Spine J. 2014 (Sep 1); 14 (9): 1879–1889 ~ FULL TEXT
Michele Maiers, DC, MPH, Gert Bronfort, DC, PhD, Roni Evans, DC, MS,
Jan Hartvigsen, DC, PhD, Kenneth Svendsen, MS, Yiscah Bracha, MS,
Craig Schulz, DC, MS, Karen Schulz, DC, Richard Grimm, MD, PhD
Northwestern Health Sciences University,
Wolfe-Harris Center for Clinical Studies,
2501 W. 84th St, Bloomington, MN 55431, USA
BACKGROUND CONTEXT: Neck pain, common among the elderly population, has considerable implications on health and quality of life. Evidence supports the use of spinal manipulative therapy (SMT) and exercise to treat neck pain; however, no studies to date have evaluated the effectiveness of these therapies specifically in seniors.
PURPOSE: To assess the relative effectiveness of SMT and supervised rehabilitative exercise, both in combination with and compared to home exercise (HE) alone for neck pain in individuals ages 65 years or older.
STUDY DESIGN/SETTING: Randomized clinical trial.
PATIENT SAMPLE: Individuals 65 years of age or older with a primary complaint of mechanical neck pain, rated =3 (0–10) for 12 weeks or longer in duration.
OUTCOME MEASURES: Patient self-report outcomes were collected at baseline and 4, 12, 26, and 52 weeks after randomization. The primary outcome was pain, measured by an 11–box numerical rating scale. Secondary outcomes included disability (Neck Disability Index), general health status (Medical Outcomes Study Short Form-36), satisfaction (7–point scale), improvement (9–point scale), and medication use (days per week).
METHODS: This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses. Blinded evaluations of objective outcomes were performed at baseline and 12 weeks. Adverse event data were collected at each treatment visit.
RESULTS: A total of 241 participants were randomized, with 95% reporting primary outcome data at all time points. After 12 weeks of treatment, the SMT with home exercise group demonstrated a 10% greater decrease in pain compared with the HE-alone group, and 5% change over supervised plus home exercise. A decrease in pain favoring supervised plus home exercise (HE) over HE alone did not reach statistical significance. Compared with the HE group, both combination groups reported greater improvement at week 12 and more satisfaction at all time points. Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short- and long-term. No serious adverse events were observed as a result of the study treatments.
CONCLUSIONS: Spinal manipulative therapy (SMT) with home exercise resulted in greater pain reduction after 12 weeks of treatment compared with both supervised plus home exercise (HE) and HE alone. Supervised exercise sessions added little benefit to the HE-alone program.
TRIAL REGISTRATION: ClinicalTrials.gov NCT00269308
From the FULL TEXT Article:
Neck pain (NP) is a considerable healthcare problem for individuals of all ages. [1, 2]
Approximately 20% of individuals 70 years of age and older experience NP at least
once a month;  among this population, NP is associated with other health complaints
and poorer self-rated health.  Considering the rapid growth of the elderly population,
the socio-economic and public health consequences of NP are serious.  It has been
recommended that commonly used pain medications should be tempered in the elderly
due to the risk of drug interaction and associated co-morbidities.  This increases the
need to investigate safe and cost-effective approaches to managing neck pain
conditions without medications, while aiming to improve the general health and quality
of life among the elderly.
Recent reviews of conservative therapies for mechanical neck disorders support the use
of manual treatment, including manipulation or mobilization, and exercise. [6–8]
However, this research has primarily focused on non-elderly individuals; there have
been no studies to date that evaluate the effectiveness of these therapies for NP in
seniors. Further, non-intensive interventions like home exercise have performed
similarly to supervised exercise and manual therapy in past studies, [9, 10] but have not
been tested in an elderly population.
The purpose of this randomized clinical trial was to determine the relative short- and
long-term effectiveness of spinal manipulative therapy with home exercise (SMT with
home exercise), supervised rehabilitative exercise and home-exercise (supervised plus
home exercise), and home exercise alone for patients 65 years and older with neck
pain, using change in average pain during the past week as the primary outcome.
This randomized clinical trial was conducted from 2004 to 2007 at the Wolfe-Harris
Center for Clinical Studies at Northwestern Health Sciences University in Minneapolis,
Minnesota. Approval was granted by the institutional review boards of all participating
institutions and informed consent was obtained from all participants.
Detailed explanations of study methods are reported elsewhere. 
Criteria for inclusion were 65 years of age or older, independent ambulation and
community dwelling, a stable pain medication plan (no changes in the prior month), and
a score of 20 points or greater on the Folstein Mini-Mental State Examination. 
Individuals had to have a primary complaint of weekly, mechanical neck pain, including
stiffness or tenderness originating from the spinal joints, discs, vertebrae, or soft tissue,
with or without radiation or neurological signs, with an average rating of ≥ 3 (0–10) over
the previous 2 weeks. [13, 14]
Randomization and Blinding
A restricted randomization sequence was computer generated with a 1:1:1 allocation
ratio using randomly permuted block sizes, which were stored in a locked cabinet
concealed from the study team. As individuals became eligible, sequentially numbered
opaque envelopes with treatment assignments were drawn in consecutive order and
opened by study staff in the presence of the study participant.
The nature of the interventions precluded blinding of patients and providers. Patient18
rated outcomes were measured by self-report questionnaires independent of staff
influence. Biomechanical assessment was conducted by study staff blinded to treatment
assignment. Patient expectations of improvement for each intervention was collected
prior to randomization using a 5–point scale (1=much better, 2=better, 3=no change,
4=worse, 5=much worse). 
All participants in the study received 12 weeks of care, which is described in more detail
elsewhere.  Standardized forms were used to document the details of treatment.
Adverse events were inquired about at each visit; documentation included
categorization for seriousness and relatedness to treatment
(http://ohsr.od.nih.gov/index.html). Providers, trained in study protocols, were monitored
for compliance through chart audits, observations, and team meetings.
Home exercise consisted of four, 45–60 minute sessions provided by 9 practitioners
certified by study investigators to instruct the study intervention (exercise therapists or
chiropractors).  Participants were given basic information regarding pain
management, including postural instructions and practical demonstrations of body
mechanics for lifting, pushing, pulling, and rising from a lying position. To supplement
consistent messaging to stay active, simple exercises were prescribed to do daily at
home, to improve flexibility, balance, and coordination, as well as enhance trunk
strength and endurance.  These included head retraction, cervical flexion and
extension (either isometric or using resistance tubing), push-ups, chest press and
seated upright rows with resistance tubing, and full spine flexion/ extension motion
cycles. Exercises were individualized based on patient ability and included graded
progressions once 20 repetitions of an exercise could be done with proper form.
Spinal Manipulative Therapy with Home Exercise
Participants allocated to this group received spinal manipulative therapy (SMT) in
addition to home exercise (described above).  Care was delivered by 11
chiropractors with a minimum 5 years of clinical practice. Pain provocation  and
static/motion palpation  findings were used to determine areas of treatment in the
cervical spine. The focus of treatment was manual SMT, aimed at inducing joint motion
using a diversified, thrust technique, and mobilization, a low velocity type of joint
oscillation.  The type of SMT and the force applied were modified to accommodate
the age and physical condition of the study participants. Adjunct therapies common to
clinical practice included limited use of light soft tissue massage, assisted stretching,
and hot and cold packs applied to the cervical and upper thoracic area. The number and
frequency of treatments was determined by the individual chiropractor, with a maximum
of 20 visits.
Supervised Rehabilitative Exercise plus Home Exercise
Participants assigned to this group participated in supervised rehabilitative exercise in
addition to home exercise (described above).  A series of 20, one hour exercise
sessions were supervised by one of 9 exercise therapists certified to deliver the
intervention by study investigators. Prescribed exercises were individualized in terms of
intensity (i.e., load and repetitions) according to patients’ abilities. Similar to the home
exercise program, emphasis was placed on performing high repetitions of low load
exercises with the aim of increasing flexibility, endurance, strength, and balance.
Supervised session expanded on the home program with supplementary exercises and
progressions to challenge neck and upper torso strength and endurance, as well as
balance, to participant tolerance. Exercise therapists supervised each session to
monitor form, modify exercises, and provide encouragement to complete repetitions.
