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Fascitis Plantar
Fascitis Plantar
DOI: 10.1097/PHM.0000000000001900
Tannaz Ahadi1, Sasan Sadeghi nik2, Bijan Forogh3, Seyed Pezhman Madani4,5, Gholam
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Reza Raissi6
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MD, Associate professor of Physical Medicine and Rehabilitation, Neuromusculoskeletal
Forogh.b@iums.ac.ir
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MD, Associate professor of Physical Medicine and Rehabilitation, Neuromusculoskeletal
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MD, ALS Clinical and Research Fellow. Montreal Neurological Institute and Hospital.
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MD, Professor of Physical Medicine and Rehabilitation, Neuromusculoskeletal Research
raissi.gh@iums.ac.ir
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Corresponding author: Gholam Reza Raissi, MD, Professor of Physical Medicine and
Fax: (98)21-88942970.
Competing Interests
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Funding or grants or equipment provided for the project from any source
None.
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Financial benefits to the authors
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None.
form
None.
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Abstract
Design: This randomized controlled trial was conducted on 35 patients with chronic PF.
Participants were randomly allocated into two groups; one group received
methylprednisolone in to the plantar fascia (n=18) and the other group received BTA
injection into the flexor digitorum brevis and quadratus plantae (n=17). All injections were
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performed under ultrasound (US) guidance. Patients were evaluated using the VAS, FAAM
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and plantar fascia thickness before the intervention, 3 weeks, 12 weeks, and 6 months after
the treatment.
Results: In both groups, patients’ pain and function improved significantly up to 3 weeks
after injection. In the BTA group, morning VAS improved significantly at 12 weeks after
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intervention and the improvement was sustained for another 3 months. In the BTA group,
FAAM-S improved in all evaluated points, while in the corticosteroid group, the
Conclusions: Both US-guided BTA and corticosteroid injection were effective in the
treatment of PF. Our study showed that the effects of BTA injection last longer than those of
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steroid injection.
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What is known: Corticosteroid injection is the most common injection for acute and chronic
PF with limited and short-term therapeutic effects and several complications. In the recent
years, botulinum toxin type a (BTA) injection into the foot intrinsic muscles has been
investigated as a treatment option for chronic PF with promising results, but with limited
available studies.
What is New: In the short-term, both treatments were effective in patients with chronic PF,
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but the effects of BTA injection last longer than those of steroid injection. BTA injection can
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Introduction
Plantar fasciitis is the most common clinical cause of plantar heel pain in the general
of the plantar fascia, causing degeneration and inflammation of the plantar fascia at its
insertion to the calcaneus bone. Also, biomechanical imbalances such as severe ankle
pronation, limited ankle dorsiflexion, and leg length discrepancy can lead to disproportionate
stretching along the plantar fascia, which contribute to inflammation of the plantar fascia and
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peri-fascial structures. The diagnosis of plantar fasciitis is based primarily upon the
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clinical presentation and physical examination. However, imaging modalities like
ultrasonography and x-ray may be required when the presenting features are atypical or the
diagnosis is unclear. 6
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The treatment of PF is primarily conservative, usually with rest, stretching, supportive heel
7, 8
support, night splints, and physical therapy modalities. In small number of cases who do
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not respond to such treatments, surgical intervention is suggested. Local corticosteroids
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are concerns regarding the adverse effects associated with corticosteroid injections such as
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In the recent years, botulinum toxin type A (BTA) injection into the foot intrinsic muscles has
been investigated as a treatment option for chronic PF.12 BTA reversibly inhibits the
are also affected like substance P, calcitonin gene-related peptide (CGRP), and glutamate. By
affecting these neurotransmitters, BTA can result in anti-nociceptive and analgesic effect and
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The need to compare novel treatments with existing therapies has always been emphasized in
the literature. Limited data exist in the literature regarding the efficacy of BTA in chronic PF.
injections on pain intensity, functional status, and plantar fascia thickness of patients with
chronic PF.
