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The Role of the Cervical Spine in Carpal Tunnel Syndrome

U

Universidad Rey Juan Carlos

Status

Completed

Conditions

Carpal Tunnel Syndromes

Treatments

Other: Physical Therapy Group
Procedure: Surgical Group

Study type

Interventional

Funder types

Other

Identifiers

NCT02233660
HUFA PI -12/0023

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Physical Therapy Group.
Experimental group
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.
Treatment:
Other: Physical Therapy Group
Surgical Group
Active Comparator group
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.
Treatment:
Procedure: Surgical Group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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