Ultrasound Therapy for Carpal Tunnel Syndrome (CTS)

This study is currently recruiting participants.
Verified February 2013 by East Kent Hospitals University NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Kamalakannan Jothi, East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01590745
First received: April 26, 2012
Last updated: February 13, 2013
Last verified: February 2013

April 26, 2012
February 13, 2013
June 2012
December 2015   (final data collection date for primary outcome measure)
Changes in Boston/Levine subjective Symptom score [ Time Frame: Baseline, 7th week, 6 months and end of 12months ] [ Designated as safety issue: No ]
Improvement in the Boston/Levine subjective Symptom score at completion of Ultrasound treatment(real or sham), a decrease of at least 1.04 points being considered a clinically significant change.
Same as current
Complete list of historical versions of study NCT01590745 on ClinicalTrials.gov Archive Site
  • Functional status score [ Time Frame: 7th week, 6 months and end of 12 months ] [ Designated as safety issue: No ]
    Improvement in functional status score, participants overall opinion of outcome, duration of Ultrasound therapy effect and relapses will be assessed for one year.
  • Nerve Conduction Studies [ Time Frame: Baseline,7th week, 6 months and end of 12 months ] [ Designated as safety issue: No ]
    Changes in Nerve Conduction Studies grading.
  • Ultrasound Imaging of Wrist(s) [ Time Frame: Baseline, 7th week, 6 and 12 months ] [ Designated as safety issue: Yes ]
    Measurements of Cross section Area (CSA)of the median nerve at the wrist(s).
Improvement in functional status score and change in Nerve Conduction Studies [ Time Frame: 7th week, 6 months and end of 12 months ] [ Designated as safety issue: No ]
Improvement in functional status score, participants overall opinion of outcome, change in Nerve Conduction Studies, duration of Ultrasound therapy effect and relapses will be assessed for one year.
Not Provided
Not Provided
 
Ultrasound Therapy for Carpal Tunnel Syndrome (CTS)
A Randomised Controlled Double Blind Trial Of Therapeutic Ultrasound in Carpal Tunnel Syndrome (CTS)

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).

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
Device: EMS Therasonic 460 Primo Ultrasound therapy
1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.
Other Name: Ultrasound treatment
  • Placebo Comparator: Sham Ultrasound regimen
    A switch in the transducer circuit allows mock ionisation as a result no ultrasound emitted.
    Intervention: Device: EMS Therasonic 460 Primo Ultrasound therapy
  • Active Comparator: Real Ultrasound therapy
    Pulsed mode ultrasound therapy
    Intervention: Device: EMS Therasonic 460 Primo Ultrasound therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female participants aged between 18 and 90 years with mild carpal tunnel syndrome (Canterbury NCS grades 1-3).
  • No Previous treatment history other than splinting and use of over the counter NSAIDs.

Exclusion Criteria:

  • Subjects diagnosed with peripheral neuropathy, secondary entrapment neuropathies diabetes mellitus, rheumatoid disease, acute trauma.
  • Previous carpal tunnel surgery.
  • Pregnancy or lactating.
  • Patients with known HIV infection.
  • Other serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study.
  • Patients unable to comply with the protocol requirements, including severe alcohol and drug use.
Both
18 Years to 90 Years
No
Contact: Kamalakannan Jothi 00441227864175 ext 74416 kamalakannan.jothi@nhs.net
Contact: Jeremy Bland 00441227864047 ext 74728 JEREMY.BLAND@ekht.nhs.uk
United Kingdom
 
NCT01590745
2011/NEURO/04/EKHT
Yes
Kamalakannan Jothi, East Kent Hospitals University NHS Foundation Trust
East Kent Hospitals University NHS Foundation Trust
Not Provided
Principal Investigator: Kamalakannan Jothi East Kent Hospitals University NHS Foundation Trust
Study Chair: Jeremy Bland East Kent Hospitals University NHS Foundation Trust
East Kent Hospitals University NHS Foundation Trust
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP