efficiacia della Back School e del Massaggio shiatsu nella lombalgia cronica

BACK SCHOOL VERSUS SHIATSU MASSAGE REFLEX THERAPY: A BLIND, PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL.
G.Mandalà(1), R.Bordonaro(2), A.Digangi(3), V.Marino(3), S.Negrini(4)
(1)Buccheri LaFerla Fatebenefratelli Hospital, Palermo, Italy; (2)Pegasus Palermo Italy; (3)La Mandragora, Palermo Italy; (4)IRCSS Don Gnocchi Milano Italy.

BACKGROUND:
Low back pain (LBP) remains a problem at epidemic proportion, a burden for the patient, the family, and the economy. Despite the multiplicity of treatments available, a clear choice of effective treatment has not emerged.
Massage therapy has a long history, and is associated with various effects that, in the symptomatic treatment, are potentially beneficial. Ernst in his systematic review analysed four trials comparing massage with other therapies. All of those trials are burdened with methodological flaws; however there is some evidence that massage is effective. Pope et al. compared spinal manipulation, with t.e.n.s., corset and massage in sub acute low back pain, but used massage like a placebo group and concluded that there are no significant differences between treatments. Also Gillan used in his trial, massage like a control group receiving non-specific back massage comparing to McKenzie protocol. Cherkin in his randomised trial, compared massage vs acupuncture and self-care in back pain persisting at least six weeks. He found that massage is clearly superior in back function and satisfaction, there were no significant differences in symptoms. Also acupuncture had better results in satisfaction. Before alternatives therapies such as massage and acupuncture, are incorporated into standard primary care practice, more scientifically rigorous studies are needed, to determine which treatments are consistently cost-effective for LBP.
INTRODUCTION:
Shiatsu Reflex Massage (1) is a therapy of pressure with finger and hands on the back, along the meridians of traditional Chinese medicine.
Before the treatment starts, the therapist fills in energetic diagnosis card.
This treatment has been standardized: 1-For the patient position, lying down prone over two mattresses with a pillow under the abdomen. 2-The licensed shiatsu therapist that administer the treatment, and her position near the patient (lying on her knees). 3-The side from where the treatment starts, that’s where is less pain. 4- The areas where to put the pressure along the body: bowel meridian, bladder meridian, and kidney meridian. 5- Pressure characteristics: perpendicular to the skin, gradual and during the expiration, without generating pain or muscles stiffening. 6- The duration of treatment: 60 minutes, twice a week, for 5 weeks.
Back School (2) it’s an educational therapy group tested and validated in acute and sub-acute low back pain; a structured program of finalized intervention on four participants conducted in a course. It’s indicated with evidence in the report of Quebec task force and in the Swedish guidelines on Spinal disorders. The course has eleven 60 minutes lessons, twice a week.
To avoid discordance depending on the different propositions of informations, different execution of exercises, or in ergonomics proves, during the course, we wrote and proceeded with the same consequential organization of the events that we administered each course. So the different courses are comparable.
The treatment has been standardized for: two lessons of informations about education and prophylaxis of low back pain, with slides support explained and commented with examples and references; six sessions of exercises for the back, worked out over a mattress on the ground. Exercises are explained in their execution at the beginning of the session, so the participant may see their developing. During the execution, the therapist supervises the participants and corrects the errors. Three lessons of ergonomics, postural education and recommended physical activities, developed with slides and examples followed by practical trials, every time with the same consecution.
Control group receive, without explain or examples, a paper with exercises to be worked out at home for a duration of 5 weeks (like the other groups). The operators in the three groups of therapy are always the same, so the treatment administered to the patient it’s near to be homogeneous. Follow up: 1 month after the end of the treatment; 3 month after; 6 month after; 1 year after the end of the course. Each follow up, the patients will fill out the questionnaires, item scales backill and McGill pain questionnaire (the patients who don’t fill out receive a phone interview); at the end of treatment and one year after there was a clinical test. Drop out criteria: During the treatment, participant: Mustn’t take drugs or other therapies for pain; must not change activities of daily living or job; must not stop the treatment and follow-ups. Aims of the trial: This study attempted to determine the relative efficacy, in reducing pain and disability, of Shiatsu massage reflex therapy in treatment of chronic low back pain, as compared with Back school and control group.
MATERIALS AND METHODS:
The reference population is in the province of Palermo heterogeneous for age (25-65) and sex; al the patients presented to the hospital ambulatory.
Inclusion criteria: low back pain (referred in a region beneath the costal arch and the buttock), the pain mustn’t radiate to the thigh or the leg.
The referred pain must be a chronic pain since three month, (at least three episodes of back pain for 1 month, during the last year). Anamnestic and clinical characteristics of non-specific back pain. Participants’ subscription, of a consent form to the trial protocol.
Exclusion criteria: anamnestic or clinical signs of specific back pain; positive ness of S.L.R.T. or Lasegue for sciatica; pain radiating to the upper thigh, signs of neurological deficit. Impossibility to keep, a protracted prone position, (not indicated for shiatsu). No previous back surgery. X-ray evidence of previous fracture, significant degenerative endangering, or rheumatic processes of the vertebral bodies, (evaluation by a skilled independent observer).
