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Physical Therapy in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conservative group
Surgical group
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel, Physical therapy, Surgery, Efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms;
  • increasing symptoms during night;
  • Tinel sign;
  • Phalen sign;
  • self-reported hand strength deficits.
  • Deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation

Exclusion Criteria:

  • if any sensory/motor deficit in ulnar or radial nerve was present;
  • previous interventions with surgery or steroid injections;
  • multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia);
  • history of neck, shoulder or arm trauma;
  • history of a systemic disease causing CTS (e.g. diabetes mellitus, or thyroid disease);
  • history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia);
  • if the patient was actively involved with or seeking litigation at the time of the study;
  • pregnancy.

Sites / Locations

  • Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conservative group

Surgical group

Arm Description

The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.

The surgical group will receive the 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.

Outcomes

Primary Outcome Measures

Changes in the intensity of pain symptoms between baseline and follow-up periods
A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week.

Secondary Outcome Measures

Changes in patients self-perceived improvement between baseline and follow-up periods
Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively.
Changes in function between baseline and follow-up periods
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) 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.
Changes in severity of the symptoms between baseline and follow-up periods
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) 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.

Full Information

First Posted
February 6, 2013
Last Updated
August 14, 2019
Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Fundación Alcorcón
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1. Study Identification

Unique Protocol Identification Number
NCT01789645
Brief Title
Physical Therapy in Carpal Tunnel Syndrome
Official Title
Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2013 (Actual)
Primary Completion Date
January 25, 2014 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Fundación Alcorcón

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and long-term follow-up periods. We hypothesized that proper physical therapy approach can be equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.
Detailed Description
Scientific evidence for the management of CTS has exhibited conflicting results. The Cochrane review concluded that surgical treatment relieves symptoms significantly better than splinting but further research is needed. A systematic review focused on physical therapy for the management of CTS included 6 studies and found weak to strong effect of neural gliding exercises. Recent studies have revealed complex nociceptive mechanisms involved in CTS which should be carefully considered during the management of these patients. Proper physical therapy interventions can modulate nociceptive processes found in CTS. We will perform a randomized clinical trial nested within a prospective cohort as our study design to determine if proper physical therapy approach targeted to modulate sensitization processes is equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal tunnel, Physical therapy, Surgery, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative group
Arm Type
Experimental
Arm Description
The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.
Arm Title
Surgical group
Arm Type
Active Comparator
Arm Description
The surgical group will receive the 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
Other
Intervention Name(s)
Conservative group
Intervention Description
The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.
Intervention Type
Procedure
Intervention Name(s)
Surgical group
Intervention Description
The surgical group will receive the 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.
Primary Outcome Measure Information:
Title
Changes in the intensity of pain symptoms between baseline and follow-up periods
Description
A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week.
Time Frame
Baseline and 1, 3, 6 and 12 months after the intervention
Secondary Outcome Measure Information:
Title
Changes in patients self-perceived improvement between baseline and follow-up periods
Description
Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively.
Time Frame
Baseline and 1, 3, 6 and 12 months after the intervention
Title
Changes in function between baseline and follow-up periods
Description
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) 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.
Time Frame
Baseline, and 1, 3, 6 and 12 months after intervention
Title
Changes in severity of the symptoms between baseline and follow-up periods
Description
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) 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.
Time Frame
Baseline, and 1, 3, 6 and 12 months after the intervention
Other Pre-specified Outcome Measures:
Title
Changes in Health-related quality of life (economic analysis)
Description
The paper-based five-level version of EuroQol-5D (EQ-5D-5L) was used.
Time Frame
Baseline, and 1, 3, 6 and 12 months after the intervention
Title
Changes in the intensity of pain symptoms between baseline and 4 years follow-up (extended follow-up)
Description
A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week.
Time Frame
Baseline and 48 months after the intervention (extended follow-up)
Title
Changes in function and severity of symptoms between baseline and 4 years follow-up (extended follow-up)
Description
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) 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.
Time Frame
Baseline and 48 months after the intervention (extended follow-up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms; increasing symptoms during night; Tinel sign; Phalen sign; self-reported hand strength deficits. Deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation Exclusion Criteria: if any sensory/motor deficit in ulnar or radial nerve was present; previous interventions with surgery or steroid injections; multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia); history of neck, shoulder or arm trauma; history of a systemic disease causing CTS (e.g. diabetes mellitus, or thyroid disease); history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia); if the patient was actively involved with or seeking litigation at the time of the study; pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Fernández-de-las-Peñas, PT, PhD, DMSc
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35194646
Citation
Liew BXW, de-la-Llave-Rincon AI, Scutari M, Arias-Buria JL, Cook CE, Cleland J, Fernandez-de-Las-Penas C. Do Short-Term Effects Predict Long-Term Improvements in Women Who Receive Manual Therapy or Surgery for Carpal Tunnel Syndrome? A Bayesian Network Analysis of a Randomized Clinical Trial. Phys Ther. 2022 Apr 1;102(4):pzac015. doi: 10.1093/ptj/pzac015.
Results Reference
derived
PubMed Identifier
32766779
Citation
Fernandez-de-Las-Penas C, Arias-Buria JL, Cleland JA, Pareja JA, Plaza-Manzano G, Ortega-Santiago R. Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial. Phys Ther. 2020 Oct 30;100(11):1987-1996. doi: 10.1093/ptj/pzaa150.
Results Reference
derived
PubMed Identifier
26281946
Citation
Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.
Results Reference
derived

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Physical Therapy in Carpal Tunnel Syndrome

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