ORIGINAL ARTICLE

A randomized controlled trial of hypnosis compared with

biofeedback for adults with chronic low back pain
G. Tan1, D.H. Rintala2, M.P. Jensen3, T. Fukui4, D. Smith4, W. Williams4,5
1 Department of Psychology, National University of Singapore, Singapore
2 Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, USA
3 Department of Rehabilitation Medicine, University of Washington, Seattle, USA
4 Michael E. DeBakey Veterans Affairs Medical Center, Houston, USA
5 The Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, USA

Correspondence Abstract
Diana H. Rintala
E-mail: drintala@bcm.tmc.edu Background: Chronic low back pain (CLBP) is common and results in
significant costs to individuals, families and society. Although some
Funding source research supports the efficacy of hypnosis for CLBP, we know little about
Grant number D4421-I from the Veterans
the minimum dose needed to produce meaningful benefits, the roles of
Health Administration Rehabilitation Research
and Development Service.
home practice and hypnotizability on outcome, or the maintenance of
treatment benefits beyond 3 months.
Conflict of interest Methods: One hundred veterans with CLBP participated in a
Mark P. Jensen is an author of two books on randomized, four-group design study. The groups were (1) an eight-session
the topic of this paper and receives royalties self-hypnosis training intervention without audio recordings for home
for the sales of those books. The other practice; (2) an eight-session self-hypnosis training intervention with
authors declare no conflict of interest.
recordings; (3) a two-session self-hypnosis training intervention with
Accepted for publication
recordings and brief weekly reminder telephone calls; and (4) an
29 April 2014 eight-session active (biofeedback) control intervention.
Results: Participants in all four groups reported significant pre- to
doi:10.1002/ejp.545 post-treatment improvements in pain intensity, pain interference and
sleep quality. The hypnosis groups combined reported significantly more
pain intensity reduction than the control group. There was no significant
difference among the three hypnosis conditions. Over half of the
participants who received hypnosis reported clinically meaningful (≥30%)
reductions in pain intensity, and they maintained these benefits for at least
6 months after treatment. Neither hypnotizability nor amount of home
practice was associated significantly with treatment outcome.
Conclusions: The findings indicate that two sessions of self-hypnosis
training with audio recordings for home practice may be as effective as
eight sessions of hypnosis treatment. If replicated in other patient samples,
the findings have important implications for the application of hypnosis
treatment for chronic pain management.

efficacy of hypnosis for chronic low back pain

1. Introduction
Low back pain is one of the most common chronic
pain problems, and results in significant costs to indi-
viduals, their families and society (Licciardone, 2008;
Lew et al., 2009). Both case studies (King et al., 2001;
Tan et al., 2010) and some controlled trials support the
(McCauley et al., 1983; Edelson and Fitzpatrick, 1989;
Crawford et al., 1998). Control conditions for these
studies have included treatments such as progressive
relaxation, cognitive behaviour therapy and attention.
Surface electromyography (sEMG) biofeedback is
another reasonable active control for hypnosis

