Ultrasound Therapy for Carpal Tunnel Syndrome (CTS)

NCT01590745 | Completed DMC

• 1 other identifier: 2011/NEURO/04/EKHT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Carpal Tunnel Syndrome

Keywords

Ultrasound therapy; Nerve Conduction studies; Boston and Levine Questionnaire; Neutral Angle Wrist Splint; Canterbury CTS scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional status score

  7th week, 6 months and end of 12 months

• Nerve Conduction Studies

  Baseline,7th week, 6 months and end of 12 months

• Ultrasound Imaging of Wrist(s)

  Baseline, 7th week, 6 and 12 months

Study Arms (2)

Sham Ultrasound regimen

PLACEBO COMPARATOR

A switch in the transducer circuit allows mock ionisation as a result no ultrasound emitted.

Device: EMS Therasonic 460 Primo Ultrasound therapy

Real Ultrasound therapy

ACTIVE COMPARATOR

Pulsed mode ultrasound therapy

Device: EMS Therasonic 460 Primo Ultrasound therapy

Interventions

EMS Therasonic 460 Primo Ultrasound therapy DEVICE

1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.

Also known as: Ultrasound treatment

Real Ultrasound therapy; Sham Ultrasound regimen

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Sites (1)

East Kent Hospitals University NHS Foundation Trusts

Canterbury, Kent, CT13NG, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 9862296 BACKGROUND

• 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.

  PMID: 9529407 BACKGROUND

• 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.

  PMID: 12535461 BACKGROUND

• 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.

  PMID: 10918269 BACKGROUND

• 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.

  PMID: 14638888 BACKGROUND

• 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.

  PMID: 11410921 BACKGROUND

• 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.

  PMID: 8176515 BACKGROUND

• 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.

  PMID: 18041054 BACKGROUND

Related Links

• Click here for more information about carpal tunnel syndrome and canterbury patients can keep in touch with specialist through this web page.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Kamalakannan Jothi

  East Kent Hospitals University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Jeremy Bland

  East Kent Hospitals University NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Highly Specialised Clinical Physiologist - Neurophysiology

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 3, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: January 3, 2018
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

GB (1)