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Results. At the primary end point, significant effects favored real dry needling over © 2014 American Physical Therapy
Association
sham dry needling for pain (adjusted mean difference: VAS first-step pain⫽⫺14.4
mm, 95% confidence interval [95% CI]⫽⫺23.5 to ⫺5.2; FHSQ foot pain⫽10.0 points, Published Ahead of Print:
95% CI⫽1.0 to 19.1), although the between-group difference was lower than the April 3, 2014
Accepted: March 31, 2014
minimal important difference. The number needed to treat at 6 weeks was 4 (95% Submitted: June 18, 2013
CI⫽2 to 12). The frequency of minor transitory adverse events was significantly
greater in the real dry needling group (70 real dry needling appointments [32%]
compared with only 1 sham dry needling appointment [⬍1%]).
P
lantar heel pain is a common phenomena.”9(p4) Myofascial trigger Method
source of pain and disability, points have been found to be preva- Study Design
with an estimated prevalence lent in other musculoskeletal condi- We conducted a parallel-group,
between 3.6% and 7.5%.1–3 Between tions, including chronic shoulder participant-blinded randomized con-
the years of 1995 and 2000 in the pain,10 patellofemoral pain,11 trolled trial comparing the effective-
United States, it was estimated that whiplash-associated disorders,12 and ness of trigger point dry needling
approximately 1 million patient vis- neck pain.13 There has been no rig- and sham dry needling.
its to office-based physicians and orous research to evaluate the prev-
hospital outpatient departments per alence of MTrPs in people with plan- Setting and Participants
year were for plantar heel pain,4 at a tar heel pain, although Imamura et Participants were recruited through
the researcher (M.P.C.) enrolling and intervention, including treatment sham needle. A real acupuncture
assessing participants; each partici- rationale, dry needling details, and needle was disposed of in a sharps
pant’s allocation was contained in treatment regimen, is outlined in container, simulating the noise and
sequentially numbered, sealed, and Table 1. effects associated with sharps
stapled opaque envelopes. Each disposal.
envelope, containing the allocation, Sham dry needling. Nonpen-
was opened immediately after all etrating sham acupuncture needles Outcome Measures
baseline measurements were (50 ⫻ 0.30 mm) were prepared All primary outcome measures were
recorded. This method has been using a protocol outlined by Tough performed at baseline and at 2, 4, 6,
used previously21 and has been rec- et al24 and sterilized prior to each and 12 weeks, and secondary out-
Interventions
The protocol, including needling
The Bottom Line
details and treatment regimen, was
formulated by general consensus23
and was guided by the MTrP model What do we already know about this topic?
(Tab. 1). Participants were treated by
Dry needling is increasingly used to manage musculoskeletal pain,
a registered podiatrist (M.P.C.) who
although there is limited evidence for its effectiveness for plantar heel
had 12 years of clinical experience
and 4 years of dry needling experi- pain.
ence. The real and sham dry nee- What new information does this study offer?
dling treatments consisted of 1 treat-
ment per week, of 30 minutes’ Real dry needling was found to be more effective than sham dry needling
duration, for 6 weeks. Participants for reducing plantar heel pain. However, the size of the effect was slightly
were followed for 12 weeks. To pre- less than a value considered clinically meaningful.
vent participants from determining
their allocation, a curtain was placed If you’re a patient, what might these findings mean
across the thoracic spine and cush- for you?
ions were positioned between their
legs. If a participant’s symptoms Although effective in reducing plantar heel pain, dry needling also was
were bilateral, both limbs were associated with frequent adverse events. These were mild and transitory
treated. (mostly needle stick pain). Patients should be made aware of this when
considering this intervention. Other effective interventions for plantar
Real dry needling. A detailed heel pain may have an additive benefit when combined with dry needling.
explanation of the real dry needling
Table 1.
Details of the Trigger Point Dry Needling Intervention Implemented in the Trial Consistent With STRICTA Recommendationsa
Variable Description
b c
Brand of acupuncture needle Seirin J-type or Hwa-To Ultraclean
Muscles dry needled Muscles assessed first included those harboring MTrPs that might have been
responsible for the participant’s pain, including the soleus, quadratus plantae,
flexor digitorum brevis, and abductor halluces muscles. Synergists and
antagonists of these muscles also were assessed for MTrPs. In addition, a search
was undertaken for MTrPs in muscles, which might have influenced the
participant’s loading of the aforementioned muscles, as well as the piriformis,
gluteus maximus, gluteus medius, gluteus minimus, tensor fascia latae, adductor
Needle length and diameter Not prespecified, but needle length typically ranged from 30 to 75 mm, with a
diameter of 0.30 mm
Needle insertions per muscle The number of needle insertions per muscle depended on the number of MTrPs to
be dry needled, participant’s tolerance to needle insertion, responsiveness of the
tissue to dry needling, and level of post-needle soreness for a specific muscle
Response elicited Dry needling of a MTrP attempted to elicit sensations such as aching, soreness, and
pressure and, if possible, a local twitch response
Manipulation of the acupuncture needle Following insertion, the acupuncture needle was withdrawn partially and advanced
repeatedly
Needle retention time The needle remained in the muscle for as long as it took to produce an appropriate
response and was tolerated by the participant; the needle then was left in situ for
5 min
a
STRICTA⫽STandards for Reporting Interventions in Clinical Trials of Acupuncture, MTrP⫽myofascial trigger point.
