Lateral Epicondylitis, Unspecified ElbowPhase 2/3NCT05125705
PRP Versus Saline in Lateral Epicondylitis
A Phase 2/3 study testing Platelet rich plasma injection and Saline injection in people with Lateral Epicondylitis, Unspecified Elbow, run by Singapore General Hospital.
Trial summary
Lateral epicondylitis (LE), also known as tennis elbow, has an estimated prevalence in the general population of 1% to 3%, peaking at age 45 years to 54 years and affect both men and women equally. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lateral Epicondylitis, Unspecified Elbow
- What is being tested?
- Platelet rich plasma injection and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Nov 2022
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age >21 years old
- History of chronic pain on the lateral side of the elbow and pain on lateral epicondyle on direct palpation and resisted dorsiflexion of the wrist for more than 3 months
- Ability of patients to provide informed consent
Who cannot join
- Previous tennis elbow surgery to affected elbow
- Previous corticosteroid injections to affected elbow
- Concurrent complementary and alternative medicine (CAM) treatments e.g. acupuncture
- Inflammatory diseases / infection / fracture / trauma
- Neck pain on ipsilateral side
- Chronic pain syndromes
Show all 11Show fewer
- Malignancies
- Pregnant or lactating females
- Consistent use of NSAIDs within 48 hours of procedure
- Systemic use of corticosteroids within 2 weeks
- History of anemia, any blood disorders, hypothyroidism
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of Lateral Epicondylitis With Platelet-Rich Plasma Versus Saline: A Double-Blinded Randomized Placebo-Controlled Trial
Lateral epicondylitis (LE), also known as tennis elbow, has an estimated prevalence in the general population of 1% to 3%, peaking at age 45 years to 54 years and affect both men and women equally. A randomised controlled trial published in The Lancet showed that 83% of the patients suffering from LE of more than 6 weeks duration on wait-and-see policy recovered only after 1 year without any therapeutic interventions. The costs associated with LE is substantial as patients not only incur hefty healthcare costs but also lose their productivity owing to their long recovery period.
Currently, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.
Read the detailed description
The pathogenesis of LE was initially believed to be a generalised inflammatory process. However, in 1979, the pathology was better understood as invading immature fibroblasts disorganizing the normal collagen architecture of the elbow, associated with immature vascular responses to cellular repair. There is a variety of treatment modalities available for LE, varying from watchful waiting without any therapeutic interventions, pharmaceutical methods such as prescribing non-steroidal anti-inflammatory drugs, physiotherapy such as encouraging bracing and exercise, injections, and surgical modalities once non-surgical options fail.
For many years, injection with glucocorticoids has remained the mainstay of treatment. However, several studies have proven that the effects of corticosteroid injections do not seem to last in the long-term, amongst which a trial published in The Lancet showed that long-term differences at 52 weeks between injections and physiotherapy was significantly in favour of physiotherapy. Recently, many studies worldwide have demonstrated that platelet-rich-plasma (PRP) stimulates cartilage repair by actively secreting growth factors which activate cell proliferation and differentiation thereby promoting tissue regeneration. It has been postulated that PRP stimulates repair mechanisms within tendons and hence promote tendon healing.
However, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. Currently, PRP treatment is not formally recognized as a treatment modality for LE in Singapore, with the accepted indications for PRP treatment being limited to non-surgical treatment of acute muscle and ligamentous injuries, and the biological augmentation of acute Achilles tendon repairs.
This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.
- Conditions
- Lateral Epicondylitis, Unspecified Elbow
- Being tested
- Platelet rich plasma injection, Saline injection
- Keywords
- platelet rich plasma, saline, randomised controlled trial
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma injectionBiological
Also called PRP
The PRP is prepared by RegenLab's RegenKit-THT, in accordance with operating instructions supplied with the kit. The device allows automated blood collection (8 mL) and blood component separation in closed circuit. After centrifugation at room temperature for 9 minutes at centrifugal force of 1500g, the RegenTHT tube is then inverted several times before re-suspension, allowing 4mL of PRP to be obtained for each tube. 2.5mL will be injected into patients
Saline injectionOther
Saline injection
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma injection | Experimental | Patients will be treated with a single PRP injection, where 8 mL of whole blood will be collected and 2.5 mL of PRP will be given to the patient. Routine physiotherapy regimens will be implemented, similar to placebo arm. Receives: Biological: Platelet rich plasma injection |
| Saline injection | Placebo comparator | Patients will be treated with 2.5 mL saline 0.9%. Routine physiotherapy regimens will be implemented, similar to intervention arm. Receives: Other: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Measured: baseline
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Measured: 6 weeks
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Measured: 3 months
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Measured: 6 months
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Measured: baseline
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Measured: 6 weeks
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Measured: 3 months
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Measured: 6 months
Visual analog scale (VAS) pain with resisted wrist extension
Rated from 0 (no pain) to 5 (extremely pain)
Measured: baseline
Visual analog scale (VAS) pain with resisted wrist extension
Rated from 0 (no pain) to 5 (extremely pain)
Measured: 6 weeks
Visual analog scale (VAS) pain with resisted wrist extension
Rated from 0 (no pain) to 5 (extremely pain)
Measured: 3 months
Visual analog scale (VAS) pain with resisted wrist extension
Rated from 0 (no pain) to 5 (extremely pain)
Measured: 6 months
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Rated from 0 (no pain) to 5 (extremely pain)
Measured: baseline
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Rated from 0 (no pain) to 5 (extremely pain)
Measured: 6 weeks
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Rated from 0 (no pain) to 5 (extremely pain)
Measured: 3 months
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Rated from 0 (no pain) to 5 (extremely pain)
Measured: 6 months
Ultrasound tendon
Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded
Measured: baseline
Ultrasound tendon
Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis, Unspecified ElbowStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenon Chua Ser, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125705
- Sponsor's protocol ID
- CIRB1
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lateral Epicondylitis With Platelet-Rich Plasma Versus Saline: A Double-Blinded Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05125705
- Acronym / sponsor ID
- CIRB1
- Conditions
- Lateral Epicondylitis, Unspecified Elbow
- Keywords
- platelet rich plasma, saline, randomised controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 18 Nov 2021 (actual)
- 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.
