Back to resultsClinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Decompression prototype splint for carpal tunnel syndrome
Standard splint for carpal tunnel syndrome
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Be medically diagnosed with carpal tunnel syndrome after electrophysiological tests and present mild to moderate involvement. This test is performed according to the standards established by the "American Academy of Physical Medicine and Rehabilitation"
- Ability to understand and communicate their symptoms and to complete the questionnaires.
Exclusion Criteria:
- Previous surgery in the carpal tunnel in the same limb Other pathologies that may be associated with carpal tunnel syndrome: traumas, pathologies or disorders of the upper limb or cervical spine (cervical radiculopathy, cervical sprain, etc.) or prior cervical surgery
- Concurrent comorbidities that may be the cause and interfere with the treatment of the carpal tunnel syndrome: diabetes mellitus, hypothyroidism, rheumatoid arthritis, fibromyalgia, reflex sympathetic dysfunction, obesity, renal disease, alcoholism, significant vitamin deficiency and associated viral or bacterial processes
- Pregnancy
- Oral drugs, physiotherapy treatment , treatment with splints or infiltrations for carpal tunnel syndrome prior or during the study.
Sites / Locations
- Elena Estébanez de Miguel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Decompression prototype splint
standard splint
Arm Description
The patients of this group will wear the decompression prototype splint.
The patients of this group will wear a standard splint.
Outcomes
Primary Outcome Measures
Intensity of symptoms at baseline
Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
Intensity of the symptoms at 6 weeks
Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
Intensity of the symptoms at 4 months
Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
Nerve conduction studies at baseline
The nerve conduction will be assess with electroneurogram.
Nerve conduction studies at 6 weeks
The nerve conduction will be assess with electroneurogram.
Self-reported symptom severity and functional status at baseline
This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
Self-reported symptom severity and functional status at 6 weeks
This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
Self-reported symptom severity and functional status at 4 months
This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
Global Perceived Effect at 6 weeks
Global perceived effect will be assess with the Global Perceived Effect scale. The global perceived effect scale (GPES) is a commonly used method for measuring patients' assessment of their condition. One of the underlying assumptions of the GPE is that it measures a global assessment of change in the patient's chief complaint. Global Perceived Effect Scale (GPES) consists of a scale of five points that varies from less than five points (much worse), zero (no change) and five points (completely recovered). The participants are asked in the following way for all the measures of the overall effect perceived: "Compared with the beginning of the episode, how do you describe your wrist/hand today?". Positive scores represent better recovery and negative scores indicate a worsening of symptoms.
Global Perceived Effect at 4 months
Global perceived effect will be assess with the Global Perceived Effect scale. The global perceived effect scale (GPES) is a commonly used method for measuring patients' assessment of their condition. One of the underlying assumptions of the GPES is that it measures a global assessment of change in the patient's chief complaint. Global Perceived Effect Scale (GPES) consists of a scale of five points that varies from less than five points (much worse), zero (no change) and five points (completely recovered). The participants are asked in the following way for all the measures of the overall effect perceived: "Compared with the beginning of the episode, how do you describe your wrist/hand today?". Positive scores represent better recovery and negative scores indicate a worsening of symptoms.
Secondary Outcome Measures
Adherence to the treatment
The participants will fill in a calendar indicating the hours of use
Full Information
NCT ID
NCT04043780
First Posted
July 30, 2019
Last Updated
November 3, 2020
Sponsor
Universidad de Zaragoza
Collaborators
Salud Aragon, Universitat de Catalunya, Institut Català de la Salut
1. Study Identification
Unique Protocol Identification Number
NCT04043780
Brief Title
Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
Official Title
Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome: a Multicentric Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
Salud Aragon, Universitat de Catalunya, Institut Català de la Salut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A multicentric randomized controlled trial has been designed to study the effects of a decompression prototype splint on symptoms, functional capacity and nerve conduction studies in patients with carpal tunnel syndrome.
Detailed Description
A decompression prototype splint was designed to simulate an manual mobilization that is able to increase the CSA of the carpal tunnel and the median nerve in cadavers. These changes are important because they may relate to the decrease in CTS symptoms.
Patients with mild or moderate carpal tunnel syndrome will be selected for the trial. They will be randomized in 2 groups. One group will wear an standard splint for carpal tunnel syndrome and the other the decompression prototype splint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decompression prototype splint
Arm Type
Experimental
Arm Description
The patients of this group will wear the decompression prototype splint.
Arm Title
standard splint
Arm Type
Active Comparator
Arm Description
The patients of this group will wear a standard splint.
Intervention Type
Device
Intervention Name(s)
Decompression prototype splint for carpal tunnel syndrome
Intervention Description
This group will wear during 6 weeks a decompression prototype splint. They we be informed to wear it as long as possible during the 6 weeks.
