Spinal Cord InjuryPhase 1/2NCT00432289
Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study
A Phase 1/2 study testing Acupuncture in people with Spinal Cord Injury, run by Craig Hospital at 1 site in United States.
Trial summary
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals admitted to Craig Hospital immediately following initial acute care hospitalization with a primary diagnosis of acute SCI will be considered for study inclusion. Participants must give their informed consent, have medical clearance from their attending physician and meet the following inclusion criteria:
- Incomplete spinal cord injury - ASIA grade B or C.
- Age 16 years or older.
- Must be admitted to Craig and enrolled in the study within 6 weeks of injury.
- Patient must be able to tolerate lying on side for 30 minutes.
- The expected length of stay will allow completion of the six-week study protocol.
- Must agree to forego any acupuncture treatment other than the treatments prescribed in this protocol during the six week study period.
Who cannot join
- Current involvement in any other clinical research trial
- Concomitant treatment with anticoagulation medication (does not include those on prophylactic doses for deep venous thrombosis)
- Any disease, concomitant injury, condition or treatment that interferes with the performance or interpretation of the neurological examinations.
- Acupuncture sites obstructed by immobilization devices, where removal would be medically contraindicated.
- Individuals with cardiac pacemakers.
- Individual has a condition that, in the judgment of the investigator, precludes successful participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for Treatment of Acute Spinal Cord Injury
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol.
Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI.
Before conducting a larger, more definitive study, this exploratory and developmental work is focused on assessing whether blinding is possible, reproducibility of the outcome measure, determine enrollment rates and effect sizes and identify clinical resources needed to conduct a larger study.
Read the detailed description
The research design for this exploratory/developmental R21 application will be the same as the anticipated design for a future definitive R01 investigation. A randomized controlled treatment study will be used to compare neurological recovery after spinal cord injury (SCI) in individuals receiving an acupuncture protocol designed to maximize treatment effectiveness (treatment protocol) with an alternative acupuncture protocol designed to minimize treatment effectiveness (control). The two acupuncture protocols will be identical except for 1) needle placement, 2) use of sham, non-penetrating needles and 3) use of electricity for needle stimulation. The two protocols are designed to be indistinguishable to an individual, so participants will remain blind to whether they are receiving the treatment or the control protocol.
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol.
Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI.
Before proposing a definitive R01 investigation to test this hypothesis, several preliminary steps are required and will be addressed in this feasibility study. Five objectives have been identified for the current R21 application as follows.
Objective 1 - Demonstrate that participants are unable to distinguish between treatment and control protocols, assuring participant blinding.
Objective 2 - Verify the inter-rater reliability of the primary outcome measures -the American Spinal Injury Association (ASIA) motor and sensory scores as defined by the ASIA Standards for Neurological Classification of SCI.1
Objective 3 - Collect pilot data for use in power analysis to determine the desired sample size in the definitive R01 investigation, including effect sizes, enrollment and dropout rates.
Objective 4 - Identify any unanticipated difficulties in implementing the treatment and control protocols and identify the clinical resources needed to conduct an R01 investigation.
Objective 5 - Prepare an application for an R01 definitive investigation including an operations manual for the protocol.
- Conditions
- Spinal Cord Injury
- Being tested
- Acupuncture
- Keywords
- neurological function
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupunture treatment 3x per week for 6 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
ASIA Standards for Neurological Classification of SCI
Measured: Baseline and 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Amit Jha, MD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432289
- Sponsor's protocol ID
- R21AT002763
- Status last verified
- Jun 2010
- First submitted
- 5 Feb 2007
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Treatment of Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00432289
- Acronym / sponsor ID
- R21AT002763
- Conditions
- Spinal Cord Injury
- Keywords
- neurological function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Feb 2007 (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.
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol.
Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI.
Before conducting a larger, more definitive study, this exploratory and developmental work is focused on assessing whether blinding is possible, reproducibility of the outcome measure, determine enrollment rates and effect sizes and identify clinical resources needed to conduct a larger study.
Detailed description
The research design for this exploratory/developmental R21 application will be the same as the anticipated design for a future definitive R01 investigation. A randomized controlled treatment study will be used to compare neurological recovery after spinal cord injury (SCI) in individuals receiving an acupuncture protocol designed to maximize treatment effectiveness (treatment protocol) with an alternative acupuncture protocol designed to minimize treatment effectiveness (control). The two acupuncture protocols will be identical except for 1) needle placement, 2) use of sham, non-penetrating needles and 3) use of electricity for needle stimulation. The two protocols are designed to be indistinguishable to an individual, so participants will remain blind to whether they are receiving the treatment or the control protocol.
Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol.
Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI.
Before proposing a definitive R01 investigation to test this hypothesis, several preliminary steps are required and will be addressed in this feasibility study. Five objectives have been identified for the current R21 application as follows.
Objective 1 - Demonstrate that participants are unable to distinguish between treatment and control protocols, assuring participant blinding.
Objective 2 - Verify the inter-rater reliability of the primary outcome measures -the American Spinal Injury Association (ASIA) motor and sensory scores as defined by the ASIA Standards for Neurological Classification of SCI.1
Objective 3 - Collect pilot data for use in power analysis to determine the desired sample size in the definitive R01 investigation, including effect sizes, enrollment and dropout rates.
Objective 4 - Identify any unanticipated difficulties in implementing the treatment and control protocols and identify the clinical resources needed to conduct an R01 investigation.
Objective 5 - Prepare an application for an R01 definitive investigation including an operations manual for the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals admitted to Craig Hospital immediately following initial acute care hospitalization with a primary diagnosis of acute SCI will be considered for study inclusion. Participants must give their informed consent, have medical clearance from their attending physician and meet the following inclusion criteria:
- Incomplete spinal cord injury - ASIA grade B or C.
- Age 16 years or older.
- Must be admitted to Craig and enrolled in the study within 6 weeks of injury.
- Patient must be able to tolerate lying on side for 30 minutes.
Key exclusion criteria (6 listed)
- Current involvement in any other clinical research trial
- Concomitant treatment with anticoagulation medication (does not include those on prophylactic doses for deep venous thrombosis)
- Any disease, concomitant injury, condition or treatment that interferes with the performance or interpretation of the neurological examinations.
- Acupuncture sites obstructed by immobilization devices, where removal would be medically contraindicated.
- Individuals with cardiac pacemakers.
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 |
|---|---|---|
| AcupunctureAcupunture treatment 3x per week for 6 weeks. | Procedure or surgery | – |
Primary outcome
ASIA Standards for Neurological Classification of SCI
Time frame: Baseline and 6 weeks post treatment
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 11 Jun 2010.
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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.
Amit Jha, MD principal investigator
Craig Hospital
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 Acupuncture in people with Spinal Cord Injury, run by Craig Hospital 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 7 inclusion and 6 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 11 Jun 2010. 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. 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?
ASIA Standards for Neurological Classification of SCI (time frame: Baseline and 6 weeks post treatment). 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 11 Jun 2010.