Carpal Tunnel SyndromePhase 2NCT00394043
Treatment Efficacy of OMT for Carpal Tunnel Syndrome
A Phase 2 study testing Osteopathic Manipulative Treatment in people with Carpal Tunnel Syndrome, run by University of North Texas Health Science Center.
Trial summary
This study investigated whether an eight-week regimen of osteopathic manipulative treatment would have immediate and lasting positive effects on the symptoms, functional limitation and physiologic impairment associated with Carpal Tunnel Syndrome. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2009
- Phase
- Phase 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with a self-reported medical diagnosis of unilateral or bilateral CTS, between the ages of 21 and 65 and all races and ethnic groups.
- Median motor nerve distal latency greater than 4.2 ms
- A difference between ipsilateral Median and Ulnar motor nerve distal latency greater than 1.5 ms.
- Median nerve sensory nerve distal latency greater than 2.2 ms
- A difference between Median and Ulnar sensory nerve peak distal latency greater than 0.2 ms
Who cannot join
- severe CTS that has progressed to muscle atrophy
- pregnancy
- previous wrist surgery on the wrist to be studied
- systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
- secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by an MRI exam of the wrist.
About this study
This study investigated whether an eight-week regimen of osteopathic manipulative treatment would have immediate and lasting positive effects on the symptoms, functional limitation and physiologic impairment associated with Carpal Tunnel Syndrome.
Read the detailed description
The incidence of Carpal Tunnel Syndrome (CTS) in adults in the U.S. ranges from 15-20% depending on the study, and costs over one billion dollars annually in medical care. Surgery for CTS accounts for much of these costs with up to one third of these patients experiencing re-occurrence of symptoms post-operatively.
The overall goal for this proposed exploratory clinical trial was to evaluate the efficacy of a conservative, manual medicine treatment as an adjunctive therapy to standard care for CTS. This pilot study utilized a prospective, randomized, placebo-controlled clinical trial methodology to examine whether an eight week treatment regimen of osteopathic manipulative treatment (OMT) when used adjunctively to standard therapy would have immediate and lasting positive effects on the symptoms, functional limitations, and physiologic impairment associated with CTS.
Male and female subjects between the ages of 20 and 65 who meet electro-physiologic and symptom/functional inclusion criteria were randomly assigned to one of three study groups, all of which will continue standard medical care with their treating physician/provider; (i) OMT plus standard medical care; (ii) placebo (sub-therapeutic ultrasound) plus standard medical care; and (iii) standard medical care only (no-treat).
Outcome measures were: 1. Median and Ulnar motor and sensory nerve conduction amplitudes and distal latencies, 2. Symptoms and Functional status, 3. Strength, 4. Sensation, 5. Interior dimensions of the carpal tunnel, and 6. Quantification (signal intensity by MRI) of water (edema) in the Median nerve and carpal tunnel. Placebo potency and blinding success will be evaluated. A preliminary investigation demonstrated our ability to recruit subjects and measure these outcomes. Power analysis based upon a decrease in the mean median motor nerve distal latency of 30% identified a minimum number of 42 subjects per treatment group.
It was expected that a significantly greater number of subjects in the OMT adjunctive treatment group would achieve the effective change in nerve latency compared to the other two treatment groups. It was also expected that the OMT adjunctive treatment group would have greater improvement of all physiological and clinical outcome measures than the other two groups.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Osteopathic Manipulative Treatment, Placebo Sub-Therapeutic Ultrasound
- Keywords
- Carpal Tunnel Sydrome, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine, Physical Medicine
- 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.
Osteopathic Manipulative TreatmentProcedure or surgery
A protocol of specific Osteopathic manipulative techniques was used.
Placebo Sub-Therapeutic UltrasoundProcedure or surgery
Sub-therapeutic ultrasound was applied in a standardized method.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | A protocol of specific osteopathic manipulative techniques was applied. Receives: Procedure: Osteopathic Manipulative Treatment |
| Placebo ultrasound | Placebo comparator | Sub-therapeutic ultrasound was applied. Receives: Procedure: Placebo Sub-Therapeutic Ultrasound |
| Standard Medical care | No intervention | Subjects did not receive either study treatment, but continued to receive standard medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Median motor and sensory distal latencies.
Improvement in the patients'self-reported symptoms and functionality scores.
Secondary outcomes (4)
Strength measured with one grip and three pinch strength tests.
Changes in sensation as measured by Current Perceptual Threshold.
Changes in the transverse and anterior/posterior interior diameters and cross-sectional areas of the carpal tunnel.
Carpal tunnel edema.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionOct 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopathic Research Center
- Investigators
- Scott T Stoll, D.O., Ph.D., Principal investigator, Osteopathic Research Center University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394043
- Sponsor's protocol ID
- 1R21AT002303-01A2
- Status last verified
- Mar 2017
- First submitted
- 27 Oct 2006
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy of OMT for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT00394043
- Acronym / sponsor ID
- 1R21AT002303-01A2
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Sydrome, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine, Physical Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- Osteopathic Research Center
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Oct 2006 (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 study investigated whether an eight-week regimen of osteopathic manipulative treatment would have immediate and lasting positive effects on the symptoms, functional limitation and physiologic impairment associated with Carpal Tunnel Syndrome.
Detailed description
The incidence of Carpal Tunnel Syndrome (CTS) in adults in the U.S. ranges from 15-20% depending on the study, and costs over one billion dollars annually in medical care. Surgery for CTS accounts for much of these costs with up to one third of these patients experiencing re-occurrence of symptoms post-operatively.
The overall goal for this proposed exploratory clinical trial was to evaluate the efficacy of a conservative, manual medicine treatment as an adjunctive therapy to standard care for CTS. This pilot study utilized a prospective, randomized, placebo-controlled clinical trial methodology to examine whether an eight week treatment regimen of osteopathic manipulative treatment (OMT) when used adjunctively to standard therapy would have immediate and lasting positive effects on the symptoms, functional limitations, and physiologic impairment associated with CTS.
Male and female subjects between the ages of 20 and 65 who meet electro-physiologic and symptom/functional inclusion criteria were randomly assigned to one of three study groups, all of which will continue standard medical care with their treating physician/provider; (i) OMT plus standard medical care; (ii) placebo (sub-therapeutic ultrasound) plus standard medical care; and (iii) standard medical care only (no-treat).
Outcome measures were: 1. Median and Ulnar motor and sensory nerve conduction amplitudes and distal latencies, 2. Symptoms and Functional status, 3. Strength, 4. Sensation, 5. Interior dimensions of the carpal tunnel, and 6. Quantification (signal intensity by MRI) of water (edema) in the Median nerve and carpal tunnel. Placebo potency and blinding success will be evaluated. A preliminary investigation demonstrated our ability to recruit subjects and measure these outcomes. Power analysis based upon a decrease in the mean median motor nerve distal latency of 30% identified a minimum number of 42 subjects per treatment group.
It was expected that a significantly greater number of subjects in the OMT adjunctive treatment group would achieve the effective change in nerve latency compared to the other two treatment groups. It was also expected that the OMT adjunctive treatment group would have greater improvement of all physiological and clinical outcome measures than the other two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Procedure: Osteopathic Manipulative TreatmentA protocol of specific osteopathic manipulative techniques was applied. |
| Placebo ultrasound | Placebo comparator | Procedure: Placebo Sub-Therapeutic UltrasoundSub-therapeutic ultrasound was applied. |
| Standard Medical care | No intervention | –Subjects did not receive either study treatment, but continued to receive standard medical care. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women with a self-reported medical diagnosis of unilateral or bilateral CTS, between the ages of 21 and 65 and all races and ethnic groups.
- Median motor nerve distal latency greater than 4.2 ms
- A difference between ipsilateral Median and Ulnar motor nerve distal latency greater than 1.5 ms.
- Median nerve sensory nerve distal latency greater than 2.2 ms
- A difference between Median and Ulnar sensory nerve peak distal latency greater than 0.2 ms
Key exclusion criteria (5 listed)
- severe CTS that has progressed to muscle atrophy
- pregnancy
- previous wrist surgery on the wrist to be studied
- systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
- secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by an MRI exam of the wrist.
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 |
|---|---|---|
| Osteopathic Manipulative TreatmentA protocol of specific Osteopathic manipulative techniques was used. | Procedure or surgery | Osteopathic Manipulative Treatment |
| Placebo Sub-Therapeutic UltrasoundSub-therapeutic ultrasound was applied in a standardized method. | Procedure or surgery | Placebo ultrasound |
Primary outcome
Changes in the Median motor and sensory distal latencies.
Improvement in the patients'self-reported symptoms and functionality scores.
4 secondary outcomes
Strength measured with one grip and three pinch strength tests.
Changes in sensation as measured by Current Perceptual Threshold.
Changes in the transverse and anterior/posterior interior diameters and cross-sectional areas of the carpal tunnel.
Carpal tunnel edema.
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 16 Mar 2017.
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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.
Scott T Stoll, D.O., Ph.D. principal investigator
Osteopathic Research Center University of North Texas Health Science Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osteopathic Manipulative Treatment in people with Carpal Tunnel Syndrome, run by University of North Texas Health Science Center.
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 5 inclusion and 5 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 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Changes in the Median motor and sensory distal latencies.. The study lists 2 primary outcomes in all. 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 16 Mar 2017.