Low and High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Dextrose 5% in water; Dextrose 15 % in Water; Isotonic sodium chloride solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low dose dextrose solution; high dose dextrose solution; isotonic saline solution
Other intervention name(s): 5% dextrose solution; 15%dextrose solution; 0.9% NaCl solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: prolotherapy; dextrose prolotherapy; tennis elbow; chronic lateral epicondylitis; dextrose therapy