Clinical trial NCT02104349: Mindfulness Meditation for Spine Surgery Pain
Official title: Mindfulness Meditation for Spine Surgery Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Meditation
Spine Surgery
Pain, Postoperative
Keywords: spine surgery
post op pain management
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the effect of mindfulness meditation technique on post-operative pain of spine surgery subjects. Subjects will participate in a 6-week mindfulness meditation program, beginning two weeks prior to spine surgery. The investigators are interested in determining if this intervention improves the ability to tolerate pain and reduces anxiety, thus reducing the need for prescribed analgesics and narcotics. The meditation intervention will be compared against a control group consisting of subjects that will undergo music therapy during the same period of time.

Detailed description: Mind body therapies which induce relaxation through the use of imagery and meditation, are being increasingly sought as treatments to assist individuals cope with stress and chronic illness. These holistic therapies have become accepted by both physicians and patients because of the recent emerging body of evidence supporting their effectiveness for a variety of physical and psychological conditions. In the case of holistic (or integrative) practices used to alleviate pain, the infrequency of adverse effects makes them particularly attractive to physicians who have become wary of the risks of prescription narcotics.

Pain medications, though they provide immediate relief, have many noted adverse side effects. These include respiratory depression, decreased heart rate and in extreme cases of misuse, death. These medications are especially prone to abuse by patients, even after their initial pain subsides. Overdosing from prescription pain killers has become a significant cause of accidental death, and providers are seeking alternative treatments for pain for their patients that do not carry this risk.

A significant body of research has investigated the benefits of meditation for a wide variety of physical and psychological conditions . However, clinical evidence for the efficacy of meditation for reducing pain is sparse, although some research suggests the mechanisms of this possible benefit , Mindfulness-Based Stress Reduction (MBSR) is a mindfulness intervention which is currently used in over 500 clinical sites around the world for patients with a wide variety of clinical problems, including pain. MBSR was developed by Jon Kabat Zinn at the University of Massachusetts in the 1970s. It is derived from the Oriental traditions of Zen Buddhism, yet free from its religious roots. It is supported by over 30 years of research that substantiate its positive effects on numerous ailments, including stress , chronic pain , anxiety and depression .

The key concept in mindfulness meditation involves learning how to observe the thoughts that enter one's mind without the passing of judgment and by keeping the focus on breathing or another constant. This is called "detached observation". The mechanisms at work are unknown but are thought to be the meditation facilitating the tuning out of distractions by learning to maintain and control attention.

The process of mindfulness meditation entails sitting in a quiet location and comfortable position with one's eyes closed. Individuals are instructed to relax and focus on their breathing, or another chosen object of attention, such as parts of the body in the body scan, body movements in mindful movement, or the act of walking in walking meditation. While the mind may wander and numerous thoughts, worries or concerns may arise, the individual learns to non-self-critically acknowledge the shift in attention, and return to the chosen object of attention. Over time, increased attentional control and awareness of mental events leads to the ability to respond more positively and less reactively to stressful events, including pain.

An early study of MBSR for chronic pain patients found that, after a 10-week training program, participants demonstrated statistically significant reductions in pain, negative body image, pain-related reductions in activity, anxiety, and depression, compared with a control group5.

Whereas the benefit of MBSR for pain has been suggested by existent research, the fact that it is an 8-week course requiring participation on a weekly basis in 2 ½ hour classes, with daily practice at home of 30-45 minutes, may limit its accessibility to some patients. This study seeks to identify an intervention that may be widely used by participants with both acute and chronic pain.

Open Focus technique is a specific mindfulness-based practice developed by Les Fehmi, PhD, of Princeton, NJ. It guides practitioners to modify their attention in ways that have been shown to promote relaxation and pain reduction, as measured by brain wave activity .

Additionally, recent research has reported actual physical and structural changes in the brain with long term practice of meditation. Benefits of mindfulness meditation appear to have a neuroplastic effect on the brain. Studies among those practicing meditation have demonstrated a change in the mass of grey matter as well as an increase in brain connectivity . The structural changes in the brain include an increased density of grey matter in the hippocampus, which is a region involved in the process of learning and memory. In addition, a decrease in density in the amygdala was noted; this region plays a role in stress and anxiety.

Eligibility criteria: Inclusion Criteria:

* Patients that will undergo spine surgery including: single level lumbar fusion, posterior cervical laminectomy fusion, cervical laminaplasty

Exclusion Criteria:

* Patients with scheduling conflicts that will render them unable to follow the weekly mindfulness mediation instruction.
* Patients with depression (established during the screening questionnaire)

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 2 weeks prior to surgery
measure: Change in Visual Analog Scale (VAS)
timeFrame: Baseline up to 6 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 2 weeks prior to surgery
measure: Oswestry Disability Index
timeFrame: baseline up to 6 weeks
measure: Perceived Stress Scale
timeFrame: 2 weeks prior to surgery
measure: Perceived Stress Scale
timeFrame: baseline up to 6 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 2 weeks prior to surgery
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline up to 6 weeks
measure: Muscle Relaxer Dosage
timeFrame: 2 weeks prior to surgery
measure: Antidepressant Dosage
timeFrame: 2 weeks prior to surgery
measure: Neuropathics Dosage
timeFrame: 2 weeks prior to surgery
measure: Narcotics Dosage
timeFrame: 2 weeks prior to surgery
measure: NSAIDS Dosage
timeFrame: 2 weeks prior to surgery
measure: Muscle Relaxers dosage
timeFrame: baseline up to 6 weeks
measure: Neuropathics dosage
timeFrame: baseline up to 6 weeks
measure: Narcotics dosage
timeFrame: baseline up to 6 weeks
measure: NSAIDS dosage
timeFrame: baseline up to 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Arthur Jenkins, III
role: PRINCIPAL_INVESTIGATOR
References: