Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361270
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2006-08-04
Brief Title:
Treatment of Veterans With Chronic Low Back Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Treatment of Veterans With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLBP
Brief Summary:
The purpose of this study is to assess the effectiveness of hypnosis in the treatment of chronic low back pain
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 106 or 361868 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 acutetransient pain resulting from burns radiological procedures or coronaryischemic 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 musculoskeletalmechanical 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
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 acutetransient pain resulting from burns radiological procedures or coronaryischemic 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 musculoskeletalmechanical 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-18610 | OTHER | Baylor College of Medicine IRB | None |