Spinal Cord InjuriesNCT03197675
Acupuncture in Spinal Cord Injury Subjects
A study testing Acupuncture in people with Spinal Cord Injuries, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 16 Feb 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75
- complete (AIS A) or incomplete SCI (AIS B-D) of the cervical, thoracic or lumbar spine from blunt or penetrating trauma
- ability to understand verbal and written English
Who cannot join
- a history of peripheral neuropathy
- medical diagnoses or conditions that preclude them from active participation (for example, moderate or severe traumatic brain injury)
- receipt of acupuncture in the last three months prior to enrollment
- presence of skin breakdown or infection over the extremities or external ears
- active participation in other research studies
- cognitive impairment that prevents understanding the test instructions
Show all 10Show fewer
- prisoner
- pregnancy
- active duty military personnel
- individuals who do not speak or understand the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
R Adams Cowley Shock Trauma Center, University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Acupuncture
- Keywords
- Chronic pain, Acupuncture
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | 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 . Receives: Other: Acupuncture |
| treatment group | Active comparator | 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: within 3 months following hospital discharge
Secondary outcomes (1)
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.
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.
Measured: within 6 months following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start14 Mar 2018
- Primary completion31 Dec 2022
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Deborah Stein, University of Maryland, Baltimore
- Investigators
- Deborah Stein, MD, MPH, Principal investigator, Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197675
- Sponsor's protocol ID
- HP-00074616
- Other IDs
- CDMRP- SC160188
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2017
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Acupuncture in Potentiating Functional Recovery in Spinal Cord Injury Subjects
- ClinicalTrials.gov ID
- NCT03197675
- Acronym / sponsor ID
- HP-00074616
- Conditions
- Spinal Cord Injuries
- Keywords
- Chronic pain, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: AcupunctureParticipants 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 . |
| treatment group | Active comparator | Other: AcupunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 75
- complete (AIS A) or incomplete SCI (AIS B-D) of the cervical, thoracic or lumbar spine from blunt or penetrating trauma
- ability to understand verbal and written English
Key exclusion criteria (10 listed)
- a history of peripheral neuropathy
- medical diagnoses or conditions that preclude them from active participation (for example, moderate or severe traumatic brain injury)
- receipt of acupuncture in the last three months prior to enrollment
- presence of skin breakdown or infection over the extremities or external ears
- active participation in other research studies
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 |
|---|---|---|
| AcupunctureParticipants 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. | Other | Control group, treatment group |
Primary outcome
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.
1 secondary outcome
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
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Deborah Stein, MD, MPH principal investigator
Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Spinal Cord Injuries, run by University of Maryland, Baltimore 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 3 inclusion and 10 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 6 Jul 2026. 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.
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?
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). 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 6 Jul 2026.