OSTENIL® TENDON injections are more effective than corticosteroid injections for the treatment of tendon disorders

Tendon disorders are the most frequent cause of pain in the musculoskeletal system of physically active individuals. There are various conservative treatment methods, but most of them only offer short-term relief. When injecting steroids in the elbow region, the risk of tendon damage also increases.1

A meta-analysis showed that steroid injections are not more effective than placebos.2 Is there also a treatment option that is effective and offers more long-term relief of tendon disorders when taken?

Gorelick et al.3,4 investigated the effectiveness of sodium hyaluronate for the treatment of various tendon disorders. 157 patients diagnosed with tennis elbow were included in the study and divided into three groups. 54 patients received a corticosteroid injection, 49 patients were given an injection with OSTENIL® TENDON (2% sodium hyaluronate) and 54 patients received a combination therapy comprising an initial corticosteroid injection and, 7-10 days later, an OSTENIL® TENDON injection. The efficacy was evaluated using the VAS score and DASH score (Disabilities of Arm, Shoulder and Hand). Follow-up examinations were carried out 6 and 12 months after treatment.

There was a significant reduction in pain after one year compared to the initial value (p<0.0001) for all three forms of treatment. The treatments with OSTENIL® TENDON and the combination therapy were significantly better (p<0.001) than the treatment with corticosteroids after one year. Furthermore, in comparison to the corticosteroid group, there were no side effects (0 vs 10). The level of pain using the VAS scale dropped in the OSTENIL® TENDON group from 10.0 to 0.5, while this only dropped to 5.5 in the corticosteroid group. After one year, combination therapy showed similar effects to the OSTENIL® TENDON treatment, however, there were more side effects attributable to the corticosteroids. The long-term effect of the treatment with OSTENIL® TENDON is also interesting. While pain in the OSTENIL® TENDON group continued to subside over the course of the study, the corticosteroid group experienced an increase in pain again after 6 months.

►Conclusion: An injection with OSTENIL® TENDON is significantly superior to treatment with corticosteroids for the treatment of tennis elbow. The effect of the treatment lasts for a period of at least one year.

A further study investigated the effect of the OSTENIL® TENDON treatment for problems with the Achilles tendon. 56 patients with a newly diagnosed case of Achilles tendinopathy which had not yet been treated were included in the study. 20 patients received an injection with OSTENIL® TENDON, 19 patients were given an injection with corticosteroids and another 17 patients received a combination therapy of rest, splint, physiotherapy and NSARs. The VAS pain scale and the FADI score (Foot and Ankle Disability Index) were used to evaluate efficacy. Follow-up examinations were carried out after 6 weeks and after 3, 6 and 12 months.

All patients suffered from severe pain in the Achilles tendon at the start of the study. The value was 10 cm on the VAS pain scale. All treatment groups exhibited a reduction in pain over the course of the study. However, the sodium hyaluronate group (SH group) was superior to the corticosteroid group at all intervals during the study. Superiority achieved statistical significance after 6 and after 12 months. The carryover effect of the OSTENIL® TENDON treatment could also be seen again here. Even one year after the end of treatment, the pain subsided continuously, while there was an increase in pain again for the steroid group. The effect of corticosteroid treatment corresponded to the effect of conservative treatment in the long term.
Both studies confirm the superiority of the OSTENIL® TENDON treatment compared to the corticosteroid treatment. The effect of the corticosteroid treatment decreases over time, while the effect of OSTENIL® TENDON is still visible even after one year.

►Conclusion: The OSTENIL® TENDON injections are significantly more effective than corticosteroid injections for the treatment of tennis elbow and problems with the Achilles tendon. The effect lasts for a period of at least 12 months.

