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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tennis Elbow
- Sponsor
- CM Chungmu Hospital
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- DASH scoring system to measure the changes in the upper extremity function
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Sang-Hoon Lhee
Director of CM Chungmu Hospital
CM Chungmu Hospital
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
Outcomes
Primary Outcomes
DASH scoring system to measure the changes in the upper extremity function
Time Frame: upon initial examination, 3-month follow-up, 6-month follow-up, 18-month follow-up, 24-month follow-up
The DASH is intended to measure how much difficulty a subject has when performing common functional tasks and activities. The DASH consists of a 30-item questionnaire with 5 response options for each item with a scale ranging from 0, which indicates "least disability," to 100, which indicates "most disability." It incorporates questions related to functional limitations, symptoms, and psychosocial problems. The DASH has been well validated and has a smaller standard error of measurement and a validity comparable to that of joint-specific measures. Based on our preliminary study, grand mean of DASH score was set to 26.05, and we decided that 8 points difference of DASH score will be the minimum detectable change.
Secondary Outcomes
- SSS (Subjective Satisfaction Score)(upon initial examination and on the 24th month)
- ultrasonography to asses changes in tendon pathology(upon initial examination, 6th month and 24th month)