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ORIGINAL RESEARCH

Efficacy of Fascial Distortion Model Treatment

for Acute, Nonspecific Low-Back Pain in
Primary Care: A Prospective Controlled Trial
Detlef Richter; Matthias Karst, MD; Hartmut Buhck, MD; Matthias G. Fink, MD

ABSTRACT
Context • Low-back pain (LBP) is a prevalent and potentially Intervention • Participants in the intervention group
crippling condition for which treatment is often unsatisfactory (FDM group) received osteopathic manipulative
from the perspectives of physicians, patients, and payers. The treatments according to the FDM, whereas the control
application of the fascial distortion model (FDM), an group (NDMG group) received an active control treatment
integrated concept for the diagnosis and manipulative following the NDMG.
treatment of musculoskeletal disorders, is conceptually Outcome Measures • Comparing the FDM group (n = 39)
promising for LBP but has not been investigated systematically. and the NDMG group (n = 38), the study measured pain
Objective • The study intended to provide proof of (visual analog scale, patient diary), functional (FFbH-R)
concept to establish the noninferiority of the FDM and self-reported vocational status, and use of medication
treatment as opposed to the therapy recommended by the (patient diary) at baseline and after 1, 4 and 12 wk of
German National Disease Management Guideline treatment.
(NDMG) for acute LBP. Results • The study found marked improvements of the
Design • The study was a prospective, nonrandomized, symptoms in both groups, with a faster onset of efficacy
controlled, parallel-group trial. and significantly less medication under the FDM
Setting • The study took place in a private practice for treatment.
surgery and orthopedics. Conclusions • FDM appears to be effective with regard to
Participants • Seventy-seven outpatients with acute LBP pain relief and functional improvement for LBP. (Altern
with an average age of 42.6 ± 13.5 y, 50.6% of whom were Ther Health Med. 2017;23(5):24-32)
male, took part in the study.

N
Detlef Richter, is a resident surgeon in surgical-orthopedic onspecific low-back pain (LBP) is a prevalent and
private practice in Alfeld, Germany. Matthias Karst, MD, is potentially disabling condition that causes a substantial
a professor in the Interdisciplinary Pain Clinic, Department economic burden due to direct and indirect costs.
of Anesthesia and Intensive Care, Medical School Hanover, Irrespective of regional and social differences, expenditures for
in Hanover, Germany. Hartmut Buhck, MD, is the owner diagnosis and treatment as well as loss of productivity and
and scientific director of Medical-Scientific Consultancy in disability payments are significant,1 and the indirect costs
Berlin, Germany. Matthias G. Fink, MD, is a professor in outweigh the direct costs by a substantial margin, rendering
the Department of Rehabilitation Medicine, Medical more effective treatment modalities economical even if they are
School Hanover in Hanover, Germany. more expensive in the short term.2,3
A broad range of treatment modalities for acute and
chronic LBP is available, comprising a variety of pharmaceutical,
Corresponding author: Hartmut Buhck, MD physical, interventional, surgical, and psychological methods,
E-mail address: [email protected] and, clearly, one therapy that fits all patients does not exist. The
broad choice of treatment options does not remotely imply
that an effective and tolerable, let alone economical, choice is
available for everybody; on the contrary, many patients deal

24 ALTERNATIVE THERAPIES, SEP/OCT 2017 VOL. 23 NO. 5 Richter—FDM Treatment for Low-Back Pain
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Table 1. Definitions of Fascial Distortions and Their Symptoms and Signs

Distortion Definition Body Language Subjective Description

Trigger band Twisted, banded fascia Finger sweeping along a painful line Burning/dragging pain
Herniated Protrusion of tissue through a fascial Finger, thumb, or knuckle pressed into the affected Dull pain
trigger point layer area
Continuum Alteration of a transition zone between Finger points at a painful spot Pain at a circumscribed
distortion bone and tendon or ligament point
Folding Three-dimensional alteration of fascial Extremities: Pain deep within the
distortion tissue, mostly joint capsule, interosseous 1. Clasping of a joint with the hand or placing a spinal column
membrane, or intermuscular septum hand on the joint (unfolding)
2. Sweeping motion with hand or finger across joint
(refolding)

