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Evaluation of plantar fasciitis improvement after shock wave therapy

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Evaluation of plantar fasciitis improvement after shock wave therapy in calcaneal spur patients by musculoskeletal ultrasonography

Soad Said El Molla1, Ahmed M. Fahmy2, Amr Mohamed Gamil1, Rehab Ali Ibrahim3*    and Mai Mohamed Kamel1

Abstract

 Background:  Plantar fasciitis due to calcaneal spur is a common cause of heel pain and functional disability, and its management presents a huge challenge for clinicians which results sometimes in unpleasant clinical outcomes. The efficacy of extracorporeal shock wave therapy (ESWT) as an alternative therapeutic option to surgical management after failure of conservative treatment has been addressed. Our aim was to evaluate the efficacy of ESWT in the treatment of plantar fasciitis in calcaneal spur patients using ultrasonography.

Results: The mean plantar fascia (PF) thickness was statistically significantly higher in the calcaneal spur patient group (5.66 ± 1.14 mm) than in the healthy control group (2.40 ± 0.35 mm), (P = 0.001). Significant PF thickness reduction, visual analog scale (VAS), and Roles and Maudsley score (RMS) improvement were observed (P < 0.001) after 4 sessions of ESWT.

Conclusion: PF thickness increases significantly in calcaneal spur patients and responds to treatment. ESWT decreases the thickness of the PF and improves pain and function significantly.

 Keywords: Calcaneal spur, plantar fasciitis, extracorporeal shock wave therapy, Ultrasonography, Heel pain

Background

Calcaneal spur is a chronic condition and is common in adult persons.  It  can  be  a  cause  of  plantar   fascia (PF) inflammation, leading  to  restriction of functional  activities  [1].

Plantar fasciitis is a frequent source of heel pain. It can affect 10% of the population. Plantar fasciitis can result from injury of the PF or due to disturbed biomechanics of the foot [2].

Risk factors include increased body weight, female gen- der, differences in limb length, altered biomechanics of the foot such as pronated foot, and prolonged standing [3].

It  is usually  a self-limiting  condition and  90% of  the patients   can  be  treated   conservatively  using  orthotics, no steroidal anti-inflammatory  medications  (NSAIDs), and exercises [4].

Surgical  treatment is  reserved  for  refractory  plantar fasciitis, usually  after  6–12 months  of  ineffective  treatment.  Nevertheless, surgical treatment carries a risk of multiple complications [5].

The use of extracorporeal shock wave therapy (ESWT) has been introduced in the 1990s as a therapeutic option for insertion   tendinopathies,  as  it  aids  in  the  healing process.  It  has  been  recently  used in  the  treatment of plantar  fasciitis which  is  refractory  to the  usual conservative measures  [6, 7].

The American Food and Drug Association (FDA) approved the use of ESWT in calcaneal spur after the positive results of Ogden et al. [8] and Buch et al. [9].

Ultrasonography has been well documented as a useful noninvasive diagnostic modality for plantar fasciitis [10], 

with  advantages  of being  non-invasive,  with  no  risk  of radiation,  and low cost [11].

 

Aim of the study

The  present   study  aimed  at  evaluating  the  efficacy  of shock wave therapy  for plantar  fasciitis in calcaneal spur patients  by musculoskeletal ultrasonography.

 

Methods

The  study  included  forty  patients   of both  sexes  with  a planter calcaneal spur confirmed by x ray  images attending  the  outpatient clinic of the  National  Institute of Neuro Motor  System as a patient  group  and twenty (20) healthy individuals with matched  age and sex as control  group.

 

Inclusion criteria

       Age > 18

  • Symptoms: heel pain > 3 months, unsuccessful conservative treatment > 6 mont
  • Pain > 5 by visual analog scale (VAS) and investigator assessm
  • Two failed pharmacologic treatments.
  • Two failed no pharmacologic treatments.
  • Single site of tenderness over plantar calcaneal tuberosity.

 

No other treatment or drugs (NSAIDs, steroids and other analgesics) were used for 4 weeks before the study began or during the study period.

