Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Surgical Group
Physical Therapy Group
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Pain, Sensitivity, Pain Thresholds, Sensitization, Physical Therapy
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Fundación Alcorcon
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical Therapy Group
Surgical Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in widespread pressure pain thresholds between baseline and follow-up periods
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.
Secondary Outcome Measures
Changes in heat and cold pain thresholds between baseline and follow-up periods
Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.
Changes in pain intensity between baseline and follow-ups periods
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.
Full Information
NCT ID
NCT02219919
First Posted
August 16, 2014
Last Updated
May 10, 2016
Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Fundación Alcorcón, Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02219919
Brief Title
Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
Official Title
Changes in Nociceptive Gain Processing After Physical Therapy and Surgery in Carpal Tunnel Syndrome: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Fundación Alcorcón, Hospital San Carlos, Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
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 Syndrome, Pain, Sensitivity, Pain Thresholds, Sensitization, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgical Group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Surgical Group
Intervention Description
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 Type
Other
Intervention Name(s)
Physical Therapy Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in widespread pressure pain thresholds between baseline and follow-up periods
Description
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.
Time Frame
Baseline and 3, 6, 9 and 12 months after the intervention.
Secondary Outcome Measure Information:
Title
Changes in heat and cold pain thresholds between baseline and follow-up periods
Description
Heat and cold pain thresholds over the carpal tunnel and the thenar eminence will be bilaterally assessed.
Time Frame
Baseline and 3, 6, 9 and 12 months after the intervention
Title
Changes in pain intensity between baseline and follow-ups periods
Description
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.
Time Frame
Baseline and 3, 6, 9 and 12 months after the intervention
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
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
Facility Information:
Facility Name
Hospital Universitario Fundación Alcorcon
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
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Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
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