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پنجشنبه، 30 فروردین 1403
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۸۸۹۹۳۰۹۸ - ۸۸۹۹۳۰۹۹
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Treatment of Low Back Pain with Specific Acupoint

28 دی 1396 18:03 | 0 نظر | 1300 بازدید | امتیاز: با 0 رای
Treatment of Low Back Pain with Specific Acupoint


Treatment of Low Back Pain with Specific Acupoint. A Double-Blind  Placebo-Controlled Trial

Marco Aurelio Dornelles, MD

Freire  Alemao,۶۱۶/۳۰۳

۹۰۴۵۰-۰۶۰ - Porto Alegre

RS - Brazil


Low back pain is a common disease that injury a lots of people, causing  physical impairment, pain and disability. It’s treatment is long lasting and  expensive to patient and society. The purpose of this trial is to offer a new  model for acupuncture treatment to low back pain Acupuncture treatment of a  chronic low back pain was studied in a placebo-controlled double-blind crossover  trial completed by ۱۸ patients. Their pain were measured by VASP (Visual Analog  Pain Scale ). These patients were randomly selected in two Groups : A and B. The  A group received acupuncture needle at points K۳ ; UB۲۳ ; UB۵۲ ; UB۵۸ during  first phase of treatment which lasted four weeks, and placebo acupoint during  the second phase of trial. The B Group ( also ۴ weeks ) that started with  placebo acupoint ( S۴۱, L۹, L۱۳ and BAXIE ) was changed during the second phase  of treatment to specific acupoints and lasted four weeks, too. A significant  reduction of ۴۳% in the "VASP" occurred in the first phase of treatment for the  A Group. On the other hand, the reduction of only ۱۷% in the B Group was not  significant. During the second phase of treatment the reduction was ۵۲ % for the  A Group and ۷۱ % for the B Group . Finally when both groups were receiving  acupuncture in specific points the reduction was significant only Group B . This  trial was completed with success using a group of points needling was  theoretically; irrelevant sites as placebo group and showed that is necessary  specific acupoints for the treatment of low back pain.
Numerous studies report the ability of acupuncture to reduce the pain in  acute and chronic cases (Pommeranz,۱۹۸۷), but most of there are either anecdotal  or employ inappropriate methodologies. In fact, scientific data for acupuncture  safety and efficacy based on well-controlled studies utilizing acceptable  methodologies and pain models is limited (MacDonald,۱۹۸۳).


A key problem with acupuncture research has been the difficulty in designing  appropriate control groups (Campbell,۱۹۹۱). In some cases elaborate physical  procedures such as mock transcutaneous nerve stimulation ( mTENS ) have been  employed (Lewith,۱۹۸۳). However, despite its frequency in the literature, this  practice is problematic because TENS in not acupuncture, and its use as a  control is questionable. Very few studies used an adequate placebo procedure  (Moore,۱۹۷۶). Another control commonly employed is "sham " acupuncture, in which  needles are inserted at variables distances from the "real " acupuncture points,  and with variable depth (Edlist et al, ۱۹۷۶). One argument suggest that pain  attenuation by sham acupuncture may be due to diffuse noxious inhibitory control  (Takeshige,۱۹۸۹), and his may confound efforts to test acupuncture effects.  Another difficult to choose sham acupuncture is the fact that to show  statistical significance in the differences between sham-point needling and  true-points needling requires huge numbers of patients ( at least ۱۲۲ per study  ), in accordance with Vicent and Richardson´s (۱۹۸۶) point of view. In this way,  sham acupuncture is not an appropriate control.


Other common problems in acupuncture studies include ambiguous inclusion or  diagnostic criteria, non-standard outcome measures, and insufficient follow-up  periods (Patel,۱۹۸۷) . In many studies, patients, evaluation procedures, and  statistical analyses are often inadequately described (Patel,۱۹۸۹).


