Kim, 2014

NCT 02049931

Type of study:

RCT

Setting and country:

Spinal center of a tertiary care teaching institution, Korea

Funding and conflicts of interest: This study was partially supported by research grants from Hanlim Pharm in Seoul, the Republic of Korea, to one author (H.-J.K.). The funds were used to pay for salaries and conference expenses. The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), froma third party in support ofan aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. In addition, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work.

Inclusion criteria:

The inclusion criteria were patient age of fifty years or older and the presence of acute back pain caused by a single-level vertebral fracture within three days of minor trauma. The fracture was defined as an axial compression of only the anterior column of the vertebral body with intact posterior elements, confirmed on magnetic resonance imaging, and the patient was without neurologic deficit. December 2012 to October 2013.

Exclusion criteria:

history of more than two recent vertebral fractures, a malignant compression fracture, neurologic compromise, a state of not walking before the fracture, a history of previous injury or surgery at the fractured level, and an inability to complete the questionnaires about pain and disability.

N total at baseline:

Intervention rigid: 20

Intervention soft: 20

Control: 20

Important prognostic factors²:

Age, mean ± SD:

rigid: 71.75 ± 7.96

soft: 66.75 ± 11.00

C: 72.25 ± 10.40

Sex:

rigid:70% F

soft: 70% F

C: 65% F

VAS back pain (0-10)

Rigid: 7.80 ± 2.08

Soft: 7.87 ± 2.07

C: 7.47 ± 1.96

ODI (0-100)

Rigid: 75.78 ± 13.56

Soft: 67.58 ± 16.12

C: 64.50 ± 17.06

SF-36 PCS

Rigid: 34.18 ± 14.58

Soft: 29.87 ± 11.87

C: 29.70 ± 13.55

SF-36 MCS

Rigid: 48.29 ± 14.93

Soft: 42.21 ± 11.75

C: 41.79 ± 10.31

Groups were comparable at baseline.

Rigid orthosis:

thoracolumbar sacral orthosis (How Medicare, Seoul, Korea).

Patients in the rigid-brace group were strictly maintained on bed rest until the custom-made orthosis was applied

Soft orthosis:

soft back braces (How Medicare, Seoul, Korea).

soft braces were ready-made and could be worn immediately upon patient enrollment in the study.

In both the rigid-brace and soft-brace groups, braces were to be worn at all times except when lying down, for the duration of 8 weeks.

No brace:

Patients in the no-brace group were allowed to walk without any brace as long as they were comfortable.

Length of follow-up:

12 weeks

Loss-to-follow-up:

Intervention rigid:

3/20 (15%), reason not specified

Intervention soft:

5/20 (25%), reason not specified

One participant in the soft-brace group died during the follow-up period for reasons believed to be unrelated to the trial.

Control:

3/20 (15%), reason not specified

Incomplete outcome data:

Not specified. Time of loss to follow-up not indicated.

Outcomes are reported at twelve weeks after the compression fracture as mean (95% CI)

Pain

VAS score for back pain 0-10, higher indicates more pain

2 weeks

Rigid: 5.5 (4.1 – 6.9) (N=20?)

Soft: 7.0 (5.7 – 8.2) (N=20?)

C: 6.0 (4.2 – 7.8) (N=20?)

12 weeks

Rigid: 3.1 (2.0 – 4.2) (N=17)

Soft: 3.7 (2.5 – 4.9) (N=15)

C: 4.6 (2.8 – 6.4) (N=17)

Opioid use

2 weeks

Rigid: 83.3%

Soft: 84.2%

C: 88.9%

12 weeks

Rigid:: 23.5%

Soft: 20.0%

C: 17.6%

QOL

The general health status was assessed using the Short Form-36 (SF-36). The raw scores for the SF-36 Physical Component Summary (PCS) and the Mental Component Summary (MCS) were transformed into norm-based scoring.

SF-36 PCS

12 weeks

Rigid: 32.7 (27.9 – 37.7)

Soft: 33.4 (27.9 – 39.1)

C: 30.5 (23.3 – 37.7)

SF-36 MCS

12 weeks

Rigid: 36.6 (27.9 – 45.7)

Soft: 33.9 (24.4 – 43.5)

C: 36.0 (27.1 – 45.0)

Activities/limitations of daily living

baseline adjusted Oswestry Disability Index (ODI) score (primary outcome). The

questionnaire comprised ten items, each with six levels of responses. Each item was scored from 0 to 5 points, and the total summation was converted to a 0-to-100-point scale.

