Treatment of Veterans With Chronic Low Back Pain

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

Detailed Description
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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.

Official Title
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Treatment of Veterans With Chronic Low Back Pain

Conditions
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Low Back Pain, Recurrent

Intervention / Treatment
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* Behavioral: Hyp-8
* Behavioral: Hyp-2 w recordings
* Behavioral: Hyp-8
* Behavioral: Hyp-8 w recordings
* Behavioral: Hyp-2 w recordings
* Behavioral: Hyp-8
* Behavioral: Hyp-8 w recordings
* Behavioral: BIO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Hyp-8<br>Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings | Behavioral: Hyp-8<br>* 8 weekly 1-hour sessions of therapist-guided hypnosis<br>* Other names: Arm 1;|
| Experimental: Arm 2 Hyp-8 w recordings<br>Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings | Behavioral: Hyp-2 w recordings<br>* 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs<br>* Other names: Arm 3;Behavioral: Hyp-8<br>* 8 weekly 1-hour sessions of therapist-guided hypnosis<br>* Other names: Arm 1;Behavioral: Hyp-8 w recordings<br>* 8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs<br>* Other names: Arm 2;|
| Experimental: Arm 3 Hyp-2 w recordings<br>Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings | Behavioral: Hyp-2 w recordings<br>* 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs<br>* Other names: Arm 3;Behavioral: Hyp-8<br>* 8 weekly 1-hour sessions of therapist-guided hypnosis<br>* Other names: Arm 1;Behavioral: Hyp-8 w recordings<br>* 8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs<br>* Other names: Arm 2;|
| Active Comparator: Arm 4 BIO<br>Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings | Behavioral: BIO<br>* 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion<br>* Other names: Arm 4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale | 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. | Subjects change on this scale from Pre-Treatment to 1 week post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale | 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. | Subjects change on this scale from Pre-Treatment to 1-week post treatment | 
| Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI) | 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. | Subjects change on this scale from Pre-treatment to 1-week post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biofeedback, Hypnosis, Low Back Pain, Recurrent, Pain beliefs, Pain coping strategies, Pain intensity, Pain interference, Pain quality, Self-help treatment, Sleep dysfunction