References:

1 Osborne H (2010): Stop injecting corticosteroid into patients with tennis elbow, they are much more likely to get better by themselves! J Sci Med Sport 13: 380-381.
2 Krogh TP, Bartels EM, Ellingsen T, Stengaard Pedersen K, Buchbinder R, et al. (2013): Comparative effectiveness of injection therapies in lateral epicondylitis: A systematic review and network meta-analysis of randomized controlled trials. Am J Sports Med 41: 1435-1446.
3 Gorelick L, Gorelick AR, Saab A, Ram E, Robinson D (2015): Lateral Epicondylitis Injection Therapy: A Safety and Efficacy Analysis of Hyaluronate versus Corticosteroid Injections. Adv Tech Biol Med 3: 130.
4 Gorelick L et al.; Single Hyaluronate Injection in the Management of Insertional Achilles Tendinopathy in Comparison to Corticosteroid Injections and Non-invasive Conservative Treatments, Sch Bull,: Jul 2015, 16-20.

NHS England: Even Longer Delays for Total Joint Replacements! What’s the solution?

A recent statement issued by NHS England’s Simon Stevens has caused concern that some patients awaiting elective knee and hip replacement operations may have to wait longer than is presently recommended to receive treatment. Current constraints on NHS funding and an increase in demand means budgets are having to be redirected to focus on A&E and cancer care.  The NHS has also stipulated that GPs should considerably reduce the number of people being referred to secondary care Consultants. 

Here are links to articles on this issue:

http://www.bbc.co.uk/news/health-39420662?

https://www.theguardian.com/society/2017/apr/02/labour-challenges-hunt-over-dropping-nhs-waiting-times-target

Are there any therapeutic options open to clinicians which may help alleviate the problems that some patients will face as a result of these changes?

It has been recognised for many years that Viscosupplementation can offer a valuable bridge between conservative care and surgery. Clinical studies have consistently shown intra-articular hyaluronic acid (HA) injections to be safe, efficacious and cost-effective (1-3). 

Before the introduction of the single injection HA OSTENIL® PLUS, OSTENIL® injections were usually administered as a course of up to 5 weekly injections. Mathies et al - in a seminal examination of the relationship between Viscosupplementation and the quality of synovial fluid - showed that Viscosupplementation could delay total knee replacements (TKR) by 4.5 to 6 months, and for some patients up to 12 months. His study also demonstrated that “OSTENIL® was safe and significantly improved symptoms in patients with painful advanced knee OA who were awaiting TKR, and that it improved the quality of life of these patients.” (4) In a larger study which examined the potential of HA for delaying knee arthroplasty, Altman demonstrated that “HA injection in patients with knee OA is associated with a dose-dependent increase in time-to-TKR” (7).

Since the introduction of OSTENIL® PLUS, patients have garnered the same symptom-reducing benefits from a single injection, and for the administering clinician - as well as the patient - the process is a lot more convenient. Significant symptomatic reduction and functional improvement was demonstrated in patients suffering moderate knee OA for up to 6 months following a single injection of OSTENIL® PLUS. (5,6). 

So why aren’t more OA patients in the UK being offered the option to help alleviate symptoms and potentially delay their joint replacement?

One of the major obstacles at present is the “Do not recommend intra-articular HA to treat osteoarthritis” in the current NIHCE guidelines on Knee OA. Although it is important to understand that the NIHCE Guidelines (CG177) DO NOT prohibit clinicians from using OSTENIL. In fact, OSTENIL® PLUS DOES meet the QLY cost to benefit criteria quoted by CG177.

Given the current climate in relation to treating degenerative joint change, clinicians and their patients have a limited number of options left open to them: simple analgesics, NSAIDs, and corticosteroid injections, none of which are entirely benign with prolonged use. Physiotherapy alone is not always an option if the joint has degenerated to such an extent that it makes exercise too painful. All this means that the impact on quality of life due to longer waiting times will be felt even more by an ageing and increasingly overweight population.

If you as an injecting physiotherapist/MSk specialist are receiving an increasing number of referrals of patients suffering symptomatic OA from GPs, have you considered Viscosupplementation as an option?

OSTENIL® injections do not require a Consultant to administer. Instead, local MSk triage services can offer a cost effective solution, providing GPs with an alternative patient treatment pathway, helping avoid unnecessary secondary care referrals - and the associated tariff fee - which would more than cover the cost of an OSTENIL® PLUS injection. As a result, not only would the ever growing demand on secondary care be ameliorated, patient waiting times could be reduced, and clinical outcomes improved. 

