wrist extensors.\n\n   In the first session of static stretching, participants are positioned seated, with elbow extension, forearm pronation, and wrist flexion with ulnar deviation. Stretching force will be applied and held for 30 to 45 seconds, adjusted according to individual tolerance. The stretch is performed six repetitions in total, including 3 times before and 3 times after the subsequent eccentric exercise.\n\n   For eccentric strengthening, participants remained seated, with full elbow extension, forearm pronation and maximum wrist extension. The key movements involve slowly lowering their wrist from extension to flexion over a time count of 30 seconds. Then, return the wrist to starting position of maximum extension with the contralateral hand. The exercise should be continued with mild discomfort of participants. When pain intensifies and become disabling, stop the exercise immediately. The eccentric exercise is performed 10 repetitions per set, across 3 sets, with 1 minute of rest in between.\n\n   The above eccentric exercise program is taught by the PI to the patients once they are included in the study. Exercise blog is required to fill in by patients as a record of their exercise process while improvement in pain or adverse effects throughout the exercise program will also be marked.\n\n   2.3.2 Selected TCM manipulation for LE Selected TCM manipulation for LE will be perform with internal rotation of the humerus, shoulder abduction, full elbow extension, and neutral position forearm and wrist. The practitioner will stabilized the wrist of the patient with one hand and the humerus with another hand, as shown in figure 4. An medial inversion with a high velocity and low amplitude thrust will be done towards the downward position of the patient.\n\n   The above manipulation will be done for group B patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho. We have obtained a professional consultation from Mr. Chiu Wai Shun, a senior physiotherapist with 20 years of clinical practice. Mr. Chiu evaluated and approved Dr. Chow's method of performing the Mills manipulation for this trial.\n\n   2.3.3 Mill's manipulation as the control group Mill's manipulation will be performed with a sitting position of the patient. The affected extremity positioned 90∘ abduction with internal rotation of the humerus, forearm pronation and wrist flexion, which will be stabilized by the practitioner. The olecranon should face upward in this position. The practitioner should stabilize the patients shoulder and holding the olecranon with the another hand, as shown in figure 5. A high velocity, low-amplitude thrust will be applied at the end of full extension of the elbow.\n\n   The above manipulation will be done for group A patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho.\n\n   2.3.4 safety of the intervention Without any invasive process or penetrative procedures, the intervention involved in this trial is considered safe. All manipulation techniques will be performed by Dr. Chow Chi Ho who has for than 10 years of clinical practice experience as a registered TCM practitioner.\n\n   To further ensure the safety of performing Mill's manipulation, which is a physiotherapy technique, professional consultation form Mr. Chiu Wai Shun is obtained. Mr. Chiu is a senior therapist with 20 years of clinical practice. Following Mr. Chiu's assessment, Dr. Chow's method of performing Mill's manipulation in this trial is approved.\n\n   Patients having severe disease and during pregnancy or lactating are excluded for the trial. Patients will be reminded to keep alert of their health conditions throughout the entire participation of the trial. If they notice any discomfort or adverse effects, they should report to the TCM practitioners immediately.\n3. Outcome Measurement In a total of 3 outcome measurements will be done at the beginning and after the last of intervention in this clinical trial, including PTREE, ROM of wrist and forearm, and pain free grip strength (PFGS).\n\n   3.1 Primary outcome Pain measurement and functional disability assessment will be conducted with PRTEE Questionnaire as shown in Appendix 1. PTREE involved 15 items which is self-reported by the patient, in order to measure their perceived pain and disability. There are three aspects in the questionnaire, including pain with 5 items, difficulty in performing usual activities with 6 items and difficulties in performing specific activities with 4 items. For each item, a scale of 1 to 10 can be chosen, hence the total score has a range of 1 to 100. Higher score indicates higher level of disability. Other than the English version of PRTEE, a recognized Chinese translated version will also be used to facilitate the responds of Chinese-speaking participants.\n\n   3.2 Secondary outcome Physical impairment measures will be evaluated by PI as the secondary outcome of the trial.\n\n   3.2.1 ROM measurement ROM of forearm and wrist will be measured with a universal goniometer. A. Degree of forearm supination and pronation is tested. The patient is positioned with elbow flexion of 90∘, keeping the forearm next to the trunk, while the forearm should be unsupported. The goniometer will be positioned parallel to the humerus. The patients is then be asked to perform forearm supination and pronation as much as they could. The range of supination or pronation will be recorded.