Intervention Type
Device
Intervention Name(s)
Standard splint for carpal tunnel syndrome
Intervention Description
This group will wear during 6 weeks a standard splint. They we be informed to wear it as long as possible during the 6 weeks.
Primary Outcome Measure Information:
Title
Intensity of symptoms at baseline
Description
Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
Time Frame
Baseline
Title
Intensity of the symptoms at 6 weeks
Description
Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
Time Frame
6 weeks
Title
Intensity of the symptoms at 4 months
Description
Intensity of the symptoms (pain, paraesthesia...) will be assess with a visual analogic scale (VAS). A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their symptom severity . When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. The scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
Time Frame
4 months
Title
Nerve conduction studies at baseline
Description
The nerve conduction will be assess with electroneurogram.
Time Frame
Baseline
Title
Nerve conduction studies at 6 weeks
Description
The nerve conduction will be assess with electroneurogram.
Time Frame
6 weeks
Title
Self-reported symptom severity and functional status at baseline
Description
This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
Time Frame
Baseline
Title
Self-reported symptom severity and functional status at 6 weeks
Description
This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
Time Frame
6 weeks
Title
Self-reported symptom severity and functional status at 4 months
Description
This outcome will be assess with The Boston Carpal Tunnel Questionnaire (BCTQ), that is a disease-specific measure of self-reported symptom severity and functional status. The Boston Carpal Tunnel Questionnaire (BCTQ), is a patient-based outcome measure that has been developed specifically for patients with CTS. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
Time Frame
4 months
Title
Global Perceived Effect at 6 weeks
Description
Global perceived effect will be assess with the Global Perceived Effect scale. The global perceived effect scale (GPES) is a commonly used method for measuring patients' assessment of their condition. One of the underlying assumptions of the GPE is that it measures a global assessment of change in the patient's chief complaint. Global Perceived Effect Scale (GPES) consists of a scale of five points that varies from less than five points (much worse), zero (no change) and five points (completely recovered). The participants are asked in the following way for all the measures of the overall effect perceived: "Compared with the beginning of the episode, how do you describe your wrist/hand today?". Positive scores represent better recovery and negative scores indicate a worsening of symptoms.
Time Frame
6 weeks
Title
Global Perceived Effect at 4 months
Description
Global perceived effect will be assess with the Global Perceived Effect scale. The global perceived effect scale (GPES) is a commonly used method for measuring patients' assessment of their condition. One of the underlying assumptions of the GPES is that it measures a global assessment of change in the patient's chief complaint. Global Perceived Effect Scale (GPES) consists of a scale of five points that varies from less than five points (much worse), zero (no change) and five points (completely recovered). The participants are asked in the following way for all the measures of the overall effect perceived: "Compared with the beginning of the episode, how do you describe your wrist/hand today?". Positive scores represent better recovery and negative scores indicate a worsening of symptoms.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Adherence to the treatment
Description
The participants will fill in a calendar indicating the hours of use
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be medically diagnosed with carpal tunnel syndrome after electrophysiological tests and present mild to moderate involvement. This test is performed according to the standards established by the "American Academy of Physical Medicine and Rehabilitation"
Ability to understand and communicate their symptoms and to complete the questionnaires.
Exclusion Criteria:
Previous surgery in the carpal tunnel in the same limb Other pathologies that may be associated with carpal tunnel syndrome: traumas, pathologies or disorders of the upper limb or cervical spine (cervical radiculopathy, cervical sprain, etc.) or prior cervical surgery
Concurrent comorbidities that may be the cause and interfere with the treatment of the carpal tunnel syndrome: diabetes mellitus, hypothyroidism, rheumatoid arthritis, fibromyalgia, reflex sympathetic dysfunction, obesity, renal disease, alcoholism, significant vitamin deficiency and associated viral or bacterial processes
Pregnancy
Oral drugs, physiotherapy treatment , treatment with splints or infiltrations for carpal tunnel syndrome prior or during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Estébanez-de-Miguel, PhD
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elena Estébanez de Miguel
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19797585
Citation
Keith MW, Masear V, Chung KC, Maupin K, Andary M, Amadio PC, Watters WC 3rd, Goldberg MJ, Haralson RH 3rd, Turkelson CM, Wies JL, McGowan R. American Academy of Orthopaedic Surgeons Clinical Practice Guideline on diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2009 Oct;91(10):2478-9. doi: 10.2106/JBJS.I.00643. No abstract available.
Results Reference
background
PubMed Identifier
12169318
Citation
Werner RA, Andary M. Carpal tunnel syndrome: pathophysiology and clinical neurophysiology. Clin Neurophysiol. 2002 Sep;113(9):1373-81. doi: 10.1016/s1388-2457(02)00169-4.
Results Reference
background
PubMed Identifier
10411196
Citation
Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.
