5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

Not Applicable

Completed

• Conditions: Lateral Epicondylitis
• Interventions: Other: %15 dextrose prolotherapy; Other: %5 dextrose prolotherapy

• Registration Number: NCT05066451
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Status Verified: 2022-02
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-25
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
%15 dextrose prolotherapy	%15 dextrose prolotherapy	A total of 3 sessions of prolotherapy solution containing 15% dextrose will be applied at the beginning, 3rd week, and the 6th week.
%5 dextrose prolotherapy	%5 dextrose prolotherapy	A total of 3 sessions of prolotherapy solution containing 5% dextrose will be applied at the beginning, 3rd week, and the 6th week.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Change from baseline pain intensity at 3, 6, and 12 weeks	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.
The upper extremity disability level	Change from baseline upper extremity disability level at 3, 6, and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	Change from baseline hand grip strength at 3, 6, and 12 weeks	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

Trial Locations

Locations (1)

İstanbul physical medicine rehabilitation training &research hospital; 🇹🇷 Istanbul, Turkey