Lateral epicondylitis (LE), also known as tennis elbow, has an estimated prevalence in the general population of 1% to 3%, peaking at age 45 years to 54 years and affect both men and women equally. A randomised controlled trial published in The Lancet showed that 83% of the patients suffering from LE of more than 6 weeks duration on wait-and-see policy recovered only after 1 year without any therapeutic interventions. The costs associated with LE is substantial as patients not only incur hefty healthcare costs but also lose their productivity owing to their long recovery period.
Currently, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.
Detailed description
The pathogenesis of LE was initially believed to be a generalised inflammatory process. However, in 1979, the pathology was better understood as invading immature fibroblasts disorganizing the normal collagen architecture of the elbow, associated with immature vascular responses to cellular repair. There is a variety of treatment modalities available for LE, varying from watchful waiting without any therapeutic interventions, pharmaceutical methods such as prescribing non-steroidal anti-inflammatory drugs, physiotherapy such as encouraging bracing and exercise, injections, and surgical modalities once non-surgical options fail.
For many years, injection with glucocorticoids has remained the mainstay of treatment. However, several studies have proven that the effects of corticosteroid injections do not seem to last in the long-term, amongst which a trial published in The Lancet showed that long-term differences at 52 weeks between injections and physiotherapy was significantly in favour of physiotherapy. Recently, many studies worldwide have demonstrated that platelet-rich-plasma (PRP) stimulates cartilage repair by actively secreting growth factors which activate cell proliferation and differentiation thereby promoting tissue regeneration. It has been postulated that PRP stimulates repair mechanisms within tendons and hence promote tendon healing.
However, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. Currently, PRP treatment is not formally recognized as a treatment modality for LE in Singapore, with the accepted indications for PRP treatment being limited to non-surgical treatment of acute muscle and ligamentous injuries, and the biological augmentation of acute Achilles tendon repairs.
This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma injection | Experimental | Biological: Platelet rich plasma injectionPatients will be treated with a single PRP injection, where 8 mL of whole blood will be collected and 2.5 mL of PRP will be given to the patient. Routine physiotherapy regimens will be implemented, similar to placebo arm. |
| Saline injection | Placebo comparator | Other: Saline injectionPatients will be treated with 2.5 mL saline 0.9%. Routine physiotherapy regimens will be implemented, similar to intervention arm. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age >21 years old
- History of chronic pain on the lateral side of the elbow and pain on lateral epicondyle on direct palpation and resisted dorsiflexion of the wrist for more than 3 months
- Ability of patients to provide informed consent
Key exclusion criteria (11 listed)
- Previous tennis elbow surgery to affected elbow
- Previous corticosteroid injections to affected elbow
- Concurrent complementary and alternative medicine (CAM) treatments e.g. acupuncture
- Inflammatory diseases / infection / fracture / trauma
- Neck pain on ipsilateral side
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 |
|---|---|---|
| Platelet rich plasma injectionAlso: PRPThe PRP is prepared by RegenLab's RegenKit-THT, in accordance with operating instructions supplied with the kit. The device allows automated blood collection (8 mL) and blood component separation in closed circuit. After centrifugation at room temperature for 9 minutes at centrifugal force of 1500g, the RegenTHT tube is then inverted several times before re-suspension, allowing 4mL of PRP to be obtained for each tube. 2.5mL will be injected into patients | Biological | Platelet rich plasma injection |
| Saline injectionSaline injection | Other | Saline injection |
Primary outcome
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Time frame: baseline
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Time frame: 6 weeks
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Time frame: 3 months
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
Time frame: 6 months
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Time frame: baseline
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Time frame: 6 weeks
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Time frame: 3 months
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
Time frame: 6 months
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Visual analog scale (VAS) pain with resisted wrist extension
Time frame: baseline
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with resisted wrist extension
Time frame: 6 weeks
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with resisted wrist extension
Time frame: 3 months
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with resisted wrist extension
Time frame: 6 months
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Time frame: baseline
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Time frame: 6 weeks
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Time frame: 3 months
Rated from 0 (no pain) to 5 (extremely pain)
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
Time frame: 6 months
Rated from 0 (no pain) to 5 (extremely pain)
Ultrasound tendon
Time frame: baseline
Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded
Ultrasound tendon
Time frame: 6 months
Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet rich plasma injection and Saline injection in people with Lateral Epicondylitis, Unspecified Elbow, run by Singapore General Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenon Chua (+65 6222 3322, kenonchua@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm (time frame: baseline). The study lists 18 primary outcomes in all. 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 Nov 2021.