PRP Versus Saline in Lateral Epicondylitis

NCT05125705 | Unknown Phase 2

• 1 other identifier: CIRB1
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lateral Epicondylitis, Unspecified Elbow

Keywords

platelet rich plasma; saline; randomised controlled trial

Outcome Measures

Primary Outcomes (18)

• 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

  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

  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

  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

  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.

  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.

  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.

  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.

  6 months

• Visual analog scale (VAS) pain with resisted wrist extension

  Rated from 0 (no pain) to 5 (extremely pain)

  baseline

• Visual analog scale (VAS) pain with resisted wrist extension

  Rated from 0 (no pain) to 5 (extremely pain)

  6 weeks

• Visual analog scale (VAS) pain with resisted wrist extension

  Rated from 0 (no pain) to 5 (extremely pain)

  3 months

• Visual analog scale (VAS) pain with resisted wrist extension

  Rated from 0 (no pain) to 5 (extremely pain)

  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)

  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)

  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)

  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)

  6 months

• Ultrasound tendon

  Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded

  baseline

• Ultrasound tendon

  Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded

  6 months

Study Arms (2)

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.

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.

Other: Saline injection

Interventions

Platelet rich plasma injection BIOLOGICAL

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

Also known as: PRP

Platelet rich plasma injection

Saline injection OTHER

Saline injection

Saline injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

MeSH Terms

Conditions

Tennis Elbow

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Kenon Chua

CONTACT

+65 6222 3322; kenonchua@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the patients and the outcome assessor will be blinded in this trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Registrar

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 18, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share