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Original paper
Acupuncture in Medicine
Abstract
Background: Fibromyalgia syndrome (FMS) is a condition characterised by the presence of chronic, widespread musculoskel-
etal pain, low pain threshold and hyperalgesia. Myofascial trigger points (MTrPs) may worsen symptoms in patients with FMS.
Objective: The purpose of this randomised controlled trial was to compare the effects of dry needling and transcutaneous
electrical nerve stimulation (TENS) on pain intensity, heart rate variability, galvanic response and oxygen saturation (SpO2).
Methods: 74 subjects with FMS were recruited and randomly assigned to either the dry needling group or the TENS group.
Outcomes measures (pain intensity, heart rate variability, galvanic skin response, SpO2 and photoplethysmography) were
evaluated at baseline and after 6 weeks of treatment. 2×2 mixed-model analyses of variance (ANOVAs) were performed.
Results: The mixed-model ANOVAs showed significant differences between groups for the sensory dimension of pain,
affective dimension of pain, total dimension of pain, visual analogue scale (VAS) and present pain intensity (PPI) (P=0.001).
ANOVAs also showed that significant differences between groups were achieved for very low frequency power of heart
rate variability (P=0.008) and low frequency power (P=0.033). There were no significant differences in dry needling ver-
sus TENS groups on the spectral analysis of the photoplethysmography and SpO2.
Conclusions: This trial showed that application of dry needling therapy and TENS reduced pain attributable to MTrPs in
patients with FMS, with greater improvements reported in the dry needling group across all dimensions of pain. Additionally,
there were between-intervention differences for several parameters of heart rate variability and galvanic skin responses.
Trial registration number: NCT02393352
Keywords
dry needling, fibromyalgia, physical therapy modalities, transcutaneous electrical nerve stimulation, myofascial trigger
points
1Department 6Andalusian
Health Service, Primary Health Medical, Distrito Sanitario
of Nursing, Physical Therapy and Medicine, University of
Almeria, Almeria, Spain Málaga, Málaga, Spain
2Instituto de Investigación Biosanitaria ibs. Granada, Granada, Spain
3Andalusian Health Service, Hospital de Poniente, Almeria, Spain Corresponding author:
4Department of Physical Therapy, University of Granada, Granada, Spain Adelaida María Castro-Sánchez, Facultad de Ciencias de la Salud,
5École de Réadaptation, Faculté de Médecine et des Sciences de la Santé, Universidad de Almería, Almería 04120, Spain.
Université de Sherbrooke, Sherbrooke, Québec, Canada Email: adelaid@ual.es
Randomisation 100 Hz; and burst frequency 2 Hz for 10 min on each pain
dermatome.20 Before applying the electrodes, the skin was
After an initial baseline evaluation, patients were ran- cleaned with chlorhexidine (2%). Electrostimulation was
domised to dry needling or TENS therapy. Both groups then applied to each active and latent MTrP for 10 min. All
were treated by a physical therapist with over 12 years of patients received one treatment session every week for 6
experience in treating patients with chronic pain and FMS. weeks.
Randomisation was performed using a computerised ran-
dom number generator before starting data collection by a
researcher not involved in the recruitment or treatment of Statistical analysis
patients. Individual patient cards numbered sequentially Statistical analyses were performed using SPSS statistical
with the randomised allocation were prepared. The cards software, version 22.0 (SPSS Inc., Chicago, IL, USA). A
were sealed inside opaque envelopes. A research assessor, value of P <0.05 was considered statistically significant.
blinded to the baseline examination, opened the envelopes After a descriptive analysis, the normal distribution of vari-
and allocated each patient to their corresponding treat- ables was verified by the Kolgomorov-Smirnov test. Mixed
ment group. model analyses of variance (ANOVAs) were used to ana-
Outcome measures were assessed at baseline (before the lyse the time effects between both groups (dry needling vs
first treatment session) and 24 hours after the 6-week inter- TENS therapy) and group interaction effects for the pri-
vention period by an investigator blinded to the randomised mary outcome (VAS from the SF-MPQ) and secondary out-
treatment received by each patient. come measurements (heart rate variability, galvanic
response, SpO2 and photoplethysmography) between base-
Interventions line and post-treatment. Changes in variable scores within
and between groups were measured by means of a 95% CI
Dry needling. Active and latent MTrPs were identified and of t-tests for paired or independent samples as appropriate.
