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Arthrokinematic Approach-Hakata Method effective in chronic nonspecific low back pain
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May 2016
Arthrokinematic Approach-Hakata Method effective in chronic nonspecific low back pain
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
A Randomized, Single-Blind, Placebo- Controlled Study on the Efficacy of the Arthrokinematic Approach-Hakata Method in Patients with Chronic Nonspecific Low Back Pain
PLoS One. 2015 Dec 8;10(12):e0144325Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
186 patients diagnosed with chronic nonspecific low back pain were randomized to receive either the Arthrokinematic approach-Hakata (AKA-H) method (manual therapy) or a sham treatment, once a month for 6 months. The purpose of the study was to determine if the AKA-H method positively affected pain, disability and quality of life after 6 months of treatment. The results suggested that patients in the AKA-H group displayed significant improvements compared to the sham group in pain scores, disability, and quality of life that generally began after 3 months and lasted for the remainder of the 6 month study period.
Publication Funding Details
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Funding:
Non-funded
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
2/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Chronic nonspecific low back pain is very common in the general population and is associated with a reduced quality of life. While this condition is prevalent in the general population a gold standard for effective management has yet to be defined. Various conservative therapies exist; however, these treatments vary in effectiveness from patient to patient. The Arthrokinematic Approach-Hakata (AKA-H) method is a manual procedure for treating abnormalities of intraarticular movement of the synovial joint and guides movement on the joint surface. Although not indicated for a specific pathology, the efficacy of the AKA-H method in the treatment of low back pain warranted examination.
What was the principal research question?
In adults with chronic low back pain, how did the Arthrokinematic approach-Hakata method affect pain and quality of life in comparison to sham treatment when assessed over 6 months?
Study Characteristics
-
Population:
186 patients diagnosed with chronic nonspecific low back pain were included. Inclusion criteria were nonspecific low back pain lasting for at least 6 months prior to the study, having received conservative orthopedic treatment without improvement, age between 18-79 years, and without surgery of the lumbar spine in the prior 6 months. Both techniques took 15-20 minutes (179 completed; Mean age: 59.8 +/- 13.1; 62% Female).
Intervention:
AKA-H group: patients received the Arthrokinematic approach-Hakata method once a month for 6 months to the sacroiliac joint using 4 techniques: upward gliding, downward gliding, superior distraction, and inferior distraction (n=93, 90 completed; Mean age: 60.0 +/- 12.7; 60% Female).
Comparison:
Sham group: patients received sham treatment once a month for 6 months (this treatment did not involve actual movement of the sacroiliac joint). Patients in this group would receive the AKA-H method after study completion (n=93, 89 completed; Mean age: 59.6 +/- 13.3; 64% Female).
Outcomes:
Outcomes included pain intensity assessed with the visual analogue scale (VAS), and quality of life assessed with a modified Roland-Morris Disability Questionnaire (RDQ) and the 36-item Short-Form Health Survey (SF-36). The primary outcome was the average level of low back pain (VAS) during the final 30 days of the 6-month treatment. VAS scores were recorded 3x a day and the average monthly scores were used.
Methods:
RCT: single-blind (patient).
Time:
Outcomes were assessed at baseline and once a month for the 6-month study duration. The average value of VAS scores for the 30 days prior to the start of the treatment were considered as pre-treatment scores.
What were the important findings?
- The mean VAS pain score at 6 months was significantly lower in the AFA-H group when compared to the sham group (31.2 +/- 18.8 vs. 45.5 +/- 22.0; p<0.0016). This difference was also observed at months 3-5 (all p<0.0016), however, no significant differences between groups were noted at months 1 and 2 (both p>0.05)
- RDQ scores were similar between groups from months 1-3 (p>0.05), however, the AFA-H group displayed significantly greater improvements at months 4 (p<0.008), 5 (p<0.0016) and 6 (AFA-H: 49.3 +/- 9.3 vs. Sham: 42.6 +/- 9.9; p<0.0016)
- SF-36 subscores were significantly better in the AFA-H group in terms of bodily pain and mental health from months 2-6, in physical functioning, social functioning, general health perception, vitality, and emotional role functioning from months 3-6, and in physical role functioning from months 4-6 (p<0.008)
- Mild side effects, including muscle weakness and lower leg numbness, were comparable between groups
What should I remember most?
For patients with nonspecific low back pain, management using the Arthrokinematic approach-Hakata method displayed significant improvements in VAS pain scores after 3 months which were sustained until final follow-up at 6 months when compared to sham treatment. Additionally, the AKA-H patients displayed significantly greater improvements in disability and quality of life, generally beginning after the third month of treatment, and lasting for the remainder of the study period.
How will this affect the care of my patients?
The results of this randomized controlled trial suggest that the Arthrokinematic approach-Hakata method, for the treatment of patients with chronic low back pain, may improve pain, disability, and quality of life after 6 months of monthly treatment when compared to a sham treatment. However, further trials using a double-blind methodology that include a more gender-balanced population are required to further elucidate the efficacy of this treatment.
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