The Role of the Cervical Spine in Carpal Tunnel Syndrome

• ClinicalTrials.gov Identifier: NCT02233660
• Recruitment Status: Completed
• First Posted: September 8, 2014
• Last Update Posted: March 15, 2016
• Sponsor: Universidad Rey Juan Carlos
• Collaborator: Hospital Universitario Fundación Alcorcón
• Information provided by (Responsible Party): César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Tracking Information

• First Submitted Date: September 3, 2014
• First Posted Date: September 8, 2014
• Last Update Posted Date: March 15, 2016
• Study Start Date: September 2014
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 8, 2014)

Changes in hand function between baseline and follow-up periods [ Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention ]

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.

Original Primary Outcome Measures (submitted: September 3, 2014)

Changes in hand function between baseline and follow-up periods [ Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention ]

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 we used the score of the functional status scale of this questionnaire as the main outcome.

Current Secondary Outcome Measures (submitted: September 3, 2014)

• Changes in active cervical range of motion between baseline and follow-up periods [ Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention ]
  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 [ Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Carpal Tunnel Syndromes

Intervention

• Other: 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.
• Procedure: 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.

Study Arms

• Experimental: 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: Other: Physical Therapy Group
• Active Comparator: 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: Procedure: Surgical Group

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 3, 2014): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02233660
• Other Study ID Numbers: HUFA PI -12/0023
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Rey Juan Carlos
• Original Study Sponsor: Same as current
• Collaborators: Hospital Universitario Fundación Alcorcón
• Investigators: Not Provided
• PRS Account: Universidad Rey Juan Carlos
• Verification Date: March 2016