Comparing Injection Treatments for Tennis Elbow

NCT03984955 | Recruiting

• 1 other identifier: R&D 1026
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Tennis elbow is one of the most common musculoskeletal problems affecting the arm and is thought to be mainly due to overuse of the muscles that extend the wrist. The pain arises from the lateral epicondyle of the humerus, where the tendons of the wrist extensor muscles attach. There are many treatment options available for tennis elbow including oral medication, physiotherapy and injection therapy. Surgical options are reserved for those who fail to respond to more conservative treatments. Physiotherapy is a widely used, non-invasive treatment option for the management of tennis elbow. Research has shown that in the longer term, physiotherapy is superior to corticosteroid injection in the treatment of tennis elbow and a meta-analysis of published research concluded that Platelet Rich Plasma injection and Hyaluronic Acid injection are superior to corticosteroid for long term pain relief in tennis elbow. At present there is not enough evidence to indicate what the 'Gold Standard' treatment for tennis elbow is, and more research is therefore needed to help guide decision-making. The aim of this study is therefore to examine the effects of injection therapy in addition to physiotherapy treatment, in comparison to physiotherapy and a control injection on pain and function in patients with tennis elbow. All participants in this study will undergo a structured, specifically designed, class-based physiotherapy intervention, in addition to being randomly allocated to receive one of the following three types of injection: (a) a control injection whereby a needle is inserted into the skin but no therapeutic substance is injection, (b) a single therapeutic injection of platelet-rich plasm or (c) a single therapeutic injection of hyaluronic acid. Baseline data will be collected at the time of recruitment and participants will be followed up at 3 months and 12 months post treatment. Outcomes will be assessed using various patient-reported outcome measures in addition to clinical examination. The primary outcome for this study is the improvement in the quick DASH score at 12 months post-treatment compared to baseline.

Conditions

Tennis Elbow; Lateral Epicondylitis; Elbows Tendonitis

Outcome Measures

Primary Outcomes (1)

• The change in Objective functional assessment as evidenced by the change in Quick Disabilities of the Arm, Shoulder and Hand (DASH) scores from pre-treatment to 12 months post treatment.

  The QuickDASH consists of 11 items which were extracted from the original 30-item DASH scale. To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the original DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).

  The QuickDASH scores will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.

Secondary Outcomes (5)

• The change from baseline in objective pain scores as evidenced by the Visual Analogue Pain Scale (VAS) at 12 months post-treatment.

  The VAS will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.

• The change in objective functional assessment as evidenced by the Oxford Elbow Score (OES)

  The OES will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.

• Change in general health-related quality of life as evidenced by change in the EQ-5D general health questionnaire.

  The EQ-5D will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.

• Relationship of pre-injection Hospital Anxiety and Depression Scale (HADS) score to the outcome

  The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.

• Change in HADS score at 12 months compared to baseline

  The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.

Study Arms (3)

Group A PRP injection

ACTIVE COMPARATOR

Platelet-Rich Plasma injection Single therapeutic injection of Platelet-Rich Plasma performed under ultrasound guidance. This group will also undergo a class-based physiotherapy intervention. This outcomes for this group will be compared to those receiving Sodium hyaluronate with mannitol (Ostenil Tendon) and those receiving the sham injection.

Device: Platelet-Rich Plasma Injection

Group B Ostenil Tendon

ACTIVE COMPARATOR

Sodium hyaluronate with mannitol (Ostenil Tendon) Single therapeutic injection of sodium hyaluronate with mannitol (marketed under the device name Ostenil Tendon) under ultrasound guidance. This group will also undergo a class-based physiotherapy intervention.

Device: Sodium hyaluronate with mannitol (Ostenil Tendon)

Group C control group

SHAM COMPARATOR

Subcutaneous sham injection. This group will also undergo a class-based physiotherapy intervention. The outcomes for this group will be compared to those receiving Sodium hyaluronate with mannitol (Ostenil Tendon) and to those receiving PRP injection.

Other: Subcutaneous sham injection

Interventions

Sodium hyaluronate with mannitol (Ostenil Tendon) DEVICE

1ml isotonic solution contains 20.0mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.

Also known as: Ostenil Tendon

Group B Ostenil Tendon

Platelet-Rich Plasma Injection DEVICE

Platelet-rich plasma (PRP) describes an autologous blood plasma fraction enriched with platelets which is then injected at the site of tendon injury.

Group A PRP injection

Subcutaneous sham injection OTHER

Sham injection will penetrate the skin, but no therapeutic substance will be injected

Group C control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invitations to participate in the study will be extended to male and female patients, 18 years and above, referred to the Orthopaedic Departments who receive a diagnosis of Lateral Epicondyle Tendinosis (with or without degenerative changes) with symptoms present for \> 3 months, whose symptoms and clinical evaluation warrant the prescription of a peri-tendinous injection to relieve symptoms and who are competent to give informed consent.

