Overview

This trial is active, not recruiting.

Condition low back pain, recurrent
Treatments emg biofeedback without hypnotic suggestion, home practice with hypnosis cds, therapist-guided hypnosis, therapist-guided hypnosis + home practice with hypnosis cds
Sponsor Department of Veterans Affairs
Start date October 2006
End date February 2010
Trial size 162 participants
Trial identifier NCT00361270, D4421-I, H-18610

Summary

The purpose of this study is to assess the effectiveness of hypnosis in the treatment of chronic low back pain.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Other)
Single-site study at MEDVA-Houston
emg biofeedback without hypnotic suggestion
8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
home practice with hypnosis cds
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
therapist-guided hypnosis
8 weekly 1-hour sessions of therapist-guided hypnosis
therapist-guided hypnosis + home practice with hypnosis cds
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs

Primary Outcomes

Measure
Brief Pain Inventory-Pain Intensity
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up

Secondary Outcomes

Measure
Brief Pain Inventory-Interference
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
Pain Quality Assessment Scale (PQAS)
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
Pittsburgh Sleep Quality Index
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
Two-Item Measures of Pain Beliefs and Coping Strategies
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
McGill Pain Questionnaire-Short Form
time frame: Pre-treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
Rand MHI-5
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
Treatment Outcomes Scale
time frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up
U of WA Relaxation and Hypnotic Treatment for Persons with Disabilities and Chronic Pain-Modified Stanford Hypnotic Susceptibility Script & Scale
time frame: At enrollment, immediately prior to 1st treatment visit, 1 week post-treatment
Phenomenology of Consciousness Inventory
time frame: 1st, 4th, & 8th week of hypnosis

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chronic low back pain for at least 6 months - Pain severity at least 5 on a 0-10 scale - Pain is primarily musculoskeletal/mechanical - Adults, at least 18 years of age Exclusion Criteria: - Acute and cancer pain - Neuropathic etiology - Severe psychopathology - Active substance abuse - Significant cognitive deficit - Previous participant of the pilot study on hypnosis chronic low back pain

Additional Information

Official title Treatment of Veterans With Chronic Low Back Pain
Principal investigator Wright Williams, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.