Treatment of Veterans With Chronic Low Back Pain (CLBP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00361270
First received: August 4, 2006
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Low Back Pain, Recurrent
Behavioral: EMG Biofeedback without hypnotic suggestion
Behavioral: Home practice with hypnosis CDs
Behavioral: Therapist-guided hypnosis
Behavioral: Therapist-guided hypnosis + home practice with hypnosis CDs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Veterans With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • McGill Pain Questionnaire-Short Form [ Time Frame: Pre-treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
  • Rand MHI-5 [ Time Frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
  • Treatment Outcomes Scale [ Time Frame: Pre-treatment, Once a week during treatment, 1 week post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Phenomenology of Consciousness Inventory [ Time Frame: 1st, 4th, & 8th week of hypnosis ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: October 2006
Estimated Study Completion Date: August 2015
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Single-site study at MEDVA-Houston
Behavioral: EMG Biofeedback without hypnotic suggestion
8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
Behavioral: Home practice with hypnosis CDs
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Behavioral: Therapist-guided hypnosis
8 weekly 1-hour sessions of therapist-guided hypnosis
Behavioral: Therapist-guided hypnosis + home practice with hypnosis CDs
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361270

Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Wright Williams, PhD Michael E. DeBakey VA Medical Center (152)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00361270     History of Changes
Other Study ID Numbers: D4421-I, H-18610
Study First Received: August 4, 2006
Last Updated: August 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Biofeedback
Hypnosis
Low Back Pain, Recurrent
Pain beliefs
Pain coping strategies
Pain intensity
Pain interference
Pain quality
Self-help treatment
Sleep dysfunction

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014