Clinical trial NCT05066451: 5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis
Official title: Demonstration and Comparison of 5% Dextrose Prolotherapy and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis
dextrose prolotherapy
pain
injection
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-04
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint
* tenderness on palpation over the lateral epicondyle
* Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test),
* \> 20 years old , \< 60 years old

Exclusion Criteria:

* Patients who received physical therapy modalities and/or steroid injections in the last 3 months,
* Having a history of malignancy,
* Pregnant cases,
* Those who have bone and joint diseases in the neck, shoulder and elbow,
* Patients with infection in the treatment area,
* Patients with arrhythmia or pacemaker in the heart,
* Patients receiving coagulation disorder or anticoagulant therapy,
* Those with local dermatological problems,
* Patients with a history of surgery in the elbow joint,
* Having a tendon tear
* Presence of nerve involvement
* Lack of cooperation and refusal to participate in the study due to cognitive dysfunction

Primary outcomes:
measure: The upper extremity disability level
timeFrame: Change from baseline upper extremity disability level at 3, 6, and 12 weeks
measure: Pain intensity
timeFrame: Change from baseline pain intensity at 3, 6, and 12 weeks
Secondary outcomes:
measure: Hand grip strength
timeFrame: Change from baseline hand grip strength at 3, 6, and 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul physical medicine rehabilitation training &research hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospita
name: Gokhan Taskin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospita
name: Fatma Nur Kesiktas, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.