 

Exclusion criteria

We excluded patients with:

  • Recent significant disease (Inflammatory arthritis, seronegative disease).
  • Prior surgery for plantar fasci
  • Neuropathy, malignancy, or
  • Plantar Fascial
  • Bilateral
  • Pregnancy.
  • Corticosteroid injection within 6 wee
  • Physical therapy within 2
  • Narcotic
  • NSAIDS within 48 h
  • Anticoagulant medication

 

These patients were submitted to:

  1. Full history taking, general clinical examination, and local examination of the foot.
  2. Weekly ESWT sessions. An ESWT device with an electrohydraulic system of (Orthospec, Medispec Inc, Montgomery Village, MD, USA) with a fixed Focus of 25 × 95 mm was used. Every patient received 4 consecutive sessions (once a week) with1000 shocks at a frequency of 96 shocks per minute. The energy density was 0.077 mj/mm2and gradually increased to 0.32 mj/mm2 to avoid initial treatment pain. The energy was dispersed over a treatment area that was large enough that the intensity of the shockwaves reached therapeutic levels while remaining generally well tolerated by recipient patients without the need for anesthesia or sedation. The effective distribution of the shockwaves is over a broad enough anatomical area that there is no need for ultrasonic or radiographic targeting.
  3. Blinded to the clinical data, musculoskeletal ultrasound imaging was conducted using 18/7 MHz linear array transducer (Toshiba, Aplio 400, Japan) to evaluate PF thickness in millimeters is about 2 cm distal to the medial calcaneal tuberosity [12]. Pre-ESWT and after 8 weeks. Participants were prone with toes resting upon the examination table. The fascia was traced in longitudinal and transverse planes from the level of the calcaneal attachment to the forefoot using B mode. Adjustment of the pain and focal point was done as necessary to optimize the image. The presence of calcification/echogenic foci within the fascia, fibers interpretation, and edema of heel fat pad were recorded.
  4. The degree of pain felt by the patients was measured subjectively using a VAS ranging from 0 = no pain to 10 = maximum pain. The Roles and Maudsley score (RMS) was used as a functional evaluation method in four level grading categories (excellent 1 indicates no pain, full movement, and activity; good 2 indicates occasional discomfort, full movement, and activity; fair 3 indicates some discomfort after prolonged activity; and poor 4 indicates pain-limiting activities), based on pain and activity ranges in daily life in pre-ESWT and after 8 weeks [13].        

X-ray was one for the control group to exclude calcaneal spur and musculoskeletal ultrasound for measurement of PF thickness.

 

Statistical analysis

 Data were collected and entered into the statistical Package for Social Science (IBM SPSS) version

  1. The quantitative data were explored  for distribution using   Kolmogorov-Smirnov and   presented  as  means, standard deviations,  and  ranges  for parametric variables and  median   with  interquartile  range   (IQR)  for  non- parametric variables. Also, qualitative variables were presented as numbers and percentages. The comparison between   two   independent  groups   with   quantitative data  and  parametric  distribution  was  done  using  the independent  t-test   while   non-parametric  data   were done   by  using   the   Mann-Whitney  test.   The   confidence  interval  was  set to 95% and  the  margin  of error  accepted  was  set  to  5%. So, the P-value was considered significant at the level of ≤ 0.05. Correlation between variables was done using Pearson’s correlation test.

    Ethical consideration

    Approval of the study conduction was obtained from the ethical committee. Written informed   consent was obtained from all participants. 

    Results

    The study included forty calcaneal spur patients attending the physical medicine, rheumatology, and rehabilitation outpatient clinic.

    The  selection  was from  both  sexes; they  were  32  females  (80%) and  8 males  (20%). Their age was 44.18 ±8.61 (range: 25–61 years). Their body mass index (BMI) was 32.14 ± 4.35 (range:  25.3–39.6 Kg/m2), 12 over- weight (27.5%), and 28 obese (72.5%). Their disease duration ranged between 3 and 120 months with a median (IQR) of 6 (4-8).

