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临床试验/NCT00361270
NCT00361270已完成不适用

Treatment of Veterans With Chronic Low Back Pain

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2006年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
2
主要终点
Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Arm 1 Hyp-8

Experimental

Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings

干预措施: Hyp-8 (Behavioral)

Arm 2 Hyp-8 w recordings

Experimental

Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings

干预措施: Hyp-2 w recordings (Behavioral)

Arm 2 Hyp-8 w recordings

Experimental

Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings

干预措施: Hyp-8 (Behavioral)

Arm 2 Hyp-8 w recordings

Experimental

Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings

干预措施: Hyp-8 w recordings (Behavioral)

Arm 3 Hyp-2 w recordings

Experimental

Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings

干预措施: Hyp-2 w recordings (Behavioral)

Arm 3 Hyp-2 w recordings

Experimental

Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings

干预措施: Hyp-8 (Behavioral)

Arm 3 Hyp-2 w recordings

Experimental

Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings

干预措施: Hyp-8 w recordings (Behavioral)

Arm 4 BIO

Active Comparator

Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings

干预措施: BIO (Behavioral)

结局指标

主要结局

Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale

时间窗: Subjects change on this scale from Pre-Treatment to 1 week post treatment

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.

次要结局

  • Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)(Subjects change on this scale from Pre-treatment to 1-week post treatment)
  • Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale(Subjects change on this scale from Pre-Treatment to 1-week post treatment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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