Patient self-report outcomes were collected at baseline and 4, 12, 26, and 52 weeks
after randomization.  The primary outcome measure was the average level of neck
pain over the previous week, as measured using an 11–box numerical rating scale (0 =
no pain, 10 = the worst pain possible).  Self-report secondary outcomes included
neck disability, general health status, satisfaction, global improvement, duration of
medication use. Neck disability was measured on the Neck Disability Index, containing
10 items relevant to NP on a scale of 0 (no disability) to 5 (maximal disability); the total
score out of 50 is converted to percentage points.  General health status was
measured by the Medical Outcomes Study SF-36  and separated into mean
physical and mental component scores. Satisfaction with care was measured on a 7–
point scale from 1 (completely satisfied, couldn’t be better) to 4 (neither satisfied nor
dissatisfied) to 7 (completely dissatisfied, couldn’t be worse). 
Global improvement in NP was measured on a 9–point scale from 1 (100% improvement) to 5 (0%
improvement) to 9 (100% worse).  Duration of medication use was the number of
days during the previous week (0–7) that participants reported taking medication for their
NP. [25, 26] Biomechanical outcomes including cervical motion, strength and endurance,
as well as hand grip strength and “Timed Up-and-Go” tests [27, 28] were collected at
baseline and week 12.  Cervical spine dynamic motion was measured using the
Zebris CMS-HS Spine Motion Analyzer (Zebris Inc.,Isny im Allgau, Germany). 
Isometric flexion and extension strength was measured by a computerized load-cell
transducer dynamometer (Promotron 3000, Promatek Medical Systems, Joilet, IL).
Static endurance was measured with participants holding their head in flexion while
supine, and in extension while prone, while holding 50% maximum voluntary contraction
resistance until muscle failure.  Hand grip strength was measured using a hydraulic
dynamometer (Jamar Hand dynamometer, Sammons Preston U.S.A., Bolingbrook, IL).
Based on change scores in average pain intensity from previous studies dealing with
the effectiveness of SMT and exercise in chronic NP patients, we anticipated a
difference between the groups of 8 percentage points in pain, the primary outcome. This
translates to a near medium effect size of f = 0.24 in both the short- and long-term. 
With an alpha level of 0.05, 70 participants per group provided power of 0.88 to detect
this difference. To allow for a drop-out rate of 15%, 240 participants (80 participants per
group) were required.
The primary analysis evaluated changes in pain, the main outcome measure, between
the 3 groups at week 12. In secondary analyses, differences in pain were also
calculated at weeks 4, 26, and 52. Longitudinal analyses were performed for the short
term (weeks 4 and 12 data), and the long-term (weeks 4, 12, 26, and 52 data). All
analyses used linear mixed model analysis, with the Tukey-Kramer adjustment for
multiple comparisons (MIXED procedure in SAS 9.1).  Baseline variables
considered to be clinically different between groups were used as covariates in analysis
if they were found to be correlated with change in pain (r = 0.5  or greater). Additional analyses were conducted to assess group differences in secondary
outcomes at individual time points and through the short- and long-term, using the
methods described above. Intention-to-treat analysis included all participants with
baseline data regardless of loss to follow up.
Multivariate analyses were conducted to assess consistency in the direction of short
and long-term differences between groups in terms of patient oriented outcomes, while
controlling for the problem of spurious significant findings due to multiple tests. 
Outcomes included in these analyses were pain, disability, general health, satisfaction,
and improvement. To take into account increasing time intervals between assessments
and to represent the cumulative burden of NP over time, “areas under the curve” were
calculated for each participant for all patient-oriented outcomes and tested for group
differences with ANOVA.  Change scores for biomechanical outcomes were
analyzed for group differences from baseline using linear mixed model analysis.
To facilitate the interpretation of the magnitude of group differences, responder
analyses were conducted using 30, 50, and 75% reductions in pain from baseline [34–36] and compared by group with 95% confidence intervals.
Sensitivity analyses were performed to reflect two different ways of handling missing
data. The first method eliminated any participant with incomplete data and restricted
analyses to those that remained; the second method used the SAS 9.1 procedure MI to
impute values for both patterned and randomly missing data. Analyses were conducted
to test assumptions of data normality and homogeneity for analysis of variance and
covariance; any data not meeting these assumptions were rank transformed.
Data were prepared for analysis by a data manager blinded to group status.