© 2014 European Pain Federation - EFIC® Eur J Pain 19 (2015) 271–280 271
RCT of hypnosis versus biofeedback for CLBP
What’s already known about this topic?
• Several studies support the efficacy of hypnosis
for chronic low back pain but several questions
remain.
What does this study add?
• This study assessed the value of self-hypnosis
practice, the role of hypnotizability, the effect of
number of sessions with a therapist, and the
maintenance of benefits after treatment ends.
because it involves face-to-face treatment sessions,
includes relaxation and focused attention, and has
been found to be somewhat effective in improving
pain, pain interference and sleep quality (Flor and
Birbaumer, 1993; Newton-John et al., 1995; Jensen
et al., 2009b; Ehrenborg and Archenholtz, 2010;
Yilmaz et al., 2010). Jensen (Jensen et al., 2009a)
compared the effect of hypnosis and sEMG biofeed-
back on chronic pain in persons with spinal cord
injury and found hypnosis to be more effective in
reducing average daily pain. However, to our knowl-
edge, there are no studies comparing hypnosis to
sEMG biofeedback for chronic low back pain (CLBP).
There also remain a number of unanswered ques-
tions regarding the effectiveness and mechanisms of
hypnosis for CLBP management. First, what is the
minimum number of therapist-guided sessions neces-
sary to obtain the desired results? Most chronic pain
studies have used 3–10 sessions and eight sessions
have been found to be effective (McCauley et al.,
1983) for chronic low back pain. Our pilot study (Tan
et al., 2010) found four sessions to be effective for
CLBP; can benefits be obtained in a very small number
of sessions? Subjects find it increasingly expensive and
difficult to attend numerous therapy sessions and to
our knowledge, no previous chronic pain and hypno-
sis studies used only two sessions. Second, what is the
role of home practice of self-hypnosis? Third, how
long will the benefits last after treatment ends?
Fourth, what is the effect of hypnotizability? Finally,
what is the effect of the amount of home practice?
This study was designed to address these questions
in the context of a controlled trial where patients with
CLBP were randomly assigned to one of four treat-
ment conditions – three involving hypnosis and one
involving sEMG biofeedback as an active control.
Based on Jensen and colleagues’ (Jensen et al., 2009a)
findings in persons with spinal cord injury, the
primary study hypothesis was that participants in the
hypnosis conditions would report greater pre- to post-
272 Eur J Pain 19 (2015) 271–280
G. Tan et al.
treatment reductions in pain intensity than those in
the biofeedback control condition. The secondary
hypotheses were that hypnosis treatment would be
more effective than the control condition for reducing
pain interference and improving sleep quality. We also
assessed (1) the role of the number of therapist-guided
hypnosis treatments; (2) the maintenance of treat-
ment effects for 6 months following treatment; (3) the
role of hypnotizability; and (4) the number of home
self-hypnosis practice sessions.
2. Methods
2.1 Study design
The study used a randomized, single-blind, four-group
design. The four treatment conditions were (1) eight
therapist-guided sessions of self-hypnosis training without
recommendations for practice (HYP-8); (2) eight therapist-
guided sessions of self-hypnosis training with recommenda-
tions for practice (HYP-PRAC-8); (3) two therapist-guided
sessions of self-hypnosis training with recommendations for
practice (HYP-PRAC-2) plus six brief, weekly telephone calls;
and (4) eight sessions of sEMG biofeedback-assisted relax-
ation training (BIO-8) that served as the control group.
2.2 Participants
Participants were recruited from the Michael E. DeBakey VA
Medical Center (MEDVAMC) Pain Management Program via
posters, the staff of the programme and advertisement in a
veterans’ newsletter. Recruitment began in December 2006
and ended in July 2009. The follow-up was completed by
March 2010. Our sampling frame comprised 888 names of
potential participants (Fig. 1). We included subjects with (1)
CLBP of at least 6 months’ duration; (2) average pain
rating ≥ 5 on a 0–10 scale during the past week; (3) pain with
a primarily musculoskeletal or mechanical aetiology; and (4)
agreement to adhere to study protocol. We excluded subjects
with (1) acute pain due to recent injury or pain due to
cancer; (2) primarily neuropathic pain aetiology; (3) severe
psychopathology, significant cognitive deficits or severe
hearing loss that would interfere with participation; (4) an
active substance abuse problem; and (5) participation in our
previous pilot study on hypnosis and CLBP (Tan et al., 2010).
See Fig. 1 for a detailed study flow diagram.
One hundred participants completed the full 8-week
treatment protocol and 59 withdrew after randomization –
33 (56%) before treatment began and 26 (44%) after par-
ticipating in at least one session. The average age of the
participants who completed the study was 55 years
(range = 25–83 years); 79% were male; 47% described their
race/ethnicity as Caucasian, 32% as African-American, 15%
as Hispanic and 6%, as other or mixed. The 59 participants
who withdrew were not significantly different than the com-
pleters in age (56 years, t = 0.62; p = 0.534), sex (86% male;
© 2014 European Pain Federation - EFIC®
G. Tan et al. RCT of hypnosis versus biofeedback for CLBP

Did not meet inclusion criteria (n = 384)
Figure 1 Study flow diagram. Note: B,
number who withdrew before the first session
and reasons they withdrew. Some participants
had more than one reason for withdrawing.
Neuropathic pain (n = 224, 58.3%)
Cogni ve impairment (n = 48, 12.5%)
Pain intensity ra ng < 5 (n = 38, 9.9%)
Substance abuse (n = 33, 8.6%)
Psycho c (n = 15, 3.9%)
Cancer pain (n = 10, 2.6%)
Suicide idea on (n = 5, 1.3%)
Disability claim pending (n = 5, 1.3%)
Pain not chronic, < 6 months (n = 2, 0.5%)
Severely hearing impaired (n = 2, 0.5%)
In previous hypnosis study (n = 2, 0.5%)
Sampling frame (n = 888)
Unable to contact (n = 90)
Deceased (n = 1)
Assessed for eligibility (n = 797)
Wait listed, never randomized
due to limita ons of therapist’s
schedule (n = 28)
Randomized (n = 159)
Declined to par cipate (n = 226)
Not interested (n = 45, 19.9%)
Did not follow through (n = 41, 18.1%)
Lived too far away (n = 35, 15.5%)
No reason recorded (n = 21, 9.3%)
Scheduling problems (n = 17, 7.5%)
Desires or receiving different treatment (n = 12, 5.3%)
Li ga on pending (n = 10, 4.4%)
Lacks transporta on (n = 9, 4.0%)
Wary of hypnosis or advised not to par cipate (n = 8, 3.5%)
Mental health problems (n = 7, 3.1%)
Has moved or soon moving away (n = 6, 2.7%)
High cost of travel to medical center (n = 4, 1.8%)
Insufficient compensa on (n = 3, 1.3%)
Desired delay, then unable to contact (n = 3, 1.3%)
Didn’t come to first appointment (n = 2, 0.9%)
Misc. (n = 3, 1.3%)

