Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01590745
Other study ID # 2011/NEURO/04/EKHT
Secondary ID
Status Completed
Phase N/A
First received April 26, 2012
Last updated January 30, 2018
Start date June 2012
Est. completion date January 3, 2018

Study information

Verified date January 2018
Source East Kent Hospitals University NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 3, 2018
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
EMS Therasonic 460 Primo Ultrasound therapy
1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.

Locations

Country Name City State
United Kingdom East Kent Hospitals University NHS Foundation Trusts Canterbury Kent

Sponsors (1)

Lead Sponsor Collaborator
East Kent Hospitals University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. — View Citation

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. — View Citation

Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000 Aug;23(8):1280-3. — View Citation

Bland JD. Do nerve conduction studies predict the outcome of carpal tunnel decompression? Muscle Nerve. 2001 Jul;24(7):935-40. — View Citation

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. — View Citation

Foley JL, Little JW, Vaezy S. Effects of high-intensity focused ultrasound on nerve conduction. Muscle Nerve. 2008 Feb;37(2):241-50. — View Citation

O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;(1):CD003219. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Boston/Levine subjective Symptom score 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 Functional status score 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
Secondary Nerve Conduction Studies Changes in Nerve Conduction Studies grading. Baseline,7th week, 6 months and end of 12 months
Secondary Ultrasound Imaging of Wrist(s) Measurements of Cross section Area (CSA)of the median nerve at the wrist(s). Baseline, 7th week, 6 and 12 months
See also
  Status Clinical Trial Phase
Completed NCT05067205 - Minimal Invasive Carpal Tunnel Release With the Novel Device N/A
Completed NCT03184688 - Platelet Rich Plasma for Carpal Tunnel Syndrome N/A
Completed NCT03582735 - Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome N/A
Completed NCT05490420 - Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome N/A
Recruiting NCT05970692 - Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Completed NCT04043780 - Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome N/A
Completed NCT03880812 - Cost Information on Carpal Tunnel Syndrome Treatment Decisions N/A
Completed NCT06464809 - Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS) N/A
Recruiting NCT05372393 - Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block N/A
Recruiting NCT05503719 - An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial N/A
Recruiting NCT05328180 - aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE) N/A
Recruiting NCT05466162 - Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome N/A
Completed NCT04060875 - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Not yet recruiting NCT06294821 - 4AP to Delay Carpal Tunnel Release (CTR) Phase 2/Phase 3
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Terminated NCT02791529 - Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release Phase 1
Completed NCT02141035 - Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome Phase 2/Phase 3
Completed NCT01887145 - Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome N/A
Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A