Participants were recruited using flyers, by announcement through the homepage of the Chair of Complementary and Integrative Medicine, Kliniken Essen-Mitte, Germany, and through a local newspaper article. Study applicants were screened twice, first by a standardized telephone interview and second by the study physician, who examined the patient at their first appointment.
All inclusion and exclusion criteria were checked again, a careful patient history was taken, and a thorough physical examination, including neurological examination, was performed to rule out a clinical suspected spinal alteration, for example, discus prolapse. All participants provided written informed consent before participating in the study. The study was planned and conducted in compliance with the Declaration of Helsinki World Medical Association and the Guidelines for good clinical practice.
The protocols were approved by the institutional review board of the University of Duisburg-Essen Medical Institutions, Germany no. Both studies were carried out independently but according to a similar protocol. At the first examination, a medical history was collected and each participant was thoroughly examined. Subjective assessments on pain and function were taken, and sensory thresholds were determined.
Subsequently the participants were randomly assigned to a home-based treatment either TG or waiting list control group WL. All patients were asked to document medication and physiotherapy treatments in a treatment diary. Fourteen days later the evaluation of NRS ratings, the questionnaire and the sensory examination were repeated for both groups. In order to rigorously ensure that at the time of enrolment, medical examination, and baseline measurement the group allocation was unknown to everybody involved in the study, randomization was performed after completion of the first baseline measurement.
The randomization procedure itself was performed as a lottery, without stratification or sequencing. The envelopes were manually shuffled before each draw and the patients picked an envelope after the completion of the first measurement. The treatment consisted of a home-based, self-administered intervention with the mechanical NSP see Figure 1. It is a medical device, which has been applied for years by patients with diverse pain syndromes. Different versions of this pad are available in various sizes. Participants were instructed to apply the NSP over a period of 14 days once daily according to the following procedure: in a first step, the patients were instructed to press both hands only NP study or both feet only BP study for 10 minutes on the mat while sitting on a chair.
The protocol is to treat the hands of patients with neck pain and feet of patients with lower back pain, respectively, prior to the actual painful area derived from clinical experience. The protocol represents the way the NSP is applied in our clinic. It was recommended to place the NSP afterwards on a soft base, for example, the bed and to lie on top of the mat with the uncovered painful part of the body neck or lower back, resp. The patients were also instructed to place a towel or a bedroll underneath the neck, if the neck was to be treated.
The participants were informed that the first 2 to 5 minutes could be painful. A daily treatment time of about 30 minutes was recommended for the painful part of the body. The ODI score ranges from 0 to The NPQ score ranges from 0 to , with higher scores indicating higher pain and lower function [ 50 ]. Sensory testing was performed in a quiet room with constant room temperature approx. In order to eliminate test-retest bias due to different assessors, only one assessor was assigned to each of the studies.
Both assessors were thoroughly trained to perform the procedure. Furthermore, sensory tests were conducted at two control sites apart from the painful area, the right hand, and foot, serving as measures of intraobserver reliability. Von-Frey-filaments are nylon filaments with a rounded tip; affixed in a rectangular manner at a handlebar. They are pressed perpendicularly with constant force onto the skin surface paravertebral, hand dorsum, and foot dorsum until the filament bends.
Using the method of limits, a psychophysical method to approximate thresholds, five threshold determinations were made, each with a series of ascending and descending stimulus intensities. The test always started with a von Frey filament that was clearly sensed by the test person. In the next step, the examiner took the next smaller filament. This procedure was repeated until the test person was unable to sense a filament. Then this particular filament was annotated as the first subliminal stimulus.
Now the test was continued in ascending order, and the next bigger filament was taken again until the test person could feel a filament. This is the next value above the threshold. The final threshold is represented by the geometric mean of these 10 values. The patient was instructed to press a button, as soon as this pressure was perceived as being painful. The final threshold was the arithmetic mean out of all 3 measurements. After the tuning fork has been induced into vibrations it was placed over the tested area.
The tested person was asked, if he sensed the vibration and should indicate, if the vibration had stopped. These trials were pilot trials not only designed to explore the effectiveness of the NSP but moreover to generate hypotheses about the potential mechanisms of action. Thus, only patients giving a complete set of data were analysed per protocol, and missing values were not imputed.
Each outcome parameter was analysed by a univariate analysis of covariance, modelling treatment as a fixed factor, and the respective baseline value as a covariate. Differences between treatment groups were tested by two-sided t -tests within these models. All analyses were conducted with the SAS statistical software release 8. Of the participants recruited for the NP-study 3 participants were lost to followup due to reasons not related to the study. Moreover, 2 participants, both from the control group, violated the treatment protocol.