If you would like more information or chat to one of our representatives, please contact us on info@trbchemedica.co.uk. You can also visit our website here: ostenil.trbchemedica.co.uk, or call us on 0845 330 7556. 


REFERENCES:

1. Möller I et al. Presented at the 6th World Conference of the Osteoarthritis Research Society International 2001; poster PB22
2. Tsvetkova E et al. Ann Rheum Dis 2010;69(Suppl3):281
3. Funk L et al. Presented at the 9th World Conference of the Osteoarthritis Research Society International 2004; poster P338
4. Mathies B et al. Presented at the 5th Symposium of the International Cartilage Repair Society. May 26–29, 2004; poster 397.
5. Borràs Verdera A et al. Poster presented at the XXV triennial world congress of the International Society of Orthopedic and Traumatology. September 6-9, 2011.
6. K Frobenius “A new high-dose treatment with intra-articular hyaluronic acid facilitates the management of osteoarthritis”. Orthopädische Praxis 46, 5, 2009
7. Altman R, Lim S, Steen RG, Dasa V (2015) “Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large U.S. Health Claims Database. PLoS ONE 10(12): e0145776. doi:10.1371/journal.pone.0145776

Why consider topical Sodium Hyaluronate (HA) in the treatment of tendinopathy?

Firstly, the difference between HA and other glycosaminoglycans is that it is non-sulfated, forms in the plasma membrane instead of the Golgi apparatus, and can be very large, with its molecular weight often reaching the millions1. HA is considered to be a key molecule in the tissue regeneration process. It has been shown to modulate via specific HA receptors, inflammation, cellular migration, and angiogenesis, which are the main phases of wound healing7.

In relation to tendinopathies, hyaluronic acid modulates a variety of cellular functions: anti-inflammatory activity, enhanced cellular proliferation and collagen deposition. Studies have shown a link between the inhibition of fibroblast proliferation, with a reduction in the formation of adhesions at the tendon healing site; by limiting the proliferation of fibroblasts, HA may reduce the risk of adhesions.2

It has sometimes been assumed, in relation to tendinopathic change, that because there is an excess of GAGs detectable within the local bio-chemical environment, there is an excess of hyaluronan, which is not necessarily the case. For example, the activity of hyaluronidase (enzymes that catalyse the degradation of hyaluronan) has been shown to increase during the healing of equine superficial digital flexor tendon injuries6.

Multiple studies analysing tendon healing have confirmed that HA reduces the formation of scars and granulation tissue, and also prevents adhesions2. Importantly, HA forms part of the extracellular matrix as a major component of ground substance, giving structure for other GAGs and proteoglycans3. In tendon healing, the GAGs provide a temporary structure in the early stages of the wound4. So without the presence of HA, there is evidence to suggest that other GAGs are of limited use. Also, high levels of HA are thought to be instrumental in scar-less healing by facilitating the movement and proliferation of fibroblasts, and by regulating the production and type of collagen5.

HA also plays an important role as a hydrating agent, being able to absorb 3,000 times its own weight in water4. HA appears to inhibit the expression of key intermediaries for the inflammatory signalling pathways (NF-kB), by reducing the expression of pro inflammatory factors, exogenous HA may reduce the fragmentation of endogenous HA and further stimulate synthesis of endogenous HA.7,8.

