Clinical trial NCT02233660: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndromes
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Fundación Alcorcón
First posted: 2014-09-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in hand function between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention
Secondary outcomes:
measure: Changes in active cervical range of motion between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention
measure: Changes in pinch grip force between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundación Alcorcon
state: Madrid
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
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.