Ultrasound Therapy for Carpal Tunnel Syndrome (CTS) (CTS)

January 30, 2018 updated by: Kamalakannan Jothi, East Kent Hospitals University NHS Foundation Trust

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).

Study Overview

Status

Completed

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Kent
      • Canterbury, Kent, United Kingdom, CT13NG
        • East Kent Hospitals University NHS Foundation Trusts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Ultrasound treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Boston/Levine subjective Symptom score
Time Frame: Baseline, 7th week, 6 months and end of 12months
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.
Baseline, 7th week, 6 months and end of 12months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status score
Time Frame: 7th week, 6 months and end of 12 months
Improvement in functional status score, participants overall opinion of outcome, duration of Ultrasound therapy effect and relapses will be assessed for one year.
7th week, 6 months and end of 12 months
Nerve Conduction Studies
Time Frame: Baseline,7th week, 6 months and end of 12 months
Changes in Nerve Conduction Studies grading.
Baseline,7th week, 6 months and end of 12 months
Ultrasound Imaging of Wrist(s)
Time Frame: Baseline, 7th week, 6 and 12 months
Measurements of Cross section Area (CSA)of the median nerve at the wrist(s).
Baseline, 7th week, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

January 3, 2018

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/NEURO/04/EKHT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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