The Role of the Cervical Spine in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndromes
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Therapy Group
Surgical Group
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndromes
Eligibility Criteria
Inclusion Criteria:
- Pain and paresthesia in the median nerve distribution
- Positive Tinel sign,
- Positive Phalen sign,
- Symptoms had to have persisted for at least 6 months
- Deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
Exclusion Criteria:
- Any sensory/motor deficit related to the ulnar or radial nerve;
- Older than 65 years of age;
- Previous surgical intervention, steroid injections or physical therapy intervention
- Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
- History of neck, shoulder, or upper limb trauma (whiplash);
- History of any systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
- History of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
- Pregnancy
Sites / Locations
- Hospital Universitario Fundación Alcorcon
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical Therapy Group.
Surgical Group
Arm Description
The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Outcomes
Primary Outcome Measures
Changes in hand function between baseline and follow-up periods
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.
Secondary Outcome Measures
Changes in active cervical range of motion between baseline and follow-up periods
A cervical range of motion (CROM) device will be used to assess cervical range of motion in a single direction: flexion, extension, lateral flexion toward or away from the side of the CTS, and rotation toward or away from the side of the CTS. For patients with unilateral symptoms, sides are classified as affected or unaffected whereas in those with bilateral symptoms, the most painful side will be considered as the affected side and the less painful side as the unaffected side.
Changes in pinch grip force between baseline and follow-up periods
Pinch grip force between the tip of the thumb with the tip of the index or the little finger will be measured with a pinch grip dynamometer
Full Information
NCT ID
NCT02233660
First Posted
September 3, 2014
Last Updated
March 14, 2016
Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Fundación Alcorcón
1. Study Identification
Unique Protocol Identification Number
NCT02233660
Brief Title
The Role of the Cervical Spine in Carpal Tunnel Syndrome
Official Title
Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Fundación Alcorcón
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function, cervical range of motion and pinch grip force induced after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The hypothesis is that manual therapy is more effective for increasing cervical range of motion and pinch grip force, but similarly effective for improving function, than surgical treatment in women with CTS.
Detailed Description
There is some evidence suggesting that CTS is associated with restricted cervical range of motion and deficits in pinch grip force. In fact, restricted cervical range of motion and deficits in pinch grip force seems to be independent of electro-diagnostic findings. These findings would be associated with the proposed "double crush syndrome" theory. However no longitudinal studies have been conducted. Further it has been demonstrated that hand function is associated to deficits in these outcomes. Since previous studies support the use of physical therapy and surgical interventions for the management of function in these patients, the aim of this study is to conduct a randomized clinical trial to determine if changes in hand function are related to changes in active cervical range of motion and pinch grip force after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or endoscopic surgery in women with CTS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy Group.
Arm Type
Experimental
Arm Description
The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
Arm Title
Surgical Group
Arm Type
Active Comparator
Arm Description
The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Intervention Type
Other
Intervention Name(s)
Physical Therapy Group
Intervention Description
The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
Intervention Type
Procedure
Intervention Name(s)
Surgical Group
Intervention Description
The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Primary Outcome Measure Information:
Title
Changes in hand function between baseline and follow-up periods
Description
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.
Time Frame
Baseline and 1, 3, 6 and 12 months after the intervention
Secondary Outcome Measure Information:
Title
Changes in active cervical range of motion between baseline and follow-up periods
Description
A cervical range of motion (CROM) device will be used to assess cervical range of motion in a single direction: flexion, extension, lateral flexion toward or away from the side of the CTS, and rotation toward or away from the side of the CTS. For patients with unilateral symptoms, sides are classified as affected or unaffected whereas in those with bilateral symptoms, the most painful side will be considered as the affected side and the less painful side as the unaffected side.
Time Frame
Baseline and 1, 3, 6 and 12 months after the intervention
Title
Changes in pinch grip force between baseline and follow-up periods
Description
Pinch grip force between the tip of the thumb with the tip of the index or the little finger will be measured with a pinch grip dynamometer
Time Frame
Baseline and 1, 3, 6 and 12 months after the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain and paresthesia in the median nerve distribution
Positive Tinel sign,
Positive Phalen sign,
Symptoms had to have persisted for at least 6 months
Deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
Exclusion Criteria:
Any sensory/motor deficit related to the ulnar or radial nerve;
Older than 65 years of age;
Previous surgical intervention, steroid injections or physical therapy intervention
Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
History of neck, shoulder, or upper limb trauma (whiplash);
History of any systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
History of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
Pregnancy
Facility Information:
Facility Name
Hospital Universitario Fundación Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
28158963
Citation
Fernandez-de-Las-Penas C, Cleland J, Palacios-Cena M, Fuensalida-Novo S, Pareja JA, Alonso-Blanco C. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Mar;47(3):151-161. doi: 10.2519/jospt.2017.7090. Epub 2017 Feb 3.
Results Reference
derived
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The Role of the Cervical Spine in Carpal Tunnel Syndrome
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