Ninety percent of the sampling frame (n = 797)

was contacted at least once. Of those con-
tacted, 48% did not meet the inclusion criteria,
28% declined participation, 4% met the criteria
but were put on a waiting list and never ran-
domized and 20% were randomized to a treat-
ment group. Pain of a primarily neuropathic
nature was the most common reason for
HYP-8 (n = 47)
Completed interven on (n = 25)
Withdrew (n = 22; B = 12)
6 lost contact (B = 5)
5 back pain intensity < 5 (B = 5)
4 me/scheduling constraints
3 wants a different treatment
2 transporta on problems (B = 1)
1 each – substance abuse (B), advised
by pastor not to par cipate (B),
unrelated legal problems (B), can’t sit
s ll long enough, treatment isn’t
helping, home prac ce causes too much
stress, hearing impaired
HYP-PRAC-8 (n = 39)
Completed interven on (n = 25)
Withdrew (n = 14; B = 9)
3 me/scheduling constraints (B = 1)
3 wary of hypnosis (B = 2)
2 back pain < 5 (B = 2)
2 pa ern of missed appointments
(B = 1)
1 each – lives too far away (B),
transporta on problem (B), lost
contact (B), unrelated health problem
(B), in jail (B), can’t sit s ll long enough,
had disturbing images with hypnosis
HYP-PRAC-2 (n = 35)
Completed interven on (n = 25)
Withdrew (n = 10; (B = 6)
4 back pain < 5 (B = 2)
2 can’t sit s ll long enough (B = 1)
1 each – lives too far away (B), having
back surgery (B), advised by surgeon
not to par cipate (B), substance abuse,
had bad dreams a er hypnosis.
BIO-8 (n = 38)
Completed interven on (n = 25)
Withdrew (n = 13; B = 6)
5 me/scheduling constraints (B = 2)
2 high cost of travel to medical center
(B = 1)
2 deceased (B = 2)
1 each – back pain < 5 (B), lives too far
away, treatment isn’t helping, pa ern
of missed appointments, believed
biofeedback was the control group

exclusion (58%) and lack of interest, lack of
follow through and living too far from the
medical centre were the most common
reasons for declining participation (20%, 18%
and 16%, respectively).
Analysed for pre-post change (n = 25)
Lost to 6-month follow up (n = 10)
10 unable to contact
Analysed for follow-up (n = 15)
Analysed for pre-post change (n = 25)
Lost to 6-month follow up (n = 1)
1 unable to contact
Analysed for follow-up (n = 24)
Analysed for pre-post change (n = 25)
Lost to 6-month follow up (n = 3)
2 mailed packet not returned
1 unable to contact
Analysed for follow-up (n = 22)
Analysed for pre-post change (n = 25)
Lost to 6-month follow up (n = 7)
4 unable to contact
2 mailed packet not returned
1 unrelated health problem
Analysed for follow-up (n = 18)

χ2 = 1.38; p = 0.291) or race/ethnicity (51% Caucasian, 40%
African-American, 7% Hispanic and 2% other or mixed
race/ethnicity; χ2 = 4.57; p = 0.206).
2.3 Procedure
Potentially eligible participants met with the coordinator at
the MEDVAMC. Eligible participants read and signed a
consent form approved by the Institutional Review Board for
Human Subject Research for Baylor College of Medicine and
Affiliated Hospitals. Research staff then collected information
about pain, medication, health history and demographics.
Participants were then tested for hypnotizability and com-
pleted the baseline outcome measures (described in the Mea-
sures section). Participants were randomly assigned by the
therapist to one of the four conditions using a table of
random numbers. The study coordinator did not know to
which group the participants were assigned.
Participants assigned to the HYP-8, HYP-PRAC-8 and
BIO-8 groups participated in a series of eight weekly face-to-
face sessions. Participants assigned to the HYP-PRAC-2 group
participated in two face-to-face training sessions, followed by
six weekly brief (average = 10 min) telephone interviews to
problem-solve and encourage practice. Each participant in
the three hypnosis groups was administered seven hypnotic
suggestions (described below) during the first two treatment
sessions. They selected the two suggestions to which they
responded the most after sessions 1 and 2. These two sug-
gestions were used in the remaining face-to-face sessions for
the HYP-8 and HYP-PRAC-8 groups, and were included in
audio recordings made for the participants in the HYP-
PRAC-8 and HYP-PRAC-2 conditions. Participants in the
HYP-PRAC-8 and HYP-PRAC-2 groups were asked to prac-
tice both with and without the audio recordings throughout
the 8-week treatment period. All participants in the HYP-
PRAC-8 and HYP-PRAC-2 groups were asked to complete
daily practice diaries to assess compliance with home practice
instructions.
Participants assigned to the BIO-8 control group received
eight sessions of sEMG-assessed relaxation training in
which sEMG electrodes were placed on the frontalis
muscles on the forehead and muscle activity was assessed
and fed back to the participant via a computer screen. Par-
ticipants were instructed to watch the computer screen and
use the visual and auditory feedback to help them learn
how to decrease their frontalis muscle tension. They were
told that an ability to decrease frontalis muscle tension
would generalize to their back muscles, so that they would
experience a sense of global relaxation and pain relief. At 1
week and 6 months after treatment ended, the coordinator
again administered the outcome measures to participants
who completed the training.
2.4 Measures
Screening measures assessed demographics, average pain
intensity, previous and current pain treatments (including
hypnosis), confirmation diagnosis of CLBP and other related
medical history. The recruitment interview also included the
Short Blessed Test (Katzman et al., 1983) to screen for sig-
nificant cognitive impairment, the Mini-International Neu-
ropsychiatric Interview (Sheehan et al., 1998) to screen for
significant psychopathology and substance abuse prob-
lem(s), and The Self-Report Leeds Assessment of Neuro-
pathic Symptoms and Signs scale (Bennett et al., 2005) to
screen for pain primarily neuropathic in nature.
Outcome measures completed at pre- and post-treatment
and at 6-month follow-up included a modified version of the
Brief Pain Inventory (Tyler et al., 2002) to assess pain inten-
sity and pain interference and the Pittsburgh Sleep Quality