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Study design, setting, and participants
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This prospective, randomized controlled trial was conducted from January to December 2020
affiliated to Iran University of Medical Sciences, Tehran, Iran. This research followed the
tents of the Declaration of Helsinki and the protocol of the study was approved by the
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regional ethics committee of Iran University of Medical Sciences. A written informed
consent was obtained from all patients before enrollment in the study. The process of the
treatment was fully explained to the patients, and they were advised that they could withdraw
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from the study at any time. The trial was registered in Iranian Registry of Clinical Trial
guidelines and reports the required information accordingly (see Supplementary Checklist,
The primary inclusion criteria were patients aged 18-65 years, diagnosed with PF for at least
2 months, and pain intensity of ≥ 4/10. The clinical diagnosis of PF was based on the
presence of tenderness at the medial calcaneal tuberosity and history of heel pain in the first
steps after a rest period which would dwindle after few steps walking. The diagnosis of PF
was confirmed with the ultrasonographic (US) study (plantar fascia thickness (PFT) of >
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4mm (measured 1 cm away from the insertion point to the bone) and areas of
hypoechogenicity.5,17
At the time of clinical presentation, all patients received a full series of weight-bearing foot x-
ray radiographs to screen for trauma, mass, and bony injuries. Patients with history of direct
trauma, positive tarsal Tinel’s sign, S1 radiculopathy, uncontrolled diabetes mellitus (defined
as fasting blood sugar > 125 with no appropriate treatment), gout, history of surgery or
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injection for PF in the last 6 months, presence of a mass or cyst at the pain location,
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sensitivity, infection signs at the injection site and posterior calcaneal pain were not included.
splint, iontophoresis, phonophoresis, or ESWT in less than last two months were also
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excluded.
Thirty eight patients with PF were randomly assigned into 2 groups using randomly
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generated treatment allocations: the corticosteroid group (n = 19) and the BTA group (n =
19). The physician who evaluated the outcome measures, the participants, and the person who
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Intervention
Subjects were placed in a prone position, feet hanging from the edge of the examination bed.
The skin over the heel plantar aspect was prepped with antiseptic and local anesthesia was
performed with a 20-gauge needle containing 1cc of lidocaine 1%. Patients received their
treatment injection under real-time US guidance. The US-guided injection was performed
with a Medison Samsung (SonoACE X8-2013- South Korea) ultrasound device (with a 5-12
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MHz linear transducer) by an experienced physiatrist using a long axis (in-plane) technique,
while the linear US probe was covered with a sterile barrier. In the corticosteroid group, US-
guided injection was performed via a medial approach. After visualizing plantar fascia, a 4-
cm 21-gauge needle was positioned into the area of maximal plantar fascia thickness, and an
performed under US-guidance. In the BTA group, after identifying foot intrinsic muscles
with the US guidance, 150Unit (U) of botulinum toxin A (Dysport®) diluted in 1.5 mL of
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normal saline, was injected (100U in the flexor digitorum brevis [FDB] and 50U in quadratus
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After injections, the patients were recommended to apply a cold pack over the injection site
for about 10 minutes at home 3 times a day for 24 hours. They were advised to avoid pressure
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on the injected heel for the next 48 hours and in case of pain, only could use acetaminophen.
Two days after the injections, the patients of both groups were asked to perform daily
stretching exercises of the calf and heel cord muscles, hold for about 30 seconds, five to six
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times and repeat 2-3 sessions per day, along with strengthening exercises of the intrinsic foot
muscles.
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Outcome measures
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Patients were assessed by the Visual Analogue Scale (VAS), Foot and Ankle Ability
Measures (FAAM) and US features. All outcome measures were assessed before the
intervention, 3 weeks and 12 weeks after. Furthermore, the VAS was reevaluated 6 months
after treatment.
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The 100-mm VAS was used to assess the patient’s pain intensity. Patients were asked to point
the place on the VAS ruler representing their morning and daily pain level (0 = no pain at all
The Foot and Ankle Ability Measure (FAAM) is one of the most appropriate instruments to
evaluate physical function in individuals with foot and ankle related impairments. It is
composed of 29 items divided into 2 subscales: 21-item ADL Subscale (FAAM-A) and 8-
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item Sports Subscale (FAAM-S). Each item is scored on a 5-point Likert scale (4 to 0) from
‘no difficulty at all’ to ‘unable to do’. Item score totals range from 0 to 84 for the ADL
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subscale and 0 to 32 for the Sports subscale and presented as percentage scores. Higher
scores indicate higher levels of function for each subscale. The validity and reliability of the
(PFT-I) and 1 cm distal to this level (PFT-1cm) were measured and reported.