Trunk:
Laying on of the hand
Cylinder Torsion of circular superficial fasciae of 1. Repeated kneading or massaging of the affected Deep-seated pain,
distortion the cylinder fascia tissue tingling, numbness, or
2. Broad sweeping of the hand over a larger painful temperature sensations
area
Tectonic 1. Loss of sliding ability of fascial Low-back pain: Stiffness
fixation surfaces 1. Placing hands over iliac crest
2. Loss of quantity and quality of 2. Twisting or jerking torso
synovia
In general:
Moving joint with great force

with severe and crippling pain despite the best efforts of their as an indicator of the underlying functional disturbance as well
physicians and a sizeable armament of diagnostic and as guidance for the appropriate manipulative treatment. The
therapeutic measures. FDM decodes categorized manual gestures (ie, pain-related
The choice of the most appropriate treatment depends body language) to 6 pathophysiological mechanisms involved
on the patient’s age, history of illness, and somatic and in the etiology of pain (Table 1).16 The treatment is subsequently
psychological comorbidities as well as the personal guided by those nonverbal expressions.
preferences of the patient and therapist; however, the The intervention mainly consists of high-velocity and
treatment should not be chosen arbitrarily but should be low-amplitude manipulations, so-called thrusts, of the
based on the best available evidence. affected joints, and specific massaging procedures at the
The assessment of the available evidence, however, is a surrounding connective tissue.20 Those procedures are based
major task in itself; a plethora of randomized controlled trials on the concept of a maladaptation of the crosslinks along the
(RCTs) and systematic reviews exist, and little robust evidence subcutaneous fasciae and a subsequent tension-free
is available beyond the efficacy of analgesics and strengthening readaptation after manipulation.
physical therapy. Therefore, treatment algorithms should be Two of the most prevalent gestures in patients with LBP
derived from evidence- and consensus-based guidelines, such indicate distortions, called the herniated trigger point and the
as that provided in the German National Disease Management trigger band.
Guidelines (NDMGs)4; the joint clinical practice guideline Herniated Trigger Point. The patient’s symptom is a dull
from the American College of Physicians and the American pain in the gluteal region or the trigonum lumbale. Typically,
Pain Society5; and the European guidelines for the management as the sign of the condition, the patient presses his or her
of acute, nonspecific LBP in primary care.6 The results of novel thumb or the knuckle of a finger into the area affected by the
treatment modalities should be evaluated using the guideline- pain, and that pressure causes some relief, which, however, is
adherent therapy as a benchmark. only transient. The therapeutic solution is to follow the
Osteopathy and manipulative treatment of LBP has patient’s body language and apply increased pressure in the
gained some interest in the past decade7-12; however, it is same area. The pressure is held until the patient experiences
difficult to judge the merits of the approach due to the variety relief (ie, after approximately 2 min). The relief is often lasting,
of methods and the overall scanty evidence. Therefore, the and the patient may not require further treatment.
therapist needs to establish the efficacy and safety of a given Trigger Band. As the sign of the condition, the patient
method by appropriate research. makes a sweeping motion with 1 or more fingers along an
One relatively novel method of manipulative diagnosis imaginary, painful, linear pathway. In LBP, that pathway
and treatment is the fascial distortion model (FDM), typically starts in the paravertebral region of the thoracolumbar
developed by the American osteopath Stephen Typaldos.13-16 spine and extends over the gluteal region to the lateral or
It is based on the concept of the fasciae as sensitive, dorsal thigh. The fascial band is treated with a sweeping
pain-permitting organs17-19 and uses the patient’s body language motion of the tip of the thumb that follows the imaginary line

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shown by the patient. The intervention typically loosens the of complaint duration in excess of the prespecified 2-week
restrictions of motion often associated with LBP. Patients often threshold. A total of 181 of the remaining 259 patients met
perceive the intervention as rather painful but report quick 1 of the exclusion criteria, most frequently because of longer
and substantial relief shortly afterward. pain duration upon close scrutiny (n = 80) or signs of specific
Systematic clinical trials of the FDM are scarce13,21,22 but causes of back pain (eg, inflammatory or rheumatic signs,
indicate efficacy that is superior to that of a placebo. The only disc herniation, lumbar fractures; n = 67). One patient was
comparative study published so far found the FDM to be lost to follow-up after the first intervention, leaving
more efficacious than conventional manipulative treatment 77 patients for evaluation.
in patients with frozen shoulders.21 The choice of treatment by the investigator was sequential
The application of the FDM in LBP is therefore promising (ie, the first 38 patients who were eligible and provided
but has not been systematically investigated. The present study informed consent to participate were treated according to
is a prospective, nonrandomized, controlled, parallel-group NDMG and the latter half according to FDM).
trial intended to provide proof of concept to establish the Patients were stratified for age, gender, and crude
noninferiority of the FDM treatment compared to the prognosis assessment (ie, the presence of LBP in the 12 months
NDMG-guided therapy for acute LBP. before enrollment and their functional capacity)24 to provide
The study’s nonrandomized design is due to the complex sufficient sample sizes for pertinent subgroup analyses.
nature of the patient-therapist interactions in FDM, as in all The study’s materials and methods are reported according
other manipulative methods of treatment. A reliable to the Transparent Reporting of Evaluations with
randomization would have required sample stratification Nonrandomized Designs (TREND) statement.23 The study’s
according to a number of criteria, and, consequently, the protocol was approved by the ethics committee of the
required sample size would have been prohibitive for an Medical School Hanover (approval No. 5846).
early-phase evaluation of the method. A successful demonstration
of noninferiority against the conventional guideline-adherent Procedures
treatment might be a rational basis for a future RCT. Patients’ statuses were evaluated at baseline and after 1, 4,
and 12 weeks of treatment. At baseline only, the research team
MATERIALS AND METHODS recorded the anamnestic duration and intensity of symptoms
Participants for the patient and his or her previous incapacitation(s) related
The study took place in a private practice for surgery and to work. At 1, 4, and 12 weeks of treatment, the research team
orthopedics of 1 member of the research team. The measured the primary, coprimary, and secondary outcome
participants were recruited at that private practice between endpoints described in the following.
July 2012 and December 2013. The primary endpoint for the efficacy analysis was the
To be included, prospective participants needed to be percentage of patients who were completely free of symptoms
(1) seeking treatment at the investigator’s private practice for at the final examination. The coprimary endpoint was the
acute, nonspecific, LBP of up to 2 weeks in duration; percentage of responders at 1, 2, and 12 weeks after treatment
(2) aged older than 18 years; (3) able and willing to understand onset.
the trial’s purpose and to communicate with the investigator; The following parameters were analyzed as secondary
and (4) willing to provide written informed consent for endpoints: (1) pain-free range of motion of the spine—finger-
participation after detailed information about the purpose floor distance and lateral flexibility; (2) incapacitation related
and methods of the study. to work in days; (3) use of analgesics, including frequency and
Prospective participants were excluded if they dosage; (4) frequency of specialist consultations; and (5) pain
(1) showed signs of inflammatory and/or rheumatic spinal scores according to the patient diaries
diseases; (2) showed signs of anatomical alterations such as
spondylarthritis or hereditary malformations; (3) had had Interventions
traumata or operations of the pelvis, hip, or spine within the Patients in the intervention group (FDM group) were
3 months prior to enrollment; (4) had neurological diseases treated according to the FDM once per week for a prespecified
or signs of nerve compression; (5) had spinal hypermobility maximum of 4 weeks, which was, however, not fully exploited
or instability; (6) had clinically significant arthritis; due to early treatment response. In addition to the FDM
(7) had malignancies; (8) had coagulation disorders; or treatment, the patients were allowed to receive all required
(9) were pregnant. guideline-conformant modalities, such as analgesic medications,
Upon visiting the clinic, eligible patients were informed topical applications, and active exercises. To provide specific
about the study’s design and about the potential benefits and information on the FDM’s efficacy, all concomitant interventions
risks of the 2 treatment alternatives. Only patients who did were meticulously recorded, and both treatment arms were
not express a preference between the FDM- and the statistically controlled for possible confounding effects of those
NDMG-based treatment were enrolled. interventions. Patients with a persistent treatment demand
Of 483 patients who called the practice for an beyond the 4 weeks of the intervention or with 6 weeks of
appointment during this period, 224 were excluded because symptoms were classified as nonresponders.

