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The effect of vitamin D repletion and proposed walking program exercise on chronic idiopathic low back pain: a randomized controlled trial

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Abstract

Objective The aim was to evaluate the relationship between vitamin D deficiency and chronic idiopathic low-back pain (LBP), and to observe the effect of vitamin D correction and a proposed walking program exercise (WPE) on the severity of LBP. Patients and methods In this randomized, controlled study, 110 patients (100 with deficiency and 10 with insufficiency of vitamin D3), 95 women and 15 men with chronic idiopathic LBP were randomly assigned to receive either oral vitamin D3 or oral vitamin therapy and a proposed walking program exercise (WPE). Group A included 55 patients, 50 with deficiency and five with insufficiency Group B included 55 patients, 50 with deficiency and five with insufficiency over 3 months. Visual analog scale 0–10 was used to assess the degree of pain intensity. Results Findings have shown that 100% of the patients included in this study (n=110) (100 deficiencies and 10 insufficiencies) had an abnormally low level of vitamin D before treatment with vitamin D therapy and WPE. By the end of the study, all the 110 patients have normalized their vitamin D level after vitamin D oral therapy and WPE (100%). However, only 49 patients (group A) (44 deficiencies and five insufficiencies) reported disappearance of LBP after vitamin D oral therapy and only 51 patients (group B) (46 deficiencies and five insufficiencies) reported disappearance of LBP after vitamin D oral therapy and WPE so the total number of responders of both groups being 100 (90.9%) cases and the total number of nonresponders of both groups being10 (9.1%) Conclusion After correction of vitamin D3 over 3 months, the authors found that the chronic LBP has improved. A combination of both (correction of vitamin D3 and WPE) is more beneficial in improving chronic LBP.
The effect of vitamin D repletion and proposed walking program
exercise on chronic idiopathic low back pain: a randomized
controlled trial
Mohamed Elwan, Mohamed Moneer
Department of Rheumatology and
Rehabilitation, Al-Azhar University, Assiut,
Egypt
Correspondence to Mohamed Elwan Sayed,
MD of Rheumatology and Rehabilitation,
Mallawy Minia, 61631, Egypt.
Tel: +20 862 570 582;
e-mail: drelwan77@yahoo.com
Received: 3 April 2020
Revised: 25 May 2020
Accepted: 7 July 2020
Published: 30 October 2020
Al-Azhar Assiut Medical Journal 2020,
18:325–329
Objective
The aim was to evaluate the relationship between vitamin D deficiency and chronic
idiopathic low-back pain (LBP), and to observe the effect of vitamin D correction and
a proposed walking program exercise (WPE) on the severity of LBP.
Patients and methods
In this randomized, controlled study, 110 patients (100 with deficiency and 10 with
insufficiency of vitamin D3), 95 women and 15 men with chronic idiopathic LBP
were randomly assigned to receive either oral vitamin D3 or oral vitamin therapy
and a proposed walking program exercise (WPE). Group A included 55 patients, 50
with deficiency and five with insufficiency Group B included 55 patients, 50 with
deficiency and five with insufficiency over 3 months. Visual analog scale 010 was
used to assess the degree of pain intensity.
Results
Findings have shown that 100% of the patients included in this study (n=110) (100
deficiencies and 10 insufficiencies) had an abnormally low level of vitamin D before
treatment with vitamin D therapy and WPE. By the end of the study, all the 110
patients have normalized their vitamin D level after vitamin D oral therapy and WPE
(100%). However, only 49 patients (group A) (44 deficiencies and five
insufficiencies) reported disappearance of LBP after vitamin D oral therapy and
only 51 patients (group B) (46 deficiencies and five insufficiencies) reported
disappearance of LBP after vitamin D oral therapy and WPE so the total
number of responders of both groups being 100 (90.9%) cases and the total
number of nonresponders of both groups being10 (9.1%)
Conclusion
After correction of vitamin D3 over 3 months, the authors found that the chronic LBP
has improved. A combination of both (correction of vitamin D3 and WPE) is more
beneficial in improving chronic LBP.
Keywords:
exercise, low-back pain, vitamin D
Al-Azhar Assiut Med J 18:325–329
©2020 Al-Azhar Assiut Medical Journal
1687-1693
Introduction
Vitamin D deficiency is a common problem among
Egyptian people who are not exposed to sunlight due to
their special habits and their jobs. There is also a high
incidence of vitamin D deficiency among healthy
Egyptian women during childhood, childbearing age,
pregnancy, and lactation, and also there is a high
incidence of vitamin D deficiency during the elderly,
geriatric period [1]. There is a strong relationship
between vitamin D level and skin exposure. Vitamin
D is produced either through photosynthesis in the
skin with exposure to ultraviolet B radiation or through
dietary sources. Avoidance of sun exposure reduces the
synthesis of vitamin D by the skin [2]. Women have
low levels of 25(OH)D than men [35]. This may be
due to the differences in body fat composition,
resulting in greater fat storage of vitamin D in
women [6]. As Egypt is an Islamic country, women
have traditional habits like the wearing clothes that
cover the whole body apart from face and hands.
