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In the treatment of lateral epicondylitis, 5% dextrose prolotherapy is aimed to be more reliable than 15% prolotherapy in terms of side effects and to show that it is similar in terms of efficacy in treatment.
For this prospective randomized controlled study, volunteer patients who met the inclusion criteria and applied to the Health Sciences University, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic will be included in the study. Participants who volunteered for the study will be divided into study groups and control groups by stratified randomization. A total of 26 volunteers will be recruited.
A solution to be used for prolotherapy is containing 30% dextrose, 2% lidocaine, and physiological saline.
In the beginning, all patients were asked about gender, age, body mass index, education level, occupation, duration of complaint, dominant side and affected extremity, previous treatments, and when the last treatment was applied.
Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.
Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.
Patients in the control group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose, initially (0.) Week 3 and Week 6. The injection will be made with the same method as the study group.
Measurements; will be evaluated at baseline (week 0), immediately after treatment at Week 3, Week 6, and Week 12.
Patients; In the evaluation of the visual analog scale (VAS), quick Disabilities of the Arm, Shoulder and Hand (QDASH), Grip strength, hand dynamometer measurements, and adverse events during the study period will be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| %5 dextrose prolotherapy | Experimental | A total of 3 sessions of prolotherapy solution containing 5% dextrose will be applied at the beginning, 3rd week, and the 6th week. |
|
| %15 dextrose prolotherapy | Active Comparator | A total of 3 sessions of prolotherapy solution containing 15% dextrose will be applied at the beginning, 3rd week, and the 6th week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| %5 dextrose prolotherapy | Other | Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact. |
| Measure | Description | Time Frame |
|---|---|---|
| The upper extremity disability level | The upper extremity disability level will be evaluated by using the Quick Disabilities of Arm, Shoulder and Hand (QDASH) scale. The maximum score is 100 points. A higher score indicates a worse disability level. | Change from baseline upper extremity disability level at 3, 6, and 12 weeks |
| Pain intensity | Pain intensity will be evaluated by using a visual analog scale (VAS). The maximum score is 10 points. A higher score indicates a worse pain level. | Change from baseline pain intensity at 3, 6, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hand grip strength | The standard evaluation tool (a hand dynamometer) will used for measuring grip and squeeze strength minimum value 0 and there is not maximum value, bigger values mean better outcome | Change from baseline hand grip strength at 3, 6, and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gokhan Taskin, MD | Istanbul Physical Medicine Rehabilitation Training and Research Hospita | Principal Investigator |
| Fatma Nur Kesiktas, Prof | Istanbul Physical Medicine Rehabilitation Training and Research Hospita | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul physical medicine rehabilitation training &research hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16518218 | Background | Fornalski S, Gupta R, Lee TQ. Anatomy and biomechanics of the elbow joint. Tech Hand Up Extrem Surg. 2003 Dec;7(4):168-78. doi: 10.1097/00130911-200312000-00008. | |
| 26114106 | Background | Kahlenberg CA, Knesek M, Terry MA. New Developments in the Use of Biologics and Other Modalities in the Management of Lateral Epicondylitis. Biomed Res Int. 2015;2015:439309. doi: 10.1155/2015/439309. Epub 2015 May 31. |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| %15 dextrose prolotherapy | Other | Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact. |
|
| 20188998 | Background | Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013. |
| 18240327 | Background | Jensen KT, Rabago DP, Best TM, Patterson JJ, Vanderby R Jr. Early inflammatory response of knee ligaments to prolotherapy in a rat model. J Orthop Res. 2008 Jun;26(6):816-23. doi: 10.1002/jor.20600. |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |