Carpal Tunnel SyndromeNCT02219919
Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
A study testing Surgical Group and Physical Therapy Group in people with Carpal Tunnel Syndrome, run by Universidad Rey Juan Carlos at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Surgical Group and Physical Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- Aug 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Fundación Alcorcon
Alcorcón, Madrid, 28922
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Surgical Group, Physical Therapy Group
- Keywords
- Carpal Tunnel Syndrome, Pain, Sensitivity, Pain Thresholds, Sensitization, Physical Therapy
- Medical subject headings
- Carpal Tunnel Syndrome, Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical GroupOther
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.
Physical Therapy GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Group | Experimental | 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. Receives: Other: Physical Therapy Group |
| Surgical Group | Active comparator | 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. Receives: Other: Surgical Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3, 6, 9 and 12 months after the intervention.
Secondary outcomes (2)
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.
Measured: Baseline and 3, 6, 9 and 12 months after the intervention
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.
Measured: Baseline and 3, 6, 9 and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón, Hospital San Carlos, Madrid
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219919
- Sponsor's protocol ID
- HUFA-12/14
- Status last verified
- May 2016
- First submitted
- 16 Aug 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Nociceptive Gain Processing After Physical Therapy and Surgery in Carpal Tunnel Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02219919
- Acronym / sponsor ID
- HUFA-12/14
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Pain, Sensitivity, Pain Thresholds, Sensitization, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón, Hospital San Carlos, Madrid
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Group | Experimental | Other: Physical Therapy GroupThe 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. |
| Surgical Group | Active comparator | Other: Surgical GroupThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical GroupThe 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 |
| Physical Therapy GroupThe 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 |
Primary outcome
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.
2 secondary outcomes
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
Changes in pain intensity between baseline and follow-ups periods
Time frame: Baseline and 3, 6, 9 and 12 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Group and Physical Therapy Group in people with Carpal Tunnel Syndrome, run by Universidad Rey Juan Carlos at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.