Lateral EpicondylitisPhase 2/3NCT00674622
Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
A Phase 2/3 study testing Prolotherapy in people with Lateral Epicondylitis and Tennis Elbow, run by University of Pittsburgh at 1 site in United States.
Trial summary
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ages 18-65, as younger individuals are more likely to have other developmental conditions and older individuals are more likely to have a significant arthritic component to their elbow pain;
- Ability to speak, read, and write English;
- Unilateral or bilateral lateral elbow pain associated with findings on exam consistent with LE and absence of other conditions that can mimic LE such as radial tunnel syndrome.
- Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.
Who cannot join
- Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
- Prior surgery of the involved elbow;
- Known allergy to lidocaine or dextrose;
- Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
- Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
- Ongoing treatment with systemic corticosteroids or immunosuppressant medications, as they may block a potential immune mechanism of the PrT and increase the risk for infection;
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- Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT;
- Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections;
- Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections;
- Pregnancy-as there is no research documenting safety of PrT during pregnancy;
- Medical necessity for taking ongoing nonsteroidal anti-inflammatory medication, beyond 1 aspirin per day for cardiac prevention, as this may diminish the effect of PrT;
- Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT.
- Prior treatment with PrT for any condition, as this may impact on blinding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Integrative Medicine at UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
About this study
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.
Read the detailed description
Same
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Prolotherapy, Placebo
- Keywords
- Lateral epicondylitis, Tennis elbow, Prolotherapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyDrug
Injection of 15% dextrose with lidocaine at the lateral epicondyle
PlaceboProcedure or surgery
Saline/lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Prolotherapy | Experimental | Deep injection with 15% dextrose in lidocaine Receives: Drug: Prolotherapy |
| Group 2-Deep Saline/Lidocaine | Placebo comparator | Deep injection with saline/lidocaine Receives: Procedure: Placebo |
| Group 3-Superficial Saline/lidocaine | Placebo comparator | Superficial injection with saline/lidocaine Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire
This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.
Measured: 6 weeks and 12 weeks post intervention
Secondary outcomes (4)
QuickDASH
The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, \& Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire "Disabilities of the Arm, Shoulder, \& Hand". It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability.
Measured: 6 weeks and 12 weeks post-intervention
Grip Strength
Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.
Measured: 6 weeks and 12 weeks post-intervention
Nirschl Pain Phase Scale
The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting "No stiffness or soreness after activity" and Phase 7 corresponding with "Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity". It was used as an indication of severity for entry into the study and as the criterion for treatment response.
Measured: 6 and 12 weeks post-intervention
Pain Threshold on Dolorimetry
Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.
Measured: 6 and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ronald M. Glick, University of Pittsburgh
- Investigators
- Ronald M Glick, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674622
- Sponsor's protocol ID
- 1R21AT003969-01A1
- Other IDs
- 1R21AT003969-01A1
- Status last verified
- May 2016
- First submitted
- 6 May 2008
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Presented at conference.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT00674622
- Acronym / sponsor ID
- 1R21AT003969-01A1
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- Lateral epicondylitis, Tennis elbow, Prolotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.
Detailed description
Same
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1-Prolotherapy | Experimental | Drug: ProlotherapyDeep injection with 15% dextrose in lidocaine |
| Group 2-Deep Saline/Lidocaine | Placebo comparator | Procedure: PlaceboDeep injection with saline/lidocaine |
| Group 3-Superficial Saline/lidocaine | Placebo comparator | Procedure: PlaceboSuperficial injection with saline/lidocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-65, as younger individuals are more likely to have other developmental conditions and older individuals are more likely to have a significant arthritic component to their elbow pain;
- Ability to speak, read, and write English;
- Unilateral or bilateral lateral elbow pain associated with findings on exam consistent with LE and absence of other conditions that can mimic LE such as radial tunnel syndrome.
- Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.
Key exclusion criteria (13 listed)
- Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
- Prior surgery of the involved elbow;
- Known allergy to lidocaine or dextrose;
- Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
- Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
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 |
|---|---|---|
| ProlotherapyInjection of 15% dextrose with lidocaine at the lateral epicondyle | Drug | Group 1-Prolotherapy |
| PlaceboSaline/lidocaine | Procedure or surgery | Group 2-Deep Saline/Lidocaine, Group 3-Superficial Saline/lidocaine |
Primary outcome
McGill Pain Questionnaire
Time frame: 6 weeks and 12 weeks post intervention
This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.
4 secondary outcomes
QuickDASH
Time frame: 6 weeks and 12 weeks post-intervention
Grip Strength
Time frame: 6 weeks and 12 weeks post-intervention
Nirschl Pain Phase Scale
Time frame: 6 and 12 weeks post-intervention
Pain Threshold on Dolorimetry
Time frame: 6 and 12 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Presented at conference.
Related trials for Lateral Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
Ronald M Glick, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prolotherapy in people with Lateral Epicondylitis and Tennis Elbow, run by University of Pittsburgh at 1 site 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 13 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
McGill Pain Questionnaire (time frame: 6 weeks and 12 weeks post intervention). 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 16 May 2016.