Effect of viscoseal on pain after subacromial decompression

• Research type

  Research Study

• Full title

  The Effect of Sodium Hyaluronate (viscoseal) on Pain and Function Following Arthroscopic Sub-Acromial Decompression Surgery - A Randomised Controlled Trial.

• IRAS ID

  121063

• Contact name

  Steven Corbett

• Contact email

  steven.corbett@gstt.nhs.uk

• Sponsor organisation

  Guy's and St Thomas' Foundation NHS Trust

• Research summary

  The subacromial bursa has important function in lubricating the shoulder to ensure pain free shoulder movements. Impingement syndrome is a common shoulder disorder resulting from inflammation of this bursa. Arthroscopic Subacromial Decompression (ASAD) is a commonly performed operation to remove the inflamed subacromial bursa and any local bony spurs, should initial conservative measures fail to resolve symptoms. Following the arthroscopy, patients can experience pain, swelling and loss of joint mobility/stiffness. This appears to vary between individuals. Whilst pain can be a result of the surgery itself, the absence of bursa following surgery can reduce the protective and lubricating functions for several days before the bursa reforms.
  Sodium hyaluronate (also known as hyaluronic acid or hyaluronan) is a natural substance. It is present in the body wherever moisture is stored or lubrication
  between layers of tissue is required to eliminate friction. Viscoseal is a 0.5% concentration, isotonic solution of Sodium hyaluronate designed as a substitute for use following arthroscopic surgery or joint lavage and has been extensively used in knees for many years. The introduction of Viscous Sodium Hyaluronate into the joint space coats the exposed bony surfaces and tendons previously covered by the bursa. By establishing a viscous, protective barrier over local bone and soft tissue pain receptors, it is hypothesised that patients will have less pain and better function than that observed with the administration of 10ml of normal saline, which we propose to use as control. A small study into the effects of instilling Hyaluronan following sub-acromial decompression was previously undertaken at Wrightington Hospital, with encouraging results and no adverse events.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  13/LO/0427

• Date of REC Opinion

  10 Jun 2013

• REC opinion

  Favourable Opinion