Acupuncture in Spinal Cord Injury Subjects

May 12, 2023 updated by: Deborah Stein, University of Maryland, Baltimore

The Use of Acupuncture in Potentiating Functional Recovery in Spinal Cord Injury Subjects

Of the more than 250,000 Americans with severe spinal cord injury (SCI), 42,000 are military veterans. The Department of Veterans Affairs is the largest single network of SCI care providers in the nation. Patients with SCI experience functional disabilities as well as chronic pain. Studies show that individuals with SCI report pain refractory to conventional treatments. Civilian and veteran patients with SCI have associated pain with impairments in physical and cognitive function, sleep, employment, social relationships, community re-integration and quality of life. In a survey of individuals with SCI, those who used acupuncture experienced a reduction of pain symptoms lasting hours after treatment, with 27.3% reporting pain relief for days. A pilot study on the use of auricular acupuncture for neuropathic pain associated with SCI showed a greater reduction of pain as measured by the Numerical Rating Scale (NRS). A recent review of randomized controlled trials regarding the use of acupuncture in SCI found that only two of sixteen included studies were of high quality. There was limited evidence for the use of acupuncture in motor functional recovery, bladder function recovery, and in pain control related to SCI. Further high quality studies are needed. This proposal is for a phase II randomized clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective/Hypothesis:

Our overarching hypothesis is that acupuncture is beneficial following acute traumatic SCI with respect to severity of neuropathic pain syndromes, patient-perceived quality of life measures, and functional outcomes. The current literature suggests that acupuncture may improve upon traditional pharmacological treatment results for SCI related pain, and that patients are seeking improved pain management in order to improve their quality of life. While data is limited, there may also be improvement in motor functional recovery with the use of acupuncture. We do know that SCI related pain limits patient participation in rehabilitation, thus advances in the management of SCI related pain is a priority in SCI research in order to improve outcomes after SCI.

Specific Aims:

Specific Aim 1: To determine whether patients treated with acupuncture started during acute care have better immediate and long-term pain scores and decreases in self-reported pain interference.

Specific Aim 2: To determine whether patients treated with acupuncture started during acute care will have better overall quality of life measurements and improvements in self-reported well-being and resilience.

Specific Aim 3: To determine whether patients treated with acupuncture started during acute care will have improvement in functional recovery in comparison to the control group.

Study Design:

This trial will compare pain scores and patient-perceived quality of life for individuals who receive early and regular acupuncture therapy to a control group. Patients with blunt or penetrating traumatic SCI will be included. The Investigators will enroll 100 subjects over a 36-month period from the R Adams Cowley Shock Trauma Center (STC). Once consent is obtained, enrolled patients will be evaluated using the ISNCSCI examination. Information about neuropathic pain and quality of life will be scored using NIH CDE recommended validated instruments within 72 hours of injury, during the 8-week treatment period, and at 3 and 6 months. The primary outcome is the improvement in NRS. The secondary outcomes are improvements in quality of life and functional recovery. Statistical analyses will involve constructive repeated measures mixed models to estimate the effect of treatment.

Clinical Impact:

The proposed trial will investigate the promising intervention of acupuncture for the management of neuropathic pain related to SCI. Improvement in neuropathic pain management is crucial in improving patients' rehabilitation, quality of life and ultimate outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Deborah Stein, MD, MPH
  • Phone Number: 410-328-3495
  • Email: dstein@umm.edu

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • R Adams Cowley Shock Trauma Center, University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age between 18 and 75
  2. complete (AIS A) or incomplete SCI (AIS B-D) of the cervical, thoracic or lumbar spine from blunt or penetrating trauma
  3. ability to understand verbal and written English

Exclusion Criteria:

  1. a history of peripheral neuropathy
  2. medical diagnoses or conditions that preclude them from active participation (for example, moderate or severe traumatic brain injury)
  3. receipt of acupuncture in the last three months prior to enrollment
  4. presence of skin breakdown or infection over the extremities or external ears
  5. active participation in other research studies
  6. cognitive impairment that prevents understanding the test instructions
  7. prisoner
  8. pregnancy
  9. active duty military personnel
  10. individuals who do not speak or understand the English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control group
Participants who are randomized to the control group will not receive any acupuncture. Participants will however be assessed weekly to obtain the same data on their pain scale and other outcome measures as the treatment group. Participants will be evaluated in person during their standard of care clinical follow up appointments at the three month and six month points for in person interviews and data collection .
Other: Acupuncture
Participants within the acupuncture treatment group will receive traditional body acupuncture with electrical stimulation for 30 minutes three times a week, additionally participants will also receive auricular acupuncture once a week with the needles retained in both ears for seven days and replaced the following week, for a total of eight weeks (24 treatments of conventional acupuncture and 8 treatments of auricular acupuncture). Relative pain levels will be measured via the NRS by a member of the research staff before and after each treatment. All participants will then be reevaluated with the described assessment tools at three months and again at six months. Acupuncturists will not participate in the three and six month evaluations of subjects.
Active Comparator: treatment group
Participants within the acupuncture treatment group will receive traditional body acupuncture with electrical stimulation for 30 minutes three times a week, additionally participants will also receive auricular acupuncture once a week with the needles retained in both ears for seven days and replaced the following week, for a total of eight weeks (24 treatments of conventional acupuncture, 8 treatments of auricular acupuncture). Pain Numeric Rating Score (NRS) will be evaluated by the research staff before and after each treatment. All participants will then be reevaluated with the described assessment tools at three months and again at six months. Acupuncturists will not participate in the three and six month evaluations of subjects.
Other: Acupuncture
Participants within the acupuncture treatment group will receive traditional body acupuncture with electrical stimulation for 30 minutes three times a week, additionally participants will also receive auricular acupuncture once a week with the needles retained in both ears for seven days and replaced the following week, for a total of eight weeks (24 treatments of conventional acupuncture and 8 treatments of auricular acupuncture). Relative pain levels will be measured via the NRS by a member of the research staff before and after each treatment. All participants will then be reevaluated with the described assessment tools at three months and again at six months. Acupuncturists will not participate in the three and six month evaluations of subjects.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compare pain assessments in patients with SCI treated with acupuncture to patients treated per standard of care alone to assess for efficacy and durability of the effect on pain following SCI.
Time Frame: within 3 months following hospital discharge
All enrolled patients will be evaluated using the complete ISNCSCI examination. Information about neuropathic pain will be scored using the ISCIPBDS (version 2.0) and ISCIPEDS. A SCI-QOL will be administered during the three month reevaluations to assess the patient's perceived quality of life. In the intervening weeks a select few ISCIPBDS items will be administered on a weekly basis until study completion.
within 3 months following hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare pain assessments in patients with SCI treated with acupuncture to patients treated per standard of care alone to assess for efficacy and durability of the effect on pain following SCI.
Time Frame: within 6 months following hospital discharge
All enrolled patients will be evaluated using the complete ISNCSCI examination. Information about neuropathic pain will be scored using the ISCIPBDS (version 2.0) and ISCIPEDS. A SCI-QOL will be administered during the six month reevaluations to assess the patient's perceived quality of life. In the intervening weeks a select few ISCIPBDS items will be administered on a weekly basis until study completion.
within 6 months following hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deborah Stein, MD, MPH, Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP-00074616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings