5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis

NCT06538194

Lateral Epicondylitis

COMPLETED NA

Low and High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis

NCT04680936

Lateral Epicondylitis

COMPLETED PHASE4

Ultrasound-Guided Dry Needling vs PRP for Refractory Lateral Epicondylitis

NCT07002879

Lateral Epicondylitis

COMPLETED NA

The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis

NCT05602571

Musculoskeletal Diseases Elbow Tendinitis Lateral Epicondylitis +1 more

COMPLETED NA

Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy

NCT06001944

Lateral Epicondylitis Tennis Elbow Tendonitis Elbow

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lateral Epicondylitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

%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.

Group Type EXPERIMENTAL

%5 dextrose prolotherapy

Intervention Type 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.

%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.

Group Type ACTIVE_COMPARATOR

%15 dextrose prolotherapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

%5 dextrose prolotherapy

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.

Intervention Type OTHER

%15 dextrose prolotherapy

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No