© 2014 European Pain Federation - EFIC® Eur J Pain 19 (2015) 271–280 273
RCT of hypnosis versus biofeedback for CLBP
Index (Buysse et al., 1989). Outcome predictors included
global hypnotizability assessed at pre-treatment using the
5-item Stanford Clinical Hypnotizability Scale (Hilgard and
Hilgard, 1994) and amount of self-hypnosis practice assessed
by participant diaries. Descriptions of the standardized mea-
sures are available only online as Supporting Information
Method S1.
2.5 Hypnotic suggestions
Participants assigned to the hypnosis treatment groups were
administered a standard relaxation induction followed by
seven suggestions in the first two sessions of treatment. The
hypnotic suggestions focused on deep relaxation, sensory
substitution, pain intensity reduction, imagined anesthesia,
decreased pain unpleasantness, managing breakthrough
pain and post-hypnotic suggestions for effective self-
hypnosis (Jensen, 2011). Each subject was allowed to pick
two favourite suggestions to individualize their hypnotic
scripts which were repeated to them for sessions 2–8.
2.6 Statistical analysis
Sample size was determined based on the results of two
previous studies that included the outcome measures for
pain intensity (Tan et al., 2010), pain interference (Tan et al.,
2010) and sleep quality (Buysse et al., 1989). The outcome
measure that required the largest sample size (20 per group)
was sleep quality. Allowing for an estimated 20% attrition
rate and several secondary hypotheses, a recruitment sample
size of 40 participants for each of the four groups was
selected.
2.6.1 Pre- to post-treatment effects of hypnosis
versus biofeedback
For testing the primary and secondary hypotheses, partici-
pants in the three hypnosis treatment conditions were com-
bined into one hypnosis group (ALL-HYP). We calculated
means and standard deviations for pre- and post-treatment.
We assessed pretreatment group equivalency with t-tests. We
performed repeated-measures analyses of variance
(ANOVAs) to test the primary and secondary hypotheses
comparing the effects of hypnosis and biofeedback on pain
intensity, pain interference and sleep quality. We performed
a responder analysis (Dworkin et al., 2008) by computing
the percentage of participants in each treatment group who
reported at least a 30% decrease in pain intensity. We cal-
culated chi-square and risk estimates for this binary
outcome.
2.6.2 Effects of hypnosis dose and practice
recommendations
We performed a series of repeated-measures ANOVAs with
hypnosis treatment condition (HYP-8, HYP-PRAC-8, HYP-
274 Eur J Pain 19 (2015) 271–280
G. Tan et al.
PRAC-2) as the independent variable and the three outcome
measures as the dependent variables. In the event of signifi-
cant between-group differences, we performed a series of
paired t-tests for the relevant outcome variable(s). We also
computed the percentage of participants in each hypnosis
group who reported at least a 30% decrease in pain intensity.
We calculated chi-square and risk estimates comparing
responder rates for the HYP-8 group with those for a com-
bined ‘practice’ group (HYP-PRAC-8 and HYP-PRAC-2).
2.6.3 Maintenance of treatment effects
We performed a series of repeated-measures ANOVAs for the
three outcome measures, with both group (hypnosis vs.
control) and time (pretreatment, post-treatment, 6-month
follow-up) as the independent variables. We also performed
paired t-tests for each outcome within each group to assess
change from pre- to post-treatment and, separately, from
post-treatment to the 6-month follow-up point. We per-
formed similar analyses comparing maintenance effects for
the three hypnosis groups. Effect sizes were computed for all
analyses using Cohen’s d for t-tests and partial eta squared
(ηp2) for ANOVAs. Description of the analyses for hypnotiz-
ability and number of home practice sessions are available
only online as Supporting Information Method S2.
3. Results
3.1 Effects of hypnosis on treatment outcomes
Means and standard deviations for the outcome mea-
sures at pre- and post-treatment are presented in
Table 1 for the ALL-HYP and BIO-8 groups. There was
no significant baseline difference between the two
groups on any outcome measure. The paired t-tests for
within-group change indicated that both groups had
significant improvements in all three outcome mea-
sures from pre- to post-treatment. There were large
effect sizes (Cohen’s ds) for pain intensity and inter-
ference for the ALL-HYP group and medium effect
sizes for the BIO-8 group (as per Cohen, 1988). For
sleep quality, the effect sizes were medium for both
groups. The repeated-measures ANOVA indicated
there were large (as per Cohen, 1992) and statistically
significant time main effects for all three outcomes,
indicating that both groups improved from pre- to
post-treatment. For pain intensity, there was a small,
statistically significant time × group interaction effect.
There was greater reduction in pain intensity in the
ALL-HYP group than in the BIO-8 group. For pain
interference the interaction effect yielded a non-
significant trend (p = 0.050). For sleep quality, the
interaction effect was not statistically significant. Clini-
cally meaningful reductions (≥30%) in pain intensity
© 2014 European Pain Federation - EFIC®
G. Tan et al. RCT of hypnosis versus biofeedback for CLBP