b
Seirin Corp, 13-7 Yokosuna-Nishicho, Shimizu-ku, Shizuoka City, Shizuoka 424-0036, Japan.
c
Suzhou Medical Appliance Factory, 14 West Qi Lin Lance, Suzhou, China.
The secondary outcome measures naire (CEQ),29 after the first treat- protocol, and (3) withdrawal from
included: (1) foot function and gen- ment only, to measure the perceived the trial. To account for missing data
eral foot health, as measured with credibility and their expectations of (16/420 VAS measurements,
the FHSQ25; (2) physical and mental the treatment. Participants also doc- 16/1,880 FHSQ pain measurements,
health, as measured with the Medical umented their level of activity in the 66/2,016 SF-36 measurements,
Outcomes Study 36-Item Short-Form previous week, at baseline, using the 30/474 CEQ measurements, and
Health Survey (SF-36), version 226; 7-day Physical Activity Recall (PAR) 20/756 DASS-21 measurements), we
(3) depression, anxiety, and stress, as questionnaire.30 Finally, participants used the multiple imputation
measured with the 21-item short- were asked at each treatment and method.32 In total, 5 imputed data-
form Depression Anxiety and Stress during the 12-week follow-up sets were created to avoid inaccu-
Scales (DASS-21),27 which uses a whether they had experienced any racy that might evolve from a single
4-point severity/frequency scale, adverse events, used other cointer- imputation.33 Baseline measures and
where a score of 0 indicates the ventions, taken pain-relieving medi- intervention group were included as
symptom “did not apply to me at all” cation for their heel pain, or devel- variables predictive of missing val-
and a score of 3 indicates the symp- oped any new medical conditions. ues. All analyses were completed
tom “applied to me very much, or using SPSS version 19 (SPSS Inc, Chi-
most of the time” for each item; (4) Data Analysis cago, Illinois), and we considered
self-reported magnitude of symptom To preserve baseline groups devel- P⬍.05 to be statistically significant.
change,28 as measured on a 15-point oped by randomization and to avoid The primary end point for predicting
Likert scale ranging from ⫹7 (“A overestimating the effectiveness of the effectiveness of dry needling for
very great deal better”) to ⫺7 (“A dry needling, all analyses were con- plantar heel pain (using the primary
very great deal worse”); and (5) foot ducted on an intention-to-treat outcome measures) was 6 weeks. If a
posture, which was evaluated using basis.31 All participants were ana- participant had bilateral symptoms,
the Foot Posture Index.25 lyzed in the group to which they data from the most painful side was
were randomly assigned regardless recorded and analyzed to satisfy the
Participants also completed the of: (1) the treatment actually assumption of independent data.34
Credibility/Expectancy Question- received, (2) deviations from the trial
Continuous outcomes measured at dropout rate were factored into the Primary Outcomes
2, 4, 6, and 12 weeks were analyzed calculation. This sample size also Both groups showed decreased pain
using an analysis of covariance was sufficient to detect an MID of 19 at the primary end point of 6 weeks;
(ANCOVA),35 with baseline scores mm (SD⫽28) for the other primary however, there were significant
included as covariates.36 Our deci- outcome measure (first-step pain, as between-group effects that favored
sion to perform an ANCOVA, which measured with a VAS).28 real dry needling over sham dry nee-
was prespecified in the trial registra- dling (Tab. 3). For first-step pain, the
tion and protocol article,37 was to Role of the Funding Source adjusted mean difference was ⫺14.4
account for regression to the mean, This study was funded by the Austra- mm (95% CI⫽⫺23.5 to ⫺5.2,
which may have occurred if there lian Podiatry Education and Research P⫽.002). For foot pain measured
Excluded (n=114)
Randomized (n=84)
Follow-up
Follow-up
38 (92.7%) at 12-wk assessment 41 (95.3%) at 12-wk assessment
Figure.
Study participant flow diagram.
11/43 [25.6%]) (eTab. 1, available at to 5). The most common delayed ous adverse events (eg, leading to
ptjournal.apta.org). adverse event (ie, adverse events days off work or hospital admission)
occurring between 1 and 7 days were reported.
All cases of immediate adverse posttreatment) was bruising, fol-
events related to needle site pain and lowed by an exacerbation of symp- After the first treatment, there was
were transient in nature. Minor, tran- toms. Delayed adverse events in the no significant difference between
sitory adverse events were reported real dry needling group were the 2 groups in their expectations of
at 70 real dry needling appointments reported at 8 real dry needling improvement in plantar heel pain.