highlighted in black and red, respectively, on the skin. All Effect sizes were calculated using Cohen’s d coefficient.
deep dry needling procedures were performed by the same Based on best estimates of pre-post improvement after a
investigator using Hong’s fast-in, fast-out technique until dry needling intervention,21 a clinically important difference
a local twitch response was achieved, targeting active and of 2.61 points on the pain scale (VAS 0–10) was used to calcu-
latent MTrPs, and using an 0.25-gauge sterilised stainless late the sample size, using G*power 3.1. A sample size of 10
steel needle 25 mm in length with a disposable guide tube participants per arm was estimated to provide a 95% CI with a
(Agupung ref A1038P).19 Dry needling was applied to the power of 80%, assuming a significance level (α) of 0.05.
following muscle pairs for 30 s: occipital, splenius capi-
tus, sternocleidomastoid (sternal and clavicular branch),
scalene (anterior, middle and posterior), trapezius, supra- Results
spinatus, infraspinatus, latissimus dorsi, iliocostal, mul- Of the 74 patients with FMS recruited for the present
tifidus (dorsal lumbar and cervical level), quadratus study, 14 men and 60 women aged from 27 to 58 years
lumborum, major and minor pectorals, abdominal, del- (mean 48.87, SD 6.80 years) met the selection criteria and
toids, triceps, biceps, extensors of the fingers, finger flex- were randomly assigned to either the dry needling group
ors, gluteus, quadriceps, hamstrings, calves and tibialis (n=37) or the TENS group (n=37) (see Table 1). A flow
anterior. Before needling, the skin was swabbed with chart of the participants’ recruitment and follow-up is
chlorhexidine (2%). Immediately after needling, com- depicted in Figure 1.
pression was applied to the treated MTrPs for 15 s, pro- The repeated measures ANOVAs showed significant dif-
ducing hypoxia. All patients received one treatment ferences between groups for the sensory dimension of pain
session every week for 6 weeks. (P=0.001), affective dimension of pain (P=0.001), total dimen-
sion of pain (P=0.001), VAS (P=0.001) and PPI (P=0.001).
TENS. Active and latent MTrPs were labelled in black and The between-group effect sizes were large, showing a Cohen’s
red, respectively, as in the dry needling group, and TensMed d of 1.35 for the sensory dimension, 1.13 for the affective
911 (Enraf Nonius Iberica SA) stimulators were applied. dimension, 1.33 for the total dimension, 1.43 for the VAS and
Each stimulator had two channels with two 2 mm cables 1.40 for the PPI dimension of pain. Significant between-group
attached to two 32 mm diameter electrodes, giving a total of post-treatment differences are shown in Table 2 (post-inter-
four electrodes per stimulator. Two electrodes were applied vention values, and scores for between-group changes with
to the pain dermatome corresponding to the muscles present- associated 95% CI for the pain dimensions of the SF-MPQ).
ing active and latent MTrPs. Muscle pairs were treated in the Pairwise comparisons to baseline values demonstrated sig-
following cranial to caudal sequence: trapezius, latissimus nificant improvements in the dry needling group for the sen-
dorsi, gluteus, quadriceps and tibialis anterior. The following sory dimension of pain (P=0.001), affective dimension of pain
parameters were used: pulse width 200 µs; pulse frequency (P=0.001), total dimension of pain (P=0.001), VAS (P=0.001)
No studies 15 10
School level 7 16
Bachelor level 12 8
University level 3 3
Values are expressed as absolute and relative frequencies (n=74) for categorical variables and as mean±SD for continuous variables. TENS,
transcutaneous electrical nerve stimulation.
Figure 1. Design and flow of participants through the trial. TENS, transcutaneous electrical nerve stimulation.
