Cumulative Trauma DisordersPhase 2NCT00029497
Sham Device, Pill Placebo or Treatment For Arm Pain
A Phase 2 study testing Acupuncture and Amitriptyline in people with Cumulative Trauma Disorders and Repetitive Strain Injury, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
This study investigates the role of two active interventions and their placebo effects in randomized control trials. The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cumulative Trauma Disorders, Repetitive Strain Injury, Carpal Tunnel Syndrome
- What is being tested?
- Acupuncture and Amitriptyline
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Jun 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated for repetitive strain injury for at least 3 months at a clinical site in the Greater Boston Area
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cambridge Hospital
Cambridge, Massachusetts, 02139
About this study
This study investigates the role of two active interventions and their placebo effects in randomized control trials. The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture device and placebo pill.
Read the detailed description
There is evidence that the magnitude of the placebo effect produced by a device is greater than that produced by a pill. If this is the case, it has significant ramifications for all trials involving devices and for our understanding of the role of the placebo effect in randomized controlled trials (RCT). This two phase study 1)investigates the role of the placebo effect in RCT's and 2)conducts two trials of treatments for persistent upper extremity pain secondary to repetitive strain injury (RSI), including carpel tunnel syndrome. In Phase I. 240 patients with RSI are randomly assigned to receive a placebo device (a recently validated sham acupuncture device) or a placebo pill (dummy amitriptyline). Our primary hypothesis is that patients will respond better to the sham device than the placebo pill. A finding that sham acupuncture produces a greater placebo response than a placebo pill has important implications for the interpretation of results in trials that compare devices to sham devices, devices to pills, and medical management to surgery. Phase II randomly assigns patients from the sham acupuncture arm of Phase I to receive either TCA or continue to receive the sham version. Patients in the placebo pill arm of Phase I will be randomly assigned to receive either AMI or continue receiving the placebo pill. From the patients'perspective, the shift in treatment assignment from Phase I to II should not be noticeable. Phase II will allow us to test whether the active treatments outperform their respective placebos. Both of these treatments have shown promise in small studies, but neither has been prospectively studied in a large trial with appropriate controls. Because Phase I also functions as a run-in period for Phase II, analysis combining both phases will allow us to examine whether a run-in has methodological advantages in a device trial. Moreover, combined analyses permit testing whether patients level of response to placebo in Phase I affects their response to active treatment Phase II. A positive finding here would contribute importantly to our understanding of the role of the placebo in RCTs.
- Being tested
- Acupuncture, Amitriptyline
- Medical subject headings
- Cumulative Trauma Disorders, Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
AmitriptylineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2002 (estimated)
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cumulative Trauma DisordersStudies 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
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ted Kaptchuk, OMD, Principal investigator, Harvard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029497
- Sponsor's protocol ID
- R01AT000402-01
- Status last verified
- Mar 2013
- First submitted
- 14 Jan 2002
- Last updated
- 22 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sham Device, Pill Placebo or Treatment For Arm Pain
- ClinicalTrials.gov ID
- NCT00029497
- Acronym / sponsor ID
- R01AT000402-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 15 Jan 2002 (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 investigates the role of two active interventions and their placebo effects in randomized control trials. The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture device and placebo pill.
Detailed description
There is evidence that the magnitude of the placebo effect produced by a device is greater than that produced by a pill. If this is the case, it has significant ramifications for all trials involving devices and for our understanding of the role of the placebo effect in randomized controlled trials (RCT). This two phase study 1)investigates the role of the placebo effect in RCT's and 2)conducts two trials of treatments for persistent upper extremity pain secondary to repetitive strain injury (RSI), including carpel tunnel syndrome. In Phase I. 240 patients with RSI are randomly assigned to receive a placebo device (a recently validated sham acupuncture device) or a placebo pill (dummy amitriptyline). Our primary hypothesis is that patients will respond better to the sham device than the placebo pill. A finding that sham acupuncture produces a greater placebo response than a placebo pill has important implications for the interpretation of results in trials that compare devices to sham devices, devices to pills, and medical management to surgery. Phase II randomly assigns patients from the sham acupuncture arm of Phase I to receive either TCA or continue to receive the sham version. Patients in the placebo pill arm of Phase I will be randomly assigned to receive either AMI or continue receiving the placebo pill. From the patients'perspective, the shift in treatment assignment from Phase I to II should not be noticeable. Phase II will allow us to test whether the active treatments outperform their respective placebos. Both of these treatments have shown promise in small studies, but neither has been prospectively studied in a large trial with appropriate controls. Because Phase I also functions as a run-in period for Phase II, analysis combining both phases will allow us to examine whether a run-in has methodological advantages in a device trial. Moreover, combined analyses permit testing whether patients level of response to placebo in Phase I affects their response to active treatment Phase II. A positive finding here would contribute importantly to our understanding of the role of the placebo in RCTs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Treated for repetitive strain injury for at least 3 months at a clinical site in the Greater Boston Area
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
| Amitriptyline | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Mar 2013.
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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.
Ted Kaptchuk, OMD principal investigator
Harvard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Amitriptyline in people with Cumulative Trauma Disorders and Repetitive Strain Injury, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites 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 1 inclusion and 0 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 22 Mar 2013. 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 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. 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.
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 22 Mar 2013.