One began a TENS treatment during the study and the other was hospitalized with severe NP and shoulder pain and received repeated acupuncture treatments. Of the 42 patients recruited for the BP-study, nobody was lost to followup or violated the protocol. Most patients in both studies were females, the average age was Pre- to posttreatment changes mean and standard deviation and estimated group differences from analysis of covariance of outcome parameters. Bold values indicate significant P values. In both studies, treatment reduced the NRS pain ratings significantly compared to the control.
Patients in the neck pain treatment group filled circle as well as in the lower back pain treatment group filled square showed a significant treatment effect compared to the controls open symbols. Patients of the neck pain treatment group filled circle had significantly lower neck-pain-related disabilities after 2 week treatment compared to patients in the waiting list control open circle.
Test-retest correlations in the control areas hands and feet were high and statistically significant, indicating good reliability and accuracy see Table 3. Patients in the neck pain treatment group filled circle as well as in the lower back pain treatment group filled square showed a significant treatment effect compared to controls open symbols. Only patients in the lower back pain treatment group filled square had a significant treatment effect compared to patients in the control group open square. Besides the discomfort or pain when lying on the pad, especially at the first minutes of the first sessions, no adverse effects of the mechanical NSP were reported.
The outcome of the two studies presented here further supports the usefulness of the NSP as a representative of naturopathic therapies in the treatment of chronic pain syndromes. To our knowledge, the two studies are the first to systematically investigate the outcome of the NSP as a therapeutic agent in two highly prevalent chronic pain syndromes. The results show that the NSP significantly reduced pain ratings in patients suffering from chronic pain of the neck or the lower back.
The effect was robust and stable even after a comparatively short treatment period as daily treatments for 2 weeks. Why the ODI was slightly worse than at baseline remains unclear. Chronification of pain may originate at the level of the nociceptor, the spinal cord, or the brain e. Although these mechanisms cannot be separated in a chronic pain condition, different treatment strategies may have their focus on different levels of the pain process. It is assumed that hyperalgesia is associated with the hyperexcitability of central neurons in the spinal cord [ 53 , 54 ].
As hypersensitivity is caused by peripheral and central sensitization [ 55 , 56 ] these changes are by far not static but build the matrix of the dynamic receptive field plasticity [ 57 ]. The peripheral sensitization is thought to be mediated by an axon reflex, which sensitizes the receptors. Central sensitization occurs with a long lasting enlargement of receptive fields and recruitment of silent nociceptors.
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The threshold for afferent stimuli is decreased, caused by permanent neuroplastic changes in the spinal cord [ 57 ]. These mechanisms are hypothesized to be involved in the development of a chronic pain disorder even when the initial injury or inflammation is no longer present [ 58 ]. The presence of widespread sensory hypersensitivity is linked to central hypersensitivity, augmented central pain processing [ 59 ], or decreased descending control of pain [ 60 ]. Naturopathic treatments that induce controlled but clearly visible injuries of the skin, such as, for example, gua sha massage or wet cupping, markedly alter the nociceptor environment.
It can be assumed that these injuries, which are often clearly visible for several days, lead to increase firing of the nociceptive fibres in the affected regions [ 61 ]. Such an increased firing for several hours up to days may directly influence the receptive fields of spinal neurons in the affected region. If this is the case, these treatments are likely to induce specific, demonstrable effects on the somatocutaneous or viscerosomatic projection areas. Such effects can be demonstrated by measuring the patients' pain thresholds.
For a comprehensive test battery on sensory testing, see the QST-protocol [ 28 , 29 ]. Interestingly enough, pressure pain thresholds were increased at the point of maximum pain in both studies, reflecting that treatment has at least locally peripherally reduced hyperalgesia to blunt pressure in both syndromes. In the BP study, reduction of deep pain sensitivity was also present remote from the most painful area. These findings suggest that part of the treatment effect seems to be due to changes of nociceptive processing in the spinothalamic tract as well as at the level of the central nervous system.
Because there were no relevant differences in VDT and MDT, a possible involvement of the lemniscal tract is not likely. Larger studies including a nontreatment control group, a healthy control group, and including further QST-tests as well as the assessment of both body sides will reveal more conclusive evidence for the pathway in question. Previous studies in which various forms of cupping therapy, for example, dry cupping [ 40 ], wet cupping [ 38 ], and pulsating cupping [ 39 ] have been examined with QST in patients with neck pain showed similar results: improvement in pain ratings, increased PPT, and no effect in VDT and MDT.
These results may suggest that the NSP and the various cupping therapies act in a similar way. The often reported deep relaxation induced by many of the manipulative and body-based therapies contributes to well-being and thus works through the affective-motivational component of pain [ 62 ] and probably adds to the overall treatment effect.
