Tennis ElbowPhase 2NCT01476605
Efficacy of Injection Therapy for Lateral Epicondylosis
A Phase 2 study testing Dextrose prolotherapy, PrT-DMS and Platelet Rich Plasma injection in people with Tennis Elbow, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
While evidence does not identify any conventional therapy as definitive for chronic lateral epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Dextrose prolotherapy, PrT-DMS and Platelet Rich Plasma injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to 1 Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor muscle provocation tests
- self-reported CLE-related pain for at least 6 months
- self-reported failure of at least 2 of the 3 most common treatments for CLE (a course of NSAIDS, physical therapy or corticosteroid injections).
Who cannot join
- current bilateral CLE
- a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
- current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity
- self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy
- current use of opioids for pain
- anticoagulation or immunosuppressive therapy in the prior month
Show all 11Show fewer
- intent to use NSAIDs or steroids
- known allergy to dextrose, acetaminophen or lidocaine
- MRI contraindications: non-compatible metal in the CLE-affected upper extremity or severe claustrophobia
- unresolved litigation
- self-reported pregnancy. Pregnant women are excluded from the study because pregnancy changes the characteristics of connective tissue including ligaments and tendons associated with CLE and, so, is an unacceptable confounder in this pilot level study. There is no report however, about dextrose, morrhuate sodium or PrT being harmful to pregnant women. Therefore we will not draw confirmatory labs to ensure that women of childbearing age are not pregnant. Rather we will accept self-report on pregnancy status at the time of consent. If a woman becomes pregnant during the study she will be dropped from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northeast Family Medical Center
Madison, Wisconsin, 53704
University of Wisconsin General Clinical Research Center
Madison, Wisconsin, 53792
About this study
Official title: The Efficacy of Prolotherapy and Platelet Rich Plasma Injections for Lateral Epicondylosis: a Pilot Study
While evidence does not identify any conventional therapy as definitive for chronic lateral epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE. The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections commonly used in the treatment of moderate-to-severe tennis elbow using clinical, biomechanical and radiological outcomes. Data from this study will support a future confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In support of this goal, the investigators propose the following research questions.
Does PrT or PRP, compared to waitlist control:
- improve pain- and function-dependent, CLE-specific quality of life among adults with CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis Elbow Evaluation?
- improve upper extremity performance among adults with CLE as assessed by a blinded assessor using elbow-specific, effort-dependent biomechanical measures of grip strength (pain-free and maximal), stiffness, effective mass and damping
- improve the radiologic appearance of several pathologic features of CLE as evaluated using imaging studies of lateral elbow structures: ultrasound to assess a) neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon stiffness ("acousto-elastic strain gauge" technique) using standardized, 0-3 severity scales, and d) MRI to assess the overall common extensor tensor tendon disease severity using a standardized 0-3 scale?
- provide satisfying treatment to subjects as assessed by a treatment satisfaction survey and a qualitative exit interview?
Read the detailed description
CLE is a prevalent, disabling condition with significant individual and societal costs. The incidence of CLE is increasing. CLE is often refractory to care. There is limited scientific evidence to support specific therapies.
PrT and PRP show promise as effective therapy for CLE that can be performed in the primary care setting. Pilot-level RCTs of PrT and PRP for CLE have reported large absolute effect sizes. Findings from invitro and animal studies are consistent with the results of clinical trials and suggest that both therapies can improve clinical outcomes and modify disease in CLE. However, prior research is limited by lack of methodological rigor, non-validated outcome measures and lack of integrated multidisciplinary outcome measures.
Positive trends in the proposed study would suggest the effect size of PrT and PRP for CLE, and allow the calculation of a robust sample size to power an R01 study, and pilot test the use of an integrated set of outcome measures. Statistically significant positive results on clinical, biomechanical and radiological outcomes would demonstrate that PrT and PRP can treat, modify the disease of and may be a cure for CLE. Such findings would provide enormous benefits to patients through improved quality of life, reduced pain and disability, and to industry and society at large through reduced workers' injury claims and absenteeism.
- Conditions
- Tennis Elbow
- Being tested
- Dextrose prolotherapy, PrT-DMS, Platelet Rich Plasma injection
- Keywords
- prolotherapy, Platelet rich plasma, tennis elbow, lateral epicondylosis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose prolotherapyProcedure or surgery
Also called dextrose
PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine
PrT-DMSProcedure or surgery
Also called Dextrose and Morrhuate sodium PrT
PrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.
Platelet Rich Plasma injectionProcedure or surgery
Also called Platelet rich plasma
Platelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues.
| Study group | Role | What they receive |
|---|---|---|
| PrT-DMS | Active comparator | 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline. Receives: Procedure: PrT-DMS |
| PrT-D | Experimental | PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine Receives: Procedure: Dextrose prolotherapy |
| Waitlist | No intervention | Not described |
| Platelet rich plasma | Active comparator | Not described Receives: Procedure: Platelet Rich Plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated tennis elbow evaluation (PRTEE)
Validated disease specific quality of life questionnaire conducted at 0, 16 (all subjects) and 32 weeks (PrT only).The PRTEE will assess elbow related quality of life at each of the specified time points. Change in quality of life score in the study groups over time will be compared.
