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Low Back Pain, RecurrentCLBPNCT00361270

Treatment of Veterans With Chronic Low Back Pain

A study testing Hyp-8, Hyp-2 w recordings and Hyp-8 w recordings in people with Low Back Pain, Recurrent, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain, Recurrent
What is being tested?
Hyp-8, Hyp-2 w recordings and Hyp-8 w recordings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteUnited States
Study dates
1 Oct 2006to 30 Jun 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030

Other trials in United States

About this study

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

Read the 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.

Being tested
Hyp-8, Hyp-2 w recordings, Hyp-8 w recordings, BIO
Keywords
Biofeedback, Hypnosis, Low Back Pain, Recurrent, Pain beliefs, Pain coping strategies, Pain intensity, Pain interference, Pain quality, Self-help treatment, Sleep dysfunction
Medical subject headings
Low Back Pain, Pain, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyp-8Behavioural

    Also called Arm 1

    8 weekly 1-hour sessions of therapist-guided hypnosis

  • Hyp-2 w recordingsBehavioural

    Also called Arm 3

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

  • Hyp-8Behavioural

    Also called Arm 1

    8 weekly 1-hour sessions of therapist-guided hypnosis

  • Hyp-8 w recordingsBehavioural

    Also called Arm 2

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

  • Hyp-2 w recordingsBehavioural

    Also called Arm 3

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

  • Hyp-8Behavioural

    Also called Arm 1

    8 weekly 1-hour sessions of therapist-guided hypnosis

  • Hyp-8 w recordingsBehavioural

    Also called Arm 2

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

  • BIOBehavioural

    Also called Arm 4

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

Study groups in NCT00361270
Study groupRoleWhat they receive
Arm 1 Hyp-8ExperimentalSingle-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings
Receives: Behavioral: Hyp-8
Arm 2 Hyp-8 w recordingsExperimentalSingle-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Receives: Behavioral: Hyp-2 w recordings; Behavioral: Hyp-8; Behavioral: Hyp-8 w recordings
Arm 3 Hyp-2 w recordingsExperimentalSingle-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings
Receives: Behavioral: Hyp-2 w recordings; Behavioral: Hyp-8; Behavioral: Hyp-8 w recordings
Arm 4 BIOActive comparatorSingle-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings
Receives: Behavioral: BIO

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. 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.

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

  2. 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.

    Measured: Subjects change on this scale from Pre-treatment to 1-week post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2006 (estimated)
  2. Study start1 Oct 2006
  3. Primary completion15 Feb 2010
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00361270
Sponsor's protocol ID
D4421-I
Other IDs
H-18610
Acronym
CLBP
Status last verified
Jul 2018
First submitted
4 Aug 2006
Last updated
27 Aug 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hyp-8, Hyp-2 w recordings and Hyp-8 w recordings in people with Low Back Pain, Recurrent, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale (time frame: Subjects change on this scale from Pre-Treatment to 1 week post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.

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