Clothing habits may be responsible for the high
prevalence of vitamin D deficiency [7].
Vitamin D deficiency has skeletal and extraskeletal
disorders including chronic pain [8] and bone
fragility [9]. There are many presentations of
vitamin D deficiency, but low-back pain (LBP)
presentation is a well-recognized one [1012]. LBP
is defined as pain between the costal margins and
inferior gluteal folds and is usually accompanied by
painful limitation of movement; it is often influenced
by physical activities and posture in most cases [13].
LBP may be classified by duration as acute (pain lasting
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Original article 325
©2020 Al-Azhar Assiut Medical Journal | Published by Wolters Kluwer - Medknow DOI: 10.4103/AZMJ.AZMJ_64_20
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for <6 weeks), subchronic (612 weeks), or chronic
(>12 weeks) [14]. Walking is a fundamental human
activity that is easy to perform, has a low risk of injury
and is associated with many health benefits [15,16]. It
has been shown that ambulation time over 8 ft
(2.4384 m) walkway correlated with higher serum 25
(OH) D concentrations [17], while many researches
have investigated exercise and advice to remain active as
a management strategy for LBP [18,19].
This study aimed to evaluate the relationship between
vitamin D deficiency and chronic idiopathic LBP, and
to observe the effect of vitamin correction and a
proposed walking program exercise (WPE) on the
severity of LBP.
Patients and methods
This study was carried out on 110 patients; 95 women
and 15 men of those attending the outpatient clinic of
our institution with their age ranging from 15to 45
years) having LBP of more than 3 months. The study
was approved by the ethical committee of AL-Azhar
Assiut faculty of Medicine and an informed consent
was obtained from each participant. The pain had been
classified as idiopathic on top of exclusion of other
causes of back pain by means of radiographic
evaluation. The patients were then subdivided into
two groups.
Group A: included 55 patients, 50 with deficiencies
and five with insufficiencies were treated with oral
vitamin D3 therapy. Group B: included 55 patients;
50 with deficiencies and five with insufficiencies were
treated with oral vitamin D3 therapy and a proposed
WPE in the form of:
Walking for 20 min under sunlight in the midday every
other day for 3 months.
Patients were first seen to assess LBP by history and
clinical examination and the presence or absence of
neurologic manifestation. Patients with
spondyloarthropathies or any other diagnosis of
inflammatory LBP, mechanical LBP fibromyalgia,
and those with a history of surgery or trauma to the
back were excluded. Patients with chronic liver disease
or renal impairment were also excluded.
Plain radiography on sacroiliac joints were done to
exclude sacroiliitis.
Plain radiography and MRI on the lumbosacral spine
were performed to exclude spinal malformations,
spondylosis, disk prolapse, spinal stenosis, pyogenic
abscesses, masses, or metastatic lesions.
The following investigations were done:
Serum 25-hydroxyvitamin D [25(OH)D], Serum
PTH, bone-specific alkaline phosphatase (ALKP),
serum Ca total and ionized, complete blood count,
erythrocyte sedimentation rate, and C-reactive protein
were done to exclude infections and malignancy.
We used the visual analog scale (VAS 010) to assess
the degree of pain before and after correction of
vitamin D and a proposed WPE as an outcome
measure for pain. We treated all patients in both
groups according to the Holick protocol (Weekly
Pearl 50 000 IU of vitamin D3 for a period of 8
weeks given to the patient to replenish the deficient
vitamin D). In the maintenance phase 50 000 IU
vitamin D3 is administered every 2 weeks. It is
recommended to measure the serum level of 25 (OH
D) after 23 months of treatment; and if the level is
above 30 ng/ml the maintenance therapy should
continue [20]. Vitamin D deficiency is typically
diagnosed by measuring the concentration of the 25-
hydroxyvitamin D in the blood, which is the most
accurate measure of stores of vitamin D in the body.
The reference range for deficiency and normal:
(1) Deficiency: less than 20 ng/ml insufficient:
2029 ng/ml.
(2) Normal: 30100 ng/ml [21].