were reported by 39 (52%) of the 75 hypnosis partici-

Effect size for

time × group
pants and 9 (36%) of the 25 BIO-8 participants.
Although participants in the ALL-HYP group, were

effect

0.042

0.039

0.009
ηp2
1.44 times more likely to have at least a 30% reduc-
tion in pain intensity, this difference in responder rates

4.29** (1, 98)

3.94* (1, 98)

0.87 (1, 98)

Time × group

was not statistically significant [χ2 = 1.92; p(1-sided) =

124; odds ratio = 1.93 (CI = 0.76–4.90); relative
effect

F (df)

risk = 1.44 (CI = 0.82–2.54); absolute risk = −0.16].

Effect size
Repeated-measures ANOVA

for time

ALL-HYP, participants who received hypnosis treatment; BIO-8, participants who received biofeedback; BPI, Brief Pain Inventory; PSQI, Pittsburgh Sleep Quality Index.
3.2 Effects of hypnosis dose and
effect

0.306

0.268

0.157
ηp2

recommendations for practice

43.15*** (1, 98)

35.93*** (1, 98)

18.31*** (1, 98)

The means and standard deviations for each of the

Time effect

three hypnosis groups are displayed in Table 2. The

results of a one-way ANOVA for between-group dif-
F (df)

ferences indicated that there was a significant baseline

difference among the three groups for pain intensity.
Effect size for
paired t-test

There was no significant baseline difference among the

Cohen’s d

three groups for pain interference or sleep quality. The

1.074
0.554
0.887
0.498
0.494
0.340

paired t-tests, which examined changes within each

hypnosis group from pre- to post-treatment, showed
Paired t-test for

that all three groups had significant improvements in

8.46*** (1, 74)
2.79** (1, 24)
7.78*** (1, 74)
2.52** (1, 24)
5.08*** (1, 74)
2.11** (1, 24)
within-group

all three outcome measures. Repeated-measures

ANOVAs revealed a large time effect of hypnosis for all
change

t (df)

three outcome measures but there was no significant

time × group interaction effect indicating that the
Post-treatment

9.43
9.22
27.02
23.67
4.57
3.99

improvement in these three variables did not differ

SD

significantly among the three hypnosis groups. Clini-

Table 1 Comparison of the effect of hypnosis versus biofeedback from pre- to post-treatment.

cally meaningful reductions (at least 30%) in pain

14.99
21.18
33.32
45.40
8.83
8.88
Mean

intensity was reported by 10 (40%) in the HYP-8

group, 13 (52%) in the HYP-PRAC-8 group and 16
Effect size for

differences

(64%) in the HYP-PRAC-2 group. Fifty-eight percent

Cohen’s d
baseline

of the participants in the combined practice groups

0.394

0.086

0.179

(HYP-PRAC-8 and HYP-PRAC-2) were responders

compared with 40% for the HYP-8 group. [χ2 = 2.163;
between-group

p(1-sided) = 0.110; odds ratio = 2.07 (CI = 0.78–5.51);

1.69* (1, 98)

0.37 (1, 98)

0.77 (1, 98)

differences

relative risk = 1.45 (CI = 0.85–2.48); absolute risk =

t-test for

baseline

−0.18]. Although these results were not statistically

t (df)

significant, participants in the combined practice

groups were 1.45 times more likely to have a 30% or
5.52
6.05
19.70
18.31
3.99
4.02
Pretreatment

SD

greater improvement in pain intensity than those in

the HYP-8 group.
23.29
25.50
54.29
55.94
10.95
10.24
Mean

3.3 Maintenance effects

75
25
75
25
75
25
n

ALL-HYP

ALL-HYP

ALL-HYP

Fig. 2A presents the means for pain intensity at pre-

Group

BIO-8

BIO-8

BIO-8

treatment, post-treatment and the 6-month follow-up

for the 79 participants (61 in the ALL-HYP group and
Outcome measure

Pain intensity (BPI)

18 in the BIO-8 group) who provided data at all three

Pain interference

time points. The ANOVA indicated a large, significant

***p < 0.001.
Sleep quality

**p < 0.05.

time main effect (F = 24.50; p < 0.001; ηp2 = 0.241)

*p < 0.10.
(PSQI)
(BPI)

and a non-significant time × group interaction effect

(F = 2.18; p = 0.116; ηp2 = 0.028). Fig. 2B presents

© 2014 European Pain Federation - EFIC® Eur J Pain 19 (2015) 271–280 275
 Table 2 Comparison of the effect of hypnosis on the three hypnosis groups from pre- to post-treatment.