You may not qualify if:

• Absence of tenderness at the lateral epicondyle.
• Congenital or traumatic bio-mechanical deformities of Elbow complex.
• Previous Corticosteroidal, Local Anaesthetic, PRP or Hyaluronic Acid injections to target elbow within the last three months.
• Known hypersensitivity to PRP, Hyaluronic acid or any excipients associated with any of the prescribed injections.
• Known contraindication to any treatments constituting normal/appropriate therapy in the view of the Consulting clinician including local infection
• Ipsilateral arm pathology severe enough to cause confusion of localised pain perception.
• Pregnant or lactating women
• Pain score less than 4/10
• Patients commenced on medication for the treatment of anxiety or depression within the last 6 weeks
• Previous involved in research in last 12 months
• Any progressive, degenerative neuromuscular disorder

Sponsors & Collaborators

• Wrightington, Wigan and Leigh NHS Foundation Trust: lead
• TRB Chemedica: collaborator

Study Sites (1)

Wrightington Wigan and Leigh NHS Foundation Trust

Wigan, Lancashire, WN6 9EP, United Kingdom

RECRUITING

Related Publications (12)

• Gliedt JA, Daniels CJ. Chiropractic treatment of lateral epicondylitis: a case report utilizing active release techniques. J Chiropr Med. 2014 Jun;13(2):104-9. doi: 10.1016/j.jcm.2014.06.009.

  PMID: 25685118 BACKGROUND

• Smidt N, van der Windt DA, Assendelft WJ, Deville WL, Korthals-de Bos IB, Bouter LM. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002 Feb 23;359(9307):657-62. doi: 10.1016/S0140-6736(02)07811-X.

  PMID: 11879861 BACKGROUND

• Lo MY, Safran MR. Surgical treatment of lateral epicondylitis: a systematic review. Clin Orthop Relat Res. 2007 Oct;463:98-106. doi: 10.1097/BLO.0b013e3181483dc4.

  PMID: 17632419 BACKGROUND

• Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.

  PMID: 17910298 BACKGROUND

• Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt N, Assendelft W. Non-steroidal anti-inflammatory drugs (NSAIDs) for treating lateral elbow pain in adults. Cochrane Database Syst Rev. 2002;(2):CD003686. doi: 10.1002/14651858.CD003686.

  PMID: 12076503 BACKGROUND

• Beard JM, Safranek SM, Spogen D. Clinical inquiries. What treatment works best for tennis elbow? J Fam Pract. 2009 Mar;58(3):159-61. No abstract available.

  PMID: 19284945 BACKGROUND

• Assendelft W, Green S, Buchbinder R, Struijs P, Smidt N. Tennis elbow. BMJ. 2003 Aug 9;327(7410):329. doi: 10.1136/bmj.327.7410.329. No abstract available.

  PMID: 12907489 BACKGROUND

• Saito S, Furuya T, Kotake S. Therapeutic effects of hyaluronate injections in patients with chronic painful shoulder: a meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken). 2010 Jul;62(7):1009-18. doi: 10.1002/acr.20174.

  PMID: 20235211 BACKGROUND

• Funk L. (2005) Hyaluronan vs Corticosteroids for Subacromial Impingement of the Shoulder. Osteoarthritis & Cartilage. 13(Suppl A)

  BACKGROUND

• Petrella RJ, Cogliano A, Decaria J, Mohamed N, Lee R. Management of Tennis Elbow with sodium hyaluronate periarticular injections. Sports Med Arthrosc Rehabil Ther Technol. 2010 Feb 2;2:4. doi: 10.1186/1758-2555-2-4.

  PMID: 20205851 BACKGROUND

• Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.

  PMID: 16735582 BACKGROUND

• 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.

  PMID: 34590307 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

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

Study Officials

• Adam Watts

  Wrightington, Wigan and Leigh NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded/masked to their group allocation: For Groups (B) and (C), the withdrawn blood will be discarded into a suitable clinical waste container out of sight of the participant in an adjoining room. The centrifuge, also in the adjoining room, will be set to run at 32000rpm for 15 minutes in order to aid in participant blinding. The class-based physiotherapy sessions will be taught be a physiotherapist who is blind to the treatment allocation of the study participants attending the class. The outcome assessments will be recorded by a member of the research team blind to the participant's treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Controlled, Randomised, Double Blind, Single Centre Trial

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: June 13, 2019
• Study Start: April 18, 2018
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)