    They were compared to 20 normal control subjects, 16 female (80%) and 4 male (20%). Their age was 43.35 ±12.2 (range: 24–61years). There  was no significant difference  in  age,  sex,  and  BMI  between   the  two  groups(Table 1).
    Pain and functional affection were the presenting features of our patients, (100%) with VAS median (IQR) 8 (7–8) and Roles and Maudsley median (IQR) 4 (4–4).

    On  ultrasound examination before  ESWT,  40  (100%) of  the  patient   group   showed   increased   PF  thickness which was significantly (P = 0.001) greater in the calcaneal spur  patients  (5.66 ± 1.14 mm) than in the asymptomatic  control  individuals  (2.40  ±  0.35 mm)  (Table  1). Thirty-eight  (95%)  of  the   patients   showed   abnormal focal  low  echogenicity  in  the  PF,  30  (75%) perifascial edema, and 2 (5%) calcifications.

    There was a strong positive significant correlation be- tween PF thickness before ESWT and the age (P ≤ 0.05), standing hours (P = 0.001), BMI (P ≤ 0.05), and VAS on awakening (P = 0.001) (Table 2) (Figs. 1, 2, and 3).

    Eight weeks after ESWT, the decrease  in PF thickness in  calcaneal  spur  patients  (5.66  ±  1.14  to  4.98  ±  1.11 mm) was highly significant (P < 0.001) (Figs. 4 and 5). A highly significant decrease of median values of VAS from

    8 to 4 (Fig. 6) and Roles and Maudsley score from 4 to 2 (P < 0.001) (Fig. 7) was seen 8 weeks after the end of ESWT (Table 3).

    No statistically  significant  correlation between  the  reduction  of PF thickness  and  decrease  in pain  and  functional scores was demonstrated (Table 4).

Discussion

The PF is a group of elastic and collagenous  fibers which originates  from  the  medial  part  of the  calcaneus and  is attached  to the forefoot along with various other  tissues. Under the effect of chronic strain, elastic fibers become straight and stiffening of the fascia occurs [14].

Plantar  heel  pain  can  be  linked  to  calcaneal  spur,  a condition   that  affects  many  people  of  all  ages.  It is a bony outgrowth on the heel  bone.  The spur tip site is within the PF origin leading to persistent traction on the PF and triggering its inflammation [15]. Calcaneal spur can be symptomatic especially with aging, obesity, in female patients, and in patients with history of osteoarthritis [16].

It  is  usually  a  self-limiting  condition.   Most  of  the patients’   symptoms    are    relieved    by    conservative treatments such  as  corticosteroid  injection,  NSAIDS, rest,  and  using  orthotics  [17].  Sometimes, therapeutic modalities   can   be used   such   as therapeutic   ultra- sound [18].

There  is an agreement that about  90% of heel pain improve with conservative measures  and that surgical management  can  be  considered   after  failure  of these  non- operative  measures.  It was reported   that ESWT might be a good alternative to surgical maneuvers which might carry the risk of complications [19].

ESWT  has  been  used  recently  as a noninvasive  and effective  modality   in  the  treatment  of  patients  with chronic   heel  pain   who  are  resistant   to  other   com- monly   used   conservative   treatments   [8].   FDA   ap- proved  ESWT  as  a  non-surgical treatment  technique in patients  with  symptomatic plantar  fasciitis, who are resistant   to  other  commonly   used  conservative  treat-  ments  [20].  Also,  the  FDA  approved  its  use  in  2002 in   patients   with   symptomatic  heel   spurs   after   the positive results  of Buch et al. [8].

Ultrasonography is an important tool in the  diagnosis and  evaluation  of patients  with plantar  fasciitis through the detection  of thickening  of the PF and  its hypoecho- genic pattern at calcaneal insertion [21].

There  might  be  a  debate  regarding  the  clinical  out- come  of  using  ESWT  as  a  therapeutic option  in  the treatment of symptomatic calcaneal spur [22, 23].

Our  aim  was  to  evaluate  the  efficacy of  ESWT  for plantar  fasciitis  in  calcaneal  spur  patients  by  musculo-  skeletal ultrasonography.

In  the  present  study,  patients  were  more  frequently females   (80%),  mostly   obese,   their   mean   BMI  was

32.4  ±  4.29,  and  their   mean   duration  was  44.18  ±

8.61  years  which  was  in  accordance  with  the  results of  previous   studies   which  reported  that  the  risk  of plantar   fasciitis  is  linked  to  increased  BMI  [24].  Patients   in  the   present   study   had   prolonged   standing hours  with a mean  of 6 h, thus  indicating  the  import-  ance  of  mechanical   factors  in  this  disease  and  sup- porting   the  results  of  other  studies  which  concluded that  plantar   fasciitis  might  be  associated  with  behaviors and  occupations related  to weight  bearing  and  in- creased  standing  [25].

The thickness of PF was measured   by ultrasound 2 cm distal to the calcaneal tuberosity.  In addition, the Level of pain was recorded in the VAS scale and RMS was used as a functional evaluation method.  A thick- ness of the PF more than 4 mm is indicative of plantar fasciitis [26]. In our  study,  a  mean  PF thickness  in calcaneal  spur  patients  (5.66  ± 1.14 mm)  was  significantly  greater  than  in  the  asymptomatic control  individuals (2.40 ± 0.35  mm).

The   main   targets   of  therapies   in  plantar  fasciitis are  to  decrease   the  level  of  pain  and  increase   the level  of  function.   In  the  present  study,  we  detected high   statistical   significance   regarding    pain   degree and  functional   evaluation  in  plantar   fasciitis  before and   after  ESWT   treatment  P  <  0.001),  supporting the  results  of  previous  studies  including Cheing  and Chang  in  2007  [27]  and Ulusoy  et  al. in  2017  [28].

In  2013,  a  meta-analysis  study  reported a  decrease  in the  pain  and  RMS on  using  ESWT  compared to  placebo  in  contrast   to  other   studies   which  concluded  that  ESWT  is ineffective  in  the  treatment of plantar fasciitis  [2],  indicating   that   assessment   of  the   role and  the  efficacy of ESWT  must  be continued as long as  there   is  controversy   to   detect   a  conclusive   response  regarding  the  target  disorder.

Measuring   PF  thickness  can  give an  idea  regarding the  effect  of  the  therapeutic  device  used.  According to  our  study,  there  was  a  significant  decrease  in  the thickness   of  the  PF  before  and  after  treatment  suggesting  that  it  might  be  used  as  an  objective  tool  in the   follow-up   of   plantar    fasciitis   treatment   using ESWT.

This  study  found  that  the  PF thickness  was  strongly correlated  with the number  of standing hours and BMI, which   might   suggest  that   decreasing  the   number  of  Standing hours and reducing body weight might prevent the development of plantar fasciitis;   further   studies should be done to investigate this finding.

 

There  was  no  statistically  significant  correlation  between  clinical  data  (VAS and  RMS)  and  PF  thickness after ESWT; this might  be due  to the  short  duration of the follow-up. Further  studies  with a  longer  duration  of follow-up  are recommended which  might  reveal the  as- association between  reduction in PF thickness  and clinical data as pain and functional scores.

Limitations

Our study had some limitations.  First, short duration of follow-up (8 weeks).  Follow-up   of extended duration could demonstrate the long-term outcomes of ESWT in patients with symptomatic calcaneal spur. Second, limited sample size.  Further studies with a larger sample size are recommended.

 

 

Conclusions

We  conclude  that  ESWT  is an  effective treatment  for chronic  plantar  fasciitis in  calcaneal  spur  patients  with significant  improvement  in  pain  and  function  scores. Ultrasound is an important tool in monitoring plantar fasciitis improvement following ESWT.

A prophylactic   program   including   weight reduction and lifestyle modification such as reducing the standing hours is recommended.

Author details

1National Institute of Neuro-Motor System, Giza, Egypt. 2Al-Azhar University, Cairo, Egypt. 3Faculty of medicine, Ain Shams University, Cairo, Egypt. Received: 15 June 2021 Accepted: 6 September  2021

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