Clinical trial NCT02052089: Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis
Official title: Prospective Randomized Clinical and Radiologic Study for the Treatment of Lateral Epicondylosis; Comparison Among PRP (Platelet-Rich Plasma) , Prolotherapy, Physiotherapy and ESWT (Extracorporeal Shockwave Therapy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Keywords: Tennis Elbow
lateral epicondylosis
lateral epicondylitis
Platelet-Rich Plasma
Extracorporeal Shockwave Therapy
Prolotherapy
Physiotherapy
Lead sponsor: CM Chungmu Hospital
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 231
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: DASH scoring system to measure the changes in the upper extremity function
timeFrame: upon initial examination, 3-month follow-up, 6-month follow-up, 18-month follow-up, 24-month follow-up
Secondary outcomes:
measure: SSS (Subjective Satisfaction Score)
timeFrame: upon initial examination and on the 24th month
measure: ultrasonography to asses changes in tendon pathology
timeFrame: upon initial examination, 6th month and 24th month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CM Chungmu Hospital
state: Yeongdeungpo-gu
Study officials:
affiliation: CM Chungmu Hospital
name: Sang-Hoon Lhee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.