Acupuncture in Spinal Cord Injury Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | March 14, 2018 |
| End Date: | December 31, 2023 |
| Contact: | Deborah Stein, MD, MPH |
| Email: | dstein@umm.edu |
| Phone: | 410-328-3495 |
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.
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.
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.
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.
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
We found this trial at
1
site
Baltimore, Maryland 21201
Phone: 410-328-3495
Click here to add this to my saved trials