Statistical analyses
Statistical analyses were performed using SPSS version
22 (IBM Corporation, Chicago, Illinois, USA). Mean,
SD, and range were estimated. It was assessed with the
analysis of variance test followed by Tukeys test and P
values of less than 0.05 were deemed statistically
significant.
Results
The results of this study are presented in Tables 1.2.3
in Table 1.
The mean for age was 28.8±8.1 (1838) in insufficiency
of vitamin D (IVD) and 30.52±10.4 (1645) in
deficiency of vitamin D (DVD) (P=0.621); the
female-to-male ratio was 14/86 in DVD and 1/9 in IVD.
Our study was done on 110 patients having
chronic idiopathic LBP. One hundred cases have
326 Al-Azhar Assiut Medical Journal, Vol. 18 No. 3, July-September 2020
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vitamin D3 deficiency with a mean 25-OH
Cholecalciferol (7.3±5.3) and LBP by VAS (mean
±SD of 8.5±1.27) and mean of PTH (110.3±139.7),
mean of ALKP (128.42±70.7), Mean of serum Ca
total (8.9±0.8) and ionized (1.08±0.09) And 10 cases
have vitamin D3 insufficiency with a mean of 25-OH
Cholecalciferol 22.2±1.1 and LBP by VAS with mean
±SD of 8.0±1.1, mean of PTH (58.63±12.33), mean
of ALKP (86.9±21.92), Mean of serum Ca total (8.7
±0.49) and ionized (1.09±0.12). After correction of
vitamin D3 in the two groups (Table 2), we found in
group A the mean of vitamin D3 deficiencies (31±1.8)
and mean of LBP by VAS (0.87±0.83) and the mean
of vitamin D3 insufficiencies (40±2.5(3564), mean of
LBP by VAS (0.89±0.86) and in group B the mean of
vitamin D3 deficiencies (37±0.83), mean of LBP by
VAS (0.28±0.58), the mean of vitamin D3
insufficiencies (45±1.9(3070), and mean of LBP
by VAS (0.20±0.4).
So, all the 110 patients have normalized their vitamin
(100%) after vitamin D oral therapy and WPE;
however, only 49 patients (group A) (44 deficiencies
and 5 insufficiencies) reported disappearance of LBP
after vitamin D oral therapy and only 51 patients
(group B) (46 deficiencies and five insufficiencies)
reported disappearance of LBP after vitamin D oral
therapy and WPE. The total number of responders of
both groups was 100 (90.9%) cases and total number of
nonresponders of both groups was 10 (9.1%) (Table 3).
Discussion
The relation between vitamin D deficiency and idiopathic
LBP has long been reported [2224]. A recent
retrospective study reported a strong association
between the severity of LBP and the deficiency of
vitamin D [25]. Not only LBP, but also other
musculoskeletal pain syndromes have also been related
to VDD; Plotnikoff and Quigley [23] found a high
prevalence (93%) of vitamin D deficiency among both
children and adults presenting to a university primary care
clinic in Minneapolis with persistent, nonspecific
musculoskeletal pain. Faraj and Mutairi [24] examined
patients attending spinal and internal medicine clinics in
Saudi Arabia over 6 years who suffered from LBP with no
obvious cause for more than 6 months and found that
Table 1 Demographic and clinical findings of patients
Insufficiency of
vitamin D [mean
±SD (range)]
Deficiency of
vitamin D [mean
±SD (range)]
P
value
Sex (no. of
males/no. of
females)
1/9 14/86
Age 30.52±10.4
(1655)
28.8±8.1
(1838)
0.621
LBP and its
duration per
month
15.9±4.5 (1224) 15.72±9.5
(636)
0.954
LBP by VAS
(010)
8.0±1.1 (510) 8.5±1.27 (810) 0.220
Mean of 25-OH
cholecalciferol
level (ng/ml)
22.2±1.1
(2124.1)
7.3±5.3
(2.819.6)
0.0001
PTH (pg/ml) 58.63±12.3
(4278.3)
110.3±139.7
(30.4972.78)
0.251
ALKP (IU/l) 86.9±21.92
(66118)
128.42±70.7
(58346)
0.73
Serum Ca total
(mg/dl)
8.7±0.49 (89.2) 8.9±0.8
(6.411.6)
0.845
Serum Ca
ionized (mg/dl)
1.09±0.12
(0.91.2)
1.08±0.09
(0.91.4)
0.874
ALKP, alkaline phosphatase; LBP, low-back pain; VAS, visual
analog scale.