Results Reference
background
PubMed Identifier
12164505
Citation
Buckle PW, Devereux JJ. The nature of work-related neck and upper limb musculoskeletal disorders. Appl Ergon. 2002 May;33(3):207-17. doi: 10.1016/s0003-6870(02)00014-5.
Results Reference
background
PubMed Identifier
17216630
Citation
Foley M, Silverstein B, Polissar N. The economic burden of carpal tunnel syndrome: long-term earnings of CTS claimants in Washington State. Am J Ind Med. 2007 Mar;50(3):155-72. doi: 10.1002/ajim.20430.
Results Reference
background
PubMed Identifier
26523842
Citation
Foley M, Silverstein B. The long-term burden of work-related carpal tunnel syndrome relative to upper-extremity fractures and dermatitis in Washington State. Am J Ind Med. 2015 Dec;58(12):1255-69. doi: 10.1002/ajim.22540. Epub 2015 Nov 2.
Results Reference
background
PubMed Identifier
16768777
Citation
Stapleton MJ. Occupation and carpal tunnel syndrome. ANZ J Surg. 2006 Jun;76(6):494-6. doi: 10.1111/j.1445-2197.2006.03770.x.
Results Reference
background
PubMed Identifier
16913614
Citation
Roel-Valdes J, Arizo-Luque V, Ronda-Perez E. [Epidemiology of occupationally-caused carpal tunnel syndrome in the province of Alicante, Spain 1996-2004]. Rev Esp Salud Publica. 2006 Jul-Aug;80(4):395-409. doi: 10.1590/s1135-57272006000400009. Spanish.
Results Reference
background
PubMed Identifier
11807347
Citation
Akalin E, El O, Peker O, Senocak O, Tamci S, Gulbahar S, Cakmur R, Oncel S. Treatment of carpal tunnel syndrome with nerve and tendon gliding exercises. Am J Phys Med Rehabil. 2002 Feb;81(2):108-13. doi: 10.1097/00002060-200202000-00006.
Results Reference
background
PubMed Identifier
27842937
Citation
Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
Results Reference
background
PubMed Identifier
22200381
Citation
Baker NA, Moehling KK, Rubinstein EN, Wollstein R, Gustafson NP, Baratz M. The comparative effectiveness of combined lumbrical muscle splints and stretches on symptoms and function in carpal tunnel syndrome. Arch Phys Med Rehabil. 2012 Jan;93(1):1-10. doi: 10.1016/j.apmr.2011.08.013.
Results Reference
background
PubMed Identifier
22786532
Citation
Page MJ, Massy-Westropp N, O'Connor D, Pitt V. Splinting for carpal tunnel syndrome. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD010003. doi: 10.1002/14651858.CD010003.
Results Reference
background
PubMed Identifier
17964883
Citation
Brininger TL, Rogers JC, Holm MB, Baker NA, Li ZM, Goitz RJ. Efficacy of a fabricated customized splint and tendon and nerve gliding exercises for the treatment of carpal tunnel syndrome: a randomized controlled trial. Arch Phys Med Rehabil. 2007 Nov;88(11):1429-35. doi: 10.1016/j.apmr.2007.07.019.
Results Reference
background
PubMed Identifier
28209506
Citation
Wang JC, Liao KK, Lin KP, Chou CL, Yang TF, Huang YF, Wang KA, Chiu JW. Efficacy of Combined Ultrasound-Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):947-956. doi: 10.1016/j.apmr.2017.01.018. Epub 2017 Feb 14.
Results Reference
background
PubMed Identifier
11439376
Citation
Manente G, Torrieri F, Di Blasio F, Staniscia T, Romano F, Uncini A. An innovative hand brace for carpal tunnel syndrome: a randomized controlled trial. Muscle Nerve. 2001 Aug;24(8):1020-5. doi: 10.1002/mus.1105.
Results Reference
background
PubMed Identifier
23583095
Citation
Li ZM, Gabra JN, Marquardt TL, Kim DH. Narrowing carpal arch width to increase cross-sectional area of carpal tunnel--a cadaveric study. Clin Biomech (Bristol, Avon). 2013 Apr;28(4):402-7. doi: 10.1016/j.clinbiomech.2013.02.014. Epub 2013 Apr 9.
Results Reference
background
PubMed Identifier
25661267
Citation
Marquardt TL, Gabra JN, Li ZM. Morphological and positional changes of the carpal arch and median nerve during wrist compression. Clin Biomech (Bristol, Avon). 2015 Mar;30(3):248-53. doi: 10.1016/j.clinbiomech.2015.01.007. Epub 2015 Jan 31.