26 ALTERNATIVE THERAPIES, SEP/OCT 2017 VOL. 23 NO. 5 Richter—FDM Treatment for Low-Back Pain
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The active control treatment was performed according to Sample-size calculations were based on that wider range
the German NDMG4 and included all modalities recommended of noninferiority and yielded a minimum of 34 patients per
therein with the exception of FDM treatment. The group, with α = .05 and a power of 80%. Statistical testing of
recommendations herein are derived from international metric and discrete parameters for significance was performed
guidelines and are mostly identical with those given in employing established nonparametric methods, with P < .05.
pertinent American5 or European6 guidelines. Accordingly, the The outcomes for the intervention were statistically tested
treatment included the following interventions in varying, for noninferiority in comparison with the therapy that followed
patient- and investigator-driven combinations: (1) analgesic the NDMG.4 Efficacy limits for primary and secondary
and anti-inflammatory pharmacotherapy, (2) active exercises, endpoints were chosen according to published studies versus a
instead of immobilization, (3) thermotherapy, and placebo, and statistical testing for noninferiority was performed
(4) relaxation/psychoeducation. according to the Consolidated Standards of Reporting Trials
Like for the intervention group, all treatments were (CONSORT) methodical principles.30,31
recorded, and patients with persisting treatment demands
beyond the 4 weeks of therapy or 6 weeks of symptoms were RESULTS
deemed nonresponders. Baseline
Seventy-seven outpatients, 38 females (49.4%) and
Outcome Measures 39 males (50.6%), participated in the trial. Their mean age
The study protocol and study report include a number of was 42.6 ± 13.5 years, with a range from 19 to 75 years, and
outcome criteria for further analysis (eg, subjective experience the patients were on average slightly overweight, with a mean
of the treatment, current complaints, FABQ26) that are not body mass index (BMI) of 26.4 ± 5.2 and a range from 18.5 to
referred to in this study. 43.9. Patients in the 2 treatment groups showed no significant
Absence From Work. This measurement was differences with respect to sociodemographic and baseline
self-reported and expressed in days of work missed by the data (Table 2).
participant. Each reporting opportunity collected only those After the start of treatment, follow-up examinations
days missed since the participant’s most recent visit to the clinic. were performed at approximately 1 week, with a mean of
Physical Examination. In the examination, the research 7.5 ± 2.9 days (T2); at approximately 4 weeks, with a mean of
team measured the finger-floor distance (in maximal pain- 30.4 ± 4.2 days (T3); and at approximately 12 weeks, with a
free anteflexion) and the Schober sign, both in centimeters. mean of 86.7 ± 6.7 days (T4) after the initial evaluation, and
Hanover Functional Ability Questionnaire. The no significant group differences existed regarding the time
questionnaire provided a score of a patient’s functional between treatment and assessment. The slight deviations of
capacity. It was specifically developed for LBP.25 the actual assessment date from exactly 1, 4, and 12 weeks
Pain Intensity Questionnaire. The study measured pain were owing to practical considerations (public holidays,
on a 10-cm visual analogue scale (VAS) with a range between appointment availabilities, etc) in the private practice study
0 (no pain at all) and 10 (excruciating, unbearable pain). A setting.
reduction of 33% in pain intensity was employed as a
threshold for response analyses.
Patient Diaries. These included pain, medication, Table 2. Participants’ Baseline Data
interference with activities of daily living and sleep. Patients
recorded pain intensity (VAS) and any intake of analgesic All Participants FDM Group NDMG Group
agents (with substance and dosing) as well as interference of Parameter N = 77 N = 39 N = 38
their back pain with activities of daily living and sleep in a Age, y
Range 19 to 75 19 to 75 20 to 69
diary throughout study duration.
Mean ± SD 42.6 ± 13.5 40.3 ± 14.8 45.0 ± 11.8
Gender, n (%)
Statistical Analyses Male 39 (50.6%) 20 (51.3%) 19 (50.0%)
The required sample size for the present trial was Female 38 (49.4%) 19 (48.7%) 19 (50.0%)
calculated based on a noninferiority hypothesis with respect BMI
to the endpoint of chronification of the acute LBP Range 18.5 to 43.9 18.5 to 37.3 19.4 to 43.9
(ie, persistence of symptoms beyond 3 months after the onset Mean ± SD 26.4 ± 5.2 25.5v± 4.7 27.4 ± 5.6
of treatment). A difference of 10% regarding that endpoint Duration of acute pain, days
was considered clinically meaningful and socioeconomically Range 1 to 18 1 to 18 1 to 14
relevant29 and, thus, was chosen as the predefined Mean ± SD 6.9 ± 4.4 6.6 ± 4.3 7.3 ± 4.5
Pain within the past 63 (81.8%) 34 (87.2%) 29 (76.3%)
difference (D) for the statistical testing for noninferiority. 12 mo, n (%)
However, due to the very low risk of side effects for the FDM
treatment in the previous experience of the research team, an Abbreviations: FDM, fascial distortion model; NDMG, German
extension of the noninferiority margin to 20% was considered National Disease Management Guideline; SD, standard
acceptable and approved by the ethics committee. deviation; BMI, body mass index

