Lateral Epicondylitis Clinical Trial
Official title:
Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy
NCT number | NCT06001944 |
Other study ID # | 665912 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 11, 2023 |
Est. completion date | April 11, 2024 |
The investigators believe that blood flow-restricted training can result in increased caste hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that changes in local metabolic activities can be effective in the process of tendon healing. The researchers' aim in the study is to investigate the effectiveness of blood flow restriction training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50% occlusion recommended for the upper extremity using the patient's systolic pressure to the severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes period for the top extremity.
Status | Recruiting |
Enrollment | 69 |
Est. completion date | April 11, 2024 |
Est. primary completion date | April 11, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Between 18 and 65 years of age, - Lateral tendinopathy diagnosis, - Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test (PRTEE). Exclusion Criteria: - Dysfunction in the shoulder, neck and/or chest area, - Local or generalized arthritis. - The neurological deficit. - Radial dysfunction, - Limitation of arm functions, - A history of shoulder or upper extremity pathology requiring surgery or treatment; - Venous thromboembolism - Inflammation or other hematological disorders. - Coronary artery disease, - Peripheral arterial disease or hypertension (systolic/diastolic blood pressure >140 mm Hg/90 mmHg), - To be pregnant, - Irritation of median nerves. - Irritation of radial nerves. - Irritation of the ulnar nerves, - The pain score is less than 30 mm. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University - Cerrahpasa | Istanbul | Büyükçekmece |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17. — View Citation
Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13. — View Citation
Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440. — View Citation
Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19. — View Citation
Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Mar 11:S0894-1130(22)00113-2. doi: 10.1016/j.jht.2022.11.005. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale | In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Primary | Painless Grip Strength | Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Primary | Patient-rated tennis elbow evaluation (PRTEE) | It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Secondary | SF-12 Quality of Life Questionnaire | The SF-12 consist of 12 items assesing physical and mental health and yields 2 summary scores; the mental component summary and physical component summary. Scoring is norm based with a mean of 50; higher scores indicate better health. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Secondary | Global Rating of Change | Global rating of change scale quantifies a patient's improvement or deterioration over time, and identifies the effect of an intervention or charts the clinical course of a condition. The patient selects between "much worse", "slightly worse", "stayed at same", "slightly better" and, "much better". | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Secondary | Range of Motion | The range of motion clarity of the shoulder, elbow, front arm and wrist joints in resting position using the gonyometer will be tested. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Secondary | Manual Muscle Testing | The upper, middle and lower trapezoidal muscles, serratus anterior, biceps brachii and triceps brachii will be evaluated. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up | |
Secondary | Pressure-Pain Threshold Measurement | An algometer is a device consisting of a frame displaying the pressure to be applied to this piston with a metal piston containing a round disk of about 1 cm in diameter at the end. The algometer will be asked to tell the patient the level of discomfort by pressing it at a straight angle to the most sensitive area in the lateral epicondyl area. The pressure value for the pain sensation will be determined as the pain threshold and the values obtained in kilograms (kg) will be recorded. | Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up |
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