Study Results
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View full resultsBasic Information
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COMPLETED
NA
161 participants
INTERVENTIONAL
2006-10-01
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 Hyp-8
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings
Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Arm 2 Hyp-8 w recordings
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Hyp-2 w recordings
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Hyp-8 w recordings
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Arm 3 Hyp-2 w recordings
Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Hyp-2 w recordings
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Hyp-8 w recordings
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Arm 4 BIO
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings
BIO
8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
Interventions
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Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Hyp-2 w recordings
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Hyp-8 w recordings
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Hyp-2 w recordings
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Hyp-8
8 weekly 1-hour sessions of therapist-guided hypnosis
Hyp-8 w recordings
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
BIO
8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pain severity at least 5 on a 0-10 scale
* Pain is primarily musculoskeletal/mechanical
* Adults, at least 18 years of age
Exclusion Criteria
* Neuropathic etiology
* Severe psychopathology
* Active substance abuse
* Significant cognitive deficit
* Previous participant of the pilot study on hypnosis chronic low back pain
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Wright Williams, PhD
Role: PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX
Locations
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Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
Countries
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Other Identifiers
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H-18610
Identifier Type: OTHER
Identifier Source: secondary_id
D4421-I
Identifier Type: -
Identifier Source: org_study_id
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