Treatment of Veterans With Chronic Low Back Pain

NCT00361270 | Completed Results

• 2 other identifiers: D4421-IH-18610
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (4)

Arm 1 Hyp-8

EXPERIMENTAL

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

Behavioral: Hyp-8

Arm 2 Hyp-8 w recordings

EXPERIMENTAL

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

Behavioral: Hyp-2 w recordings; Behavioral: Hyp-8; Behavioral: Hyp-8 w recordings

Arm 3 Hyp-2 w recordings

EXPERIMENTAL

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

Behavioral: Hyp-2 w recordings; Behavioral: Hyp-8; Behavioral: Hyp-8 w recordings

Arm 4 BIO

ACTIVE COMPARATOR

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

Behavioral: BIO

Interventions

Hyp-8 BEHAVIORAL

8 weekly 1-hour sessions of therapist-guided hypnosis

Also known as: Arm 1

Arm 1 Hyp-8

Hyp-2 w recordings BEHAVIORAL

2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs

Also known as: Arm 3

Arm 2 Hyp-8 w recordings

Hyp-8 w recordings BEHAVIORAL

8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs

Also known as: Arm 2

Arm 2 Hyp-8 w recordings

BIO BEHAVIORAL

8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion

Also known as: Arm 4

Arm 4 BIO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pain; Parasomnias

Interventions

bradykinin, Hyp(3)-TyrMe(8)-; DMAC2L protein, human

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

The study is done on a population of Veterans and may not generalize to the larger population. The same provider administered treatment for all four groups.

Results Point of Contact

• Title: Wright Williams, Ph.D., ABPP
• Organization: Michael E DeBakey VAMC

wright.williams@va.gov

713-794-7629

Study Officials

• Wright Williams, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 8, 2006
• Study Start: October 1, 2006
• Primary Completion: February 15, 2010
• Study Completion: June 30, 2018
• Last Updated: August 27, 2018
• Results First Posted: August 26, 2015

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)