SPINAL HIGH-VELOCITY LOW AMPLITUDE MANIPULATION IN ACUTE NONSPECIFIC LOW BACK PAIN: A DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL IN COMPARISON WITH DICLOFENAC AND PLACEBO
 
   

Spinal High-velocity Low Amplitude Manipulation in Acute
Nonspecific Low Back Pain: A Double-blinded Randomized
Controlled Trial in Comparison With Diclofenac and Placebo

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
   Frankp@chiro.org
 
   

FROM:   Spine 2013 (Apr 1);   38 (7):   540–548

von Heymann, Wolfgang J. Dr. Med; Schloemer, Patrick Dipl. Math;
Timm, Juergen Dr. RER, NAT, PhD; Muehlbauer, Bernd Dr. Med

Competence Center for Clinical Studies;
and Institute for Biometrics, University of Bremen, Bremen, Germany


Thanks to Dynamic Chiropractic for access to these Key Findings from the study

  • "There was a clear difference between the treatment groups: the subjects [receiving] spinal manipulation showed a faster and quantitatively more distinct reduction in the Roland Morris Disability scores" (compared to subjects receiving diclofenac therapy).

  • "Subjects [also] noticed a faster and quantitatively more distinct reduction in [their] subjective estimation of pain after manipulation. ... A similar observation was made when comparing the somatic part of the SF-12 inventory ... indicating that the subjects experienced better quality of life after the spinal manipulation compared to diclofenac."

  • "The rescue medication was calculated both for the mean cumulative dose (numbers of 500 mg paracetamol tablets) and for the number of days on which rescue medication was taken. ... In the diclofenac arm, the patients on average took almost 3 times as many tablets and the number of days [taking the tablets] was almost twice as high" compared to patients in the manipulation arm. While the authors note that these results were not significant due to large between-individual variations (meaning a few patients could have taken many tablets, throwing off the overall totals), it still suggests that value of spinal manipulation vs. drug therapy (because even if both patient groups had taken the same amount of rescue medication for the same number of days, it wouldn't discount the fact that patients in the manipulation group showed significant improvement on outcome variables compared to patients in the diclofenac group).


The Abstract

Editor's Note: For that small group of nay-sayers out there, yes, this article does not mention the word Chiropractic, but this study utilized side-posture High-velocity Low Amplitude (HVLA) Manipulation (aka Diversified Technique), which is what is taught in every chiropractic school, and is practiced by the great bulk of Chiropractors around the world for the last 118 years. Hear me now and believe me later: No one does it better! The next natural study would be to pit chiropractic care, in all it's glory (diversified vs. drop tables vs. instrument adjusting etc.), against basic SMT, as practiced by these German individuals. Then we'll know for sure.

STUDY DESIGN:   A randomized, double-blinded, placebo-controlled, parallel trial with 3 arms.

OBJECTIVE:   To investigate in acute nonspecific low back pain (LBP) the effectiveness of spinal high-velocity low-amplitude (HVLA) manipulation compared with the nonsteroidal anti-inflammatory drug diclofenac and with placebo.

SUMMARY OF BACKGROUND DATA:   LBP is an important economical factor in all industrialized countries. Few studies have evaluated the effectiveness of spinal manipulation in comparison to nonsteroidal anti-inflammatory drugs or placebo regarding satisfaction and function of the patient, off-work time, and rescue medication.

METHODS:   A total of 101 patients with acute LBP (for <48 hr) were recruited from 5 outpatient practices, exclusion criteria were numerous and strict. The subjects were randomized to 3 groups:

(1) spinal manipulation and placebo-diclofenac;

(2) sham manipulation and diclofenac;

(3) sham manipulation and placebo-diclofenac.

Outcomes registered by a second and blinded investigator included self-rated physical disability, function (SF-12), off-work time, and rescue medication between baseline and 12 weeks after randomization.

RESULTS:   Thirty-seven subjects received spinal manipulation, 38 diclofenac, and 25 no active treatment. The placebo group with a high number of dropouts for unsustainable pain was closed praecox. Comparing the 2 active arms with the placebo group the intervention groups were significantly superior to the control group. Ninety subjects were analyzed in the collective intention to treat. Comparing the 2 intervention groups, the manipulation group was significantly better than the diclofenac group (Mann-Whitney test: P = 0.0134). No adverse effects or harm was registered.

CONCLUSION:   In a subgroup of patients with acute nonspecific LBP, spinal manipulation was significantly better than nonsteroidal anti-inflammatory drug diclofenac and clinically superior to placebo.


Fron the Full Text Article:

INTERVENTIONS

After the patient presented in an outpatient practice with acute LBP complaint and after having given written informed consent, the patient was examined carefully for exclusion criteria according to the study protocol. A big number of patients had to be excluded or had refused to sign the informed consent. The number of patients not registered may be calculated as 5 times the subjects included. If eligible and after signing the informed consent the subject was randomized (using a phone call to the involved and responsible Institute of Biometrics) to spinal manipulation plus placebo tablets or to diclofenac 50 mg tablets 3 times a day plus sham manipulation, or to the placebo control group in which the subject received sham manipulation plus placebo tablets.

During the second phase of the trial, the subjects were randomized to one of the active treatments only. All subjects were supplied with paracetamol 500 mg tablets to be taken whenever needed, but not more than 6 tablets a day. No other concomitant analgesic medication, acupuncture, or homeopathy was allowed.

To avoid too many variables as well as to receive consistent and clear evidence by the outcome, spinal manipulation was performed using the most popular segmental technique in Germany for the lumbar spine, almost identical to osteopathic HVLA manipulation ( Figure 7A, B ) 29:

  • The patient lies in the lateral recumbent position on the side without the identified segmental irritation with the physician standing at the side of the table facing the patient.

  • The physician palpates between the spinous processes of the dysfunctional segment and fl exes the patient’s upper leg at knee and hip until this segment opens in a neutral position of fl exion. Extension has to be avoided.

  • The lower leg can be flexed at hip and knee as much as necessary for the exact segmental positioning, but must stay secure on the table. The upper leg can reach as far over the table as necessary for a relaxed, but safe position of the patient on the table.

  • While getting into a deep contact with 2 fingers of the caudad hand to the table-faced side of the upper spinous process of the identifi ed dysfunctional segment, the physician places the cephalad hand in the antecubital fossa of the patient’s upper arm while resting the forearm gently on the patient’s upper lateral thorax directly below the shoulder.

  • The physician’s fingers of the caudad hand remain ( Figure 7A ) in deep contact with preliminary rotational tension on the spinous process while resting the forearm on the lateral pelvis, with the wrist building a “bridge.”

  • The patient’s shoulder and pelvis ( Figure 7B ) are axially rotated in opposite directions. The patient inhales and exhales, and during exhalation, further rotational “slack” is taken up as a diagnostic probation mobilization to exclude contraindications against an impulse.

  • With the patient relaxed and exhaling, the physician applies out of the rotational slack a HVLA thrust simultaneously moving with his forearms the pelvis and sacrum towards him and the shoulder girdle into the opposite direction while pulling the upper spinous process of the dysfunctional segment upwards.

  • The effectiveness of the technique has to be checked immediately according to the protocol. Eventually the technique has to be repeated.



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