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Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
physiotherapy
extracorporeal shockwave therapy
prolotherapy
platelet-rich plasma
Sponsored by
CM Chungmu Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Tennis Elbow, lateral epicondylosis, lateral epicondylitis, Platelet-Rich Plasma, Extracorporeal Shockwave Therapy, Prolotherapy, Physiotherapy

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CM Chungmu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Physiotherapy

extracorporeal shockwave therapy

Prolotherapy

Platelet-rich plasma

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 22, 2014
Last Updated
January 29, 2014
Sponsor
CM Chungmu Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02052089
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CM Chungmu Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Tennis Elbow, lateral epicondylosis, lateral epicondylitis, Platelet-Rich Plasma, Extracorporeal Shockwave Therapy, Prolotherapy, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
patients were educated to do stretching and eccentric strengthening exercise of wrist extensor muscles
Arm Title
extracorporeal shockwave therapy
Arm Type
Experimental
Arm 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.
Arm Title
Prolotherapy
Arm Type
Experimental
Arm Description
injection of 20% dextrose (3cc mixed with 0.3cc of lidocaine) to ECRB tendon was done under ultrasound guidance
Arm Title
Platelet-rich plasma
Arm Type
Experimental
Arm Description
3 cc of PRP (Harvest SmartPReP 2 APC 30 Process Kit, Harvest Technologies, Plymouth, MA) was injected into ECRB tendon under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
physiotherapy
Other Intervention Name(s)
Physical Therapy, Rehabilitation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
extracorporeal shockwave therapy
Other Intervention Name(s)
ESWT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
prolotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
platelet-rich plasma
Other Intervention Name(s)
PRP
Intervention Description
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.
Primary Outcome Measure Information:
Title
DASH scoring system to measure the changes in the upper extremity function
Description
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.
Time Frame
upon initial examination, 3-month follow-up, 6-month follow-up, 18-month follow-up, 24-month follow-up
Secondary Outcome Measure Information:
Title
SSS (Subjective Satisfaction Score)
Description
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.
Time Frame
upon initial examination and on the 24th month
Title
ultrasonography to asses changes in tendon pathology
Description
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.
Time Frame
upon initial examination, 6th month and 24th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Hoon Lhee, MD PhD
Organizational Affiliation
CM Chungmu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CM Chungmu Hospital
City
Seoul
State/Province
Yeongdeungpo-gu
ZIP/Postal Code
150-034
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34590307
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.
Results Reference
derived

Learn more about this trial

Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

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