Clinical trial NCT06538194: Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis
Official title: Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis
mesotherapy
prolotherapy
elbow pain
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale (VAS) during resting, activity, and at night, and for functional status with a short version of the upper limb-specific disabilities of the arms, shoulder, and hand (Quick-Dash) and Oxford Elbow Score.

Detailed description: This randomised-controlled single-blind prospective study was carried out at a Physical Medicine and Rehabilitation out-patient clinic. After approval by the Ethics Committee, all participants signed a written informed consent form. The research was conducted in accordance with the Helsinki Declaration.

Participants

The study will include individuals with lateral epicondylitis who are between the ages of 20 and 60 and have had elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers and tenderness over the lateral epicondyle were required for the diagnosis of lateral epicondylitis. Patients with the following exclusion criteria were not accepted into the study:

* Recent upper-extremity surgery,
* Recent upper extremity trauma, fracture, or dislocation,
* Upper-extremity peripheral neuropathy,
* Infectious processes of joint or soft tissues of the upper extremity
* Decompensated heart or respiratory failure
* Rheumatologic Diseases
* Psychiatric Disorders
* History of allergy to ingredients of injection solution

Demographic informations were recorded. Severity of elbow pain in resting, activity and if present night pain were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash) and Oxford Elbow Score.

Following clinical assessment, patients were divided into three treatment groups randomly. Mesotherapy, Prolotherapy and Control groups. Exercise and resting wrist splints were recommended for all groups.

The first group received mesotherapy: For this group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 with saline will be made. A 30 gauge, 4 mm mesotherapy injector will be used for the application. The lateral epicondyle will be the site of an intradermal injection. Of that amount, 2.5 cc will be applied point-by-point at intervals of 1-2 cm, and the remaining 2.5 cc will be applied using the napage method, 0.1 cc of solution were given with each injection.

Group 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals.

Only exercise and resting wrist splints will be administered to the third group, which is the control group.

All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.

Eligibility criteria: Inclusion Criteria:

Elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers Tenderness over the lateral epicondyle

Exclusion Criteria:

* Recent upper-extremity surgery,
* Recent upper extremity trauma, fracture, or dislocation,
* Upper-extremity peripheral neuropathy,
* Infectious processes of joint or soft tissues of the upper extremity
* Decompensated heart or respiratory failure
* Rheumatologic Diseases
* Psychiatric Disorders
* History of allergy to ingredients of injection solution

Primary outcomes:
measure: VAS
timeFrame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
measure: short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash)
timeFrame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
measure: Oxford Elbow Score
timeFrame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Science University Haydarpasa Numune Research and Training Hospital
state: Uskudar
Study officials:
References:
citation: Arias-Vazquez PI, Castillo-Avila RG, Tovilla-Zarate CA, Quezada-Gonzalez HR, Arcila-Novelo R, Loeza-Magana P. Efficacy of prolotherapy in pain control and function improvement in individuals with lateral epicondylitis: A Systematic Review and Meta-analysis. ARP Rheumatol. 2022 Apr-Jun;1(2):152-167.
citation: Piraccini E, Biondi G. Prolotherapy: Regenerative Medicine for Lateral Epicondylitis. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):509-510. doi: 10.5152/TJAR.2020.82356. Epub 2020 May 18.