Repeated-measures ANOVA
ANOVA for
between-group Effect size for Paired t-test for Effect size for
baseline baseline within-group Effect size for Effect Size for Time × group time × group
Pretreatment differences differences Post-treatment change paired t-test Time effect Time effect effect effect
Outcome
measure Group n Mean SD F (df) ηp2 Mean SD t (df) Cohen’s d F (df) ηp2 F (df) ηp2

Pain intensity HYP-8 25 24.28 5.44 3.18* (2, 72) 0.081 17.52 10.24 3.64** (1, 24) 0.810 71.92** (1, 72) 0.500 1.18 (2, 72) 0.032
(BPI) HYP-PRAC-8 25 24.50 5.52 14.16 8.78 6.02** (1, 24) 1.267

276 Eur J Pain 19 (2015) 271–280

HYP-PRAC-2 25 21.08 5.14 13.28 9.04 5.23** (1, 24) 1.179
Pain interference HYP-8 25 61.20 17.55 2.50 (2, 72) 0.065 39.08 29.39 4.20** (1, 24) 0.911 58.98** (1, 72) 0.450 0.05 (2, 72) 0.001
(BPI) HYP-PRAC-8 25 52.06 19.62 31.88 25.60 4.89** (1, 24) 1.012
HYP-PRAC-2 25 49.60 20.65 29.00 25.99 4.36** (1, 24) 0.889
Sleep quality HYP-8 25 11.36 3.55 2.02 (2, 72) 0.053 9.96 4.37 2.07* (1, 24) 0.425 26.14** (1, 72) 0.266 1.45 (2, 72) 0.039
RCT of hypnosis versus biofeedback for CLBP

(PSQI) HYP-PRAC-8 25 11.80 4.08 8.72 4.31 4.75** (1, 24) 0.953
HYP-PRAC-2 25 9.68 4.15 7.80 4.92 2.30* (1, 24) 0.466

BPI, Brief Pain Inventory; HYP-8, participants who received eight face-to-face hypnosis treatments; HYP-PRAC-8, participants who received eight face-to-face hypnosis treatments and recommendations
for home practice; HYP-PRAC-2, participants who received two face-to-face hypnosis treatments and recommendations for home practice; PSQI, Pittsburgh Sleep Quality Index.
*p < 0.05.
**p < 0.001.

Sleep quality index (mean ± SE) BPI pain interference (mean ± SE) BPI pain intensity (mean ± SE)

C
B
A

0
10
20
30
40

0
7
14
21
0
25
50
75
100
23.5
26.0

10.6
11.2
52.8
56.8

Pretreatment

back; BPI, Brief Pain Inventory.

ALL-HYP
Pain intensity

8.1
9.4
Sleep quality
Pain interference
14.7
21.6

31.0
49.6

Post-treatment

BIO-8
8.4
10.7
16.3
20.8

34.9
46.0

6-Month follow-up
G. Tan et al.

cated a large and significant time main effect

tically significant time main effect (F = 11.22;

sleep quality. The ANOVA revealed a large and statis-
cant time × group interaction effect (F = 3.24; p =

© 2014 European Pain Federation - EFIC®

The results of paired t-tests for pretreatment to post-
p < 0.001; ηp2 = 0.127) and a non-significant time ×
similar results for pain interference. The ANOVA indi-

Figure 2 Comparison of ALL-HYP (n = 61) and BIO-8 (n = 18) groups for

group interaction (F = 1.67; p = 0.192; ηp2 = 0.021).
0.042; ηp2 = 0.040). Fig. 2C presents the results for
(F = 16.68; p < 0.001; ηp2 = 0.178) and a small, signifi-

received hypnosis treatment; BIO-8, participants who received biofeed-

ence and (C) sleep quality over 6 months. Note: ALL-HYP, participants who
maintenance of treatment effects on (A) pain intensity, (B) pain interfer-
G. Tan et al. RCT of hypnosis versus biofeedback for CLBP

A three time points. The ANOVA indicated a large and

40
Pain intensity
significant time main effect (F = 34.91; p < 0.001;
ηp2 = 0.376) and a non-significant time × group inter-
BPI pain intensity (mean ± SE)

30 action effect (F = 0.64; p = 0.640; ηp2 = 0.022). Fig. 3B

25.3
24.3
presents similar results for pain interference. The
20 21.5 18.4 ANOVA indicated a large, significant time main effect
19.3
13.9
17.3 (F = 33.54; p < 0.001; ηp2 = 0.366) and a non-
13.3 significant time × group interaction effect (F = 0.76;
12.9
10
p = 0.556; ηp2 = 0.025). Fig. 3C presents the means for
sleep quality. The ANOVA indicated a large and statis-
0 tically significant time main effect (F = 17.51;
p < 0.001; ηp2 = 0.232) and a non-significant
B
100 time × group interaction effect (F = 0.49; p = 0.747;
ηp2 = 0.016). The results of paired t-tests from pretreat-
BPI pain interference (mean ± SE)

