Treatment of Veterans With Chronic Low Back Pain (CLBP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00361270
First received: August 4, 2006
Last updated: April 22, 2016
Last verified: April 2016
  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: Hyp-8
Behavioral: Hyp-2 w recordings
Behavioral: Hyp-8 w recordings
Behavioral: BIO

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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale [ Time Frame: Subjects change on this scale from Pre-Treatment to 1 week post treatment ] [ Designated as safety issue: No ]
    The change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.


Secondary Outcome Measures:
  • Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale [ Time Frame: Subjects change on this scale from Pre-Treatment to 1-week post treatment ] [ Designated as safety issue: No ]
    The change score measures the difference between pre-treatment scores on the Brief Pain Inventory-Interference Scale (NRS: 0 no interference - 10 complete interference) and 1- week post treatment scores for the 10 items. Change is calculated as pre-treatment minus post treatment.

  • Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Subjects change on this scale from Pre-treatment to 1-week post treatment ] [ Designated as safety issue: No ]
    The change score is the difference between pre-treatment scores on the Pittsburgh Sleep Quality Index (PSQI) and the 1-week post-treatment scores. Positive values indicate a reduction in sleep problems. The PSQI was scored on 19 items with 7 component scores ranging from 0 no difficulty falling asleep to 3 severe difficulty, then component scores added to create global score ranging from 0 no difficulty falling asleep to 21 severe difficulty falling asleep.


Enrollment: 161
Study Start Date: October 2006
Estimated Study Completion Date: December 2016
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Hyp-8
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings
Behavioral: Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Other Name: Arm 1
Experimental: Arm 2 Hyp-8 w recordings
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Behavioral: Hyp-2 w recordings
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Other Name: Arm 3
Behavioral: Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Other Name: Arm 1
Behavioral: Hyp-8 w recordings
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Other Name: Arm 2
Experimental: Arm 3 Hyp-2 w recordings
Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Behavioral: Hyp-2 w recordings
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Other Name: Arm 3
Behavioral: Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Other Name: Arm 1
Behavioral: Hyp-8 w recordings
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Other Name: Arm 2
Active Comparator: Arm 4 BIO
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings
Behavioral: BIO
8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
Other Name: Arm 4

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   (Adult, Senior)
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, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Wright Williams, PhD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00361270     History of Changes
Other Study ID Numbers: D4421-I  H-18610 
Study First Received: August 4, 2006
Results First Received: November 13, 2014
Last Updated: April 22, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
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 August 25, 2016