Man Ther. 2016 (Dec); 26: 183–191 ~ FULL TEXT
Michele J Maiers, Maria A Hondras, Stacie A Salsbury,
Gert Bronfort, Roni Evans
Wolfe-Harris Center for Clinical Studies,
Northwestern Health Sciences University,
Bloomington, MN, USA.
BACKGROUND: Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care.
METHODS/DESIGN: This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain.
DISCUSSION: Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures.
TRIAL REGISTRATION: ClinicalTrials.gov
From the FULL TEXT Article:
Spinal conditions are among the leading causes of pain and
disability worldwide (Vos et al., 2012). Back-related leg pain (BRLP)
or sciatica is a prevalent and costly variation of low back pain that
remains understudied (Kent and Keating, 2008; Hill et al., 2011;
Kongsted et al., 2012; Konstantinou et al., 2013). While BRLP is
commonly treated with prescription medications, injections, or
surgery, little evidence supports the routine use of these interventions
(Jacobs et al., 2011; Pinto et al., 2012a,b). Further, patients
may prefer more conservative options, including spinal
manipulation, exercise, or self-care (Sherman et al., 2004; Lurie
et al., 2008; Bederman et al., 2010; Lyons et al., 2013), yet
research investigating those interventions is limited (Leininger
et al., 2011). A recent controlled clinical trial by our group examined
whether spinal manipulative therapy (SMT) added to home
exercise with advice (HEA) was advantageous over HEA alone
among chronic BRLP sufferers (Bronfort et al., 2014). Patients who
received SMT & HEA reported greater improvements in most
patient-rated outcomes, including pain and disability, after 12
weeks of care. Medication use, global improvement, and satisfaction
remained significantly different between groups after 1 year.
Those who received SMT & HEA reported significantly greater
satisfaction with their care at weeks 12 and 52, compared to those
who received HEA alone.
Satisfaction is a recommended patient-centered outcome for
clinical practice and research (Dworkin et al., 2005; Browne et al.,
2010), and is also a topic of growing interest for spine care practitioners
and patients (Borkan et al., 1995; Skelton et al., 1996;
Verbeek et al., 2001, 2004; Evans et al., 2003; Corbett et al., 2007;
Slade et al., 2009a,b,c; Snelgrove and Liossi, 2013). While patients'
perceptions of their medical encounters can positively influence
health outcomes (Fischer et al., 1999), uncertainties
surrounding the meaning and measurement of satisfaction (Fenton
et al., 2012; Haldeman, 2012; Godil et al., 2013; Leininger et al.,
2014; Breen and Breen, 2003) limit its utility as an outcome.
Further, efforts to incorporate patient preferences into evidencebased
healthcare are undermined when their satisfaction is not
considered or understood. (IOM, 2010). Research to understand
what treatments patients perceive as worthwhile for treating
conditions with greater risk of poor outcomes and higher costs, like
sciatica (Hill et al., 2011), may address this knowledge gap.
Treatment options and healthcare costs for spinal conditions have
climbed without evidence of substantive improvement in patient
outcomes and satisfaction (Martin et al., 2008, 2009; Chou et al.,
2009; Delitto et al., 2012). To address these concerns, we conducted
a qualitative study alongside the clinical trial (Schulz et al., 2011;
Bronfort et al., 2014) to investigate patients' satisfaction with conservative
treatments for BRLP. Our research questions were:
What factors do individuals with BRLP consider when determining
satisfaction with care?
What characteristics of SMT and home exercise do participants
like and dislike?
What aspects of care contribute to participants' perception that
the care they received was or was not worthwhile?
A two-site, controlled clinical trial enrolled 192 individuals with
chronic BRLP to receive 12 weeks of SMT & HEA or HEA (Bronfort
et al., 2014). Eleven chiropractors delivered SMT and 13 providers
(7 chiropractors, 5 exercise therapists and 1 personal trainer)
delivered HEA. Institutional Review Boards at the research centers
approved the study. Participants provided written consent.