Pain interference
75
ment to post-treatment and post-treatment to
follow-up for Fig. 3A–C are available only online as
62.5
51.1 Supporting Information Results S1. The results for
50 48.2
37.9 42.9 hypnotizability and number of home practice sessions
38.6 are available only online as Supporting Information
31.6
25 25.3 Results S2 and Supporting Information Table S1.
25.6

0
4. Discussion
C
21
Sleep quality 4.1 Effects of hypnosis on treatment outcomes
Sleep quality Index (mean ± SE)

We found support for the study hypothesis that par-

14
11.7
10.7 8.8
9.4
8.7
7 6.6
7.0
0 consistent with the literature and provide further
Pretreatment Post-treatment
HYP-8 HYP-PRAC-8
Figure 3 Comparison of HYP-8 (n = 15), HYP-PRAC-8 (n = 24) and HYP-
PRAC-2 (n = 22) groups for maintenance of treatment effects on (A) pain
intensity, (B) pain interference and (C) sleep quality over 6 months. Note:
BPI, Brief Pain Inventory; HYP-8, participants who received eight face-to-
face hypnosis treatments; HYP-PRAC-8, participants who received eight
face-to-face hypnosis treatments and recommendations for home prac-
tice; HYP-PRAC-2, participants who received two face-to-face hypnosis
treatments followed by six weekly brief telephone calls and recommen-
dations for home practice.
treatment and post-treatment to follow-up for
Fig. 2A–C are available only online as Supporting
Information Results S1.
Fig. 3A presents the means for pain intensity at pre-
treatment, post-treatment and the 6-month follow-up
for the three groups of hypnosis participants (n = 15 in
the HYP-8 group; 24 in the HYP-PRAC-8 group and 22
in the HYP-PRAC-2 group) who provided data at all
ticipation in self-hypnosis training would result in
greater reductions in pain intensity than participation
9.6 in a biofeedback intervention. We did not find support
9.1
for the hypotheses that hypnosis would be more effec-
tive than biofeedback for reducing pain interference
and improving sleep quality. The results are generally
6-Month follow-up albeit limited support to the efficacy of hypnotic anal-
HYP-PRAC-2
gesia (e.g. Montgomery et al., 2000; Patterson and
Jensen, 2003). When interpreting the findings, it is
important to keep in mind that we used an active
control condition. Compared with wait-listed or usual
treatment control groups, the use of active controls
makes it more difficult to find significant treatment
effects (Williams et al., 2012; web reference). Treat-
ment involving sEMG biofeedback has been shown to
be efficacious for pain management (e.g. Tan et al.,
2003). Moreover, Patterson and Jensen (2003) have
argued that relaxation training contains many
‘hypnotic-like’ components and noted that response
to relaxation training has been found to be associated
with hypnotizability. Our biofeedback intervention
contained two of the basic components of hypnotic
treatment (focused awareness, plus suggestions),
making it arguably a type of hypnotic intervention.
The lack of ongoing additional suggestions during
sEMG biofeedback may explain, at least in part, why

