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Ultrasound Therapy for Carpal Tunnel Syndrome (CTS)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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).


Condition Intervention
Carpal Tunnel Syndrome
Device: EMS Therasonic 460 Primo Ultrasound therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Double Blind Trial Of Therapeutic Ultrasound in Carpal Tunnel Syndrome (CTS)

Resource links provided by NLM:


Further study details as provided by East Kent Hospitals University NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham Ultrasound regimen
A switch in the transducer circuit allows mock ionisation as a result no ultrasound emitted.
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
Active Comparator: Real Ultrasound therapy
Pulsed mode ultrasound therapy
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590745

Contacts
Contact: Kamalakannan Jothi 00441227864175 ext 74416 kamalakannan.jothi@nhs.net
Contact: Jeremy Bland 00441227864047 ext 74728 JEREMY.BLAND@ekht.nhs.uk

Locations
United Kingdom
East Kent Hospitals University NHS Foundation Trusts Recruiting
Canterbury, Kent, United Kingdom, CT13NG
Contact: Kamalakannan Jothi    0441227864175 ext 74416    kamalakannan.jothi@nhs.net   
Contact: Jeremy Bland    00441227864047 ext 74728    JEREMY.BLAND@ekht.nhs.uk   
Principal Investigator: Kamalakannan Jothi         
Sponsors and Collaborators
East Kent Hospitals University NHS Foundation Trust
Investigators
Principal Investigator: Kamalakannan Jothi East Kent Hospitals University NHS Foundation Trust
Study Chair: Jeremy Bland East Kent Hospitals University NHS Foundation Trust
  More Information

Additional Information:
Publications:
Responsible Party: Kamalakannan Jothi, Highly Specialised Clinical Physiologist - Neurophysiology, East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01590745     History of Changes
Other Study ID Numbers: 2011/NEURO/04/EKHT
Study First Received: April 26, 2012
Last Updated: February 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by East Kent Hospitals University NHS Foundation Trust:
Ultrasound therapy
Nerve Conduction studies
Boston and Levine Questionnaire
Neutral Angle Wrist Splint
Canterbury CTS scale

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Cumulative Trauma Disorders
Disease
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014