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Statistical analysis
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Outcome measures were analyzed using SPSS software V24. The Kolmogorov-Smirnov test
was used to verify the normal distribution of variables. The interaction effect of time and
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group on outcome measures was evaluated using mixed ANOVA and post hoc tests
(Bonferroni test). The significant threshold was considered to be less than 0.05. For baseline
values that were significantly different, these values were entered as co-variance in ANOVA
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Results
The study was carried out with 2 groups of 19 patients. During the study, 3 participants
dropped out (1 case in the corticosteroid group did not show for follow-up sessions, and 2
subjects were excluded from the BTA group due to post-injection pain and administration of
anti-inflammatory medication). Finally, data for 18 patients in the corticosteroid group (16
females and 2 males with a mean age of 43.94 ± 8.61 years) and 17 in the BTA group (11
females and 6 males, with a mean age of 47.29 ± 9.91 years) was analyzed.
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No significant difference was observed between two treatment groups regarding baseline
demographics and characteristics except for baseline daily VAS, and PFT-1cm and PFT-I
(Table 1). As a result, we conducted analysis only on morning VAS, FAAM-A, and FAAM-s
variables. The inter-group analyses of outcome measures are demonstrated in table 2. There
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was a significant interaction between time and group in terms of morning VAS ( p<0.001)
andFAAM-S (p=0.49). This implied that the behavior of our treatment groups did differ
regarding the changes of the above-mentioned outcomes in favor of the BTA group.. The
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morning VAS improvement was also significantly higher in the BTA group in all time
periods except between baseline and 1st and 2nd (week-12) follow-up. In the period between
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1st and 2nd follow-up, a higher change in FAAM-S was observed in the BTA group. In
periods between baseline and 2nd visit and between 1st and 2nd visit, significant changes were
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observed in favor of the BTA group. Of note, significant difference was observed between
two treatment groups in neither outcome regarding short-term changes (between baseline and
1st visit).
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The inter- and intra-group analyses of outcome measures are demonstrated in table 3. In the
BTA group, the morning VAS improved significantly toward 12 weeks after intervention and
the improvement was sustained for another 3 months. FAAM-A improved significantly in all
follow-ups compared to baseline in both groups. In the BTA group, FAAM-S improved in all
evaluated points, while in the corticosteroid group, the improvement was significant only
when comparing follow-ups values to baseline.No serious adverse effects were observed in
either group.
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Discussion
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Local corticosteroid injection has long been established as an effective treatment for PF. 10 In
the recent years, BTA injection into the foot intrinsic muscles has been suggested to be an
effective treatment for PF; however, few studies have compared its effectiveness with
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intrafascial corticosteroid injection. In this study, 35 patients with PF were randomly assigned
into two groups to receive either corticosteroid or BTA injections. The study intended to
compare different outcome measures including morning VAS and functional status as
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measured by FAAM-A and FAAM-S. Based on our findings, both groups showed significant
reduction in morning VAS and improvements in FAAM scores; however, longer functional
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In recent years, few randomized controlled trials have been conducted exploring the relative
efficacy of new and emerging therapies such as BTA in comparison with local corticosteroid
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injection as an established treatment for PF . Diaz-Llopis et al.19 conducted the first trial
comparing BTA with corticosteroid in PF. After one month evaluation, patients in both
However, after 6-month evaluation, patients who received BTA injection continued to show
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clinical improvements. In contrary, the patients in the corticosteroid group did not show
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further improvements. In another study by Elizondo-Rodriguez et al. , both BTA and
The improvement was sustained in the BTA group until 6 months of follow-up, but not in the
corticosteroid group. Moreover, BTA was associated with better and more rapid short-term
therapeutic effects. In our study, similar to the findings of Diaz-Llopis et al.19and Elizondo-
Rodriguez et al. 12, both treatments showed to be effective in reducing pain and improving the
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function, but the effects of BTA injection last longer than those of steroid injection.
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The short-term and long-term efficacy of BTA was also shown in a trial by Babcock et al. 20,
in which BTA resulted in significant improvements in pain relief and overall foot function at
both 3 and 8 weeks after treatment. In another engaging study, Ahmad et al., 13
conducted a
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randomized placebo controlled trial comparing 50 patients with PF. The authors reported
significant improvement in subjective pain scores following the administration of BTA into
the plantar fascia after a period of six months and one year when compared to a placebo of
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saline.
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Although the exact nature of PF is not fully understood, several mechanisms have been
described for the pain induced by PF. These include excessive tension in the fascia, local
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inflammation, chronic pressure and ischemic pain due to thickened plantar fascia,
relieve patients’ symptoms primarily by its action on relaxing muscles and thus, recovering
the windlass mechanism of the plantar fascia, which results in decreased tension on the
plantar fascia and local neurovascular structure. (2) As our study result suggests, BTA
injection was followed by a stable decrease in fascia thickness for 12 weeks. The PFT is
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regarded as an indicator of the extent of inflammation, in which increased thickness is
associated with more severe inflammation.26 This effect, combined with the expected reduced
tension of intrinsic muscles could lead to significant pain relief and functional improvement.
