Saitama Prefectural University

No increase in 6-week treatment effect of Mechanical Diagnosis and Therapy with the use of the LUMOback in people with non-

acute non-specific low back pain and a directional preference of extension: a randomized controlled trial

Hiroshi Takasaki1,2, Satoru Aoki2, Stephen May3

1: Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Japan2: Department of Rehabilitation, Aoki Chuo Clinic, Kawaguchi, Japan3: Faculty of Health and Wellbeing, Sheffield Hallam University, UK

LUMOback (Lumo Bodytech Inc., Mountain View, CA, USA)

BackgroundStrong evidence: (Delitto et al. 2012)

Mechanical loading strategies in a specific direction resulting in ① Centralization② Improvement of symptoms and mobility of the back

Low back pain (LBP) with related (referred) lower extremity pain including acute LBPAcute, subacute or chronic LBP

ü Directional preference (DP) : Specific direction resulting in centralization and/or improvement of symptoms and mobility

ü Posterior Derangement syndrome: DP of lumbar extension

Mechanical Diagnosis and Therapy (MDT) (i.e., McKenzie Approach) Ø One of the most commonly used physical therapy approaches for the management of LBP

(Ladeira, et al. 2015; Davies et al. 2014)

ü The LUMOback works on i-phone application, continuously monitors the pelvic position during everyday life and can provide real-time feedback to avoid a slouched posture using a vibration alert.

Lumbar extension exercises&

Postural education(Sitting: Lumbar roll)

management

Treatment effect of MDT may be enhance with real-time feedback with the LUMOback in patients with Posterior Derangement syndrome.

Hypothesis

Design: RCT Inclusion criteria: 1) ≥18 years of age, 2) non-specific LBP, 3) symptoms lasting for ≥ 1 month, 4) using a smartphone and 5) undertaking LBP management based on MDT only.

Not considered eligible: 1) patients with a history of back or lower quadrant surgery or trauma within the past 6 months, 2) patients with a history of nerve root block within the past 4 weeks, 3) patients with a history of neuropathic pathology such as diabetes or polyneuropathies, vascular disease in the lower extremity, systemic disease or inflammatory arthropathy, 4) patients with any contraindication to manual therapy techniques such as fracture, infection or severe osteoporosis, and 5) individuals with who cannot communicate well for some reason.

Exclusion criteria were no DP of lumbar extension.

Participants

Interventions ü The MDT interventions (20-40 minutes) by a credentialed therapist

Ø Acceptable inter-examiner reliability to detect the DP of extension and MDT lumbar classification (May, et al. 2006)

MDTü Postural education to maintain neutral lumbopelvic posture

ü Postural correction in sitting with a McKenzie lumbar roll

ü 10 reps/3h of lumbar extension loading (see below) + EIL therapist’s O/P and/or PA mobilization (when necessary in the clinic) (https://extendfitness.com)

Extension in standing (EIS)

EIS with Sustained Natural Apophyseal Glide (SNAG) using fists

EIS with SNAG using a towel

Extension in lying (EIL)

EIL with self-overpressure (O/P)

EIL with self-O/P with a towel

EIL with O/P with somebody’s help

MDT+LUMObackü Same MDT interventions

ü Wearing the LUMOback at the level of the L5-S1 daily for the full 6-week of the intervention, except when playing water sports, taking a shower or sleeping

ü Threshold of ‘very slouched’ was considered clinically relevant in the MDT intervention (Takasaki H, 2017) and thus a ‘very slouched’ posture which lasted for ≥ 5 sec triggered feedback with LUMOback vibration.

LUMOback settingl Participants undertook the calibration in neutral standing when they first put on the LUMOback in the morning. l Once it is calibrated, the LUMOback device can determine the angle of the pelvis relative to the calibrated angle. l The threshold of ‘very slouched’ included ≥7°posterior or ≥14°anterior tilt of the pelvis relative to the calibrated angle in

sitting and ≥8°posterior or ≥12°anterior tilt of the pelvis relative to the calibrated angle in standing.

Outcomes u Primary outcome measure: the Global Rating of Change Scale (0-6)

u Secondary outcome measures: 1) Pain intensity using the P4 2) Magnitude of disability using the Oswestry Disability Index3) Self-reporting functional limitations using the Patient Specific Functional scale4) Quality of life using the SF-36 version 2-week5) Sagittal mobility of the trunk assessed by a blinded examiner using the Figure Floor Distance and a

Modified Schober's Test

TABLE 1. Summary of the patients analyzed in the current study at the initial Mechanical Diagnosis and Therapy (MDT) session.

Values are presented as mean (SD) or numbers [%].

Abbreviations: SF-36v2, 36-Item Short-Form Health Survey version 2.a0 = no pain, 40 = the highest pain intensity.bGreater values indicate more severe disability.c0 = unable to perform activity, 10 = able to perform activity at the same level as before injury or problem.d50 = national average, greater values indicate a better condition.ePositive value indicates that the finger reaches above the floor and negative value indicates that the finger reaches below the floor.fmeasured by a Modified Schober's Test: Max = 15.0 cm, smaller values indicate grater lumbar extension range of motion in standing.

Results

① Comparable baselines between the groups except Finger Floor Distance

Variables MDTgroup(n=10)

MDT+LUMOback group(n=10)

Women,number(%) 3[30%] 5[50%]

Age(years) 40.4(13.8) 41.1(10.7)

P4(0-40)a 19.7(7.8) 18.6(5.5)

Painduration(months) 26.5(35.9) 24.4(37.2)

Oswestry DisabilityIndex(%)b 28.4(15.8) 29.1(8.3)

PatientSpecificFunctionalscale(0-10)c 4.3(1.5) 4.5(1.7)

SF-36v2physicalcomponentsummaryscore(nationalstandardvalue,50)d 36.1(6.5) 40.8(7.8)

SF-36v2mentalcomponentsummaryscore(nationalstandardvalue,50)d 48.8(3.8) 47.2(8.2)

FingerFloorDistance(cm)e 1.1(9.5) 12.0(18.2)

Lumbarextensionrangeofmotion(cm)f 12.6(1.4) 12.8(0.8)

TABLE 2. Mean (SD) values of the Global Rating of Change Scale (GRCS) and of the change of the secondary outcome measures from baseline to each follow-upa and those mean differences between the groups with those associated 95% confidence intervals (CIs).

Abbreviations: ODI, Oswestry Disability Index; PSFS, Patient Specific Functional scale; PCS, SF-36 version 2-week physical component summary score; MCS, SF-36 version 2-week mental component summary score; FFD, Finger Floor Distance; Ex ROM, Lumbar extension range of motion. a[Value at each follow-up] – [Value at the baseline]b0 = worse than ever, 1 = much worsened, 2 = slightly worsened, 3 = no change, 4 = slightly improved, 5 = much improved, 6 = completely recoveredcA higher sum score indicated more spreading pain. 0 = no pain, 40 = the highest pain intensity.dGreater values indicate more severe disability.e0 = unable to perform activity, 10 = able to perform activity at the same level as before injury or problem.f50 = national average, greater values indicate a better condition.gPositive value indicates that the finger reaches above the floor and negative value indicates that the finger reaches below the floor.hmeasured by a Modified Schober's Test: Max = 15.0 cm, smaller values indicate grater lumbar extension range of motion in standing.

② Negligible mean difference between the groups at each follow-up, with 95% CIs that included zero

Variables

3-weekfollow-up 6-weekfollow-up

(A)MDTgroup(n=10)

(B)MDT+LUMOback

group(n=10)

(A-B)Difference[95%CIs]

(C)MDTgroup(n=10)

(D)MDT+LUMOback

group(n=10)

(C-D)Difference[95%CIs]

GRCS(0-6)b 4.7(0.8) 4.7(0.5) 0[-0.6to0.6] 4.9(0.5) 4.9(0.5) 0[-0.5to0.5]

P4(0-40)c -5.1(10.6) -6.7(7.7) 1.6[-7.6to10.8] -10.0(10.7) -12.1(6.5) 2.1[-6.7to10.9]

ODI(%)d -12.4(17.3) -10.0(9.4) -2.2[-16.1to11.7] -17.0(19.0) -19.6(9.5) 2.6[-12.3to17.5]

PSFS(0-10)e 2.4(2.1) 1.9(3.0) 0.6[-2.0to3.2] 3.6(2.2) 3.8(3.0) -0.3[-2.9to2.3]

PCSf 4.3(10.5) 1.8(12.1) 2.5[-8.7to13.8] 13.7(13.0) 13.6(8.3) 0[-10.7to10.8]

MCSf 6.0(5.8) 3.7(6.9) 2.3[-4.0to8.6] 2.6(8.5) 2.1(4.0) 0.4[-6.1to7.0]

FFD(cm)g -2.7(4.9) -0.6(6.6) -2.2[-7.9to3.6] -2.7(9.6) -3.3(11.2) 0.6[-9.8to10.9]

ExROM(cm)h -0.5(0.8) -0.6(1.3) 0.1[-0.9to1.1] -0.7(0.9) -1.2(1.0) 0.5[-0.4to1.5]

ü There was nobody who rated the GRCS ≤ 2 in each follow-up.

ü There was nobody who did not undertake the exercises at all over three successive days.

ü In the MDT + LUMOback group, the mean (SD) compliance rate of wearing the LUMOback was 88% (15%), where the mean (SD) posture score was 64% (14%).

Variables MDTgroup(n=10)

MDT+LUMOback group(n=10)

Treatmentsessionsfromthebaselinetothe3-weekfollow-up 4.0(1.2) 4.1(0.8)

Treatmentsessionsfromthe3-weekfollow-uptothe6-weekfollow-up 2.8 (1.2) 2.4(0.7)

Numberofsetswith10repetitionsofexercisesperday 3.7(1.5) 3.7(1.6)

TABLE 3. Mean (SD) for treatment sessions and home exercise executing rate.

ü The compliance rate of wearing the LUMOback was 88%

High compliance rate of the LUMOback.

ü Regarding home exercises, when 100% compliance was defined as 5 sets/day, the 3.7 sets/day was 74% compliance.

Home exercise adherence can be considered acceptable.

ü The dropout rate was 9% and the mean of the GRCS was 4.7 in each group.

6 weeks would be reasonable as duration of the MDT intervention to compare the size of the treatment effect.

ü There was nobody who rated the GRCS ≤ 2 in each follow-up

The method tested in the current study was safe and acceptable to the participants.

ü The mean posture score of the MDT + LUMOback group over the 6-week intervention was 64%, which is similar to those without a history of LBP in a previous study [4].

Postural correction had been successfully undertaken in the patients of the MDT + LUMOback group.

Discussions

Positive findings for a larger trial

Findings to reconsider undertaking a larger trial

ü All measures demonstrated negligible mean difference between the groups at each follow-up, with 95% CIs that included zero.

Any clinically important differences in the treatment effect are not likely to be detected between the MDT and MDT + LUMOback groups at least for 6 weeks.

• Usual MDT may be sufficient in postural education resulting in reduction of LBP.

• A primary driver for reduction of LBP may not be postural correction but exercise in the DP.

Too much caution for posture might rather be harmful for LBP management by increasing fear of movements in particular sitting and/or forward bending…

Limitations and further studies

ü Rather than undertaking a larger trial, a promising future research agenda may be:

• Investigating patients’ preference to keep using the LUMOback for their management of posture

• Comparing recurrence rate of LBP between those with and without the use of a wearable device to manage habitual posture such as the LUMOback using a long-term follow-up.

ü Reasons for the lack of group differences in the treatment effect are unclear due to the lack of LUMOback data in the MDT group.

Necessary to understand sitting behavior and habitual posture in order to optimize education for posture

We are currently undertaking a cohort study monitoring habitual lumbopelvic posture and time spent in sitting using the LUMOback through the course of MDT management from 1 week before the initial MDT session to 6 weeks after the initial session.

Poster Presentation at EUROSPINE 2018 in Barcelona

This study has been published in Physiotherapy, September 2018, Pages 347-353

Ethical approval: This study was approved by the institutional research ethics committee in the Saitama Prefectural University (No. 28011).Funding: This work was supported by JSPS KAKENHI Grant Number 15121265.Conflict of interest: None of the authors has any potential conflict of interest. Academic record of Dr. Hiroshi Takasaki

Key messages

Disclosure information

p It was the aim to preliminarily investigate if the treatment effect of MDT could be enhanced with the use of real-time feedback with the LUMOback in patients with Posterior Derangement syndrome.

p A larger multi-center trial using the current methods is not justified due to the lack of difference in the treatment effect of MDT within 6 weeks, with or without the use of the LUMOback for assisting postural correction.