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Figure 1. Results of Statistical Testing for Noninferiority of Table 3. Outcome of Primary and Selected Secondary Endpoints
the Primary Endpoint
All Participants FDM Group NDMG Group
N = 77 N = 39 N = 38
Parameter Mean ± SD Mean ± SD Mean ± SD
Freedom from 38 (49.4%) 20 (51.3%) 18 (47.4%)
symptoms at 12 wk after
treatment onset, n (%)
Response after, n (%)
1 wk 71 (92.2%) 37 (94.9%) 34 (89.5%)
4 wk 76 (98.7%) 39 (100.0%) 37 (97.4%)
3 mo 75 (97.4%) 39 (100.0%) 36 (94.8%)
Finger-floor distance (cm)
baseline 35.4 ± 21.5 34.1 ± 22.8 36.7 ± 20.4
after 1 wk 13.9 ± 12.2 13.9 ± 13.9 13.9 ± 10.4
after 4 wk 09.0 ± 10.0 08.7 ± 12.0 09.3 ± 7.6
after 3 mo 08.9 ± 12.5 10.1 ± 12.6 07. 7 ± 12.4
Schober sign (cm)
NDMGM Better Odds Ratio FDM Better baseline 1.92 ± 0.66 1.95 ± 0.65 1.89 ± 0.69
after 1 wk 3.00 ± 0.73 2.87 ± 0.66 3.13 ± 0.78
Note: The endpoint had a prespecified Δ requiring 10% or after 4 wk 3.22 ± 0.74 3.21 ± 0.74 3.23 ± 0.75
20% of patients to be completely symptom free at the end after 3 mo 3.88 ± 0.80 3.18 ± 0.68a 3.59 ± 0.86a
FFbHR (%)
of observation, respectively. If the lower 95% confidence
baseline 60.5 ± 22.9 61.5 ± 20.6 59.5 ± 25.3
interval would have been within the green area (depicting the after 1 wk 78.6 ± 17.7 77.2 ± 19.4 80.0 ± 15.9
more “generous” 20% interval), noninferiority would have after 4 wk 85.5 ± 16.0 85.7 ± 17.3 85.3 ± 14.6
been demonstrated. Both intervals were prespecified and after 3 mo 87.7 ± 15.6 86.3 ± 16.2 89.1 ± 15.0
tested, but only the 20% interval is shown in the figure. Inability to work (d)
baseline 1.81 ± 3.34 1.41 ± 3.23 2.21 ± 3.44
after 1 wk 2.51 ± 4.68 1.97 ± 4.51 3.05 ± 4.85
Abbreviations: NDMG, German National Disease after 4 wk 2.99 ± 5.84 2.38 ± 5.09 3.61 ± 6.52
Management Guideline; FDM, fascial distortion model. after 3 mo 3.26 ± 5.91 2.69 ± 5.23 3.84 ± 6.56

a
Primary Endpoint P < 0.05 for comparison between groups
Overall, 38 of the 77 patients (49.4%) were completely
free of symptoms at the time of the final examination at Abbreviations: FDM, Fascial Distortion Model; NDMG,
12 weeks after initiation of the treatments (Table 3). The German National Disease Management Guideline; SD, standard
primary endpoint was met in 20 of the 39 patients (51.3%) in deviation; FFbHR, Hanover Functional Ability Questionnaire
the FDM group and in 18 of the 38 patients (47.4%) in the
NDMG group (odds ratio [OR], 1.29; 95% confidence Table 4. Number of Participants Taking NSAIDs and
interval [CI], 0.52 to 3.21), with the difference not being Ibuprofen Doses During the First Week
statistically significant. Statistical testing for noninferiority
with a prespecified Δ of 20% yielded an inconclusive result All FDM NDMG
with regard to the primary endpoint (Figure 1). Participants Group Group
According to the primary response criterion of ≥33% N = 77 N = 39 N = 38
Parameter N (%) N (%) N (%) P Value
pain reduction on the VAS, the FDM group consistently Ibuprofen
scored slightly better than controls, but the difference was Intake 67 (87.0%) 33 (84.6%) 34 (89.5%) .737
statistically not significant throughout the observations. Dose, mg/7 d, 7746 ± 3245 6872 ± 3523 8594 ± 2813 .052
mean ± SD
Secondary Endpoints Additional analgesic 10 (14.9%) 3 (9.1%) 7 (20.6%) .305
The evaluation of participants’ pain diaries showed that or anti-inflammatory
medication for the
their complaints—pain intensity and frequency, impairment 67 patients taking
of activities of daily living, and interference with sleep— ibuprofen
declined in both groups, but the improvements occurred Other analgesic or 3 (30.0%) 2 (33.3%) 1 (25.0%) 1.000
noticeably faster under FDM when compared to the NDMG- anti-inflammatory
medication for the
guided treatment. The differences were not statistically
10 patients not taking
different and diminished beyond the first week, so that ibuprofen
toward then end of observation, both groups showed more or
less identical behavior. A slow further improvement of the Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs;
aforementioned complaints occurred until approximately FDM, fascial distortion model; NDMG, German National
week 6, after which the patients’ statuses remained largely Disease Management Guideline; SD, standard deviation.

28 ALTERNATIVE THERAPIES, SEP/OCT 2017 VOL. 23 NO. 5 Richter—FDM Treatment for Low-Back Pain
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Figure 2. Pain Intensity on a VAS During Observation of Use of FDM Therapy all but 2 points of observation, with the
and an NDMG-adherent Control Treatment latter 2 points of observation being
No significant differences between treatment groups
inconclusive.
Statistical significance for noninferiority (P < .05) Statistical significance for
noninferiority (P < .05)
Analysis of further secondary
endpoints such as analgesics demand
Control
confirmed the assessment derived from
Treatment the remission/response and pain analyses.
The faster onset of effects under FDM
therapy became evident when the analgesic
Pain Intensity (VAS, mean ± SD)

medication was studied (Table 4). Between

day 3 and week 2, significantly fewer
patients in the FDM group required
analgesics and/or nonsteroidal anti-
inflammatory drugs (NSAIDs). The
difference was consistently in the order of
magnitude of one third (ie, if 3 to 3.5
additional patients had been treated with
FDM, 1 of them would have been able to
cease medical treatment completely). See
Figure 3. More specifically, Table 4 shows
Abbreviations: VAS, visual analogue scale; FDM, fascial distortion model; the number of patients under ibuprofen
NDMG, German National Disease Management Guideline; SD, standard medication, a standard NSAID in NDMG-
deviation; FFbHR, Hanover Functional Ability Questionnaire. guided treatment, with the administered
doses. The proportion of patients under
Figure 3. Percentage of Patients With Analgesic Medication During the First medication was largely equivalent, with
Week of FDM Therapy and an NDMG-adherent Control Treatment the patients under FDM requiring an
appreciably smaller amount, and the
difference of approximately 1700 mg/week
only just failing to be statistically
significant.
Δ 28% - 32% Functional parameters in Table 3
P = .05
NNT = 3.2
to 3.5
confirmed the tendency toward slightly
better results for the FDM, largely without
statistical significance. However, the
consistent observation of a difference of
approximately 1 day of incapacitation
related to work might be economically, if
not statistically, significant.

