Carpal Tunnel SyndromePhase 1/2NCT00929123
Mechanisms of Neural Mobilization in the Treatment of Chronic Pain
A Phase 1/2 study testing neural mobilization in people with Carpal Tunnel Syndrome, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- neural mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2009
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- signs and symptoms of carpal tunnel syndrome for greater than 12 weeks
Who cannot join
- non english speaking
- prior surgery for carpal tunnel syndrome
- systemic condition known to affect sensation
- chronic pain condition other than carpal tunnel syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. The investigators hypothesized that individuals receiving a neural mobilization technique known to directly stress the median nerve would demonstrate greater improvements in clinical pain and function, experimental pain sensitivity, and median nerve function than those receiving a sham technique.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- neural mobilization, sham neural mobilization, healthy controls
- Keywords
- manual therapy, carpal tunnel syndrome, central sensitization
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neural mobilizationProcedure or surgery
Also called upper limb tension test with median nerve bias
manual therapy technique known to directly stress the median nerve
sham neural mobilizationProcedure or surgery
sham technique mimicking the neural mobilization which is not specific to the median nerve
healthy controlsOther
People without carpal tunnel syndrome for comparison
| Study group | Role | What they receive |
|---|---|---|
| neural mobilization | Experimental | manual therapy technique known to directly stress the median nerve Receives: Procedure: neural mobilization |
| sham neural mobilization | Placebo comparator | manual therapy technique known to directly stress the median nerve without any stimulation. Receives: Procedure: sham neural mobilization |
| Healthy Controls | Active comparator | People without carpal tunnel syndrome for comparison Receives: Other: healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
thermal and pressure pain sensitivity
Measured: immediate effect
Secondary outcomes (5)
grip strength
Measured: 3 weeks
wrist range of motion
Measured: 3 weeks
clinical pain
Measured: 3 weeks
self report of disability
Measured: 3 weeks
median nerve function
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Steven Z George, PhD, Principal investigator, University of Florida Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929123
- Sponsor's protocol ID
- R21AT002796
- Other IDs
- R21AT002796, R21AT002796-01A1
- Status last verified
- Mar 2015
- First submitted
- 25 Jun 2009
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bialosky JE, Bishop MD, Price DD, Robinson ME, Vincent KR, George SZ. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. J Orthop Sports Phys Ther. 2009 Oct;39(10):709-23. doi: 10.2519/jospt.2009.3117.
PubMed 19801812Bialosky JE, Bishop MD, Robinson ME, Price DD, George SZ. Heightened pain sensitivity in individuals with signs and symptoms of carpal tunnel syndrome and the relationship to clinical outcomes following a manual therapy intervention. Man Ther. 2011 Dec;16(6):602-8. doi: 10.1016/j.math.2011.06.003. Epub 2011 Jul 20.
PubMed 21764354Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
PubMed 19027342
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Neural Mobilization in the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT00929123
- Acronym / sponsor ID
- R21AT002796
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- manual therapy, carpal tunnel syndrome, central sensitization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Jun 2009 (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.
The purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. The investigators hypothesized that individuals receiving a neural mobilization technique known to directly stress the median nerve would demonstrate greater improvements in clinical pain and function, experimental pain sensitivity, and median nerve function than those receiving a sham technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| neural mobilization | Experimental | Procedure: neural mobilizationmanual therapy technique known to directly stress the median nerve |
| sham neural mobilization | Placebo comparator | Procedure: sham neural mobilizationmanual therapy technique known to directly stress the median nerve without any stimulation. |
| Healthy Controls | Active comparator | Other: healthy controlsPeople without carpal tunnel syndrome for comparison |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 70 years of age
- signs and symptoms of carpal tunnel syndrome for greater than 12 weeks
Key exclusion criteria (4 listed)
- non english speaking
- prior surgery for carpal tunnel syndrome
- systemic condition known to affect sensation
- chronic pain condition other than carpal tunnel syndrome
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 |
|---|---|---|
| neural mobilizationAlso: upper limb tension test with median nerve biasmanual therapy technique known to directly stress the median nerve | Procedure or surgery | neural mobilization |
| sham neural mobilizationsham technique mimicking the neural mobilization which is not specific to the median nerve | Procedure or surgery | sham neural mobilization |
| healthy controlsPeople without carpal tunnel syndrome for comparison | Other | Healthy Controls |
Primary outcome
thermal and pressure pain sensitivity
Time frame: immediate effect
5 secondary outcomes
grip strength
Time frame: 3 weeks
wrist range of motion
Time frame: 3 weeks
clinical pain
Time frame: 3 weeks
self report of disability
Time frame: 3 weeks
median nerve function
Time frame: 3 weeks
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 17 Mar 2015.
- Results publication: PubMed 19801812Bialosky JE, Bishop MD, Price DD, Robinson ME, Vincent KR, George SZ. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. J Orthop Sports Phys Ther. 2009 Oct;39(10):709-23. doi: 10.2519/jospt.2009.3117.
- Results publication: PubMed 21764354Bialosky JE, Bishop MD, Robinson ME, Price DD, George SZ. Heightened pain sensitivity in individuals with signs and symptoms of carpal tunnel syndrome and the relationship to clinical outcomes following a manual therapy intervention. Man Ther. 2011 Dec;16(6):602-8. doi: 10.1016/j.math.2011.06.003. Epub 2011 Jul 20.
- Results publication: PubMed 19027342Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
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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.
Steven Z George, PhD principal investigator
University of Florida Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing neural mobilization in people with Carpal Tunnel Syndrome, run by University of Florida at 1 site in United States.
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 2 inclusion and 4 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
thermal and pressure pain sensitivity (time frame: immediate effect). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929123, which also lists 3 linked publications.
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 17 Mar 2015.