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

NCT04680936 | Completed Phase 4

• 1 other identifier: 14
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis (tennis elbow) is an enthesopathy seen in 1-2% of the population aged 30-65 years, which can occur in the lateral epicondyle origo of the extensor carpi radialis brevis and longus muscles, after frequently repetitive activities and can lead to limitations in the daily life activities of the patients. The diagnosis is made by anamnesis and clinical examination, cases that last more than 3 months are defined as chronic lateral epicondylitis. Treatment options are analgesics, non-steroidal anti-inflammatory drugs, hand-wrist splints, eccentric strengthening exercises for forearm muscles and wrist dorsiflexors, injection therapies, physical therapy agents such as therapeutic ultrasound, ESWT(extracorporeal shockwave therapy), low-level laser therapy, and surgery. Prolotherapy is a treatment method that is performed with repetitive injections of a small amount of irritant or sclerosing solutions such as hypertonic dextrose, phenol-glycerin-glucose, or sodium morrhuate and aims to activate the healing process by increasing the blood flow around the damaged tendinopathy or enthesopathy area with the effect of these solutions. Hypertonic dextrose solutions in concentrations ranging from 12.5-20% are frequently used in prolotherapy. Prolotherapy can be done with ultrasound guidance or by determining anatomical landmarks. The injection is applied to the annular ligament, lateral epicondyle, and supracondylar area where the forearm extensor muscles adhere. Injection side effects and complications are pain, bruising, muscle spasm, nerve or vessel damage at the injection site. Based on previous studies, the low dose of dextrose solutions (1%, 5%, and 10%) may have a similar effect with fewer side effects than higher concentrations of dextrose solutions (15%, 20%, 25%) and the low dose may have fewer cell damage. Thus, it may be possible to apply an effective treatment method with fewer side effects in the treatment of lateral epicondylitis. Also, in this study, the effect of inflammation created by injection of saline in one group and the inflammatory, proliferative and angiogenic effects of dextrose injected in other groups at different concentrations on the treatment outcome will be compared.

Conditions

Lateral Epicondylitis

Keywords

prolotherapy; dextrose prolotherapy; tennis elbow; chronic lateral epicondylitis; dextrose therapy

Outcome Measures

Primary Outcomes (4)

• Evaluation of the effect of prolotherapy injection on hand grip strength.

  Evaluation of the effect of prolotherapy injection on hand grip strength Hand grip strength will be measured with Hand-Dynamometer, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).

  Change of the hand grip strength at baseline, 3 weeks and after the injection treatment (12th week).

• Evaluation of elbow pain that develops at rest and movement before, during and after injection treatment.

  Elbow pain at rest and movement will be assessed by Visual Analogue Scale, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).

  Change in elbow pain at baseline, 3 weeks and after the injection treatment (12th week).

• Evaluation of elbow pain threshold, before, during and after injection treatment.

  Elbow pain threshold will be assessed by Pain Algometer, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).

  Change in elbow pain threshold at baseline, 3 weeks and after the injection treatment (12th week).

• Assessment of the effect of elbow pain on daily life activities.

  Daily life activities will be measured with Quick-DASH(Disabilities of Arm, Shoulder and Hand) Questionnaire, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).

  Change of the effect of elbow pain on daily life activities at baseline, 3 weeks and after the injection treatment (12th week).

Secondary Outcomes (2)

• Evaluation of the clinical improvement.

  week 3 and 12

• Evaluation of the injection side effects and complications.

  12 weeks

Study Arms (3)

low dose dextrose arm (5% dextrose)

ACTIVE COMPARATOR

Prolotherapy injection will be made with 5% dextrose solution for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded.

Drug: Dextrose 5% in water

high dose dextrose arm (15% dextrose)

ACTIVE COMPARATOR

Prolotherapy injection will be made with 15% dextrose solution for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded.

Drug: Dextrose 15 % in Water

Isotonic saline arm (0.9% NaCl)

ACTIVE COMPARATOR

Prolotherapy injection will be made with isotonic saline for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded.

Drug: Isotonic sodium chloride solution

Interventions

Dextrose 5% in water DRUG

low dose dextrose solution

Also known as: 5% dextrose solution

low dose dextrose arm (5% dextrose)

Dextrose 15 % in Water DRUG

high dose dextrose solution

Also known as: 15%dextrose solution

high dose dextrose arm (15% dextrose)

Isotonic sodium chloride solution DRUG

isotonic saline solution

Also known as: 0.9% NaCl solution

Isotonic saline arm (0.9% NaCl)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who admit Kirsehir Ahi Evran University Hospital and is diagnosed with lateral epicondylitis,
• Participants with unilateral or bilateral lateral epicondylitis and pain and functional limitations due to this condition,
• who can read and write in Turkish,
• participant's admission participating in the study,

You may not qualify if:

• receiving any injection therapy to the elbow area in the last 3 months,
• participants with complaints less than 3 months(acute lateral epicondylitis)
• previously surgery on the elbow area,
• having a history of acute trauma or fracture in the elbow area,
• have local dermatological problems,
• have a local infection in the treatment area,
• those who are allergic to dextrose,
• with coagulation disorders or using anticoagulant drugs,
• with an autoimmune disease,
• with type 1 or type 2 diabetes mellitus,
• have unregulated hypertension,
• have immune dysfunction,
• with malignancy or diagnosed with a malignancy in the last 5 years,
• pregnancy or lactation,
• having cervical radiculopathy in the same extremity,

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kirsehir Ahi Evran University Hospital

Kırşehir, Turkey (Türkiye)

Location

Related Publications (4)

• Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.

  PMID: 27429562 BACKGROUND

• Tsai SW, Hsu YJ, Lee MC, Huang HE, Huang CC, Tung YT. Effects of dextrose prolotherapy on contusion-induced muscle injuries in mice. Int J Med Sci. 2018 Jul 30;15(11):1251-1259. doi: 10.7150/ijms.24170. eCollection 2018.

  PMID: 30123064 BACKGROUND

• Sims SE, Miller K, Elfar JC, Hammert WC. Non-surgical treatment of lateral epicondylitis: a systematic review of randomized controlled trials. Hand (N Y). 2014 Dec;9(4):419-46. doi: 10.1007/s11552-014-9642-x.

  PMID: 25414603 BACKGROUND

• Ciftci YGD, Tuncay F, Kocak FA, Okcu M. Is Low-Dose Dextrose Prolotherapy as Effective as High-Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis? A Double-Blind, Ultrasound Guided, Randomized Controlled Study. Arch Phys Med Rehabil. 2023 Feb;104(2):179-187. doi: 10.1016/j.apmr.2022.09.017. Epub 2022 Oct 13.

  PMID: 36243123 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Glucose; Water; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• FIGEN TUNCAY, PROF.,M.D.

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind Study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT OF PHYSICAL MEDICINE AND REHABILITATION

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 21, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)