References

1.       Fraser JR, Laurent TC, Laurent UB (1997). "Hyaluronan: its nature, distribution, functions and turnover" (PDF). J. Intern. Med. 242 (1): 27–33. doi:10.1046/j.1365-2796.1997.00170.x. PMID 9260563.
2.       Michele Abate, Cosima Schiavone, and Vincenzo Salini, “The Use of Hyaluronic Acid after Tendon Surgery and in Tendinopathies,” BioMed Research International, vol. 2014, Article ID 783632, 6 pages, 2014. doi:10.1155/2014/783632.
3.       Bertolami, C.N. (1984)Glycosaminoglycan interactions in early wound repair. In: Hunt, T.K., Heppenstall, R.B., Pines., Rovee, D. (eds). Soft and Hard Tissue Repair: Biological and clinical aspects. Eastbourne: Praeger Scientific.
4.       Snyder, R.J. (1999)Wound management: a global perspective. Ostomy/Wound Management 45: 9, 26-30.
5.       Desai, H. (1997)Ageing and wounds, part 2: healing in old age. Journal of Wound Care 6: 5, 237-239.
6.       J. W. Foland, G. W. Trotter, B. E. Powers, R. H. Wrighley, and F. W. Smith, “Effect of sodium hyaluronate in collagenase-induced superficial digital flexor tendinitis in horses,” American Journal of Veterinary Research, vol. 53, no. 12, pp. 2371–2376, 1992.
7.       Litwiniuk M., Krejner A., Grzela T. (2016). Hyaluronic acid in inflammation and tissue regeneration. Wounds 28, 78–88.
8.       Litwiniuk, Malgorzata, Alicja Krejner, and Tomasz Grzela. "Hyaluronic Acid In Inflammation And Tissue Regeneration". Wounds 28.3 (2016): n. pag. Print.

What to do after joint injections

You have just had an injection with hyaluronic acid to treat osteoarthritis, but what else can you do?

Exercising helps to prolong the benefit
of hyaluronic acid joint injections

After your injection with OSTENIL® hyaluronic acid (or: sodium hyaluronate) into your knee joint, or other synovial joint, you may want to utilise and prolong the positive effects of the treatment and get your joints moving again. Your Physiotherapist or GP can give you some helpful advice on which exercises and type of activity would be most suitable to further improve and stabilise your joints.
Here are some ideas:

Knee, shoulder and hip:

• Frequent exercising that won't put too much pressure on the joints: e.g. swimming, walking, cycling
• Specific physiotherapy exercises to strengthen the muscles surrounding the joint
• Reducing weight

Fingers and toes:

• Regular movement exercises to maintain joint flexibility
• Bathing fingers and toes in warm water to reduce pain
• Stretching fingers and toes as far as pain allows

Back joints:

• Strengthening and stretching abdominal muscles (back and stomach muscles)
• Relaxing painful back muscles by applying warmth, e.g. hot water bottle

New Treatment of Tendon Disorders: Ostenil Tendon

New Product Launch: OSTENIL^® TENDON

For the treatment of pain and reduced mobility
due to tendinopathy

TRB Chemedica (UK) Ltd have today announced that they have taken the successful OSTENIL^® range concept into a new realm: that of the treatment of tendon disorders. OSTENIL^® TENDON is a visco-elastic solution of 2% hyaluronic acid and 0.5% mannitol for peritendinous or intrasheath injection, and is designed to restore tendon function, by reducing pain and improving tendon mobility.

How does OSTENIL® TENDON work? The macro-molecular characteristics of sodium hyaluronate, already proven in their effectiveness in osteo-arthritis, increase the gliding effect and reduce adhesions – the tendon functions again as it is fully lubricated. At the same time sodium hyaluronate blocks the pain receptors and inhibits the movement of inflammatory mediators. This prevents the inflammation from getting any worse.

OSTENIL® TENDON is presented in a pre-filled syringe with 2ml content for single application. It contains 2% fermentative sodium hyaluronate (40mg/2ml), it is completely free from animal derived protein and therefore particularly well tolerated. 10mg Mannitol has been added in order to protect the sodium hyaluronate from premature degradation by free radicals, thus stabilising the solution and reducing the rate of deterioration (Mendoza 2007). OSTENIL^® TENDON is injected around the affected tendon or into the tendon sheath.

Peter Hunt, Managing Director, said, “We are very excited about OSTENIL^® TENDON and feel confident that it will benefit many people with impaired tendon function.”