Dry needling 20.95±6.00 12.51±7.38 0.001* 8.43 (6.49 to 10.38) −8.81 (−11.84 to –5.78)
Dry needling 10.05±2.24 5.51±3.75 0.001* 4.54 (3.52 to 5.56) −3.54 (−5 to −2.08)
Dry needling 31±7.06 18.03±10.72 0.001* 12.97 (10.38 to 15.56) −12.35 (−16.67 to −8.03)
Dry needling 7.86±1.18 4.81±1.98 0.001* 3.05 (2.31 to 3.80) −2.68 (−3.55 to − 1.80)
Dry needling 3.49±0.87 2.03±0.99 0.001* 1.46 (1.06 to 1.86) −1.30 (−1.72 to −0.87)
*P<0.05.
Values are expressed as mean±SD for baseline and 6 weeks post-treatment and as mean score change (95% CI) for within- and between-group values. TENS, transcutaneous electrical nerve stimulation.
and PPI (P=0.001); improvements were also observed in the aspects of pain and the present pain intensity in comparison
TENS group for the affective dimension (P=0.005) and total to the TENS group, showing large between-group differ-
dimension of pain (P=0.025), as well as the VAS (P=0.03) and ences. In addition, dry needling showed a moderate differ-
PPI (P=0.001). The effect sizes were large for the dry needling ence compared with the TENS intervention for the very low
group (minimum d=1.26, maximum d=1.94) and ranged from and low frequency power of heart rate variability. By con-
negligible to moderate for the TENS group (minimum d=0.18, trast, the only between-group difference in the galvanic
maximum d=0.72) in these pain dimensions of the SF-MPQ. skin responses was found for the Ag/AgCl forehead elec-
Significant within-group pre-/post-treatment improvements trodes α parameter, showing the EPA-SPA dispersion of the
are shown in Table 2 (pre-/post-intervention values and scores current, but this was negligible. Both therapies generated
for within-group changes with associated 95% CI for the pain an improvement in all pain subscales, except for the sen-
dimensions of the SF-MPQ). sory dimension following TENS intervention; however, in
The mixed model ANOVAs showed that significant the dry needling group the effect sizes were large, while in
differences between groups were achieved for very low fre- the TENS group they ranged from negligible to moderate.
quency power of heart rate variability (VLF) (P=0.008) and The dry needling group showed small pre-post intervention
low frequency power (LF) (P=0.033). For these rates, changes for the Valsalva ratio, estimated DO2, and metal
between-groups differences showed a moderate effect size hand electrodes SDC positive and negative. In the TENS
(VLF d=0.62; LF d=0.76). Within-group analysis showed a group, the within-group changes ranged from small to
significant pre-/post-treatment difference in the dry needling moderate for the quantity of normal-to-normal intervals
group for Valsalva ratio (P=0.030); significant differences and very low power of heart rate variability, EPA-SPA dis-
were also noted in the TENS group for quantity of NN inter- persion and δ of conductances (δ left foot–right foot).
vals (P=0.025) and for VLF (P=0.021). The effect size for These results may be explained by the following hypoth-
Valsalva ratio in the dry needling group was small (d=0.24) esis regarding the effect of dry needling therapy: (1) A nor-
and ranged from small to moderate in the TENS group (min- malisation of the altered chemical milieu from the MTrP.9,22
imum=0.26, maximum d=0.60) (Supplemental Table 1). (2) A decrease in systemic stress, improving homeostasis
The group*time interaction for the 2×2 mixed model and restoring the normal physiology of soft tissues.9,23 This
ANOVA showed no significant differences in the dry nee- therapy elicits a local twitch response that reduces the
dling versus TENS groups in the spectral analysis of the SpO2 trigger points and in turn the local tenderness of the bands
and photoplethysmography. However, pairwise comparisons of fibres of MTrPs, decreasing the excessive release of ace-
showed significant differences after dry needling for estimated tylcholine and the activation of nicotinic acetylcholine
DO2 (P=0.014), with a Cohen’s d of 0.29 (small effect size). receptors, disinhibiting the acetylcholinesterase at the