Recruitment, Retention, and Baseline Data
Of 593 individuals evaluated, 241 were enrolled in the study. A summary of patient
recruitment, participation, and attrition is shown in Figure 1. Baseline demographic and
clinical characteristics were comparable across groups with two exceptions: grip
strength and expectations (Table 1). Neither was found to be correlated with the primary
outcome and thus were not included as covariates in the analyses.
Patient-rated outcomes for each time point and between-group comparisons are shown
in Tables 2 and 3.
There were statistically significant between-group differences in self-reported pain at 12
weeks in favor of the SMT with home exercise group compared to both the supervised
plus home exercise, and home exercise alone groups. The greatest difference was
between the SMT with home exercise and home exercise alone groups (approximately
percentage points). A decrease in pain favoring the supervised plus home exercise
group compared to the home exercise alone group was similar in magnitude to the
contrast between the SMT with home exercise and supervised plus home exercise
groups but was not statistically significant. The short-term longitudinal analysis showed
more pain reduction in the SMT withHE group compared to both the supervised plus
home exercise, and home exercise alone groups. The majority of this is based on
between-group differences at the week 12 time point.
There were no significant between-group differences in pain during post treatment
follow-up at weeks 26 and 52. While the long-term longitudinal analysis resulted in a
statistically significant between-group difference in pain in favor of the SMT with home
exercise group over the home exercise alone group, the magnitude of difference at
week 52 was one-third of what it was at 12 weeks. Similar to the short-term analysis,
the long-term difference can be attributed mainly to between-group differences at the
week 12 time point. Area under the curve (AUC) analyses showed no statistically
significant between-group differences in terms of pain through either the short- or longterm.
There were statistically significant group differences in terms of improvement favouring
the SMT with home exercise group over the home exercise alone group at week 12 and
week 26, and favouring the supervised plus home exercise group over the home
exercise alone group at week 12. Both combination groups were more satisfied than the
home exercise alone group at all time points. The SMT with home exercise group
reported a statistically significant decrease in duration of medication use compared to
both groups at week 52. AUC analysis showed an advantage of the SMT with home
exercise group over the supervised plus home exercise group in terms of medication
use in the long-term. There were small improvements across all groups in terms of
disability and general health status, but nearly all between-group differences failed to
reach statistical significance. There were no significant between-group differences in
biomechanical outcomes (Table 4).
The multivariate analysis showed a statistically significant advantage of the SMT with
home exercise group over the home exercise alone group in both the short- and long
term, consistent with the pattern of results of the linear mixed model analysis.
Figure 2 shows the proportions of participants by group who achieved or exceeded 30,
50, or 75% reduction in pain at the week 12 and 52 follow-up time points. Group
differences clearly favoured SMT with home exercise over home exercise alone at week
12. These group differences were no longer present at week 52.
Missing Data Analysis
Of the 241 participants randomized, 228 (95%) provided data on the primary outcome,
pain, at all time points; 239 provided data through week 12. Two participants died
before completing the trial and six withdrew due to competing co-morbidities (3) and
personal reasons (3). Results of sensitivity analyses were nearly identical to those from
the primary analyses.
The average number of chiropractic visits was 15.1 (range 5–19); six of the 80
participants randomized to this group were considered to be non-compliant with their
treating chiropractors’ recommendations or attendance at the four home exercise
program sessions. The average number of supervised exercise sessions was 16.6
(range 0–19), with four of the 82 participants considered non-compliant (attending fewer
than 80%, or 16, sessions). In the group receiving HE alone, five of the 79 randomized
participants did not attend the four instructional sessions required for compliance
(Figure 1). The frequency with which participants conducted exercises at home was not
measured in any of the groups.
No serious adverse events were observed as a result of the study treatments. One
severe, unexpected adverse event related to treatment was reported in the supervised
plus home exercise group: a participant fell and fractured his radius while performing
study-related exercises during a supervised visit. Non-serious, expected adverse events
were frequently reported in all three treatment groups (56% in the SMT with home
exercise group; 90% in the supervised plus home exercise group; 58% in the home
exercise alone group). Relatedness of these events to study treatment was not
assigned, nor were non-serious events graded in terms of severity. They typically
required little to no modification of activity or only symptomatic therapy. The most
common adverse events in all three groups included an aggravation of neck symptoms,
muscle soreness, lower and upper extremity joint pain, back pain, and stiffness.
