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Studying Finger-thumb Grip in Patients With Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02830828
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

INTRODUCTION Carpal tunnel syndrome (CTS) is a common condition that results in impaired hand function. In cases of CTS the "pinch grip" force between the thumb and index finger becomes unnecessarily high to prevent objects from slipping when they are picked up.

HYPOTHESES The proposed study will investigate the following hypotheses regarding CTS.

As an object is picked up, the investigators suspect there will be several points at which grip force will be different between patients with different severities of CTS, i.e. grip may deteriorate as CTS gets worse.

The investigators also suspect grip force will be affected depending on the weight of the object, i.e. patients with CTS may struggle with objects of a certain weight.

Patients with CTS sweat less, and this may affect their grip. The investigators suspect that pinch grip in CTS patients is disproportionately altered by the frictional properties of the object and by the moistness of the skin.

The investigators suspect patients with CTS will be less able to adapt to sudden changes in an object's weight.

The investigators wish to examine how the above are affected after surgical treatment of CTS.

METHODS The investigators will include patients with symptomatic, idiopathic CTS, aged between 18 and 80 years. The investigators' centre will recruit CTS patients who will attend their National Health Service (NHS) outpatient appointment followed by nerve conduction studies. An equal number of healthy participants will be recruited for comparison purposes.

At the aforementioned appointment, patients will undertake a pinch grip force test using a device that will test the above points.

Patients will have normal care under their surgeon, which may include an operation for treatment of CTS. Therefore some patients will be invited back to have grip tests again after their operation. No aspect of the study will prevent a patient from receiving their normal National Health Service (NHS) care.


Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Other: Investigation of precision pinch grip control

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Does Disease Severity, Object Weight, Object Friction, and Sudden Changes to Object Weight Affect Precision Pinch Grip Force in Carpal Tunnel Syndrome?
Study Start Date : March 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017


Groups and Cohorts

Group/Cohort Intervention/treatment
Patients
Patients fulfilling inclusion/exclusion criteria referred to the PI with suspected carpal tunnel syndrome.
Other: Investigation of precision pinch grip control
Controls

Healthy volunteers fulfilling inclusion/exclusion criteria with no symptoms of carpal tunnel syndrome.

Mid-study, it was elected to also match patients to their own contralateral disease-free hand to act as a control.

Other: Investigation of precision pinch grip control


Outcome Measures

Primary Outcome Measures :
  1. Change in Precision Pinch Grip Force measured during a pinch-hold up activity over time during follow-up [ Time Frame: Assessed at initial outpatient appointment, at 3, 6 and 12 months ]
    Precision pinch grip force will be measured over time during a pinch-hold up activity. Change in this force will be observed over time at 3, 6 and 12 months follow-up.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
See inclusion/ exclusion criteria.
Criteria

Inclusion criteria:

Patients with symptomatic, idiopathic CTS (as affirmed by clinical examination and NCS) presenting to clinic Aged between 18 and 80 years In contrast to other studies the investigators would include patients with; Previous upper limb injuries Previous upper limb surgery or CTS intervention (e.g. steroid injections) Diabetes mellitus Any other upper limb nerve neuropathies or upper limb neurology Upper limb musculoskeletal degenerative disease (osteoarthritis) Thyroid disease, (Zhang et al. 2011). This will create a pragmatic study design, generalisable to a wider population in clinical practice.

Exclusion Criteria:

Central neurological or psychiatric disease Visual impairment or any other impairment that would interfere with the patient's ability to perform the study tests Pregnant patients. (Criteria based on prior research (Zhang et al. 2011)).

Control population is as previously specified.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830828


Contacts
Contact: Thomas E Pidgeon, BMedSc, MBChB 0121 371 4992 tompidgeon@hotmail.com
Contact: Dominic Power, FRCS 0121 371 4992 dominic.power@uhb.nhs.uk

Locations
United Kingdom
University Hospitals Birmingham Queen Elizabeth Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Thomas Pidgeon, BMedSc, MBChB    0121 371 4992    tompidgeon@hotmail.com   
Contact: Dominic Power, FRCS    0121 371 4992    Dominic.power@uhb.nhs.uk   
Sub-Investigator: Thomas Pidgeon, BMedSc, MBChB         
Sponsors and Collaborators
Thomas Edward Pidgeon
University of Birmingham
Investigators
Principal Investigator: Dominic Power, FRCS University Hospital Birmingham
More Information

Publications:
Responsible Party: Thomas Edward Pidgeon, Chief Investigator, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02830828     History of Changes
Other Study ID Numbers: RRK5257
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

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