© 2014 European Pain Federation - EFIC® Eur J Pain 19 (2015) 271–280 277
RCT of hypnosis versus biofeedback for CLBP
the biofeedback treatment was somewhat less effective
than the hypnosis treatments. This small but consis-
tent difference in efficacy between biofeedback and
hypnosis has also been shown by others (Jensen et al.,
2009a). Future investigators might consider alterna-
tive control conditions for hypnosis trials, such as
patient education or cognitive therapy, both of which
tend to have minimal impact on pain intensity (Jensen
et al., 2011).
4.2 Clinical improvement in outcomes
To address questions regarding clinical improvement,
we performed responder analyses as recommended by
the IMMPACT group (Dworkin et al., 2008). We
found that clinically meaningful reductions (at least
30%) in pain intensity were reported by 52% of the
hypnosis participants and 36% of the biofeedback par-
ticipants. Although this difference was not statistically
significance, the direction lends support to the ANOVA
analysis.
4.3 Effects of hypnosis dose and
practice effects
We also explored the dose and practice effects of hyp-
nosis. Improvement in pain intensity, pain interfer-
ence and sleep quality did not differ significantly
among the three hypnosis groups. This finding sug-
gests that effective self-hypnosis training can be deliv-
ered at a very low cost (e.g. as little as two face-to-face
sessions with a therapist) along with hypnosis audio
recordings for home practice. We know of no other
psychosocial pain intervention that can be effectively
provided in as few as two sessions. Although the
results for clinically meaningful pain intensity reduc-
tion (i.e. ≥30%) were not statistically significant in this
sample, the direction of the results suggests that home
practice may improve the results. Further research is
needed.
4.4 Maintenance of treatment effects
Our study also assessed the longer term (up to 6
months) maintenance of the treatment effects. In
general, we found that the beneficial effects of hypno-
sis (both in terms of reductions in pain intensity and
pain interference) were maintained for at least 6
months post-treatment for all three hypnosis groups.
Moreover, there was no difference in maintenance
between the three hypnosis groups. The finding of
maintenance of benefits for at least 6 months post-
treatment is consistent with one previous study
278 Eur J Pain 19 (2015) 271–280
G. Tan et al.
(Jensen et al., 2009a) showing long-term mainte-
nance of hypnotic analgesic benefits in a sample of
individuals with chronic pain and disability. Discus-
sion of the results for hypnotizability and frequency of
practice is available online only as Supporting Infor-
mation Discussion S1.
4.5 Limitations
The study is limited by the fact that it is primarily
targeted on male veterans with a long-standing history
of generally severe chronic musculoskeletal low back
pain. Thus, the findings do not necessarily generalize
to non-veterans or to individuals with low back pain
of shorter duration. Second, we excluded individuals
with evidence for neuropathic pain, further limiting
the generalizability of the findings. Recent research
suggests that hypnosis may be even more effective for
neuropathic pain than it is for non-neuropathic pain
(Jensen et al., 2009a). Future researchers should
examine the potential moderating influence of pain
type on outcome.
Third, there was a high dropout rate (37%) among
the 159 participants who were randomized to a treat-
ment group. More than half (56%) of the 59 persons
who dropped out did so before attending any treat-
ment sessions. Although the withdrawal rate in our
study is high, it is comparable to another randomized
controlled study at another Veterans Affairs medical
centre (VAMC) examining the relative effectiveness of
behavioral therapy for chronic heart failure (Chang
et al., 2004; web reference). After consenting to par-
ticipate, 29% withdrew before beginning treatment.
Many veterans live a fairly long distance from VAMCs.
Common reasons for withdrawing from research
studies that require many visits include lack of trans-
portation, time and effort needed to attend, and finan-
cial costs of travel. Thus, higher dropout rates may
occur more frequently in VAMC research studies with
high participant burden conducted at veterans’
medical centres than in research conducted at sites
where most of the participants live nearby.
4.6 Strengths
In spite of the limitations, this study makes important
contributions to the field of pain management for
persons with CLBP. First, this study is one of very few
randomized controlled trials of self-hypnosis for this
population. Second, we examined the efficacy of a
very brief (two-session) treatment, thus addressing
the issue of the cost of treatment. Third, we assessed
long-term (6 months) outcomes.
© 2014 European Pain Federation - EFIC®
G. Tan et al.
Conclusions
This study demonstrated that individuals with CLBP
could benefit from learning self-hypnosis. Specifically,
significant and substantial reductions in pain intensity,
pain interference and improvement in sleep quality
were found for those assigned to each of the three
hypnosis treatment conditions. It is also noteworthy
that this is the first published study examining the
dose effect of self-hypnosis training, and we found that
this treatment could be effectively delivered with very
limited resources; specifically, with as few as two face-
to-face sessions.
This study also replicated the finding that it is pos-
sible to carry out a standardized self-hypnosis training
protocol that allows for treatment tailoring, in this
case with individualized hypnotic suggestions (Jensen
et al., 2009a,b; Tan et al., 2010). Chronic pain remains
a major issue related to significant financial costs and
suffering (Institute of Medicine, 2011); consequently,
this finding is important for the applicability of hyp-
nosis to clinical populations. Given the minimal cost,
the lack of significant adverse effects of this non-
invasive treatment, as well as its demonstrated effi-
cacy, our findings suggest that self-hypnosis might be
considered as a viable first-line treatment for the man-
agement of CLBP.
Author contributions
Gabriel Tan: PI of the research project. Took primary
responsibility for the design and implementation of the
study and for the design and interpretation of the data
analyses. Wrote the first draft of the Introduction, Methods
and Discussion sections, and provided significant editorial
input into the Results section; Diana H. Rintala: Co-PI of
the research project. Provided significant input into study
design and performed the bulk of the data analyses. Pro-
vided significant input into the interpretation of the results
and provided significant editorial input into the entire
paper; Mark P. Jensen: Provided significant input into the
study design, data analysis plan, and interpretation of the
results, and provided significant editorial input into
the entire paper; Tenley Fukui: Provided significant input
into the study design, wrote the treatment manuals in con-
sultation with co-authors, was the study clinician, and pro-
vided significant editorial input into the entire paper;
Donna Smith: Coordinated the research project and pro-
vided significant input into the development and imple-
mentation of the protocols; Wright Williams: Provided
significant editorial input into the entire paper, and served
as site PI for the completion of the study. All authors have
reviewed and are in agreement with the submission of this
article for publication in the European Journal of Pain.
© 2014 European Pain Federation - EFIC®
RCT of hypnosis versus biofeedback for CLBP
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Supporting Information
Additional Supporting Information may be found in the
online version of this article at the publisher’s web-site:
Discussion S1. Hypnotizability and frequency of practice.
Method S1. Measures.
Method S2. Statistical analysis.
Results S1. Maintenance effects within groups.
Results S2. Hypnotizability and frequency of practice.
Table S1. Spearman rho correlation coefficients of the rela-
tionship between number of practice sessions and change in
the outcome variables during the 8-week treatment period.
© 2014 European Pain Federation - EFIC®