Supplemental Table 2 shows baseline, post-intervention, motor endplates. (3) A reduction of peripheral and central
within-group and between-group differences with associated sensitisation.9 Evidence suggests that dry needling therapy
95% CI for photoplethysmography and SpO2. hyperstimulates the pain-generating area, normalising the
The mixed model ANOVAs only showed significant dif- local sensory inputs,9,24 and produces natural opioid-mediated
ferences between groups for the silver/silver chloride (Ag/ pain suppression by activating local α–δ nerve fibres.9 There
AgCl) forehead electrodes α parameter (EPA-SPA disper- is also stimulation of the inhibitory interneurons, promot-
sion) (P=0.049), but with a between-group Cohen’s d of zero ing normal pain transmission to the sensory brain cortex.9,25
(negligible effect size). Nevertheless, pairwise comparisons Hence, dry needling may have an impact on central pro-
with baseline values demonstrated significant changes in cesses, removing nociceptive inputs and normalising syn-
the dry needling group for metal hand electrodes SDC+ aptic efficacy.26 (4) Dry needling may also increase local
(P=0.045) and for metal hand electrodes SDC− (P=0.028); tissue blood perfusion and produce a relaxation of the sar-
significant differences were also observed in the TENS group comeres by regulating the interaction of the actin–myosin
for the Ag/AgCl forehead electrodes α parameter (EPA-SPA complex in the muscle fibre bands containing MTrPs.27
dispersion) (P=0.021) and for δ of conductances (δ left foot– These mechanisms can effect local hypoalgesia in active
right foot) (P=0.001). The effect sizes were small for the dry and latent trigger points.28 Furthermore, the decrease in the
needling group (minimum=0.29, maximum d=0.33) and combination of pain intensity, the number of active MTrPs
ranged from small to moderate for the TENS group (mini- and the pressure pain threshold after dry needling therapy
mum=0.35, maximum d=0.65). Table 3 shows baseline, post- support the relationship between these aspects and segmen-
intervention, within-group and between-group differences tal and central sensitisation.27,28
with associated 95% CI for galvanic skin responses. Although both therapies in our study produced a reduc-
tion in pain dimensions in patients with FMS, the effect
sizes were higher after the dry needling therapy than the
Discussion TENS intervention. These results are in line with several
In the present study, 6 weeks dry needling therapy signifi- studies that have found an immediate reduction in pain
cantly reduced the global, sensory, affective and evaluative after a dry needling intervention.29–32 The meta-analysis
Dry needling 3.24±2.52 2.97±2.37 0.351 0.27 (−0.22 to 0.75) 0.40 (−0.45 to 1.26)
Castro-Sánchez et al.
Dry needling 3.19±2.68 2.79 ± 1.60 0.779 0.40 (−0.15 to 0.94) 0.10 (−0.58 to 0.77)
Dry needling 0.69±0.007 0.69±0.008 0.122 0.001 (− 0.002 to 0.004) −0.003 (−0.007 to 0.001)
Dry needling 9.86±5.49 8.29±5.40 0.250 1.57 (0.04 to 3.10) 1.33 (−0.95 to 3.62)
Dry needling 22.56±19.40 17.23±13.06 0.890 5.33 (0.61 to 10.06) 0.54 (−7.28 to 8.37)
Dry needling 10.11±4.93 8.79±7.54 0.688 1.33 (−0.85 to 3.50) 0.58 (−2.28 to 3.43)
Dry needling 18.01±15.80 17.39±16.06 0.492 0.63 (−4.79 to 6.05) −2.38 (−9.25 to 4.49)
(Continued)
8
Table 3. (Continued)
Dry needling −10.86±8.73 −13.78±7.90 0.006* 2.92 (−1.10 to 6.93) 4.62 (1.40 to 7.85)
Dry needling 11.30±9.50 12.05±8.74 0.407 −0.76 (−3.79 to 2.28) −1.59 (−5.40 to 2.21)
Dry needling 26.62±8.51 24.59±11.37 0.628 2.03 (−1.05 to 5.10) −1.22 (−6.20 to 3.77)
*P<0.05.
Values are expressed as mean±SD for baseline and 6 weeks post-treatment and as mean score change (95% CI) for within- and between-group values.
Ag/AgCl, silver/silver chloride disposable electrodes (AgCl precipitation); EIS, Electro Interstitial Scan; HF, high frequency; SDC+, conductance in μS of each anode–cathode pathway; SDC−, conductance
in μS of each cathode–anode pathway. TENS, transcutaneous electrical nerve stimulation.
Acupuncture in Medicine
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