Besides, several authors suggested that BTA is associated with local anti-inflammatory and
analgesic effects by its role on local neurotransmitters including Substance-P and glutamate
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.
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There are several techniques of ultrasound-guided plantar fascia injection in the literature,
including superficial, deep and intrafascial injections. Intrafascial injection is the most
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commonly used technique in the literature . There are some concerns regarding
corticosteroid injection superficial to the plantar fascia, as it may cause fad pad atrophy 28. In
addition, corticosteroid injection in the calcaneal region may increase the risk of plantar
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fascia rupture. To our knowledge, to date, there is no definite consensus upon the most
appropriate technique for PF injection. In the present study, we used intrafascial injection as
this technique was used in several similar studies with no adverse events.
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This study has a number of limitations. The main limitations were the relatively small sample
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size and lack of a control group, which decrease the generalizability of the results. Other
limitations were the lack of power analysis for missing data and the impossibility of complete
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blinding (the therapist) due to the nature of the interventions. More studies with a greater
sample size and appropriate blinding of the patients are needed to establish the efficacy of
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Conclusions
Both corticosteroid and BTA injections were effective in the treatment of PF. Our study
showed that the effects of BTA injection last longer than those of steroid injection. No
serious adverse effects were observed in either group. BTA injection can be considered as an
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Conflicts of interest
None
Acknowledgements
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The present study was performed as thesis, Iran University of Medical Sciences, Tehran, Iran.
The authors wish to express their gratitude to Dr. Masoume ZoghAali and Dr. Khatereh
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Abdolmaleki for their contribution in preparation of the manuscript.
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28. Babaei-Ghazani A, Fadavi HR. Reply to the Letter to the Editor: Ultrasound-Guided
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Figures and legends
Figure 1 A longitudinal sonogram view of a patient with plantar fasciitis, showing the flexor
digitorum brevis and quadratus plantae muscles. CB: calcaneus bone; FDB: flexor digitorum
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Figure 1
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Table 1. Participants’ demographics and baseline evaluations
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29.1 ± 4.4 28.7 ± 5.0
Daily VAS 49.4 ± 9.9 70.0 ± 11.1 < 0.001
Morning VAS 66.6 ± 19.7 78.8 ± 15.7 0.53
FAAM-A 60.2 ± 16.1 57.3 ± 15.4 0.597
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FAAM-S 44.6 ± 20.9 44.6 ± 21.5 0.995
PFT-I (mm) 2.88 ± 0.6 2.1 ± 0.8 0.003
PFT-1cm (mm) 3.73 ± 0.4 4.5 ± 0.6 < 0.001
Data are presented as number (%), or mean ± standard deviations.
Abbreviations: BTA: Botulinum toxin; tDCS: Transcranial direct current stimulation; BMI: Body Mass
Index, VAS: Visual Analogue Scale, FAAM-A: Foot and Ankle Ability Measures - Activities of Daily
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Living Subscale; FAAM-S: Foot and Ankle Ability Measures - Sports Subscale; PFT-I: Plantar Fascia
Thickness at insertion level; PFT-1cm: Plantar Fascia Thickness 1 cm distal to insertion
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Table 2. The inter-group analysis of outcome measures
Group and
Before After 3 After 6
Outcome After 12 weeks Time
intervention weeks months
Interaction
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74.21 ±
60.20 ± 16.13 76.65 ± 20.36A
Corticosteroid 19.97A
.530
70.79 ±
BTA 57.35 ± 15.42 79.72 ± 20.62A
17.76A
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FAAM-S, mean ± Std. deviation
63.72 ±
44.62 ± 20.92 68.97 ± 25.15A
Corticosteroid 22.02A
.049
59.74 ± A
BTA 44.67 ± 21.56 79.41 ± 13.31
24.08A
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A: no statistical significance between Corticosteroid and BTA group. ± P-Value > 0.05
B: statistical significance between Corticosteroid and BTA group. ± P-Value ≤ 0.05
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Table 3. The inter- and intra-group analysis of outcome measures in different time periods.
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Between-group P-value .918 .399 .333
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BTA -15.07 ± 3.96B -34.74 ± 3.83B -19.67 ± 4.02B
Between-group P-value .494 .107 .015
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