Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome

May 10, 2016 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Changes in Nociceptive Gain Processing After Physical Therapy and Surgery in Carpal Tunnel Syndrome: A Randomized Clinical Trial

This randomized clinical trial will investigate changes in pain intensity and nociceptive gain processing after the application of either physical therapy or surgery in women with carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain intensity, widespread pressure pain sensitivity and segmental thermal changes after the application of a physical therapy program based on desensitization maneuvers of the central nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up periods. We hypothesize that the physical therapy intervention targeted to desensitization of the central nervous system is more effective than surgical intervention for modulating altered nociceptive gain processing in women with CTS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a complex pain syndrome including both peripheral and central sensitization mechanisms. In fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain processing. In addition, these sensitization processes seem to be independent of electro-diagnostic findings. Previous studies support the use of physical therapy and surgical interventions for the management of pain and disability in these patients. However, there is no evidence related to changes in nociceptive gain process after the application of any therapeutic intervention. Preliminary evidence suggests that manual therapies can modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized clinical trial to determine if manual therapies including desensitization maneuvers of the central nervous system are effective to decrease widespread pressure pain and thermal pain hypersensitivity in women with CTS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Alcorcón, Madrid, Spain, 28922
        • Universidad Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pain and paresthesia in the median nerve distribution
  • increasing symptoms during the night,
  • 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 or steroid injections;
  • multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
  • history of neck, shoulder, or upper limb trauma (whiplash);
  • history of a systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
  • history of other medical conditions (eg, rheumatoid arthritis, fibromyalgia);
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Physical Therapy Group
The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
Other: Physical Therapy Group
The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in widespread pressure pain thresholds between baseline and follow-up periods
Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention.
Pressure pain thresholds over the median, ulnar and radial nerves, and over the cervical spine, the second metacarpal, and tibialis anterior muscles will be bilaterally assessed.
Baseline and 3, 6, 9 and 12 months after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in heat and cold pain thresholds between baseline and follow-up periods
Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention
Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.
Baseline and 3, 6, 9 and 12 months after the intervention
Changes in pain intensity between baseline and follow-ups periods
Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention
An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week. The mean value of the 3 scores will be used in the analysis at each follow-up period.
Baseline and 3, 6, 9 and 12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Rey Juan Carlos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital San Carlos, Madrid
Hospital Universitario Fundación Alcorcón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUFA-12/14

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