The Role of the Cervical Spine in Carpal Tunnel Syndrome

NCT ID: NCT02233660

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

Carpal Tunnel Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical Therapy Group.

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.

Group Type: EXPERIMENTAL

Physical Therapy Group

Intervention Type: OTHER

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.

Surgical Group

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.

Group Type: ACTIVE_COMPARATOR

Surgical Group

Intervention Type: PROCEDURE

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.

Interventions

Physical Therapy Group

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: OTHER

Surgical Group

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: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role: collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

César Fernández-de-las-Peñas

Head Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Fundación Alcorcon

Alcorcón, Madrid, Spain

Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28158963 (View on PubMed)

Other Identifiers

HUFA PI -12/0023

Identifier Type: -

Identifier Source: org_study_id