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Treatment of Veterans With Chronic Low Back Pain (CLBP)

Primary Purpose

Low Back Pain, Recurrent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyp-8
Hyp-2 w recordings
Hyp-8
Hyp-8 w recordings
Hyp-2 w recordings
Hyp-8
Hyp-8 w recordings
BIO
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Recurrent focused on measuring Biofeedback, Hypnosis, Low Back Pain, Recurrent, Pain beliefs, Pain coping strategies, Pain intensity, Pain interference, Pain quality, Self-help treatment, Sleep dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Arm 1 Hyp-8

Arm 2 Hyp-8 w recordings

Arm 3 Hyp-2 w recordings

Arm 4 BIO

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 4, 2006
Last Updated
July 26, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00361270
Brief Title
Treatment of Veterans With Chronic Low Back Pain
Acronym
CLBP
Official Title
Treatment of Veterans With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2006 (Actual)
Primary Completion Date
February 15, 2010 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent
Keywords
Biofeedback, Hypnosis, Low Back Pain, Recurrent, Pain beliefs, Pain coping strategies, Pain intensity, Pain interference, Pain quality, Self-help treatment, Sleep dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Hyp-8
Arm Type
Experimental
Arm Description
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings
Arm Title
Arm 2 Hyp-8 w recordings
Arm Type
Experimental
Arm Description
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Arm Title
Arm 3 Hyp-2 w recordings
Arm Type
Experimental
Arm Description
Single-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Arm Title
Arm 4 BIO
Arm Type
Active Comparator
Arm Description
Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings
Intervention Type
Behavioral
Intervention Name(s)
Hyp-8
Other Intervention Name(s)
Arm 1
Intervention Description
8 weekly 1-hour sessions of therapist-guided hypnosis
Intervention Type
Behavioral
Intervention Name(s)
Hyp-2 w recordings
Other Intervention Name(s)
Arm 3
Intervention Description
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Intervention Type
Behavioral
Intervention Name(s)
Hyp-8
Other Intervention Name(s)
Arm 1
Intervention Description
8 weekly 1-hour sessions of therapist-guided hypnosis
Intervention Type
Behavioral
Intervention Name(s)
Hyp-8 w recordings
Other Intervention Name(s)
Arm 2
Intervention Description
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Intervention Type
Behavioral
Intervention Name(s)
Hyp-2 w recordings
Other Intervention Name(s)
Arm 3
Intervention Description
2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
Intervention Type
Behavioral
Intervention Name(s)
Hyp-8
Other Intervention Name(s)
Arm 1
Intervention Description
8 weekly 1-hour sessions of therapist-guided hypnosis
Intervention Type
Behavioral
Intervention Name(s)
Hyp-8 w recordings
Other Intervention Name(s)
Arm 2
Intervention Description
8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs
Intervention Type
Behavioral
Intervention Name(s)
BIO
Other Intervention Name(s)
Arm 4
Intervention Description
8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
Primary Outcome Measure Information:
Title
Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale
Description
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.
Time Frame
Subjects change on this scale from Pre-Treatment to 1 week post treatment
Secondary Outcome Measure Information:
Title
Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale
Description
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.
Time Frame
Subjects change on this scale from Pre-Treatment to 1-week post treatment
Title
Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Subjects change on this scale from Pre-treatment to 1-week post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wright Williams, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Veterans With Chronic Low Back Pain

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