Treatment of Veterans With Chronic Low Back Pain
The purpose of this study is to assess the effectiveness of hypnosis in the treatment of chronic low back pain.
Chronic low back pain (CLBP) is one of the most disabling and common conditions (Loeser, 2001). Eighty percent of men and women will suffer from acute back pain at some point in their lives, with an estimated 10% becoming chronic (King et al., 2001); and the cost of CLBP to society is staggering (Turk, 2002). For example, a nation-wide study of the VHA Health Care System by Yu and colleagues (Yu et al., 2003) reported that 10.6% or 361,868 veterans who were being cared for by the VA suffered from CLBP, costing the system an estimated $22 million dollars in fiscal year 1999 alone. This figure applies to the cost of medical care only and does not include the cost from the impact of the condition on the veterans such as disability, lost wages, and other associated medical and psychiatric conditions as well as untold suffering and interference in daily activities.
The efficacy of hypnosis as a treatment for acute and some chronic pain conditions has been well documented. One recent meta-analysis of 18 studies indicated a moderate to large hypno-analgesic effect (Montgomery et. al., 2000). Included in this meta-analysis were studies of a variety of clinical pain syndromes, such as acute/transient pain resulting from burns, radiological procedures, or coronary/ischemic pain, as well as chronic pain due to cancer or headaches. However, none of the studies in this review targeted CLBP. The authors concluded that ".the average participant treated with hypnosis demonstrated greater analgesic response than 75% of participants in standard and no-treatment groups" (page 143). Similarly, Patterson and Jensen (2003) reviewed randomized control trials of hypnosis and clinical pain, and concluded that "Hypnosis has a reliable and significant impact on acute procedural pain and chronic pain conditions."
The proposed research will (1) conduct a randomized controlled clinical trial to further validate and confirm the findings from a recently completed pilot project showing that hypnosis is efficacious in reducing pain intensity and pain interference and the improving the quality of life of veterans suffering from CLBP (see preliminary studies section, below), (2) evaluate the relative importance of home practice of hypnosis, (3) determine if the beneficial effects of hypnosis are long lasting, and (4) determine the predictors of treatment outcome, in particular, hypnotizability (a general and stable trait ability to respond to hypnotic suggestions), but also frequency of practice. In this study, a control condition will be used that is credible to patients, but is known to have only minimal effects on pain.
The four treatment groups are: Group 1 - full in-person hypnosis series (8 sessions) without home practice, Group 2 - full in-person hypnosis series (8 sessions) with home practice with CDs, Group 3 - brief in-person hypnosis series (2 sessions) with home practice with CDs, and Group 4 - a minimally effective control condition (minimal biofeedback (8 sessions) designed to appear credible but have minimal effects). Subjects: 160 subjects will be recruited from the MEDVAMC Pain Management Program via posters and the program staff. Inclusion criteria: Chronic low back pain for at least 6 months, pain severity at least 5 on a 0-10 scale, and pain is primarily musculoskeletal/mechanical. Exclusion criteria: Acute and cancer pain, neuropathic etiology, severe psychopathology, active substance abuse, significant cognitive deficit, and previous participant of the pilot study on hypnosis and chronic low back pain. Outcome measures that will be administered pre- and post-intervention include: Brief Pain Inventory, Numeric Rating Scale, Pittsburgh Sleep Quality Scale, McGill Pain Questionnaire, Pain Quality Assessment Scale, Rand MHI-5, Hypnosis Treatment Outcome Measure, and the Two-Item Measures of Pain Beliefs and Coping Strategies. A process measure is the frequency of home practice.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Low Back Pain, Recurrent
EMG Biofeedback without hypnotic suggestion, Home practice with hypnosis CDs, Therapist-guided hypnosis, Therapist-guided hypnosis + home practice with hypnosis CDs
Michael E. DeBakey VA Medical Center (152)
Active, not recruiting
Department of Veterans Affairs
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00361270
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A state of increased receptivity to suggestion and direction, initially induced by the influence of another person.
Nursing care given to an individual in the home. The care may be provided by a family member or a friend. Home nursing as care by a non-professional is differentiated from HOME CARE SERVICES provided by professionals: visiting nurse, home health agencies, hospital, or other organized community group.
Home Care Agencies
Public or private organizations that provide, either directly or through arrangements with other organizations, home health services in the patient's home. (Hospital Administration Terminology, 2d ed)
Home Care Services
Community health and NURSING SERVICES providing coordinated multiple services to the patient at the patient's homes. These home-care services are provided by a visiting nurse, home health agencies, HOSPITALS, or organized community groups using professional staff for care delivery. It differs from HOME NURSING which is provided by non-professionals.
Nursing, Private Duty
The practice of nursing by a registered or licensed nurse to care for a specific patient in a health facility or in the home.
Hypnotic trance and mindfulness meditation have both been shown to have benefits for physical health. The current study seeks to determine if there are distinct patterns of brain activity...
The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1)...
Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosi...
This study will examine whether hypnosis can reduce the frequency and intensity of pain in patients with sickle cell disease. Patients 18 years of age and older with sickle cell disease a...
This study is intended to investigate neurophysiological mechanisms of hypnosis using transcranial magnetic stimulation (TMS) and assessment of motor cortex excitability in healthy volunte...
Hypnodontics, or the use of hypnosis in dentistry, is not widely used throughout the dental profession. Many patients seeking to use this therapy to help them access dental treatment are forced to see...
Introduction. "Instrumental hypnosis" allows researchers to model clinical symptoms in the laboratory, creating "virtual patients" with reversible disturbances in, for example, perception, action, mem...
Introduction. Mirrored-self misidentification is the delusional belief that one's reflection in the mirror is a stranger. Current theories suggest that one pathway to the delusion is mirror agnosia (a...
Although hypnosis was accepted in 1958 by the American Medical Association as an adjunct treatment, it remains an underused modality for alleviation of clients' suffering. This hesitancy to apply esta...
Spectral EEG analysis studies showed that in the state of "animal hypnosis," the known increase in the power of biopotentials in the delta frequency range (0.3-3 Hz) and decrease in the theta range (...