Influence of Baseline on Outcomes

Because of the very high percentage
of patients who met the coprimary
endpoint of response to treatment, the
analysis of possible confounding factors
Abbreviations: FDM, fascial distortion model; NDMG, German National Disease did not promise to be informative and
Management Guideline; NNT, number needed to treat. was therefore omitted. The results of the
logistic regression for the primary
unchanged. No recurrence of complaints was observed endpoint of freedom from symptoms at 12 weeks after
within the observation period. treatment are shown in Table 5. None of the baseline
As an example, Figure 2 shows the VAS values for pain parameters showed a significant influence on the outcome in
intensity in both groups. Between days 2 and 5, an appreciable, the multifactorial testing, and in particular, no tendency
albeit insignificant, difference was found in favor of the existed at all indicating a detrimental influence for patients
patients under FDM treatment that then evened out from day with more severe symptoms at baseline. The tendency toward
6 onward. More important than that slight difference was the a slightly better outcome after FDM treatment was confirmed,
fact that statistical testing yielded results showing noninferiority with a 14% difference in the OR, and younger patients,
with regard to pain intensity, with a prespecified Δ of 1 cm, for females, and patients without pain within the 10 months

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Table 5. Influence of Baseline Parameters on Treatment Outcome, the Primary Endpoint

Unifactorial Evaluation Multifactorial Evaluation

Factor Group (unit) Odds Ratio (95 % CI) P value Odds Ratio (95 % CI) P value
Treatment modality FDM treatment 1.16 (0.47 to 2.86) .73 1.14 (0.40 to 3.26) .80
Gender Male 2.20 (0.88 to 5.55) .093 2.28 (0.80 to 6.51) .12
Age Per year 0.96 (0.93 to 1.00) .048 0.97 (0.93 to 1.01) .12
Duration of pain Per day 0.97 (0.88 to 1.08) .59 0.99 (0.88 to 1.12) .93
Pain with the prior 10 mo None 3.13 (0.87 to 11.2) .081 3.10 (0.74 to 12.9) .12
Pain upon diagnosis Per unit VAS 0.96 (0.75 to 1.23) .73 0.95 (0.71 to 1.28) .75
FFbHR upon diagnosis Per % 1.01 (0.99 to 1.03) .57 1.00 (0.97 to 1.02) .77

Abbreviations: CI, confidence interval; FDM, fascial distortion model; FFbHR, Hanover Functional Ability Questionnaire.

