Treatment of Veterans With Chronic Low Back Pain
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/29/2018 |
| Start Date: | October 1, 2006 |
| End Date: | June 30, 2018 |
The purpose of this study is to assess the effectiveness of hypnosis in the treatment of
chronic low back pain.
chronic low back pain.
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.
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.
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
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