Acupuncture can be applied to any of several hundred known acupuncture points  all over the body. It has been reported that the application of acupuncture to a  particular point is critical for analgesia to develop in a region of body (Croze  et al,۱۹۷۶) . Although the old Chinese acupuncture theory of a hypothetical  system of energy channels or meridians was considered the basis for acupuncture  specificity (Chang,۱۹۷۹), the current scientific explanation over this  specificity is conflicting. Chung(۱۹۸۹) demonstrate no evidence for stimulation  point specificity for the production of analgesia, although other papers has  been showed that acupuncture point stimulation is not effective in causing  analgesia in all animals, classifying rats in two types, the responders and  nonresponders to acupuncture points (Takeshige,۱۹۸۳) and acupuncture points and  nonacupuncture points are distinguished by differing central pathway  (Takeshige,۱۹۸۹).


In order to resolve some of the methodological problems apparent in the  literature and develop a model for appropriate acupuncture evaluation of low  back pain, we have completed a pilot study.


The present study is placebo-controlled and double-blind, which objectives  are:
۱ - to observe if the use of a group of acupoint selected without effect over  the low back pain is an appropriate control group; and
۲ - if there are acupoint specific to treat low back pain.
Twenty acupuncture naive patients with chronic low back pain without  rhizopathy and had been failed to derive sufficient relief from appropriate  conventional methods of treatment were included after they accepted the study  design. All patient were referred to us before they were examined by a clinical  assistant who blinded regarding what treatment group the patient belonged to.  The patients were informed that we studying the effect of two different methods  equally efficient against their low back pain. Thus, the patients were informed  that placebo treatment will be an efficient new acupuncture treatment.


Before the patients were examined a random process was used to divide the  sexes and age equally as possible between the two groups. The acupuncture group  had ۷ females and ۳ males and placebo group ( nonspecific acupuncture points )  had ۶ females and ۴ males, whith ۵۲ years old of mean age for first group and ۵۴  years old for the last group.


The treatments were given twice a week for eight weeks. All patients were  randomly allocated to either of two groups. Group A received specific  acupuncture needles at points K۳, UB۲۳, UB۵۲ and UB۵۸ bilaterally, and one  needle at DU۳ and DU۴ as described by Traditional Chinese Medicine ( TCM )  (Pommeranz,۱۹۸۷) to treat low back pain during first phase of treatment lasting  four weeks. Group B received placebo acupoints defined like acupoints without  effects over low back pain, in accordance with TCM at points S۵۱, L۹ and LI۳,  bilaterally and two needles at Baxie acupoints, lasting four weeks as in the  Group A. Then after that period the patients crossed over and received the  alternate for four weeks. The maximum number of treatments between the two  phases was arbitrarily defined as ۱۰ ( ten ).


Huskisson (۱۹۷۴) described an visual analogue scales for subjective  measurement of pain. A horizontal line ۱۰۰ mm in length, with ۰, "no pain at all  "and ۱۰ ", pain as severe as it could possibly be’’ at the left and right  extremes, respectively, scored by measuring the distance of patient’s mark  before each treatment phase by an independent Clinical Assistant. Initial  assessment was followed by a one-week baseline observation period during which  the patients recorded pain severity using the Visual Analogue Scale of Pain (  VASP ) and that assessment had served for control in each group.(TABLE I ).




Acupuncture was performed according to TCM (Pommeranz,۱۹۸۷) by a physician  trained at the Chinese Traditional medical Research Institute in Pekin (Author).  With the patient in lateral decubitus, ۱۰ (ten) needles were inserted close the  spinal at tenderness points and at distance acupoints defined as efficient to  complete the treatment. The needles were left in situ for ۳۰ minutes with no  further stimulation.


The placebo group consisted in the use of local and distant acupuncture  points withouth relation with low back pain, in accordance with TCM. Ten needles  were used at each treatment session and left in situ for ۳۰ minutes with no  further stimulation in the same way like acupuncture group.


The t-Test, at significant level for p < .۰۵ , was used to compare the  specific acupoints against nonspecific acupoints and whether that nonspecific  acupoints may be considered an adequated placebo procedure.


Results are presented for the ۱۸ patients who completed the trial. Two  patients failed to complete the first phase of group B ( placebo ). The patients  reported that the pain was the same at beginning of treatment and they not  continue the trial.