The SMT with home exercise group showed a greater decrease in pain by the end of
the 12 week treatment period compared to both the supervised plus home exercise,
and home exercise alone groups. There were small, non-significant differences between
the supervised plus home exercise and home exercise alone groups at all time points.
The SMT with home exercise group rated their improvement higher than the home
exercise alone group both at the end of treatment and during follow-up. The combined
treatment groups reported greater satisfaction than those in the home exercise alone
group at all time points. Reported adverse events were common and primarily
musculoskeletal in nature, similar to what is reported in the literature. [37, 38]
The advantage the SMT with home exercise group demonstrated over the other two
groups must be considered from both individual and group perspectives.  Among
neck pain sufferers, a change in pain of 2.5 on a 0–10 scale is considered a minimal
clinically important difference.  IMMPACT consensus recommendations for chronic
pain reporting suggest changes of approximately 2 points, or 30–36% from baseline,
indicate “meaningful” decreases in pain and a decrease of over 4 points, or 50% from
baseline, is considered “substantial.”  From an individual perspective, nearly two
thirds of those who received SMT with home exercise reached what is considered a
substantial decrease in pain after 12 weeks, with three quarters of the group achieving
meaningful change.  The proportion of individuals reaching 50% reduction in pain
after 12 weeks of treatment is greater in the SMT with home exercise group than in the
home exercise alone group.
This should be interpreted with caution, as no absolute
standards for meaningful differences between groups of responders currently exist. 
From a group perspective, the magnitude of pain reduction in the SMT with home
exercise group in this study is larger than that previously measured by our team among
20–65 year olds receiving similar treatment,  which is also larger than those
reported in a review of manual therapies for neck pain in the general population.  In
addition to the outcomes reported in this study, the lack of serious adverse events,
tolerability, and high adherence to care suggest the combination of SMT with home
exercise is an effective treatment in seniors with chronic neck pain. 
The majority of research on chronic musculoskeletal conditions to date has focused on
short courses of care, as opposed to long-term management. This may be short
sighted, as NP is often chronic or recurrent in nature and part of a constellation of co
morbidities.  In complicated cases such as these, a more appropriate therapeutic
approach is probably to focus on management of exacerbations and functional
limitations, as opposed to resolving the condition. This theory may explain, in part, why
there is no clear gold standard for treatment for any age group. [40, 41] The clinical and
cost-effectiveness of a management strategy has yet to be explored in an elderly
population with spine-related complaints. A study to test this question is currently
underway (ClinicalTrials.gov Identifier NCT01057706).
Neither of the combined treatment groups showed an advantage over home exercise
alone in terms of biomechanical outcome measures. This is of particular interest for the
supervised rehabilitative exercise group, which was designed specifically to improve
motion and endurance using high repetitions of low resistance exercise. Despite a lack
of difference between the supervised plus home exercise, and home exercise alone
groups in biomechanical outcomes, supervised exercise may have other benefits in an
aging population, including reduced kinesiophobia, or fear avoidance. These outcomes
were not a focus in this study and should be considered in future trials.
While some literature suggests rehabilitative exercise may be effective for NP in the
non-elderly,  it did not result in significantly better outcomes compared to home
exercises alone in the senior patients in this study. This may be due to our focus on low
resistance exercise, versus higher resistance approaches used in other studies.
Research on SMT for NP in the non-elderly adult population suggests it is most effective
when combined with exercise. [6–8] The results of this study do not allow us to deduce
whether HE provided any additional benefit compared to SMT alone; however, advice
and recommendations for home exercises are commonly employed by practitioners who
use SMT;  the combination of these therapies in this trial reflect typical clinical
Strengths and Limitations
This study met standards set by Consolidated Standards of Reporting Trials. [43, 44]
Compliance with treatment and follow-up rates for data collection were high, and there
was no difference in adherence between groups. Active interventions preclude the
ability to blind participants and providers. Further, variation between groups in provider
attention and the impact of non-specific effects were not controlled for in this trial. While
these may contribute to some of the treatment effect, the pragmatic design of this study
more accurately reflects actual treatment encounters associated with these therapies.
SMT with home exercise resulted in greater decreases in pain after 12 weeks of
treatment compared to both the supervised plus home exercise and the home exercise
alone groups. Supervised exercise sessions appear to add little to home exercise alone.
There were no long term differences in pain between groups.
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