2 weeks

Rigid: 53.2 (41.6 – 65.4)

Soft: 60.8 (51.0 – 70.4)

C: 55.2 (44.8 – 65.4)

12 weeks

Rigid: 33.0 (23.8 – 43.2)

Soft: 37.83 (26.77 – 48.90)

C: 35.95 (25.42 - 46.47)

Secondary fractures

Not reported

Complications

Not reported

Participation (including work)

Not reported

Muscle strength

Not reported

Authors’ conclusions:

The Oswestry Disability Index scores for the treatment of compression fractures without a brace were not inferior to those with soft or rigid braces. Moreover, the improvement in back pain and progression of anterior body compression were similar among the three groups.

Pfeiffer, 2011

Type of study:

RCT

Setting and country: Single Center, Germany

Funding and conflicts of interest:

Funded by ‘‘medi Inc, Bayreuth,

Germany,’’ which also provided the

orthoses used in this clinical trial.

However, ‘‘medi Inc’’ had no control

over the decision to approve or submit

the manuscript for publication.

No conflicts of interest have been reported by the authors or by any individuals in

control of the content of this article.

Inclusion criteria:

ambulatory, community-dwelling

women 60 yrs or older who were recruited through newspaper advertisements. At least one clinical vertebral fracture caused by osteoporosis within the last 6 mos and an angle of kyphosis above 60 degrees as measured using stereo-photomorphometry.

Exclusion criteria:

disorders affecting bone mineral metabolism (e.g., renal disease, hyperthyroidism, primary hyperparathyroidism, hypercortisolism, and osteomalacia) and severe degenerative diseases of the spine such as osteoarthritis, scoliosis, and malignancies.

N total at baseline:

Intervention rigid: 36

Intervention soft: 36

Control: 36

Important prognostic factors²:

Age, mean ± SD:

I rigid: 72.8 ± 7.1

I soft: 72.3 ± 6.7

C: 69.7 ± 8.9

Vertebral fractures:

I rigid: 2.0 ± 2.7

I soft: 1.6 ± 2.8

C: 2.1 ± 2.4

Nonvertebral fractures:

I rigid: 0.9 ± 1.1

I soft: 1.0 ± 1.3

C: 1.1 ± 1.2

Groups were comparable at baseline.

“Spinomed” orthosis, 2h/day for 6 months*

“Spinomed active” orthosis (soft), 2h/day for 6 months*

No orthosis for 6 months*

* After completion of the

first 6 months, group C should be provided with the

orthosis, whereas groups A and B should serve as

controls. The beneficial course of the first intervention phase, however, led to the fact that the participants in groups A and B refused to stop wearing the orthosis.

Length of follow-up:

12 months

Loss-to-follow-up:

Intervention rigid: 3/36 subjects stopped after 6 months due to continued pain

Intervention soft: 2/36 subjects stopped treatment prematurely because of low comfort and inconvenience.

Control:

During the first 6 months of observation, 3/36 subjects underwent kyphoplasty and were excluded.

Incomplete outcome data:

Not specified

Outcomes are reported as absolute change at 6 months compared to baseline, mean ± SD

Pain

Miltner’s rating scale.

The patients were requested to mark their intensity of

perceived pain on a scale rated from 1 to 4 whereby

1 indicates low; 2, moderate; 3, severe; and 4, very

severe pain

Spinomed: -1.5 ± 1.2 (N=36)

Active: -1.4 ± 1.1 (N=36)

C: +0.1 ± 0.9 (N=36)

QOL

Not reported

Activities/limitations of daily living

Limitations of daily living assessed by scores for disability and ability of self-care.

Disability: based on Leidig-Bruckner: The ability to get up from a supine position without use of the hands (0 = possible without difficulties, 1 = possible with moderate pain, 2 = possible with severe pain, 3 = impossible)

Spinomed: -2.1 ± 1.6

Active: -2.0 ± 1.5

C: +0.2 ± 0.8

Self-care

The assessment could be answered as follows: 1,

possible without extra help; 2, overall possible, dependent

on help in some cases (cleaning windows, drawing curtains, and carrying heavy bags); 3, possible but with difficulties and increased time, dependent on help in some cases; 4, possible but with

difficulties and increased time, dependent on help even in routine cases (shopping, ironing, and cleaning floor); 5, dependent on extra help for everyday routine functions (cleaning, cooking); 6, nursing

care needed.

Spinomed: -0.9 ± 1.1

Active: -1.1 ± 1.3

C: +0.2 ± 0.5

Secondary fractures

Not reported

Complications

Not reported

Participation (including work)

Not reported

Muscle strength

Back extensor strength (in N)

Spinomed: 189 ± 141 (N=36)

Active: 166 ± 120 (N=36)

C: 7 ± 55 (N=36)

Abdominal flexor strength (N)

Spinomed: 94 ± 71 (N=36)

Active: 135 ± 83 (N=36)

C: 23 ± 46 (N=36)

Authors’ conclusions:

the orthoses used in this study increases trunk

muscle strength and thus improves posture and body

height in patients with vertebral fractures caused

by osteoporosis. In addition, a better quality-of-life

is achieved using pain reduction, decreased limitations

of daily living, and augmented well-being.

