Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03197675
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2017-06-19
Brief Title:
Acupuncture in Spinal Cord Injury Subjects
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Use of Acupuncture in Potentiating Functional Recovery in Spinal Cord Injury Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Of the more than 250000 Americans with severe spinal cord injury SCI 42000 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 273 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:
ObjectiveHypothesis
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None