Ultrasound Therapy for Carpal Tunnel Syndrome (CTS)
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal Tunnel Syndrome (CTS) is a recognisable pattern of symptoms and signs, which are
      caused by compression of the median (middle) nerve as it passes through the carpal tunnel at
      the wrist.

      This condition affects individuals by causing pain, numbness, tingling sensations and
      sometimes weakness in the fingers and may extend to shoulder and neck areas. The cause for
      most cases is unknown (idiopathic) though some common conditions are associated with an
      increased incidence, including obesity, pregnancy, hypothyroidism, arthritis, diabetes, and
      trauma.

      Diagnosis is primarily clinical and the condition is easily recognised from the
      characteristic symptoms in straightforward cases but diagnostic support is provided by
      investigations such as nerve conduction studies and ultrasound imaging.

      Treatment may include splinting, local steroid injection at wrist, activity
      modification,physical or occupational therapy (controversial), medications, and surgery.
      Treatment with local therapeutic ultrasound has been suggested to be effective but existing
      trials are inconclusive.

      Wrist splinting is only partially effective with a success rate of 34%, Steroid injection is
      followed by frequent relapses and there remains uncertainty about the safety of serial
      injections. Surgery is effective but has a small but significant incidence of permanent
      complications. Any demonstrably effective and safe addition to the therapeutic options would
      be a significant advance in treatment. Therapeutic ultrasound at present appears a promising
      option, having a very good safety record but so far uncertain evidence of efficacy.

      In our trial patients, with mild carpal tunnel syndrome, confirmed by nerve conduction
      studies, will all be given wrist splints so that no patients will be left untreated. They
      will be randomly allocated to either therapeutic or sham ultrasound therapy (20 sessions over
      7 weeks) and followed up for 1year. The patients, operators of the ultrasound equipment and
      assessors will all be blind to treatment allocation.

      The effect of treatment on symptoms will be assessed using a validated questionnaire and
      nerve conduction studies will be repeated at completion of the ultrasound treatment, 6 and 12
      months.

      This study is designed to find out to whether therapeutic ultrasound is an effective
      treatment for carpal tunnel syndrome (CTS).
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is the commonest peripheral nerve disorder in the UK. Average
      annual incidences (per 100 000) were 139.4 for women and 67.2 for men in East Kent, UK.

      It has significant economic impact, on average having the largest recuperation period of all
      injuries / illness that require days away from work. It causes tingling, numbness or pain in
      the distribution of the median nerve (the thumb, index, and middle fingers, and half the ring
      finger) that is often worse at night and causes wakening. The pathology of idiopathic CTS is
      a non-inflammatory fibrosis of the subsynovial connective tissue surrounding the flexor
      tendons but the causes are not fully understood.

      Many treatments have been proposed but reviews performed by the Cochrane collaboration have
      found firm evidence in support of only:

        1. Surgical decompression of the carpal tunnel.

        2. Steroid therapy (local injection or systemic administration).

        3. Neutral angle wrist splinting.

      None of the available evidence based treatments for CTS are entirely satisfactory. Splinting
      is only partially effective with a success rate of 34%, Steroid injection is followed by
      frequent relapses and there remains uncertainty about the safety of serial injections.
      Surgery results in a small but significant incidence of permanent morbidity from
      complications.

      Any demonstrably effective and safe addition to the therapeutic options would be a
      significant advance. Of the many candidate treatments, therapeutic ultrasound at present
      appears the most promising and is therefore the subject of this proposal Therapeutic
      ultrasound has a very good safety record and is essentially non-invasive.

      In this trial, patients with mild carpal tunnel syndrome, confirmed by nerve conduction
      studies, will all be given wrist splints. They will be randomly allocated to either real or
      sham ultrasound therapy (20 sessions over 7 weeks) and followed up for 1 year. The effect of
      treatment on symptoms will be assessed using a validated questionnaire and nerve conduction
      studies will be repeated at completion of the ultrasound treatment at 7th week and further
      after 6 and 12 months time.

      This will be a randomised, double blind, single-centre, clinical trial conducted by East Kent
      Hospitals University Foundation Trusts (Kent and Canterbury Hospital), with follow-up for 1
      year from completion of treatment. Following randomisation, patients will be required to
      attend the clinic for 20 sessions over a 7 weeks period (5x weekly for 2 weeks then 2x weekly
      for 5 weeks).
    

Intervention name(s): EMS Therasonic 460 Primo Ultrasound therapy
Intervention type(s): Device
Intervention description(s): 1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.
Other intervention name(s): Ultrasound treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound therapy; Nerve Conduction studies; Boston and Levine Questionnaire; Neutral Angle Wrist Splint; Canterbury CTS scale