Chronic Pain Clinical Trial
Official title:
Telehealth Therapy for Chronic Pain
The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.
Chronic pain affects at least 15% of the veteran population and represents a high priority
for the VA. In addition to primary pain conditions, chronic pain is a common secondary
condition resulting from battlefield injuries, traumatic accidents, and congenital and
acquired disorders. Unlike most forms of acute pain, treatment options available for
patients suffering from chronic pain frequently offer only short-term or partial relief from
symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability
and emotional distress and improvement in quality of life and activity levels.
Chronic pain rehabilitation has evolved from a primarily one dimensional, medically oriented
approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to
pain management with physiological, cognitive, behavioral, and emotional components. This
conceptualization of pain recognizes that multiple intervention modalities, including
psychosocial approaches, are required when providing treatment to chronic pain patients.
A relatively new psychosocial approach to chronic pain management and rehabilitation
involves acceptance of pain-related experiences. The Acceptance and Commitment Therapy (ACT)
model is based on the theory that attempts to escape, avoid, or control negative experiences
that cannot be changed, such as chronic pain, may paradoxically contribute to the increased
experience of them. Instead of seeking to control the negative experience, ACT teaches
individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and
to engage in behaviors that are consistent with personal values and goals when total
elimination of pain or other negative experiences is not possible. Empirical support for
acceptance-based approaches to chronic pain management is growing. Data from one of the
first comparisons of ACT to a well-established psychosocial intervention,
Cognitive-Behavioral Therapy (CBT), performed at VASDHS by the PI, suggests that ACT may be
superior to CBT as an adjunctive treatment for chronic pain.
The proposed study assembles a multidisciplinary team with extensive experience in chronic
pain interventions research to evaluate the benefits of a brief, individual psychosocial
in-person or telehealth intervention which could be easily integrated into multidisciplinary
pain rehabilitation programs throughout the VA system to reduce disability in veterans with
chronic pain secondary to other conditions. Specifically, we propose to examine the effects
of a promising new chronic pain intervention based on ACT principles on the primary outcome
of pain interference and secondary outcomes of emotional distress, quality of life, physical
activity, pain intensity, and treatment satisfaction among 196 veterans with chronic benign
pain as a secondary condition. The participants are randomized to between-subjects design
where in-person ACT intervention will be compared with telehealth ACT intervention. Outcomes
include an objective measure of physical activity, actigraphy, as well as self-reported
measures and will be evaluated at baseline, 4 weeks, 8 weeks (end of treatment), 3-month
follow-up and at a 6-month follow-up period to investigate maintenance of gains. Telehealth
sessions are conducted using secure video-conferencing equipment at the most convenient
clinic for the participant. Thus, the proposed project has the potential to enhance the
current VA standard of care as well as to add to the scientific literature on psychological
models and rehabilitation of chronic pain.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
| Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
| Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
| Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
| Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
| Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
| Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
| Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
| Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
| Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
| Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
| Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
| Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|