Table I compares decrease in Visual Analogue Scales of Pain ( VASP ) in the  patients groups before and after treatment sessions and the pain reduction  observed and the baseline observation. A significant reduction in the VASP  occurred in the first treatment phase for Group A and, inversely, in the Group B  the reduction was not significant. The reduction was ۴۳% for Group A receiving  acupuncture, and ۱۷ % for Group B receiving placebo. Further reduction in the  VASP occurred in both groups during the second phase of treatment. The reduction  was ۵۲ % for Group A, now receiving placebo, and ۷۱ % for Group B, now receiving  acupuncture. This reduction was significant for only Group B .








( ۱ WEEK )









۴۹.۲ %

۴۸.۹ (۲.۸)

۲۷.۵ (۲.۴)

۴۳ % ( S )


۴۳.۴ %

۴۴.۲ (۲.۷)

۳۶.۶ (۳.۶)

۱۷ % (NS)




۲۷.۵ (۲.۴)

۱۳ (۱.۳)

۵۲ % (NS)



۳۶.۶ (۲.۶)

۱۰.۶ (۱.۲)

۷۱ % (S)


S = Significant ( p <.۰۵ )
NS = Not Significant
Because patients entered the study on voluntary basis, the group was  self-selected and randomised trial was defined. This may be important because  the patient’s expectant attitude to acupuncture could affect the response to  treatment (Mendelson et al,۱۹۸۳) . The same way, the clinical observer that  assessed all patients at the beginning and the end of each course of treatment  and the physician that applied the needles were blinded one each other.  Therapist expectant effects upon patient assessement and other methodological  artifacts may equally well create the appearance of trends in data  (Patel,۱۹۸۷;Patel,۱۹۸۹) which do not deserve to be with this design. This trial  was double-blind as it was not possible to be sure that the patients would not  describe, during the second assessment, the methods of treatment that had been  employed.


Although, in this trial was not used a rest period between the phases this is  not important, because the follow-up periods have been variable with the effects  of acupuncture persisting since ۴۰ hours (Fox,۱۹۷۶) until ۱۲ months  (Carlson,۱۹۹۳). The relative long-term follow-up data is especially  disappointing with chronic pain patients where the need to demonstrate lasting  benefits from any new treatment is of paramount importance  (Richardson,۱۹۸۶).


The overall significance of point location is unclear as yet. The majority of  studies investigating this question have compared acupuncture at classical sites  with needle insertion at random or theoretically irrelevant locations  (Patel,۱۹۸۷). Of eleven controlled clinical trials in this category five find  classical acupuncture to be significantly more effective than the control group  and the remaining find non-significant differences in favour of acupuncture. In  this trial were tested with success the use of a group of points needling at  theoretically irrelevant sites as a placebo group.


Satisfactory pain relief was defined by Beecher (۱۹۵۵) as a ۵۰ percent or  greater reduction of pain severity. More recently, a reduction of ۳۳ percent in  pain severity has been accepted as significant (Moertel,۱۹۷۶). Based on this  criterion, in the first phase of the trial acupuncture led to satisfactory pain  relief (۴۳ % ), whereas placebo did not ( ۱۷ % ). This was reversed during the  second phase, with the placebo group reporting ۵۲ % pain reduction against with  ۷۱ % for the acupuncture group. However, the both groups had reduction on VASP  during the trial, when the acupuncture was used the results were more  significant than placebo acupuncture group. Group A showed a significant  reduction on the first phase of trial and although that effect can be observed  on the second phase of the trial this was lesser than Group B, now using  acupuncture points. Possibly, this effects is attributed to a physiological or  psychological states induced by the first treatment and persisting during the  second phase of the trial (Price et al,۱۹۸۴) or an increase in the endorphin  level in the cerebrospinal fluid (Sjolund et al,۱۹۷۷), caused for any  stimulation on the body skin (Han, ۱۹۸۹).


This study have been concluded the following :
a- this pilot study provides an effective model for evaluation of efficacy on  low back pain.
b- the present trial successfully established a valid nonspecific group of  acupoints as a control group (placebo ).
c- specific acupoints to treat low back pain, in accordance with TCM, is more  effective than nonspecific acupoints used like placebo.




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