All participants received home exercise advice during four, onehour,
individual sessions (Schulz et al., 2011). Information included
BRLP causes, encouragement to return to normal activities, and exercise
instructions to enhance mobility and trunk endurance. Participants
were encouraged to perform home exercises daily.
Participants allocated to SMT & HEA attended up to 20 treatments,
with the number and frequency of visits left to the discretion of the
chiropractor. The primary treatmentwas SMT; soft tissue techniques,
mobilization, heat/cold therapy facilitated the manual therapy.
Participants were invited to complete an audio-recorded individual
interview at 12-weeks, following collection of self-report
outcomes. Ten study coordinators, trained in interviewing best
practices to enhance consistency (Newman and Benz, 1998), conducted
the 15-min, in-person interviews at their respective institutions.
No interviewer provided study interventions.
Participants were assured confidentiality to allow them to speak
without repercussion (Britten, 1996). A semi-structured interview
with open-ended questions (Table 1) provided standardized data
collection across sites. The terms ‘chiropractic treatments’ and
‘home exercise program’ differentiated between treatments. Interviews
were transcribed verbatim. Research staff compared a
random sample of transcripts to the audio-recordings to assess
accuracy before import into NVivo® v9.2 (QSR International Pty Ltd,
Victoria, Australia) for data management and analysis.
We used deductive and inductive content analysis to identify
themes and summarize responses to individual questions (Lincoln
and Guba, 1985; Bauer, 2000). An interdisciplinary team comprised
of three chiropractors (MM, MH, RE) and a registered nurse (SS), all
who had advanced research training, conducted the analysis; no
author conducted any interviews. The codebook was based on previous
studies by two authors (RE, MM) in similar populations (Evans
et al., 2003; Haanstra et al., 2013). MH and MM conducted the
analysis, reading and coding interviews independently, thenmeeting
every 5e10 interviews to reach consensus. The codebookwas refined
iteratively, based on emergent themes and the population-specific
context (Bauer, 2000). Methodological decisions also were documented
(Lincoln and Guba, 1985). SS, who was not involved in the
parent trial, conducted quality assurance checks on a random 10% of
coded interviews after sets of 50 interviews. These quality assurance
checks did not add new codes but clarified coding nuances between
the primary analysts (<5% of coded passages). RE and SS adjudicated
areas where consensus was not reached (<1% of coded passages).
The frequency of each theme was quantified and representative
quotations selected (Bauer, 2000; Creswell and Plano Clark, 2011).
Information was organized into a hierarchy of broad themes, which
represented concepts in their general sense, and subthemes. We
highlighted between-group differences in theme frequency when
considered clinically relevant, and identified themes that emerged
across different questions in the interviews that provided context for
the analysis of participants' responses.
A total of 174 (91%) participants completed interviews (Figure 1). Of
the 18 non-participants, three (2 HEA, 1 SMT & HEA) completed the
12-week questionnaires,11 (8 HEA, 3 SMT & HEA) failed to return to
the clinic and 4 discontinued participation due to adverse effects (2
HEA, 1 SMT & HEA) or co-morbidities (1 HEA). Table 2 displays
demographic and baseline clinical characteristics of participants.
diagram for back-related
leg pain trial.
Demographic and clinical characteristics of participants who completed qualitative interviews.
When participants considered factors underlying their satisfaction,
the most cited themewas interaction with others (n = 120),
including study providers and research staff (Table 3).
Number of participants indicating determinants of satisfaction, by parent theme and most frequent subthemes.
SMT & HEA participants identified these factors more frequently than HEA participants:
“The professionalism really made a difference with me. Everybody
was very professional, very knowledgeable. They do their job, and
they showed genuine concern about how I felt.”
(10068 SMT & HEA)
Perceived treatment effect (changes in general condition, BRLP,
biomechanical function) was noted by 90 participants. While
SMT & HEA participants (n = 52) commented on a general treatment
effect, the groups were similar in noting specific change or
lack of change in their pain, leg symptoms, and function. Some
individuals expressed a clear relationship between satisfaction and
“My pain level or physical health at the end”
Others provided less tangible descriptions:
“The way I was feeling every morning.”
