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

NCT ID: NCT04680936

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-05-21

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.

Detailed Description

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.

Dextrose is an ideal proliferant agent due to its ability to dissolve in water, exists in the blood chemically, and to led safely apply to more than one place. It is known that hypertonic dextrose solutions dehydrate the cells in the injection area, cause local tissue trauma, attracts granulocytes and macrophages to the damaged area, and triggers healing. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

low dose dextrose arm (5% dextrose)

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.

Group Type: ACTIVE_COMPARATOR

Dextrose 5% in water

Intervention Type: DRUG

low dose dextrose solution

high dose dextrose arm (15% dextrose)

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.

Group Type: ACTIVE_COMPARATOR

Dextrose 15 % in Water

Intervention Type: DRUG

high dose dextrose solution

Isotonic saline arm (0.9% NaCl)

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.

Group Type: ACTIVE_COMPARATOR

Isotonic sodium chloride solution

Intervention Type: DRUG

isotonic saline solution

Interventions

Dextrose 5% in water

low dose dextrose solution

Intervention Type: DRUG

Dextrose 15 % in Water

high dose dextrose solution

Intervention Type: DRUG

Isotonic sodium chloride solution

isotonic saline solution

Intervention Type: DRUG

Other Intervention Names

5% dextrose solution; 15%dextrose solution; 0.9% NaCl solution

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

• 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,
• with cognitive dysfunction,
• patients with paralysis in the same extremity,
• lack of cooperation due to cognitive impairment,
• participant's refusal to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

YILDIZ GONCA DOGRU

RESIDENT OF PHYSICAL MEDICINE AND REHABILITATION

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FIGEN TUNCAY, PROF.,M.D.

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran Universitesi

Locations

Kirsehir Ahi Evran University Hospital

Kırşehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27429562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30123064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25414603 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36243123 (View on PubMed)

Other Identifiers

14

Identifier Type: -

Identifier Source: org_study_id