5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

NCT05066451 | Completed

• 1 other identifier: FTRTEZTASKIN
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; dextrose prolotherapy; pain; injection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Hand grip strength

  Change from baseline hand grip strength at 3, 6, and 12 weeks

Study Arms (2)

%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.

Other: %5 dextrose prolotherapy

%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.

Other: %15 dextrose prolotherapy

Interventions

%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.

%5 dextrose prolotherapy

%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.

%15 dextrose prolotherapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

İstanbul physical medicine rehabilitation training &research hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 16518218 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.

  PMID: 26114106 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.

  PMID: 20188998 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.

  PMID: 18240327 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow; Pain

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 4, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 25, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)