Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis
- Conditions
- Tennis Elbow
- Interventions
- Procedure: physiotherapyProcedure: extracorporeal shockwave therapyProcedure: prolotherapyProcedure: platelet-rich plasma
- Registration Number
- NCT02052089
- Lead Sponsor
- CM Chungmu Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physiotherapy physiotherapy patients were educated to do stretching and eccentric strengthening exercise of wrist extensor muscles extracorporeal shockwave therapy extracorporeal shockwave therapy 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. Prolotherapy prolotherapy injection of 20% dextrose (3cc mixed with 0.3cc of lidocaine) to ECRB tendon was done under ultrasound guidance Platelet-rich plasma platelet-rich plasma 3 cc of PRP (Harvest SmartPReP 2 APC 30 Process Kit, Harvest Technologies, Plymouth, MA) was injected into ECRB tendon under ultrasound guidance
- Primary Outcome Measures
Name Time Method DASH scoring system to measure the changes in the upper extremity function 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 Outcome Measures
Name Time Method SSS (Subjective Satisfaction Score) upon initial examination and on the 24th month SSS (Subjective Satisfaction Score) which is answered by following question.
" How do you feel now compared to the condition before treatment in terms of satisfaction"
0 - It is worse. Not satisfied at all
1. - There are no change and still it is as uncomfortable as before. Not satisfied at all
2. - Slightly improved but less than 50% of the pain is subsided. Not so satisfied.
3. - About 50% of the pain or discomfort is gone. Slightly satisfied, but not so much
4. - About 75% of the pain or discomfort is gone. Definitely better. Satisfied.
5. - More than 75% of the pain or discomfort is gone. Much better and very satisfied.ultrasonography to asses changes in tendon pathology upon initial examination, 6th month and 24th month In our study, we measure the changes in the hypoechogenicity of the tendon and via color doppler to determine the amount of vascularity noted in the tendon.Ultrasonography (US) is an important tool in sports medicine and rheumatology, and a common outcome measure in clinical trials. In general, US is a noninvasive, widely available, and inexpensive imaging technique for assessing tendon pathology. The high acoustic contrast with the surrounding tissue makes tendons particularly suitable for ultrasonographic examination. US findings in tendinopathy in general are characterized by increased tendon size, Doppler activity, irregularity of the fibrillar appearance, focal hypoechoic areas, and calcifications.
Trial Locations
- Locations (1)
CM Chungmu Hospital
🇰🇷Seoul, Yeongdeungpo-gu, Korea, Republic of