(10203 SMT & HEA).
Participants also mentioned the nature of treatment (n = 66) as
a factor in their satisfaction. This included quality of care as noted
by SMT & HEA participants (n = 47), and the supervision or instruction
during the exercise program mentioned by HEA participants
(n = 17). Information was another component of satisfaction
(n = 48), particularly for HEA participants (n = 29) as compared to
the SMT & HEA group (n = 19):
“I took into account mainly the information that was given to me…
specifically the back pain… the origin and how I could reduce it.
What kinds of things could I do for the long term? I think that's
what probably what interested me the most.”
Other themes taken into account when determining satisfaction
included appointment management (n = 32), expectations of care
(n = 23), and the overall experience of the research study (n = 16).
Perceptions of home exercise with advice
Participants liked the perceived treatment effects of HEA (n = 63), noting the general
effects of exercise:
“Just doing them, it certainly was helping”
“what I liked is I felt better”
liked how HEA impacted biomechanical function (n = 18), pain
(n = 8), and physical health (n = 7):
“...I just felt like I was getting my core stronger. I didn't even know I
could use my abdominal muscles anymore. But (the therapist) got
me doing sit-ups and that helped I think.”
Participants expressed appreciation for the convenience of doing
HEA at their own pace (n = 34), the program structure which
created a habit of exercise (n = 26), interactions with exercises
therapists (n = 14), and information they received (n = 6):
“I think that it kind of gets you going in the morning and it just is
good for your back. It's good for you. And if I hadn't come here, I
wouldn't have been doing them.”
While 40 participants stated there was nothing about HEA they
liked least, many participants (n = 47) expressed a dislike for the
self-discipline required by the HEA program:
“It required discipline and I'm not a real disciplined person... I had
to work at keeping that as part of my routine.”
Many participants were divided in their valuations of HEA
specifics. While some participants liked the exercise handouts,
others preferred the information be provided in another format.
Some participants stated the exercises offered an appropriate
degree of challenge, others thought specific exercises were too
hard or too easy. For some, the amount of individualized supervision
from the therapists was sufficient, while for others either
more or less contact was desired. Participants also differed in
whether they liked or disliked the ‘dose’ of HEA or the time
“…the types of exercises that were given and then explaining how
to do them, when to do them… that process I think has helped…
making the commitment that, yep, that's a daily thing that's going
to be done.”
(14539 SMT & HEA)
“I guess trying to find a consistent time to do things. That's not
always easy to do because my schedule's not the same from day to
(14087 SMT & HEA)
Perceptions of chiropractic treatments
Table 4 also depicts participants' likes and dislikes of chiropractic
SMT. Participants noted the perceived treatment effects (n = 60) as
themost liked aspect of SMT:
“I always felt really good right after being adjusted.”
(13576 SMT & HEA)
Patient-provider interactions were viewed favorably by many participants, which reflected perceived competence, personal attributes, and the approach of providers:
“It's more a personal emotional thing, than a physical thing, it was
again that [provider] was so extremely attending to me. He was
always, really trying to see the person in me, and work with that,
and seek out things. This was what I enjoyed most that I was taken
(13979 SMT & HEA)
Some participants liked the information they received (n = 13),
including the cause of their BRLP or treatment options. Others
appreciated specific elements of chiropractic treatments (n = 12):
“The flexing of the spine and the stretching of the spine were the two
things that really got me loosened up and made me feel like I could
stoop over, walk normal, not drag my one leg...”
(10009 SMT & HEA)
Fifty-one participants said there was nothing they liked least
about SMT. Eight participants disliked the frequency, time
commitment, or elements of appointment management:
“I have to drive here so far and so by the time I got here I was stiff.
[The problem] wasn't really the actual adjustments, it was just that
getting here was the biggest hassle.”
(SMT & HEA 15047)
One participant expressed dislike having seen different providers
due to scheduling concerns:
“I felt that maybe some days that because it wasn't the same individual
every time, that, the quality was different. Not that it was
any worse, it was just different.”
