Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

CM Chungmu Hospital

Status: Completed

Conditions: Tennis Elbow

Treatments: Procedure: extracorporeal shockwave therapy; Procedure: physiotherapy; Procedure: prolotherapy; Procedure: platelet-rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02052089

CMH-2014-04

Details and patient eligibility

About

The purpose of this study is to find the optimal treatment method for chronic lateral epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated tendon.The hypothesis is that there will be significant difference between treatment groups and control group (physiotherapy) and also there will be significant difference among treatment groups.

Full description

231 patients were randomized using a Random Sequence Generator (Random.org) into 4 groups: Group A (physiotherapy as a control, n=58), Group B (ESWT, n=62), Group C (Prolotherapy, n=56) and Group D (PRP, n=55). In group A, patients were educated to do stretching and eccentric strengthening exercise of wrist extensor muscles. In group B patients were treated with 3 sessions of high-energy shock wave therapy ESWT (Evotron, Switech medical, Kreuzlingen, CH) in 2 weeks interval. Total energy flux density ranged from 0.1 to 0.14 mJ/mm2 (1500 impulses). Shockwave was targeted over lateral epicondyle where maximum tenderness was located. In group C, injection of 20% dextrose (3cc mixed with 0.3cc of lidocaine) to ECRB tendon was done under ultrasound guidance and in group D, 3 cc of PRP (Harvest SmartPReP 2 APC 30 Process Kit, Harvest Technologies, Plymouth, MA) was injected into ECRB tendon under ultrasound guidance. 22G needle was used for injection in group C and D. The primary outcome measure is DASH scoring system which is recorded on the initial, 3rd, 6th, 18th and 24th month. Secondary outcome measures were ultrasonography (measured on initial, 6th and 24th month) and SSS (Subjective Satisfaction Score) measured on initial and 24th month. After 24 months from the last procedure, all serial questionnaires and physician-filled-SSS sheets were gathered and analyzed by a one-way analysis of variance and Scheffe post-test. A value of p<0.01 was considered statistically significant.

Enrollment: 231 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 35 to 80 years of age
• history of elbow pain in the region of the lateral epicondyle for more than 6 months
• more than 3 months of treatment for lateral epicondylosis before enrollment in the study with no subjective improvement
• pain on resisted extension of wrist
• local tenderness to palpation at the lateral epicondyle
• confirmed as lateral epicondylosis on ultrasound imaging

Exclusion criteria

• history of steroid or botulinum injection(s) within 6 months before study enrollment
• other elbow pathology including nerve compression, previous elbow fracture, limited elbow range of motion, abnormal simple radiographic findings, history of elbow surgery and inflammatory arthropathies
• upper extremity pain or discomforts from shoulder or wrist or hand

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 4 patient groups

Physiotherapy

Active Comparator group

Description:

patients were educated to do stretching and eccentric strengthening exercise of wrist extensor muscles

Treatment:

Procedure: physiotherapy

extracorporeal shockwave therapy

Experimental group

Description:

patients were treated with 3 sessions of high-energy shock wave therapy ESWT (Evotron, Switech medical, Kreuzlingen, CH) in 2 weeks interval. Total energy flux density ranged from 0.1 to 0.14 mJ/mm2 (1500 impulses). Shockwave was targeted over lateral epicondyle where maximum tenderness was located.

Treatment:

Procedure: extracorporeal shockwave therapy

Prolotherapy

Experimental group

Description:

injection of 20% dextrose (3cc mixed with 0.3cc of lidocaine) to ECRB tendon was done under ultrasound guidance

Treatment:

Procedure: prolotherapy

Platelet-rich plasma

Experimental group

Description:

3 cc of PRP (Harvest SmartPReP 2 APC 30 Process Kit, Harvest Technologies, Plymouth, MA) was injected into ECRB tendon under ultrasound guidance

Treatment:

Procedure: platelet-rich plasma