Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-06-30
2018-01-03
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sham Ultrasound regimen
A switch in the transducer circuit allows mock ionisation as a result no ultrasound emitted.
EMS Therasonic 460 Primo Ultrasound therapy
1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.
Real Ultrasound therapy
Pulsed mode ultrasound therapy
EMS Therasonic 460 Primo Ultrasound therapy
1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.
Interventions
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EMS Therasonic 460 Primo Ultrasound therapy
1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No Previous treatment history other than splinting and use of over the counter NSAIDs.
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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East Kent Hospitals University NHS Foundation Trust
OTHER_GOV
Responsible Party
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Kamalakannan Jothi
Highly Specialised Clinical Physiologist - Neurophysiology
Principal Investigators
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Kamalakannan Jothi
Role: PRINCIPAL_INVESTIGATOR
East Kent Hospitals University NHS Foundation Trust
Jeremy Bland
Role: STUDY_CHAIR
East Kent Hospitals University NHS Foundation Trust
Locations
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East Kent Hospitals University NHS Foundation Trusts
Canterbury, Kent, United Kingdom
Countries
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References
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Oztas O, Turan B, Bora I, Karakaya MK. Ultrasound therapy effect in carpal tunnel syndrome. Arch Phys Med Rehabil. 1998 Dec;79(12):1540-4. doi: 10.1016/s0003-9993(98)90416-6.
Ebenbichler GR, Resch KL, Nicolakis P, Wiesinger GF, Uhl F, Ghanem AH, Fialka V. Ultrasound treatment for treating the carpal tunnel syndrome: randomised "sham" controlled trial. BMJ. 1998 Mar 7;316(7133):731-5. doi: 10.1136/bmj.316.7133.731.
O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):CD003219. doi: 10.1002/14651858.CD003219.
Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000 Aug;23(8):1280-3. doi: 10.1002/1097-4598(200008)23:83.0.co;2-y.
Bland JD, Rudolfer SM. Clinical surveillance of carpal tunnel syndrome in two areas of the United Kingdom, 1991-2001. J Neurol Neurosurg Psychiatry. 2003 Dec;74(12):1674-9. doi: 10.1136/jnnp.74.12.1674.
Bland JD. Do nerve conduction studies predict the outcome of carpal tunnel decompression? Muscle Nerve. 2001 Jul;24(7):935-40. doi: 10.1002/mus.1091.
Banta CA. A prospective, nonrandomized study of iontophoresis, wrist splinting, and antiinflammatory medication in the treatment of early-mild carpal tunnel syndrome. J Occup Med. 1994 Feb;36(2):166-8. doi: 10.1097/00043764-199402000-00012.
Foley JL, Little JW, Vaezy S. Effects of high-intensity focused ultrasound on nerve conduction. Muscle Nerve. 2008 Feb;37(2):241-50. doi: 10.1002/mus.20932.
Related Links
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Click here for more information about carpal tunnel syndrome and canterbury patients can keep in touch with specialist through this web page.
Other Identifiers
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2011/NEURO/04/EKHT
Identifier Type: -
Identifier Source: org_study_id
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