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NCT Number: NCT04680936

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kirsehir Ahi Evran University Hospital

Kırşehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
  • participants who do not have exclusion criteria,

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.

Treatment and study plan

Dextrose 5% in water

Drug

low dose dextrose solution

Other names: 5% dextrose solution

Dextrose 15 % in Water

Drug

high dose dextrose solution

Other names: 15%dextrose solution

Isotonic sodium chloride solution

Drug

isotonic saline solution

Other names: 0.9% NaCl solution

Primary outcomes

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

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

    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).

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

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

    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).

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

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

    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).

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

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

    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).

Secondary outcomes

  1. Evaluation of the clinical improvement.

    Time frame: week 3 and 12

    Clinical improvement of the patients will be evaluated subjectively with the Global Disease Assessment Questionnaire, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).

  2. Evaluation of the injection side effects and complications.

    Time frame: 12 weeks

    Side effects and complications that may occur after injection treatments will be evaluated and compared between groups.

Sponsors and collaborators

Lead sponsor

Ahi Evran University Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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