Table 2 LBP by VAS and vitamin D3 levels after vitamin D oral therapy alone and with WPE for 3 months
Deficiency of vitamin D [mean±SD (range)] Insufficiency of vitamin D [mean±SD (range)]
LBP by
VAS
(010)
Mean of 25-OH Cholecalciferol
measurement (ng/ml)
LBP by
VAS
(010)
Mean of 25-OH cholecalciferol
measurement (ng/ml)
Responders to vitamin D oral therapy for 3
months (group A)
0.87±0.83
(03)
31±1.8 (3050) 0.89±0.86
(04)
40±2.5 (3564)
Responders to vitamin D oral therapy and
WPE for 3 months (group B)
0.28±0.58
(02)
37±0.83 (3045) 0.20±0.4
(01)
45±1.9 (3070)
Pvalue 0.066 0.01 0.114 0.01
LBP, low-back pain; VAS, visual analog scale; WPE, walking program exercise.
Table 3 Symptomatic response to oral therapy with vitamin D
alone and with WPE in both groups
Deficiency of
vitamin D [n
(%)]
Insufficiency
of vitamin D
[n(%)]
Total
[n
(%)]
Total number of patient 100 (100) 10 (100) 110
(100)
Responders to vitamin D
oral therapy (group A)
44 (44) 5 (50) 49
(44.5)
Responders to vitamin D
oral therapy and WPE
(group B)
46 (46) 5 (50) 51
(46.4)
Total number of
responders
90 (90) 10 (100) 100
(90.9)
Total number of
nonresponders
10 (10) 0 10
(9.1)
WPE, walking program exercise.
The effect of vitamin D repletion Elwan and Moneer 327
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about 83% had abnormally low levels of vitamin D. All
patients showed significant improvement after correction
of their vitamin D level. The authors concluded that
screening of patients with chronic LBP for vitamin D
deficiency should be mandatory [24]. Plehwe and Carey
described two patients with failed spinal fusion for chronic
LBP, who were subsequently found to have severe vitamin
D deficiency. The patients responded well to vitamin D
supplementation. The authors recommended the need for
the attending surgeons to be aware about the vitamin D
status in their patients as VDD may result in failure of
spinal fusion surgery with substantial costs of further
surgery and hospitalization [26]. Schwalfenberg
reported six cases of improvement of chronic LBP or
failed back surgery after vitamin D repletion in a Canadian
family practice setting [27]. Moreover, low physical
activity has also been associated with LBP [28].
Numerous management strategies have been tried for
nonspecific LBP and are recommended in most evidence-
based guidelines [14], including exercise programs [29].
Vitamin D has the potential to decrease pain and
inflammation by modulating sensory neuron
excitability [30]. It has been shown that ambulation
time over 8 ft (2.4384 m) walkway correlated with
higher serum 25 (OH) D concentrations [17].
In this study, we aimed at evaluating the effect of
vitamin D correction and WPE on idiopathic
chronic LBP. We found that a combination of both
is more beneficial in improving this chronic LBP.
Regarding vitamin D supplementation, in line with
our results, several studies have reported on the
beneficial effects of vitamin D for patients with
deficiency [24,26,27].On the other hand, a recent
meta-analysis has reported on the pooled results
from three studies prescribing vitamin D3 for
nonspecific LBP (dosage ranging from 25 to 179 μg
daily and treatment duration ranging from 6 to 16
weeks) failed to show a beneficial effect on pain
intensity compared with a placebo (weighted
MD=1.90, 95% confidence interval: 7.06 to 10.86,
P=0.678, n=3) [31]. The authors suggest that the
effect of vitamin D supplementation is not different
for individuals with nonspecific LBP or LBP resulting
from osteoporosis or vertebral fractures. Moreover, the
active form, alfacalcidol (1 μg daily for 12 months) was
less effective than no intervention [12 months (010
pain scale): 95% confidence interval: 0.52 to 0.72,
P=0.752] or other conservative/pharmacological
interventions for individuals with LBP resulting
from osteoporosis or vertebral fractures [32,33].
Another randomized, controlled trial that prescribed
an overall dosage (179 μvitamin D3 daily for 6 weeks)
failed to demonstrate a beneficial effect for people with
nonspecific LBP [34].
Conclusion
This study demonstrated that after correction of
vitamin D3 within 3 months chronic LBP was
improved and after correction of vitamin D3 and
using WPE a combination of both is more
beneficial in improving this chronic LBP.
Current clinical guidelines for managing chronic LBP
should include assessment of vitamin D status, and
recommend physical activity and regular exercise in
those found to be deficient.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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Article
Full-text available
Background Vitamin D is associated with musculoskeletal function in our body, and its deficiency is a common health problem all over the world. Low back pain (LBP) is an important health problem in terms of low quality of life, loss of work power, and cost of diagnosis and treatment approaches. Aims The purpose of this study is to investigate the relationship between pain severity and Vitamin D deficiency in patients who applied to pain polyclinic with LBP. Settings and Design This was a retrospective, observational study. Subjects and Methods The files of patients aged between 18 and 70 years who applied to our hospital between January and February 2018 were examined retrospectively by a specialist. Serum 25-hydroxyvitamin D (25(OH)D) level, Visual Analogue Scale (VAS), age, education level, marital status, working status, and body mass index (BMI) values recorded in patient files were included in the study. The limit value of Vitamin D was accepted as 20 ng/mL. Patients were divided into two groups according to their levels of Vitamin D. Patients with serum 25(OH)D levels below 20 ng/mL were considered as the deficiency of Vitamin D (Group 1) and patients with 20 ng/mL and over 20 ng/mL values were considered as normal in terms of Vitamin D (Group 2). Statistical Analysis Used Descriptive statistical data were presented as mean, standard deviation, numbers, and percentage. There was no difference between the normally distributed group and the non-normally distributed group in terms of vitamin D levels. To compare the frequencies, the Chi-square test was used. To define the linear association between independent variables and Vitamin D level, Spearman's rho correlation coefficients were calculated. Results The level of Vitamin D was measured in 98 patients aged 18–70 years who applied to our hospital's polyclinic due to LBP during the study period. The deficiency of vitamin was detected in 84 (85.7%) of the patients, while Vitamin D was found in 14 (14.3%) as normal. Groups were similar in terms of age, gender, BMI, educational level, marital status and working status (p> 0.05); however, there was a statistically significant difference between the two groups in terms of VAS score and levels of Vitamin D (P < 0.001 and P < 0.001, respectively). While there was a negative correlation between D vitamin level and VAS score (r = −0.594, P < 0.001), there was no correlation between age, gender, BMI, education level, marital status, and working status (P > 0.05). Conclusions The deficiency of Vitamin D is often asymptomatic, and also, it can cause bone and muscle pain. In our study, we determined that the severity of pain increased in patients with LBP as the deficiency of Vitamin D increased. For this reason, we recommend to be evaluated the level of Vitamin D in patients with LBP.
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To synthesise the evidence relating to the effectiveness of advice, the relevance of its content and frequency, and to compare the advice being offered to acute, subacute and chronic low back pain (LBP) patients. A systematic review of Randomised Controlled Trials (RCTs) using advice, either alone or with another intervention. The QUOROM guidelines and the Cochrane Collaboration Back Review Group Guidelines for Systematic Reviews were followed throughout: methodological assessment identified RCTs of 'high' or 'medium' methodological quality, based on their inclusion of at least 50% of the specified internal validity criteria. Outcome measures were analysed based on five recommended core outcome domains; pain, work disability, back-specific function, generic health status and satisfaction with care. Relevant RCTs (n=56) were scored for methodological quality; 39 RCTs involving 7347 patients qualified for inclusion, based upon their methodological quality. Advice as an adjunct to exercise was most effective for improving pain, back-specific function and work disability in chronic LBP but, for acute LBP, was no more effective for improving these outcomes than simple advice to stay active. Advice as part of a back school was most effective for improving back-specific function in subacute LBP; these trials generally demonstrated long-term positive results. Advice as an adjunct to exercise was the most common form of treatment for acute and chronic LBP; advice as part of a back school was most commonly used for subacute LBP. Fifteen percent of acute LBP trials had a positive outcome, compared to 86% and 74% of subacute and chronic LBP trials respectively. A wide variety of outcome measures were used, making valid comparisons between treatment outcomes difficult. The advice provided to patients with LBP within RCTs varied considerably depending on symptom duration. The findings of this review have important implications for clinical practice, and for the design of further clinical trials in this area. Advice to stay active is sufficient for acute LBP; however, it appears that RCTs do not commonly reflect these recommendations. No conclusions could be drawn as to the content and frequency of advice that is most effective for subacute LBP, due to the limited number and poor quality of RCTs in this area: this review provides preliminary support for advice as part of a back school approach. Given that the effectiveness of treatment for subacute symptoms will directly influence the development of chronicity, these results would suggest that education and awareness of the causes and consequences of back pain may be a valuable treatment component for this patient subgroup. For chronic LBP there is strong evidence to support the use of advice to remain active in addition to specific advice relating to the most appropriate exercise, and/or functional activities to promote active self-management. More investigation is needed into the role of follow-up advice for chronic LBP patients.