(10013 SMT & HEA)
Study care was considered worthwhile by 152 (87%) participants,
while only three participants said the care was not
worthwhile. Eighteen participants replied that some aspects of
the care were worthwhile, while other aspects were not
(Figure 2). One audio recording did not include a response to the
last question. Two of three participants who answered “no”
and 13 of the 18 participants who answered “yes/no” to
whether the study treatments were worthwhile were from the
Perceived treatment effect (n = 117) was the most frequent
reason participants evaluated the worthwhile nature of study care
as they did, particularly for those receiving SMT & HEA. As one
“It took away my pain. It gave me back a life. When you're in pain so much of the time, it affects your whole... everything. I have a new outlook on life now.”
(13091 SMT & HEA)
Perceived treatment effects also were important for a participant who did not consider care worthwhile:
“Just nothing changed. [My] leg stayed the same, lower back got a little worse.”
(14668 SMT & HEA)
Participants who rated care as worthwhile or partially so valued their interactions with providers and staff (n = 52) and the information provided about their BRLP condition (n = 34):
“... It helped me to exchange and hear a doctor's opinion, a doctor who has a lot of experience with what I amgoing through. So it was so precious to me to get the feedback. And, realistically hear what the outcome could be or what can be done, what cannot be done. It was the exchange that I got.”
(13979 SMT & HEA)
Participants who deemed study care as not worthwhile or only partially so stated preferences to receive SMT or more supervised HEA (n = 2):
“Yeah, I guess to be honest I was hoping to be in the chiropractic group... I've done physical therapy and had about the same results, so I was hoping for the other component.”
SMT & HEA participants who said the care was not worthwhile (n = 4) cited previous experiences with chiropractic or had unmet preferences for muscle work or manipulation to other spinal
Other notable themes
Body awareness (n = 41) and emotional well-being (n = 28) were mentioned as perceived treatment effects, neither of which were captured in the self-reported outcomes of the main trial. Body awareness was described as an attentiveness to the physical changes experienced in the body or an increased control over the
body and its function:
“[I learned] how to handle myself better... how to work my body better so I'm not causing my body more discomfort”
(13619 SMT & HEA)
Emotional well-being expressed a change in mood or attitude:
“It's added more quality to my life... I'm even happier!”
Others noted a change in outlook:
“It gave me back a normal life. When you're in pain so much of the time... your whole outlook is down. It's like I have a new outlook on life now.”
(13091 SMT & HEA)
For some, affirmation of their pain experience provided emotional relief:
“It gives me such confidence to know that I'm not just screwed up in the head (laughter)! I think that sometimes when you just keep hurting and hurting [you need to] just make sure.”
(10151 SMT & HEA)
Many participants (n = 53) mentioned their expectations regarding changes in pain, other symptoms, or co-morbid conditions:
“I really came in here thinking I'll probably be helped, but I won't be helped... to where I'll be pain free.”
(10009 SMT & HEA)
Other participants described pre-treatment expectations that differed from their trial experience:
“... when I first started, I remember going, ‘Well how is this going to make me better?’ cause they're just simple little exercises that you wouldn't think would help – and they do.”
(13211 SMT & HEA)
Participants stated their treatment either was (n = 14) or was not (n = 9) congruent with their beliefs about health, such as exercise adherence or preferences for non-pharmacological approaches:
“I am kind of a holistic person myself. I prefer not to just to take a pill if I have pain, I prefer to try to manage it in other ways.”
(13751 SMT & HEA)
Other participants (n = 21) discussed the random allocation process as tempering their perceptions of study treatment:
“My contacts were rather limited because I was in the exercise only.”
For others, the study was worthwhile because of treatment allocation:
“The... thing that... really helped me with my overall pain and the whole program was the fact that I got on both the physical exercise portion of it plus the chiropractic treatment and at the very beginning that chiropractic treatment I feel helped me considerably. I could see that the exercise was starting to take over and help the whole situation through.”