\n\n   B. Degree of wrist flexion and extension will be tested. The patient is positioned with elbow flexion of 90∘ and forearm pronation. The goniometer is placed with the distal arm along the lateral side of the fifth metacarpal and the proximal arm placed along the lateral side of the triquetrum of forearm. The ROM will be recorded at the lateral view.\n\n   3.2.2 Pain Free Grip Force (PFGS) measurement In addition, PFGS will be measured with a handgrip dynamometer. PFGS refers to the maximum amount of force generated by the patient before any pain is felt. The patient is positioned with elbow extension, forearm pronation and slight wrist extension. The patient will do 3 gripping with the dynamometer in total and the mean of the three trials will be used.\n4. Adverse events and its management Observation of adverse effects starts once the patients received manipulation treatment, either Mill's manipulation or selected TCM manipulation. If the patient notice any adverse effects, they should record it on daily basis. Adverse events that may arise during the intervention will be categorized and managed based on their severity. Mild or transient effects are defined as short-term, self-limiting symptoms that resolve without the need for formal medical intervention. These may include local soreness, stiffness, or redness and swelling. In such cases, ice packs can be applied locally; if symptoms diminish within 24 hours, the intervention may continue as planned. Moderate adverse effects are those that interfere with daily activities but do not present an immediate threat to life. These may involve muscle strain, ligament sprain, non-subsided redness and swelling, or increased pain lasting several days. Participants experiencing these symptoms are instructed to report to the researcher immediately, and a clinically prepared ointment will be provided for local application. Severe adverse effects refer to serious or life-threatening complications, such as prolonged redness, swelling, and pain lasting more than a week, or other significantly unfavorable outcomes. In such cases, the intervention will be terminated immediately, and the researcher must be notified without delay.\n5. Termination Criteria Participants will be withdrawn from the study upon the occurrence of any criteria listed below.\n\n   A. Adverse effect categorized as severe occurs. B. Patient being pregnant. C. Any severe diseases listed in the exclusion criteria is diagnosed. D. Life-threatening illness occurs. E. Underwent a surgery during the trial period.\n6. Statistical analysis The difference between the change score of baselines and endpoint of the intervention and the control will be analyze with a linear-mixed effect model. Jamovi (2.7.17) will be used in data analyzing.\n7. Ethical Requirement This trial will endorse the highest ethical standards, following the core principles of autonomy, beneficence, justice and non-maleficence. As informed in the consent signed by participants, there participation is entirely voluntary, having the right to withdraw from the trial anytime with no consequences. Under ethical considerations, this trial is designed with minimized potential harm, while attaining the purpose of providing alternative treatment options for LE patients. Patient's data collected from the study will be encrypted.\n\n   Ethical approval application will be submitted to the Clinical Research Ethics Panel of the Research Ethics Committee of Hong Kong Baptist University.\n8. Potential implementation of the results This study is designed to promote TCM manipulation treatment in treating LE by proving its safety and effectiveness. A positive result could establish TCM as a viable therapeutic alternative in treating LE through pain reduction and recurrence management, hence, increase the overall quality of life of LE patients. In addition, it may contribute to the evidence based for TCM in musculoskeletal disease treatment.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Group A: Treatment with Selected TCM manipulation","EXPERIMENTAL","Selected TCM manipulation for LE will be perform with internal rotation of the humerus, shoulder abduction, full elbow extension, and neutral position forearm and wrist. The practitioner will stabilized the wrist of the patient with one hand and the humerus with another hand. An medial inversion with a high velocity and low amplitude thrust will be done towards the downward position of the patient.\n\nThe above manipulation will be done for group B patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho. We have obtained a professional consultation from Mr. Chiu Wai Shun, a senior physiotherapist with 20 years of clinical practice. Mr. Chiu evaluated and approved Dr. Chow's method of performing the Mills manipulation for this trial.",[38],"Other: Selected Traditional Chinese Medicine manipulation",{"label":40,"type":35,"description":41,"interventionNames":42},"Group B: Treatment with Mill's Manipulation as the control","Mill's manipulation will be performed with a sitting position of the patient. The affected extremity positioned 90∘ abduction with internal rotation of the humerus, forearm pronation and wrist flexion, which will be stabilized by the practitioner. The olecranon should face upward in this position. The practitioner should stabilize the patients shoulder and holding the olecranon with the another hand. A high velocity, low-amplitude thrust will be applied at the end of full extension of the elbow.\n\nThe above manipulation will be done for group A patients for 4 times, once a week, at Lui Seng Chun by Dr. Chow Chi Ho.",[43],"Other: Mill's Manipulation",[45,48],{"type":6,"name":46,"description":36,"armGroupLabels":47,"otherNames":20},"Selected Traditional Chinese Medicine manipulation",[34],{"type":6,"name":49,"description":41,"armGroupLabels":50,"otherNames":20},"Mill's Manipulation",[40],[52],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Ying Ching Chan","CONTACT","97259392","22229264@life.hkbu.edu.hk",[58],{"facility":59,"status":20,"city":60,"state":20,"zip":20,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok, Hong Kong","Hong Kong","HK",{"type":63,"coordinates":64},"Point",[65,66],114.17469,22.27832,{"lat":66,"lon":65},[69],{"name":70,"role":54,"phone":71,"phoneExt":20,"email":20},"Lui Seng Chun","3411 0628",{"type":73,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100657796","efficacy-and-safety-of-selected-traditional-chinese-medicine-elbow-manipulation-versus-mills-manipulation-as-control-for-lateral-epicondylitis-100657796",false,"NCT07843771","Efficacy and Safety of Selected Traditional Chinese Medicine Elbow Manipulation Versus Mill's Manipulation as Control for Lateral Epicondylitis","Efficacy and Safety of Selected Traditional Chinese Medicine Elbow Manipulation Versus Mill's Manipulation as Control for Lateral Epicondylitis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Tenderness was elicited over the lateral epicondyle, extending 2-3 centimeters distal to it over the ECRB and extensor digitorum tendons.\n* Pain in lateral elbow with resisted extension of wrist and middle finger\n* Pain in lateral elbow with forceful grasp\n* Normal ROM of elbow\n* Pain reproduced with resisted isometric contraction of wrist extensors during loaded test\n* Absence of numbness and tingling at forearm, hand and fingers\n* Absence of neck pain and stiffness\n* Age 18 to 65\n* Pain duration of more than 4 weeks with local tenderness near the lateral epicondyle\n* Obtain a positive result in either Cozens Test or Mills' Test.\n\nExclusion Criteria:\n\n* Patients that are pregnant and lactating\n* Had any form of administration of non-steroidal inflammatory drugs during the past two weeks\n* Had received steroid injections during the past two months\n* Patients with severe comorbidities, for example, poorly regulated Diabetes Mellitus, coagulopathy, goiter, liver-kidney disease, acute-chronic inflammation and any malignancies\n* Infected or ulcerated skin around the lateral epicondylitis\n* Had received any physical therapy treatment during the past two months\n* Had received acupuncture during the past two weeks\n* History of elbow surgery, fracture (distal humerus fracture, olecranon fractures and radial head and neck fractures), dislocation, infection, inflammation, tumor, rapidly progressive neurological deficit, neurovascular compromised and compartment syndrome\n* Presence of osteoporosis",true,"ALL","18 Years","65 Years",{"count":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"NA","Background: Lateral epicondylitis (LE), also referred to as lateral elbow tendinopathy and tennis elbow, is commonly seen clinically as an orthopedic disease. Joint manipulations is a common LE treatment, which mainly decrease pain and increases range of motion (ROM). This greatly improve the quality of life of LE patients. The selected Traditional Chinese Medicine (TCM) manipulation is created by Prof. Ng Zhong Neng and clinically used in treating LE for more than 20 years. To date, there is no statistical demonstration regarding the safety and effectiveness of this technique. Consequently, this clinical trial is designed to provide the first systematic evaluation of the technique's efficacy and safety.\n\nObjective: To evaluate the efficacy and safety of selected TCM elbow manipulation in treating LE.\n\nMethods: A clinical trial will enroll 40 eligible patients diagnosed with LE who meet the inclusion criteria. They will be randomized into two groups, having 20 participants in each group. Group A will receive an exercise program and a manipulation treatment of Mill's manipulation. Meanwhile, Group B will receive the same exercise program and the selected TCM manipulation. Patient Related Tennis Elbow Evaluation (PRTEE), ROM of wrist and forearm, and pain free grip strength (PFGS) of the affected elbow will be evaluated at the beginning and after the last of intervention in this clinical trial. Treatment effect and sequence effect will be analyze with a linear-mixed effect model by Jamovi (2.7.17).",[93,94],"To Evaluate the Efficacy and Safety of Selected TCM Elbow Manipulation in Treating","Lateral Epicondylitis","NOT_YET_RECRUITING","2026-09-23",{"date":98,"type":99},"2026-09-28","ACTUAL",{"date":101,"type":87},"2026-09-15",{"date":103,"type":87},"2026-12-31",{"name":5,"class":6},1]