Measured: 0, 16 and 32 weeks
Secondary outcomes (1)
Biomedical (grip strength), ultrasound (US) and magnetic resonance imaging (MRI)
Pain-free- and maximum-grip strengths will be using a hand dynamometer, a simple squeeze device with which the force of the subject's grip strength is recorded.US and MRI will be obtained at baseline and 16 weeks.
Measured: 0 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJun 2009
- Primary completion1 Nov 2011
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Rabago, MD, Principal investigator, University of Wisconsin, Department of Family MedicineJohn Wilson, MD, Principal investigator, UW Dept of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476605
- Sponsor's protocol ID
- H-2008-0148
- Other IDs
- G0810
- Status last verified
- Feb 2019
- First submitted
- 25 Oct 2011
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Prolotherapy and Platelet Rich Plasma Injections for Lateral Epicondylosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT01476605
- Acronym / sponsor ID
- H-2008-0148
- Conditions
- Tennis Elbow
- Keywords
- prolotherapy, Platelet rich plasma, tennis elbow, lateral epicondylosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While evidence does not identify any conventional therapy as definitive for chronic lateral epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE. The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections commonly used in the treatment of moderate-to-severe tennis elbow using clinical, biomechanical and radiological outcomes. Data from this study will support a future confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In support of this goal, the investigators propose the following research questions.
Does PrT or PRP, compared to waitlist control:
- improve pain- and function-dependent, CLE-specific quality of life among adults with CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis Elbow Evaluation?
- improve upper extremity performance among adults with CLE as assessed by a blinded assessor using elbow-specific, effort-dependent biomechanical measures of grip strength (pain-free and maximal), stiffness, effective mass and damping
- improve the radiologic appearance of several pathologic features of CLE as evaluated using imaging studies of lateral elbow structures: ultrasound to assess a) neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon stiffness ("acousto-elastic strain gauge" technique) using standardized, 0-3 severity scales, and d) MRI to assess the overall common extensor tensor tendon disease severity using a standardized 0-3 scale?
- provide satisfying treatment to subjects as assessed by a treatment satisfaction survey and a qualitative exit interview?
Detailed description
CLE is a prevalent, disabling condition with significant individual and societal costs. The incidence of CLE is increasing. CLE is often refractory to care. There is limited scientific evidence to support specific therapies.
PrT and PRP show promise as effective therapy for CLE that can be performed in the primary care setting. Pilot-level RCTs of PrT and PRP for CLE have reported large absolute effect sizes. Findings from invitro and animal studies are consistent with the results of clinical trials and suggest that both therapies can improve clinical outcomes and modify disease in CLE. However, prior research is limited by lack of methodological rigor, non-validated outcome measures and lack of integrated multidisciplinary outcome measures.
Positive trends in the proposed study would suggest the effect size of PrT and PRP for CLE, and allow the calculation of a robust sample size to power an R01 study, and pilot test the use of an integrated set of outcome measures. Statistically significant positive results on clinical, biomechanical and radiological outcomes would demonstrate that PrT and PRP can treat, modify the disease of and may be a cure for CLE. Such findings would provide enormous benefits to patients through improved quality of life, reduced pain and disability, and to industry and society at large through reduced workers' injury claims and absenteeism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PrT-DMS | Active comparator | Procedure: PrT-DMS1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline. |
| PrT-D | Experimental | Procedure: Dextrose prolotherapyPrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine |
| Waitlist | No intervention | – |
| Platelet rich plasma | Active comparator | Procedure: Platelet Rich Plasma injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-65 years
- diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor muscle provocation tests
- self-reported CLE-related pain for at least 6 months
- self-reported failure of at least 2 of the 3 most common treatments for CLE (a course of NSAIDS, physical therapy or corticosteroid injections).
Key exclusion criteria (11 listed)
- current bilateral CLE
- a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
- current carpal tunnel syndrome, other elbow pathology, or acute trauma of the CLE-affected upper extremity
- self-reported history of bleeding disorders, other hematologic conditions, inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or neuropathy
- current use of opioids for pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose prolotherapyAlso: dextrosePrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine | Procedure or surgery | PrT-D |
| PrT-DMSAlso: Dextrose and Morrhuate sodium PrTPrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline. | Procedure or surgery | PrT-DMS |
| Platelet Rich Plasma injectionAlso: Platelet rich plasmaPlatelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues. | Procedure or surgery | Platelet rich plasma |
Primary outcome
Patient rated tennis elbow evaluation (PRTEE)
Time frame: 0, 16 and 32 weeks
Validated disease specific quality of life questionnaire conducted at 0, 16 (all subjects) and 32 weeks (PrT only).The PRTEE will assess elbow related quality of life at each of the specified time points. Change in quality of life score in the study groups over time will be compared.
1 secondary outcome
Biomedical (grip strength), ultrasound (US) and magnetic resonance imaging (MRI)
Time frame: 0 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- University of Wisconsin Department of Family MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Rabago, MD principal investigator
University of Wisconsin, Department of Family Medicine
John Wilson, MD principal investigator
UW Dept of Family Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextrose prolotherapy, PrT-DMS and Platelet Rich Plasma injection in people with Tennis Elbow, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rated tennis elbow evaluation (PRTEE) (time frame: 0, 16 and 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.