Results Reference
background
PubMed Identifier
29635191
Citation
Bueno-Gracia E, Ruiz-de-Escudero-Zapico A, Malo-Urries M, Shacklock M, Estebanez-de-Miguel E, Fanlo-Mazas P, Caudevilla-Polo S, Jimenez-Del-Barrio S. Dimensional changes of the carpal tunnel and the median nerve during manual mobilization of the carpal bones. Musculoskelet Sci Pract. 2018 Aug;36:12-16. doi: 10.1016/j.msksp.2018.04.002. Epub 2018 Apr 4.
Results Reference
background
PubMed Identifier
30195102
Citation
Bueno-Gracia E, Perez-Bellmunt A, Lopez-de-Celis C, Shacklock M, Salas-Lopez A, Simon M, Alvarez-Diaz P, Tricas-Moreno JM. Dimensional changes of the carpal tunnel and median nerve during manual mobilization of the carpal bones - Anatomical study. Clin Biomech (Bristol, Avon). 2018 Nov;59:56-61. doi: 10.1016/j.clinbiomech.2018.09.001. Epub 2018 Sep 3.
Results Reference
background
PubMed Identifier
25547237
Citation
Bulut GT, Caglar NS, Aytekin E, Ozgonenel L, Tutun S, Demir SE. Comparison of static wrist splint with static wrist and metacarpophalangeal splint in carpal tunnel syndrome. J Back Musculoskelet Rehabil. 2015;28(4):761-7. doi: 10.3233/BMR-140580.
Results Reference
background
PubMed Identifier
18638040
Citation
De Angelis MV, Pierfelice F, Di Giovanni P, Staniscia T, Uncini A. Efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome: a randomized controlled study. Acta Neurol Scand. 2009 Jan;119(1):68-74. doi: 10.1111/j.1600-0404.2008.01072.x. Epub 2008 Jul 13.
Results Reference
background
PubMed Identifier
26195619
Citation
Golriz B, Ahmadi Bani M, Arazpour M, Bahramizadeh M, Curran S, Madani SP, Hutchins SW. Comparison of the efficacy of a neutral wrist splint and a wrist splint incorporating a lumbrical unit for the treatment of patients with carpal tunnel syndrome. Prosthet Orthot Int. 2016 Oct;40(5):617-23. doi: 10.1177/0309364615592695. Epub 2015 Jul 20.
Results Reference
background
PubMed Identifier
20581649
Citation
Zinnuroglu M, Baspinar M, Beyazova M. Carpal lock and the volar-supporting orthosis in mild and moderate carpal tunnel syndrome. Am J Phys Med Rehabil. 2010 Sep;89(9):759-64. doi: 10.1097/PHM.0b013e3181e721ed.
Results Reference
background
PubMed Identifier
10918269
Citation
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.
Results Reference
background
PubMed Identifier
26444330
Citation
Barbosa RI, Fonseca Mde C, Rodrigues EK, Tamanini G, Marcolino AM, Mazzer N, Guirro RR, MacDermid J. Efficacy of low-level laser therapy associated to orthoses for patients with carpal tunnel syndrome: A randomized single-blinded controlled trial. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):459-66. doi: 10.3233/BMR-150640.
Results Reference
background
PubMed Identifier
25446519
Citation
Celik B, Paker N, Celik EC, Bugdayci DS, Ones K, Ince N. The effects of orthotic intervention on nerve conduction and functional outcome in carpal tunnel syndrome: A prospective follow-up study. J Hand Ther. 2015 Jan-Mar;28(1):34-7; quiz 38. doi: 10.1016/j.jht.2014.07.008. Epub 2014 Oct 6.
Results Reference
background
PubMed Identifier
11690728
Citation
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Results Reference
background
PubMed Identifier
12058083
Citation
Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2002 Jun 11;58(11):1589-92. doi: 10.1212/wnl.58.11.1589. No abstract available.
Results Reference
background
PubMed Identifier
27630413
Citation
Weng C, Dong H, Chu H, Lu Z. Clinical and electrophysiological evaluation of neutral wrist nocturnal splinting in patients with carpal tunnel syndrome. J Phys Ther Sci. 2016 Aug;28(8):2274-8. doi: 10.1589/jpts.28.2274. Epub 2016 Aug 31.
Results Reference
background
PubMed Identifier
26683079
Citation
Oteo-Alvaro A, Marin MT, Matas JA, Vaquero J. [Spanish validation of the Boston Carpal Tunnel Questionnaire]. Med Clin (Barc). 2016 Mar 18;146(6):247-53. doi: 10.1016/j.medcli.2015.10.013. Epub 2015 Dec 10. Spanish.
Results Reference
background
PubMed Identifier
29538382
Citation
Healy A, Farmer S, Pandyan A, Chockalingam N. A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions. PLoS One. 2018 Mar 14;13(3):e0192094. doi: 10.1371/journal.pone.0192094. eCollection 2018.
Results Reference
background
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Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
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