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Treatment of Veterans With Chronic Low Back Pain

Treatment of Veterans With Chronic Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00361270
Acronym
CLBP
Enrollment
161
Registered
2006-08-08
Start date
2006-10-01
Completion date
2018-06-30
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALHyp-8

8 weekly 1-hour sessions of therapist-guided hypnosis

BEHAVIORALHyp-2 w recordings

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

BEHAVIORALHyp-8 w recordings

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

BEHAVIORALBIO

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity ScaleSubjects change on this scale from Pre-Treatment to 1 week post treatmentThe 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

MeasureTime frameDescription
Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference ScaleSubjects change on this scale from Pre-Treatment to 1-week post treatmentThe 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)Subjects change on this scale from Pre-treatment to 1-week post treatmentThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Single-site study at MEDVA-Houston Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis
49
Arm 2
Single-site study at MEDVA-Houston Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs
39
Arm 3
Single-site study at MEDVA-Houston Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs
35
Arm 4
Single-site study at MEDVA-Houston EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
38
Total161

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event0110
Overall StudyAfraid of Hypnosis1200
Overall StudyDeath0002
Overall StudyLost to Follow-up4100
Overall StudyPhysician Decision0010
Overall StudyProblems with Transportation4000
Overall StudyProtocol Violation9454
Overall StudyWithdrawal by Subject6637

Baseline characteristics

CharacteristicArm 4TotalArm 3Arm 1Arm 2
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants25 Participants5 Participants9 Participants6 Participants
Age, Categorical
Between 18 and 65 years
33 Participants136 Participants30 Participants40 Participants33 Participants
BPI Interference11.36 units on a scale
STANDARD_DEVIATION 3.55
56.15 units on a scale
STANDARD_DEVIATION 20.15
49.60 units on a scale
STANDARD_DEVIATION 20.65
61.20 units on a scale
STANDARD_DEVIATION 17.55
52.06 units on a scale
STANDARD_DEVIATION 19.62
BPI Pain Intensity25.50 units on a scale
STANDARD_DEVIATION 6.05
24.37 units on a scale
STANDARD_DEVIATION 6.26
21.08 units on a scale
STANDARD_DEVIATION 5.14
24.28 units on a scale
STANDARD_DEVIATION 5.44
24.50 units on a scale
STANDARD_DEVIATION 5.52
PSQI10.24 units on a scale
STANDARD_DEVIATION 4.02
11.16 units on a scale
STANDARD_DEVIATION 4.17
9.68 units on a scale
STANDARD_DEVIATION 4.15
11.36 units on a scale
STANDARD_DEVIATION 3.55
11.80 units on a scale
STANDARD_DEVIATION 4.08
Sex: Female, Male
Female
8 Participants31 Participants8 Participants7 Participants8 Participants
Sex: Female, Male
Male
30 Participants130 Participants27 Participants42 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 491 / 391 / 350 / 38
serious
Total, serious adverse events
0 / 490 / 390 / 350 / 38

Outcome results

Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
Hypnosis-8Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale17.52 units on a scaleStandard Deviation 10.24
Hypnosis-Practice 8Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale14.16 units on a scaleStandard Deviation 8.78
Hypnosis Practice 2Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale13.78 units on a scaleStandard Deviation 9.04
Biofeedback - 8Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale21.18 units on a scaleStandard Deviation 9.22
Secondary

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.

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

ArmMeasureValue (MEAN)Dispersion
Hypnosis-8Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale39.08 units on a scaleStandard Deviation 29.39
Hypnosis-Practice 8Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale31.88 units on a scaleStandard Deviation 25.66
Hypnosis Practice 2Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale29.00 units on a scaleStandard Deviation 25.99
Biofeedback - 8Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale45.4 units on a scaleStandard Deviation 23.67
Secondary

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.

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

ArmMeasureValue (MEAN)Dispersion
Hypnosis-8Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)9.96 units on a scaleStandard Deviation 4.37
Hypnosis-Practice 8Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)8.72 units on a scaleStandard Deviation 4.31
Hypnosis Practice 2Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)7.8 units on a scaleStandard Deviation 4.92
Biofeedback - 8Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)8.88 units on a scaleStandard Deviation 3.99

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026