(32%) compared with 1 appointment appointments (3%) compared with 1 There was also no significant differ-
(⬍1%) in the sham dry needling case (⬍1%) in the sham dry needling ence between groups regarding how
group. This difference in frequency group. This difference in frequency believable, convincing, and logical
of adverse events between the 2 of adverse events between the 2 the treatment appeared (eTab. 2,
groups equates to an absolute risk groups equates to an ARI of 3% (95% available at ptjournal.apta.org).
ratio (ARI) of 29% (95% CI⫽23% to CI⫽⫺0.5% to 6%) and an NNH of
35%) and an NNH of 3 (95% CI⫽1 33 (95% CI⫽18.6 to 184.7). No seri-
(Tab. 5). Less frequently needled Age (y) 54.4 (12.4) 57.8 (12.0)
muscles included the abductor digiti Sex (male), n (%) 17 (41.4) 27 (62.8)
minimi and flexor hallucis longus. Height (cm) 168.2 (10.7) 171.1 (8.8)
Treatments averaged 4 needles per
Weight (kg) 86.6 (22.6) 82.9 (13.2)
session (range⫽2– 8), each retained
Table 3.
Mean Scores and Mean Difference Between Groups for Primary Outcome Measuresa
Pain (FHSQc)
suggest we treated both groups tion that might be considered clini- ment per week) of dry needling of
equally. Second, the number and cally worthwhile.28 Finally, the the calf and heel regions, following a
duration of treatments were unique criteria used in this study to 4-week period of Chinese acupunc-
restricted, which would not nor- diagnose MTrPs have proven to be ture. Perez-Millan and Foster45 also
mally occur in clinical practice, challenging from a clinical trial per- demonstrated a significant reduction
although in our previous consensus spective, as the criteria has limited in pain (46% improvement) in 18
study,23 30 experts worldwide reproducibility and validity.42 Never- participants with plantar heel pain
agreed upon this protocol. Third, the theless, we used MTrP diagnostic cri- with a 6-week (1 treatment per
statistical analysis included an evalu- teria that clinicians implement in week) program of Chinese medicine
ation of only between-group effects everyday practice, and any issue acupuncture and dry needling of the
and did not include a model that with the reproducibility of the crite- heel and arch. However, these trials
evaluated a group ⫻ time interac- ria would largely be negated, as both were case series of poor method-
tion. Fourth, the dry needling tech- groups were assessed in a similar ological quality,19 which lacked con-
nique conducted in the study was manner. trol groups. Therefore, the effects of
performed by only a single podia- the MTrP treatment are likely to have
trist, which might affect the general- The results of our study are consis- been overestimated due to con-
izability of the findings. Fifth, the tent with a meta-analysis that founding and possible bias.
participants recruited into the trial showed acupuncture was superior
might not be entirely representative to sham treatment for chronic pain43 The effect of dry needling for plantar
of people with plantar heel pain, as and with 2 meta-analyses that estab- heel pain found in this trial might be
there might be systematic differ- lished dry needling of MTrPs was sig- explained by nonspecific and spe-
ences between those people who nificantly better than sham treatment cific elements of the treatment.46 It is
are willing to participate in an exper- and usual care for pain.17,18 Our find- widely recognized that nonspecific
iment and those who elect not to ings are also similar to those of other components of an acupuncture treat-
participate.41 Sixth, it might be studies that evaluated the effective- ment, such as time spent in the con-
expected that with a significant ness of MTrP needling for plantar sultation, patient expectations, the
reduction in pain, there might also heel pain.44,45 Tillu and Gupta44 practitioner/patient alliance, and
be an improvement in foot function. found significant improvement in 18 credibility of the intervention, might
However, our study was not pow- adults with plantar heel pain (68% affect the outcome.47 The extent to
ered to detect changes in foot func- improvement) with 2 weeks (1 treat- which these factors contributed to
Table 4.
Mean Scores and Mean Difference Between Groups for Secondary Outcome Measures at 6 and 12 Weeksa
Anxiety (DASS-21)
Stress (DASS-21)
the effect found in our trial is tionnaire, where there was no differ- puncture. Nevertheless, dry nee-
unclear. However, we believe the ence between the 2 groups. dling has been proposed to influence
difference between groups for pain pain by affecting the biochemical
scores was due to the specific effect A number of mechanisms might help environment and local blood flow
of the acupuncture needle, as we explain the effect of dry needling surrounding an MTrP, and ultimately
controlled for nonspecific treatment over sham dry needling in this trial, the central nervous system. Shah et
effects using rigorous randomized although the current physiological al48 found that dry needling signifi-
controlled trial methods. This argu- mechanisms to explain the effects of cantly reduced the concentration of
ment is supported by the findings of dry needling are largely derived from substance P and calcitonin gene-
our Credibility/Expectancy Ques- research involving traditional acu- related peptide surrounding an MTrP
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