Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

Tennis Elbow Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052089
• Other study ID #: CMH-2014-04
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 29, 2014
• Start date: March 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2014
• Source: CM Chungmu Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Procedure:
• physiotherapy
Physiotherapy is the treatment of a wide range of conditions and injuries to the body through the use of various forms of passive mobilisation, massage, electrotherapy and exercises.
• extracorporeal shockwave therapy
Extracorporeal shockwave therapy (ESWT) is noninvasive procedure, and has been shown to be effective in the treatment of chronic tendon pathology in the elbow, shoulder and plantar fascia. Shock wave therapy is traditionally categorized as either low energy (<0.2 mJ/mm2) or high energy (>0.2 mJ/mm2). Rompe, et al have hypothesized that there is an overstimulation of nerve fibers, resulting in an immediate analgesic effect (hyperstimulation analgesia). Physical effects on cell permeability and induction of diffusible radicals have also been postulated to cause disruption of the tendon tissue, resulting in induction of a healing process.
• prolotherapy
Prolotherapy has been defined as the iatrogenic stimulation of wound healing and tissue repair through the injection of an irritant solution into damaged ligaments and tendons. Prolotherapy solutions are purported to initiate an inflammatory cascade at the site of injection, which induces fibroblast proliferation and subsequent collagen synthesis, resulting in a tighter and stronger ligament or tendon. The primary mechanism of action of prolotherapy is to induce a small inflammatory response to promote adequate healing or more viable scar tissue formation that results in stronger fibrous tissue at the lateral epicondyle, which leads to improved function and reduced pain.
• platelet-rich plasma
Platelet-rich plasma (PRP) is defined as an autologous concentration of human platelets in a small volume of plasma which is mechanically treated to increase the concentration of platelets compared to whole blood. The supraphysiological concentration of platelets will provide a locally increased concentration of growth factors and cytokines that are contained within the platelets themselves.Based on these concepts, it is believed that PRP can augment or stimulate healing with the same biologic healing process that normally occurs in the human body after injury.

Locations

Country	Name	City	State
Korea, Republic of	CM Chungmu Hospital	Seoul	Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor	Collaborator
CM Chungmu Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH scoring system to measure the changes in the upper extremity function	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.	upon initial examination, 3-month follow-up, 6-month follow-up, 18-month follow-up, 24-month follow-up	No
Secondary	SSS (Subjective Satisfaction Score)	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; - There are no change and still it is as uncomfortable as before. Not satisfied at all; - Slightly improved but less than 50% of the pain is subsided. Not so satisfied.; - About 50% of the pain or discomfort is gone. Slightly satisfied, but not so much; - About 75% of the pain or discomfort is gone. Definitely better. Satisfied.; - More than 75% of the pain or discomfort is gone. Much better and very satisfied.	upon initial examination and on the 24th month	No
Secondary	ultrasonography to asses changes in tendon pathology	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.	upon initial examination, 6th month and 24th month	No