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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Low Back Pain, Recurrent
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1 Hyp-8 | Experimental | Single-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 recordings | Experimental | Single-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 recordings | Experimental | Single-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 BIO | Active comparator | Single-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.
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)
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
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.
- First posted8 Aug 2006 (estimated)
- Study start1 Oct 2006
- Primary completion15 Feb 2010
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Wright Williams, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Veterans With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00361270
- Acronym / sponsor ID
- CLBP / D4421-I
- Conditions
- Low Back Pain, Recurrent
- Keywords
- Biofeedback, Hypnosis, Low Back Pain, Recurrent, Pain beliefs, Pain coping strategies, Pain intensity, Pain interference, Pain quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 15 Feb 2010 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Posted 26 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Hyp-8 | Experimental | Behavioral: Hyp-8Single-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist without audio recordings |
| Arm 2 Hyp-8 w recordings | Experimental | Behavioral: Hyp-2 w recordings, Behavioral: Hyp-8, Behavioral: Hyp-8 w recordingsSingle-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour hypnosis with hypnotherapist with audio recordings |
| Arm 3 Hyp-2 w recordings | Experimental | Behavioral: Hyp-2 w recordings, Behavioral: Hyp-8, Behavioral: Hyp-8 w recordingsSingle-site study at MEDVA-Houston Behavioral: 2 weeks 1-hour hypnosis with hypnotherapist with audio recordings |
| Arm 4 BIO | Active comparator | Behavioral: BIOSingle-site study at MEDVA-Houston Behavioral: 8 weeks 1-hour EMG biofeedback without audio recordings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Acute and cancer pain
- Neuropathic etiology
- Severe psychopathology
- Active substance abuse
- Significant cognitive deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyp-8Also: Arm 18 weekly 1-hour sessions of therapist-guided hypnosis | Behavioural | Arm 1 Hyp-8 |
| Hyp-2 w recordingsAlso: Arm 32 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs | Behavioural | Arm 2 Hyp-8 w recordings |
| Hyp-8Also: Arm 18 weekly 1-hour sessions of therapist-guided hypnosis | Behavioural | Arm 2 Hyp-8 w recordings |
| Hyp-8 w recordingsAlso: Arm 28 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs | Behavioural | Arm 2 Hyp-8 w recordings |
| Hyp-2 w recordingsAlso: Arm 32 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs | Behavioural | Arm 3 Hyp-2 w recordings |
| Hyp-8Also: Arm 18 weekly 1-hour sessions of therapist-guided hypnosis | Behavioural | Arm 3 Hyp-2 w recordings |
| Hyp-8 w recordingsAlso: Arm 28 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs | Behavioural | Arm 3 Hyp-2 w recordings |
| BIOAlso: Arm 48 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion | Behavioural | Arm 4 BIO |
Primary outcome
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
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.
2 secondary outcomes
Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale
Time frame: 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)
Time frame: Subjects change on this scale from Pre-treatment to 1-week post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wright Williams, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
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.