- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219919
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
100
Phase
- 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
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Madrid
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Alcorcón, Madrid, Spain, 28922
- Hospital Universitario Fundacion Alcorcon
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Alcorcón, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
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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
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 |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
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.
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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.
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Baseline and 3, 6, 9 and 12 months after the intervention.
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Secondary Outcome Measures
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
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Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.
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Baseline and 3, 6, 9 and 12 months after the intervention
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Changes in pain intensity between baseline and follow-ups periods
Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention
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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.
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Baseline and 3, 6, 9 and 12 months after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2014
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
August 16, 2014
First Submitted That Met QC Criteria
August 16, 2014
First Posted (ESTIMATE)
August 19, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUFA-12/14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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