Kato, 2019

Type of study: RCT

Setting and country:

multicenter, 71 hospitals,

Japan

Funding and conflicts of interest:

This work was supported by Grants-in-Aid from the Japan Agency for Medical Research and

Development Grant Number 16dk0110008h0003 (to AO).

The authors declare no conflict of interest.

Inclusion criteria:

patients aged between 65 and 85 years who had received a diagnosis of one fresh osteoporotic compression fracture between T10 and L2 within four weeks of injury. August 2014 to September 2016

Exclusion criteria:

more than two previous compression fractures from T10 to L2, previous spinal surgery, neurological deficits, inability to complete questionnaires, and serious comorbid conditions such as serious cancer and infection

N total at baseline:

Intervention: 141

Control: 143

Important prognostic factors²:

For example

Age, mean (SD):

I: 76.0 (5.2)

C: 75.5 (5.4)

Sex:

I: 100% F

C: 100% F

Mean time since fracture, weeks

I: 1.5 (1.2)

C: 1.5 (1.3)

No prevalent vertebral fracture, n (%)

I: 107 (76)

C: 105 (73)

Groups were considered comparable at baseline.

Rigid brace

N=141

rigid thoracolumbosacral orthosis, which is a single-piece molded plastic brace with an opening on the front

braces were to be worn at all times for 12 weeks

Soft brace

N=143

soft thoracolumbosacral orthosis, which is made from an elastic cotton/nylon material and has steel stays with an opening on the front

braces were to be worn at all times for 12 weeks

Length of follow-up:

48 weeks

Loss-to-follow-up:

Week 12

Intervention: 1/141

Reasons

Patient decision, Dementia, severe collapse progression, osteoporosis medication, No reason given

Control: 5/143

Reasons

Patient decision, operation, Changing hospital, neurological deficit, No reason given

Week 48

Intervention: 27/141

Reasons

Patient decision, Dementia, severe collapse progression, osteoporosis medication, Changing hospital, died, No reason given

Control: 29/143

Patient decision, operation, Changing hospital, neurological deficit, pneumonia, died, lumbar canal stenosis operation, No reason given

Incomplete outcome data:

Not specified

Outcome measures and effect size (include 95%CI and p-value if available):

Pain

VAS for lower back pain (0 to 100, higher scores indicating severe pain), mean (SD)

12 weeks

Rigid: 28.9 (24.1)

Soft: 29.1 (23.9)

48 weeks

Rigid: 28.2 (25.8)

Soft: 26.3 (27.0)

Use of pain medication (non-opiates and weak opiates)

12 weeks

Rigid: 32/130 (24.6%)

Soft: 40/133 (30.1%)

48 weeks

Rigid: 17/114 (14.9%)

Soft: 18/114 (15.8%)

QOL

EQ-5D-3L , -0.111 to 1, with higher scores indicating higher QOL

12 weeks

Rigid: 0.70 (0.20)

Soft: 0.72 (0.18)

48 weeks

Rigid: 0.73 (0.20)

Soft: 0.74 (0.22)

Activities/limitations of daily living

Pain-related disorder of JOABPEQ, 0 to 100, with higher scores indicating better function

12 weeks

Rigid: 69.5 (31.7)

Soft: 73.1 (30.0)

48 weeks

Rigid: 57.3 (29.8)

Soft: 60.6 (29.4)

Secondary fractures

Rigid: 7/140 (5.0%)

Soft: 9/141 (6.4%)

odds ratio 0.78 (95% CI 0.23 to

2.42)

Complications

Not reported

Participation (including work)

Social life function of JOABPEQ, 0 to 100, with higher scores indicating better function

12 weeks

Rigid: 50.9 (27.8)

Soft: 53.6 (26.0)

48 weeks

Rigid: 57.7 (28.4)

Soft: 63.4 (24.2)

Muscle strength

Not reported

Authors’ conclusions:

We found that the 12-week rigid-brace treatment for acute vertebral compression fractures did not result in statistically greater prevention of spinal deformity, better QOL, or lesser back pain than

soft-brace treatment at 48 weeks. Therefore, the routine use of a custom-made rigid brace for acute vertebral compression fractures is not justified.

Li, 2014

Type of study:

RCT

Setting and country:

Pilot trial, Hong Kong

Funding and conflicts of interest:

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

The authors declare that there is no conflict of interest.

Inclusion criteria:

(1) age: 55 years or above, (2) female, (3) clinical diagnosis of OVF with radiographs, (4) back pain secondary to OVF, and (5) affected vertebrae between T1 and L5.