(10009 SMT & HEA)
Nine participants reflected on a personal transformation, using emotional words like “amazing” and “miracle” to describe the change in their pain. For others, participation changed their views of the chiropractic profession:
“I have to confess that as a nurse... initially chiropractic practice was not always recognized as something that was legitimate. I've learned it can be... this has validated it more. I would really like to know more about chiropractic practice.”
The importance of exercise for managing sciatica also was considered a transformative experience for some:
“... really opened my eyes on how much more activity I could do under the circumstances that I'm in... I didn't have any clue that I could be that active, and that I should be active.”
(13624 SMT & HEA)
This qualitative study elicited participants' perceptions of the
treatments they received during a clinical trial for BRLP. While
other qualitative studies have reported back pain patients' accounts
of treatment, (Hopayian and Notley, 2014), few have done so in a
population of individuals with BRLP, or evaluated specifically which
aspects of treatment patients value (Evans et al., 2003; Ong et al.,
2011; Hall et al., 2010; O'Keeffe et al., 2015).
Participants placed high value on their interactions with study
providers (chiropractors and exercise therapists) and research staff
when determining their satisfaction with care. This theme was
most common among those receiving SMT & HEA, and may help
explain the advantages observed in this group in terms of satisfaction,
pain, and disability in the parent trial (Bronfort et al., 2014).
While possibly an artifact of attention bias, this result indicates
participants' appreciation of the quality of interactions which
might be atypical to what they were accustomed to receiving (Slade
et al., 2009a; Gulbrandsen et al., 2010; Macneela et al., 2010; Toye
and Barker, 2012; Farin et al., 2013). This aligns with recent quantitative
(Hall et al., 2010) and qualitative (O'Keeffe et al., 2015) evidence
that suggests positive patienteprovider interactions in
rehabilitation settings are associated with reduced pain and
disability and higher satisfaction with care. Regardless, our parent
trialwas designed to assess the comparative effectiveness of adding
SMT to HEA as delivered in practice. The emphasis placed on the
patienteprovider interaction highlights the importance of contextual
effects of care and should be optimized rather than ignored.
Participants also valued the perceived treatment effect of study
interventions. Overall improvement and changes in pain or functional
status were common perceived effects that influenced
satisfaction with care and whether treatment was judged as
worthwhile. While patient-rated pain and disability are routinely
used as primary outcomes in back pain research (Deyo et al., 2014),
our interviews suggest that other patient-centered outcomes
should be considered in future studies. Some participants described
subtle changes in their body awareness and emotional well-being.
Others cited transformative experiences that changed their perceptions
of their health or healthcare. These findings are similar to a
large qualitative study of participants from five randomized studies
of complementary and alternative medicine (CAM) therapies (Hsu
et al., 2010), which identified several important domains not typically
addressed in low back pain research. These included changes
in emotional states, body awareness, relaxation, coping ability, and
patient activation. In another qualitative study that explored the
characteristics of massage therapy encounters that clients valued
(Smith et al., 2009), hands-on intervention facilitated positive
therapeutic encounters that influenced trust and psychological
comfort, modulating the experience and outcomes perceived from
the encounters. Based on these results and our own findings, researchers
should consider broadening the range of outcome measures
to better reflect patients' experiences with CAM therapies,
providing further insight into why patients choose CAM in
conjunction with or instead of conventional medical treatments.
Information received about the nature and care of BRLP was
important to participants in both groups; this theme was more
prevalent among HEA participants. Previous research suggests back
pain patients are often dissatisfied with the information received
from healthcare providers (McIntosh and Shaw, 2003). Ong et al.
(2011) demonstrated the need for patients with sciatica to ‘make
sense’ of their BRLP, to understand why they are experiencing such
symptoms, how their leg symptoms are related to the spine, and
the possible treatments and prognoses. Others have found that
patients with back pain assess high quality consultations as those
including both diagnosis-based information (e.g., examination results,
disease causation) and provider communication validating
patient experience (i.e., taking patient concerns seriously, discussing
psychosocial issues) (Staiger et al., 2005).