Physical examination: conducted trough a point up card, to be proposed every time the same way and complete by one Physician (Dr. Mandalà), with a numeric index on Range of Motion and S.L.R. test. R.O.M. was assessed by the Schober test, while the patient stood ink skin marks were made at the midline at the level of L5 another 5 and 10 cm above the first. Then the patient was asked to bend forward and the distance between the skin marks was measured again. S.L.R.Test was assessed with the patient supine; the examiner raised the inferior limb with extended knee and the foot at right.
Then a blind skilled observer evaluated the X-ray, with the intent to avoid the exclusion criteria.
Assessment procedures: After the physical examination, the patients who met inclusion\exclusion criteria are invited to fill-in three cards.
1) The first card is concerning: personal data and general informations on studies, work and habits of daily living or hobbies; anamnestic informations about previous illness and the characteristics of back pain (duration and location, pain with rest or movement); drugs assumption; previous therapies; maintenance of work and activity; traumas and work dissatisfaction.
2) The second is the 11 items scale “Backill”, a one-dimensional pain/ disability measure for l.b.p., tested and validated in its fit, reliability.
3) The third card is one of the most used item scale for pain measure: the 15 items McGill Pain Questionnaire (Italian validated version) a multidimensional pain measure, evaluating three dimensions of pain, sensorial, affective and estimative. We used the short 8 items form. The patient was assisted in the compilation of cards.
After filling-in the cards the participants were randomised with a computer game, giving three colours for treatment that we called A, B or C.
Interventions: The same licensed therapists according to the standardized protocols always administered interventions; the duration of treatment was homogeneous for the three groups, 5/6 weeks, also the control group must work out home exercises for 5/6 weeks. At the end of treatment the patients wrote a formal opinion like: I feel better or I don’t feel better and like I’m satisfied of the treatment or I’m not satisfied.
At the end of one year follow up, the cards, marked with treatment A, B, C, are evaluated by an independent blind observer for the data analysis, the results and the statistics calculation.
Subjects: This clinical trial started in December 1999; at May 2001 there is a Progressive enlisting of 56 patients, 22% (10) male and 68 % (36) female, the mean age of the sample was 44 year old (m. 41,4 – f. 44,9), the mean age in the group A was 45,6 in the group B was 43,2, in the group C was 45,1.
RESULTS:
At the end of May 2001 of 56 patients enlisted, 21 concluded one year follow up. Compliance: 46 (82 %) of the enrolled patients concluded treatments and continued the follow-up; they are still full complying. 10 patients (18%) were drop out from the trial because not or partially complying. Baseline comparability: since patients were randomly assigned to their treatment group, one would expect comparability between groups with regard to all the variables measured at baseline. There is a difference between the control group and the others in the M.P.Q. scale. Preliminary differences at later visit: one-year follow-up is available only for 21 patients. This number is a little sample to be significant, but the trial is going on and the enlisting growing up. Seems to be few, but significant differences between the two therapy group and the control group, in the results of the two item scales Backill and MPQ, little better for the back school group. Also the formal judgment on satisfaction and improving, find in the two therapy groups satisfied patients that refer to feel better.
CONCLUSIONS:
This is a declaration of methods. We don’t’ want to conclude with preliminary results on poor numbers, but the rigour of the selection standards, needs time to enlist big number of patients. It’s our intention to make this trial become polycentric with other Italian or European shiatsu or back school centres.
Future results will be published successively.
REFERENCES:
1- E.Ernst MD: “Massage therapy for low back pain: a systematic revue”: Journal of Pain Symp. Man. Elsevier, 17(1): 65-69 (1999).
2- M.Pope, R. Phillips et al. « A prospective randomized three –week trial of spinal manipulations, Transcutaneous Muscle Stimulation, Massage and Corset in the treatment of subacute Low back pain. ». Spine 19(22): 2571-2577 (1994).
3- M.Gillan, J.Ross et al. « The natural History of trunk list, its associated disability and the influence of McKenzie Management ». Eur. Spine Jour. 7(6): 480-483, (1998).
4- D.Cherkin et al.: « Acupuncture vs. Massage vs. Self care for persisting back pain: a randomised trial”. Back Letter, Lippincot&Wilkins, 13(11). 127-130 (1998).
5- L.Tesio, C.Granger, R.Fiedler: “a unidimesional pain/disability measure for low-back pain syndromes”. Pain 69: 269-278 (1997).
6- Versloot et al.: »The cost-effectiveness of a back school program in industry”. Spine 17: 22-27, (1992).
7- R.Melzack:”The McGill pain questionnaire: major properties and scoring methods”. Pain 1: 275-283 (1975).
8- G.Majani, E.Sanavio: “Semantics of pain in Italy: the italian version of the McGill Questionnaire”. Pain 22: 399-405 (1985).
9- R.Melzack: “The short-form McGill pain questionnaire”. Pain 30: 191-197 (1987).
10- G. Mandalà: “Metodologia diagnostica nella lombalgia” Sicilia Ortop. 1: 16-18 (1998).
11- O.Menoni, F.DeMarco, et al.: ”La back school per un efficace trattamento delle rachialgie “. Milano E.P.M. Ed. ( 1994).