prior to enrollment fared slightly better than their respective earlier improvement under FDM therapy—were observed in
counterparts. a study on use of the FDM for a frozen shoulder.21 Even
under full consideration of the methodological constraints of
Adverse Events early exploratory research, that finding strongly indicates the
In addition to the known collateral effects of FDM ability of FDM treatment to exploit the individual patient’s
treatment that were part of the consent form, such as pain existing potential for quick and substantial improvement.
and subcutaneous hematomas, no adverse events occurred in Moreover, the validity of those observations was
either group. underlined by a reduced demand for analgesic medication
and by the fact that patients under the FDM treatment
DISCUSSION returned to work one day before their NDMG-treated
The unmet needs in the treatment of acute LBP are counterparts. Although the difference was not statistically
undeniable and substantial, both with regard to the individual significant, again owing to the current study using a proof-of-
patient’s well-being and from a payers’ perspective,5 and, concept design resulting in low statistical power, its economic
therefore, exploratory research such as presented in the effect may potentially be substantial. It is well established that
present trial is well justified. Before the discussion of the absence form work causes the majority of the overall
present trial’s results, the proof-of-concept character of the economic burden of LBP,1,32 and a gross expenditure of
study has to be emphasized. The FDM as such has scarcely €150 to €300 per sick-leave day can be estimated from data of
been investigated systematically,21 and no evidence had been insurers, hospital operating companies, and published
published on its application in LBP as of October 2015. pertinent evidence.33
Therefore, the current research team decided to gather some German health surveillance is notoriously sketchy and
solid, albeit preliminary, evidence from a nonrandomized unreliable, and pain syndromes especially are therefore
trial before launching a much more expensive RCT. difficult to quantify.34 However, the data of the largest payer
Against that background, the results of the present trial in Germany showed approximately one million sick-leave
appear very conclusive, and the fact that the CONSORT- cases, at approximately 14 days of absence, in 2008.35
conformant test for noninferiority was inconclusive should According to those figures, a savings of €150 million per year
not be given too much weight. In fact, although the primary would be attainable in that insured population alone, even
endpoint could technically not be shown to be noninferior, based on the lower margin of the aforementioned estimate,
the pain intensity for the intervention group on the VAS was and that is an order of magnitude in which a payer should
noninferior at all but one points of assessment; moreover, the certainly be interested. From an economic standpoint, the
observation was confirmed with noticeably lower doses of systematic application of FDM instead of NDMG-guided
analgesic medication being taken by the FDM patients. That treatment might save substantial amounts if the data in the
observation is all the more remarkable because the patients present trial could be validated by a further study, and
were self-dosing the medication, (ie, taking it ad libitum) and funding of pertinent research could be in the best interests of
the FDM intervention as such is rather painful in the short all stakeholders involved.
term. That pain might have prompted the patient to take the The major principle of FDM is the common reflection of
NSAID after treatment to alleviate the immediate effects. the course of injury and the therapist’s evaluation of the
Overall, the current research team’s observations showed patient’s body language and clinical symptoms, which
that the 2 examined interventions yielded a largely equivalent altogether can lead to a diagnosis and an exactly defined
effect over the entirety of the observation period, but the therapeutic consequence. Therefore, the patient participates
beneficial effects occurred noticeably earlier in patients as a director of her or his own treatment.
treated according to the FDM. It is remarkable that the same The exact mechanism of action of the FDM method is
results—efficacy equivalent to established treatment but currently elusive. The originator of the method assumed an

30 ALTERNATIVE THERAPIES, SEP/OCT 2017 VOL. 23 NO. 5 Richter—FDM Treatment for Low-Back Pain
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influence on fibroblast activity, and, consequently, alterations concept of the method’s efficacy. Future studies should reach
of the extracellular connective-tissue matrix.13-16 Whereas beyond that point and elucidate the mechanism of action of
that model is reasonably plausible to explain a slowing of the the method more specifically. Presently, it is open to debate
progress of inflammatory alterations in the periarticular as to the extent that the efficacy of the FDM, which has been
tissue of the spinal column, it is hardly a sufficient concept convincingly demonstrated in the present trial, is owing to
for the quick pain relief and mobility gains observed in the the specific methodological principles of FDM treatment.
current study’s participants as well as those with a frozen
shoulder in the previously published study.21 CONCLUSIONS
A leading characteristic of the FDM treatment is the FDM was shown to be efficacious with regard to specific
significant discomfort/pain that patients experience during pain relief and functional improvement in patients with LBP,
the manipulation. In contrast to some simplistic assumptions, and its results were comparable with guideline-adherent
inflicting pain as such is not an effective means to treat it36; treatment. The potential of FDM to become part of the
however, a body of evidence is emerging concerning the standard armament of treatment modalities for LBP should
modulation of pain-signal transmission and processing be elucidated in further RCTs.
through counterstimulation.37,38 Results of clinical trials have
indicated that so-called sham interventions that inflict AUTHOR DISCLOSURE STATEMENT
The research team received no funding in relation to the study and has no conflicts of
physical stimuli without following proposed therapeutic interest.
principles can show some efficacy in LBP and other painful
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