There are several limitations in these studies. However, the analysis of covariance with the respective baseline value as a covariate controls in part for this difference. Moreover, the high percentage of female participants in both studies exceeds the gender-specific back or neck pain prevalences [ 9 ] likely suggesting that more female than male patients are interested in CAM treatments [ 63 ], therefore, the generalisability of the results to a male patient population is limited.
The waiting list control strategy may be considered a potential weakness of the study. However, there is no valid inactive sham control for the needle stimulation pad available to date. Even the blunting of the sharp needle tips would still induce a rather strong mechanical stimulation. Therefore, a waiting list control seemed to be the best way to control for the effect of anticipation or for being included into a study.
Considering the fact that in clinical trials of conservative treatments for chronic nonspecific NP, changes in pain scores are generally similar between waiting-list control and placebo control groups [ 64 ], and the fact, that the sensory threshold measurements are not easy to see through for the study participants, we feel confident that the described treatment effects are valid. However, there are no good sham protocols for most these procedures available, although attempts to construct such controls are very innovative [ 65 ].
Blinding remains an issue to be debated on and furthermore, it was recently argued that, for example, sham acupuncture is associated with large unspecific effects [ 66 ].
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This probably also accounts for any sham procedure for most of these interventions. Future clinical trials with a definite character should therefore compare different therapies with regard to their comparative effectiveness. In the two pilot studies presented here, a rather short-treatment protocol with defined treatment units was applied. However, in clinical practice, patients apply the pad typically whenever they feel intense pain and that may be several times a day.
Until now no data are available, which treatment duration and frequency reveal the best therapeutic results. Because these studies were pilot studies, we used a pragmatic approach and did not change a protocol that derived from clinical experience, which means that participants pressed their hands NP study or their feet BP study in advance of the painful area.
It is not clear if this protocol influences the outcome, but this question could be included in further trials. The needle stimulation pad revealed a substantial potential for the alleviation of chronic NP and BP. Furthermore, psychophysical data support the assumption that the pad reveals its effects at least partly on a subcortical level of the pain processing system. A further benefit of the device is the fact that it is easy to use, safe, and does not require a therapist.
National Center for Biotechnology Information , U. Evid Based Complement Alternat Med. Published online Sep Author information Article notes Copyright and License information Disclaimer. Received May 20; Accepted Jul This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
This article has been cited by other articles in PMC.
Abstract Objectives. Methods 2. Participants Inclusion criteria were age between 18 and 75 and nonspecific NP or lower BP for at least three consecutive months. Study Design The study was planned and conducted in compliance with the Declaration of Helsinki World Medical Association and the Guidelines for good clinical practice. Treatment Allocation In order to rigorously ensure that at the time of enrolment, medical examination, and baseline measurement the group allocation was unknown to everybody involved in the study, randomization was performed after completion of the first baseline measurement.
Intervention The treatment consisted of a home-based, self-administered intervention with the mechanical NSP see Figure 1. Open in a separate window. Figure 1. Mechanical Sensitivity to Superficial versus Deep Stimuli Sensory testing was performed in a quiet room with constant room temperature approx. The control group was offered the same NSP postintervention. Data Analysis These trials were pilot trials not only designed to explore the effectiveness of the NSP but moreover to generate hypotheses about the potential mechanisms of action.
Figure 2. Figure 3. Table 1 Baseline characteristics. Table 2 Pre- to posttreatment changes mean and standard deviation and estimated group differences from analysis of covariance of outcome parameters. Pain and Disability In both studies, treatment reduced the NRS pain ratings significantly compared to the control. Figure 4. Figure 5.
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Mechanical Pain and Detection Thresholds Test-retest correlations in the control areas hands and feet were high and statistically significant, indicating good reliability and accuracy see Table 3. Table 3 Spearman correlation coefficients for detections thresholds in control areas. Figure 6. Figure 7. Adverse Effects Besides the discomfort or pain when lying on the pad, especially at the first minutes of the first sessions, no adverse effects of the mechanical NSP were reported. Discussion The outcome of the two studies presented here further supports the usefulness of the NSP as a representative of naturopathic therapies in the treatment of chronic pain syndromes.
Conclusion The needle stimulation pad revealed a substantial potential for the alleviation of chronic NP and BP. References 1. Andersson GBJ. Epidemiological features of chronic low-back pain. The Lancet. The Saskatchewan health and back pain survey: the prevalence of low back pain and related disability in Saskatchewan adults. The Saskatchewan health and back pain survey: the prevalence of neck pain and related disability in Saskatchewan adults. Sun, N. Vu, W. Beeson, E. Span, E. Farquhar, M. Bormann, Z. Baer, S. Sreekumar, J. Kuchenreuther, F. Dean Toste, H. Blanch, D. Clark, Metabolic Engineering , Sreekumar, Z.
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