The Role of the Cervical Spine in Carpal Tunnel Syndrome

NCT02233660 | Completed DMC

• 1 other identifier: HUFA PI -12/0023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndromes

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1, 3, 6 and 12 months after the intervention

Secondary Outcomes (2)

• Changes in active cervical range of motion between baseline and follow-up periods

  Baseline and 1, 3, 6 and 12 months after the intervention

• Changes in pinch grip force between baseline and follow-up periods

  Baseline and 1, 3, 6 and 12 months after the intervention

Study Arms (2)

Physical Therapy Group.

EXPERIMENTAL

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.

Other: Physical Therapy Group

Surgical Group

ACTIVE COMPARATOR

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.

Procedure: Surgical Group

Interventions

Physical Therapy Group 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.

Physical Therapy Group.

Surgical Group 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.

Surgical Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Hospital Universitario Fundación Alcorcón: collaborator

Study Sites (2)

Hospital Universitario Fundación Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• 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.

  PMID: 28158963 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 8, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

ES (2)