Exclusion criteria:

(1) premorbid: bed-bound, (2) previous spine surgery, (3) vertebral collapse with underlying pathology (e.g. multiple myeloma and metastasis), (4) dementia/cognitive impairment, (5) patients with neurological deficits secondary to osteoporotic fracture, and (6) severe degenerative change of spine such as osteoarthritis and scoliosis.

N total at baseline:

Intervention: 27

Control: 24

Important prognostic factors²:

Age, mean ± SD:

I: 82 ± 8.3 years

C: 81 ± 6.6 years

One level of vertebral fracture (range: T12–L5)

I: 15/27 (55.6%)

C: 10/24 (41.7%)

Two levels of vertebral fracture (range: T11–S1)

I: 7/27 (25.9%)

C: 9/24 (37.5%)

At least three levels of vertebral fracture (range: T4–L5)

I: 5/27 (18.5%)

C: 5/24 (20.8%)

Groups were not comparable at baseline for number of fractures.

Spinomed orthosis

first week of disease onset: standard rigid thoracolumbosacral orthosis. 24 h/day

weeks 2-3: Spinomed orthosis 3 h/day during rehabilitation training; soft lumbar orthosis for the rest of the time

Soft lumbar orthosis

first week of disease onset: standard rigid thoracolumbosacral orthosis. 24 h/day

weeks 2-3: soft lumbar orthosis

Length of follow-up:

3 weeks

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not specified

Posttreatment values (3 weeks) are presented as mean (SD).

Pain

NRS 0-10, level 10 means extreme pain and level 0 means no pain at all.

I: 4.0 (2.0)

C: 4.5 (2.1)

QOL

Not reported

Activities/limitations of daily living

Functional Independence Measure-motor Scores (FIM-motor Scores). It includes 18 items to measure how much assistance is required for the individual to carry out activities of daily living. Total score is a value between 18 and 126 and the higher scores indicate the more independent.

I: 70.2 (9.0)

C: 61.8 (11.5)

Elderly Mobility Scale (EMS), a standardized validated scale for assessment of mobility in more frail elderly patients. This scale assesses seven dimensions of functional performance, which include locomotion, balance, and key position changes in daily living. The maximum score of EMS is 20 and higher scores indicate better performance.

I: 9.6 (3.7)

C: 9.9 (4.5)

Modified Functional Ambulation Category (MFAC). Functional mobility test to classify the patient’s walking capacity, which is separated as seven levels of ambulatory status (i.e. lyer, sitter, dependent walker, assistant walker, supervised walker, indoor walker, and outdoor walker). The maximum score of MFAC is 20 and higher scores indicate more independent in mobility (scores larger than 14 means independent in mobility).

I: 4.6 (1.2)

C: 4.7 (1.1)

Secondary fractures

Not reported

Complications

Not reported

Participation (including work)

Not reported

Muscle strength

Not reported

Authors’ conclusions:

Both groups were found to significantly reduce the patients’ pain level and limitations of daily life (p < 0.05). The effect of the two types of spinal orthoses on the pain level reduction and functional mobility level gain did not show signifi

cant difference (p > 0.05) at the subacute stage.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Kato, 2019

UMIN000014876

Definitely yes

Reason: secure, encrypted, web-based system that

enabled computer-generated random treatment assignment

No information

Definitely no

Reason: physicians and patients could not be blinded to the

treatment after they were assigned to a specific study group.

Radiographic evaluators at all outcome points were blinded (outcomes not included in current analysis).

Probably yes

Reason: Loss to follow-up was infrequent at short term follow-up, and similar in both groups.

Probably yes

Reason: All relevant outcomes were reported

Probably yes

Reason: No other problems noted

SOME CONCERNS for patient reported outcome measures due to lack of blinding

Kim, 2014

Definitely yes

Reason: randomization was performed

using a computer-generated randomization list

Definitely yes

Reason: randomization was concealed from the first author before the randomized allocation

Definitely no

Reason: physicians and patients could not be blinded to the Intervention.

Assessors of radiographic measurements (not included in current analysis) were unaware of the treatment method.

Probably yes

Reason: Loss to follow-up was infrequent in intervention and control group.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes

Reason: No other problems noted

SOME CONCERNS for patient reported outcome measures due to lack of blinding

Li, 2014

No information

No information

Definitely no

Reason: physicians and patients could not be blinded to the Intervention.

Probably yes

Reason: Loss to follow-up was infrequent in intervention and control group.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes

Reason: No other problems noted

HIGH due to lack of blinding and lack of information about generation and concealment of allocation

Pfeiffer, 2011

Definitely yes

Reason: The randomization of study subjects was performed externally by a statistical consultant bureau

No information

Definitely no

Reason: physicians and patients could not be blinded to the

Intervention.

Probably yes

Reason: Loss to follow-up was infrequent in intervention and control group.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes

Reason: No other problems noted

SOME CONCERNS for patient reported outcome measures due to lack of blinding