To empower individuals to self-manage BRLP symptoms, all
participants in the parent trial received instructions for home exercise
and advice about caring for spinal conditions. There is evidence
that self-efficacy is a predictor of outcome for
musculoskeletal care (Miles et al., 2011), and that low self-efficacy
for physical activity is an independent predictor of poor disability
outcome among individuals with back pain (Rasmussen-Barr et al.,
2012). Further, self-efficacy may predict patients' engagement with
exercise (Kroll et al., 2012). Acknowledging the importance participants
in our study placed on the interpersonal interaction and
information, clinicians would be wise to explore patients' selfefficacy
beliefs before recommending exercise, pain management,
or self-care strategies (Bair et al., 2009). Further, providers should
consider how to engage patients in pain self-management
(Matthews et al., 2015). A strong partnership with health professionals
may directly impact patients' ability to self-manage their
back pain (Fu et al., 2016). This may take the form of providers who
express empathy and concern, individualize recommendations, and
offer simple information about exercise and managing minor side
effects (Carnes et al., 2012; Matthias et al., 2012).
Strengths and limitations
These qualitative findings provide insights into the parent
clinical trial (Bronfort et al., 2014) and are strengthened by its large
sample size of 174 interviewees, sampled in two research centers.
Only 9% of trial participants did not provide interviews. Another
strength was our interdisciplinary team of data analysts who undertook
multiple coding rounds to reach 100% consensus, added
new themes to the initial codebook, and expanded our interpretations
to address broader issues in healthcare beyond
manual therapy. While time intensive, this process improved the
overall quality of the analysis and trustworthiness of results
Of interest is the distribution of themes between groups, an
important difference given healthcare professionals often advise
home exercise without providing hands-on therapy. Specifically,
the SMT & HEA participants offered more diverse comments to all
research questions compared to HEA participants. This finding may
be the result of differences in clinical encounters between groups. It
is uncertain whether this constitutes a limitation of the qualitative
study, or instead serves as an accurate reflection of additional
contextual factors experienced by SMT & HEA participants. We
were surprised that no mention was made of side effects as a ‘liked
least’ theme, given that 30% of the SMT & HEA group and 42% of the
HEA group reported them in the parent trial (Bronfort et al., 2014).
It is possible that patients' considered these minor enough to not
mention. Indeed, few individuals reported a lack of improvement or
worsening of symptoms in the study, leading to an underrepresentation
of those with more negative experiences.
Another limitation is the influence of participants' relationships
with research staff who served study coordinator roles, many of
whom conducted the interviews. Responses may have skewed toward
the positive to please researchers. Future studies might
engage participants in the analysis to confirm or disconfirm investigators'
codes and interpretations.
Finally, participants received study treatments at no monetary
cost. The authors suspect this may have influenced the affirmative
responses indicating that receiving study care was “worthwhile”
(Halpern et al., 2004; Grady, 2005). Participants may have identified
other determinants of satisfaction or held a different threshold
for whether care was worthwhile had they incurred a cost with
This qualitative study illustrates that patient satisfaction is
rooted in the quality of the patienteprovider relationship, although
perceived symptom improvements, relevant clinical information
about sciatica and its treatment, and the distinct qualities of those
treatments are important drivers of satisfaction for patients who
received non-pharmacological treatments for their back-related leg
pain. Global measures of satisfaction may not adequately represent
the range of patients' experiences and perceptions of spinal
manipulative therapy or home exercise. In addition to providing
insight to the quantitative results of the parent trial, these findings
suggest that tailored interventions to enhance patienteprovider
relationships may facilitate compliance and enhance satisfaction
This project was supported by funds from the U.S. Department
of Health and Human Services (HHS), Health Resources and Services
Administration (HRSA), Bureau of Health Professions (BHPr),
Division of Medicine and Dentistry (DMD) under grant number
R18HP07638, Chiropractic and Self-Care For Back-Related Leg Pain.
This information or content and conclusions are those of the author
and should not be construed as the official position or policy of, nor
should any endorsements be inferred by the U.S. government, HHS,
HRSA, BHPr or the DMD.
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