Shoulders and Elbows

TRB Chemedica (UK) Ltd supported another event this summer related to sports medicine: the BESS Annual Scientific Meeting held in Torquay (15-17 June 2012). BESS stands for British Elbow and Shoulder Society.

The annual meeting in June attracted many delegates from all parts of the UK, to attend lectures and seminars on the techniques and latest developments in shoulder and elbow surgery and other treatment options.

TRB Chemedica (UK) Ltd had a stand at the trade exhibition during the congress, and TRB staff talked to many stand visitors about the benefits of sodium hyaluronate treatments for traumatic and degenerative joint disease in the shoulder and elbow.

OSTENIL^® is the only Sodium Hyaluronate product recommended in the formulary for the world-wide sports event in England this year. This fact, coupled with the experience that many of the delegates already had with OSTENIL^® and OSTENIL^® PLUS, helped to promote the OSTENIL^® range as a valid treatment option.

OSTENIL^® and OSTENIL^® PLUS come in the form of syringes which can be injected into the synovial joint either to prevent or to postpone surgery.

Sodium hyaluronate can also be used post-arthroscopy: VISCOSEAL^® replaces the lost synovial fluid that was washed out during the arthroscopic procedure and helps to promote joint homeostasis.

We look forward to supporting other conferences later on in 2012 where we can talk to sports physicians and medical specialists about the benefits of the OSTENIL^® range, and on how it can help rehabilitate our sporting champions.

New Packaging

We at TRB Chemedica are currently in the process of updating the packaging of our products. Our customers will have already noticed the new Vismed multi bottle which now comes in a new easy-to-use "Just squeeze" dispenser bottle. Vismed single-dose vials as well as Vismed light have also changed their appearance. Vismed gel will follow in 2-3 months' time.

In the orthopaedic product range used for the treatment of osteoarthritis, Ostenil Plus and Ostenil mini have also been transformed in appearance, with Ostenil to follow shortly. Ostenil Tendon is an exciting new product used for the treatment of tendinitis and already reflects the new packaging style.

Last but not least, Viscoseal now comes in a totally new presentation: in syringe form, which makes it easier to handle in the operating theatre.
Visit our website or contact us on info@trbchemedica.co.uk for more details.

Sports Rehab & Trauma Conference 2012

Sports Rehab & Trauma Conference 2012

With the biggest sporting tournament on Earth about to come to London in the summer, there has been enormous interest from medical, surgical and rehabilitation specialists in the UK as to what tips and techniques clinical specialists from around the world might have to offer when it comes to keeping their athletes in tip top form.

At a very busy sports medicine and trauma meeting, held at Chelsea Football Club’s Stamford Bridge Football Ground, over 1000 delegates from all over Europe listened to presentations and seminars, given by some of the world’s leading sports physicians and surgeons, on rehabilitating sporting champions when they have picked up injuries.

The Isokinetic (International Conference on Sports Rehab’ and Trauma), which ran over 2 days (21-22 April 2012) was supported by TRB Chemedica (UK) Ltd, who had a trade exhibition stand at the event. Many of the problems raised by delegates visiting the stand related to maintaining optimum performance for athletes during arduous competitive seasons.  Traumatic and degenerative changes in articular joints are very common amongst top athletes, irrespective of which sport they play. Relieving pain and enhancing range of motion in articular joints are key factors in helping get these athletes back to peak form, and this was a theme that came up regularly in all the key presentations throughout the meeting.

The Ostenil Range of non-animal derived Sodium Hyaluronate injections, manufactured by TRB Chemedica, are specifically designed and licensed for the treatment of traumatic and degenerative changes in synovial joints. Not surprisingly, many of the specialist medical and physiotherapy delegates stated they already had experience with Ostenil and Ostenil Plus, and the fact that Ostenil is the only Sodium Hyaluronate product recommended in the formulary for the up - coming games reinforced their trust in the product range.

TRB Chemedica (UK) Ltd will be attending a host of sports medicine and surgical meetings throughout the rest of 2012, and our staff look forward to speaking with medical and rehabilitation specialists about the Ostenil range, and how it can help keep their patients at the top of their game!