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ANAT SHASHUA, MPT1 • SHLOMO FLECHTER, MD, PhD2 • LIAT AVIDAN, BPT1
DANI OFIR, BPT1 • ALEX MELAYEV, BPT1 • LEONID KALICHMAN, PT, PhD3
on Plantar Fasciitis:
A Randomized Controlled Trial
H
eel pain is a common phenomenon, occurring in approximately microscopic tears when it inserts into the
10% of the population over a lifetime,7,10,28 and the leading calcaneus. This condition is better re-
ferred to as fasciopathy or fasciosis.7,17,28
cause of treatment for foot and ankle pathologies.33 Of
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
1
Bat-Yamon Physical Therapy Clinic, Clalit Health Services, Tel Aviv, Israel. 2Bat-Yamon Medical Center, Clalit Health Services, Tel Aviv, Israel. 3Department of Physical Therapy, The
Leon and Matilda Recanati School for Community Health Professions, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel. The study was approved
by the Helsinki Committee of Clalit Health Services and registered on the National Institutes of Health website ClinicalTrials.gov (registration number NCT01439932). The authors
certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the
article. Address correspondence to Anat Shashua, 10 Feldman Street, Nes-Ziona 74058 Israel. E-mail: Anatsh6@clalit.org.il t Copyright ©2015 Journal of Orthopaedic & Sports
Physical Therapy®
the risk of PF. The other 2 studies found pain intensity (measured by pressure
no significant difference between a case pain threshold). Design
A
group with PF and a control group with- Cleland et al7 compared manual ther- n interventional, prospective,
out PF.18,26,30 Therefore, additional stud- apy and exercise with electrophysical single-blind randomized controlled
ies are needed to evaluate the possible therapy and exercise. The control group trial.
association of ankle DF range of motion was treated by iontophoresis with dexa-
with PF. methasone and stretching exercises. The Setting
Treatment options for PF are contro- intervention group received the same All study procedures were performed at
versial.8,10,19,25 The Cochrane review from stretching exercise protocol combined the Bat-Yamon Physical Therapy Clinic of
201010 examined 19 randomized trials with various manual techniques, includ- Clalit Health Services, Tel Aviv District,
that included treatment by steroid injec- ing soft tissue massage; mobilization; Tel Aviv, Israel.
tions, shockwaves, night splints, orthot- and manipulation of the talocrural joint,
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
ics, and heel pads. Most of the treatment rearfoot complex, tibiofibular joint, and Sample
options produced a marginal advantage intertarsal joint. When knee or hip joint Recruitment occurred from October 2011
compared to no treatment or a control impairments were found, manual tech- through December 2012 (a period of 15
treatment, such as stretching. Guide- niques were performed. The outcome months). The study participants were
lines of the Orthopaedic Section of the measures included 2 patient self-report enrolled and recruited from patients who
American Physical Therapy Association questionnaires (the Lower Extremity were receiving physical therapy treatment
from 200825 cited additional treatments Functional Scale [LEFS] and the Foot and were diagnosed with PF or a calcane-
but also found no clear advantage to and Ankle Ability Measure) and a numer- al spur. Inclusion criteria were as follows:
these treatments compared to a placebo ic pain-rating scale (NPRS) for heel pain. aged 18 to 75 years, pain at the bottom
Journal of Orthopaedic & Sports Physical Therapy®
or control treatment, and a lack of strong The manual therapy group demonstrated of the heel generated by pressure, and an
evidence from randomized controlled tri- a significant improvement in pain and increase in pain (NPRS, greater than 3)
als to support them. function outcomes. Due to the diverse in the morning on taking a few steps or
Manual therapy for PF includes soft manual techniques (soft tissue as well after prolonged non–weight bearing. Ex-
tissue manipulation techniques, mobi- as joint mobilizations) and involvement clusion criteria were as follows: tumors,
lization, and manipulation of the ankle of joints distant from the foot (knee and prolonged use of steroids, below-the-
and foot joints. A number of case series hip), it was difficult to conclude whether knee fracture occurring during the last
have demonstrated rapid improvement the joint mobilizations applied on ankle year, prior foot surgeries, tarsal tunnel
in pain and function following mobiliza- and foot joints had any therapeutic effect. syndrome, fat-pad syndrome, pregnancy,
tion and manipulation techniques to the To date, studies have mainly report- and not being available in the coming
talocrural, subtalar, and first tarsometa- ed on soft tissue techniques to improve month. The study was approved by the
tarsal joints, supporting further study in range of motion in patients with PF. Pre- Helsinki Committee of Clalit Health Ser-
randomized controlled trials.25 vious studies found that ankle joint mobi- vices in Meir Hospital, Kfar Saba, Israel.
In a randomized controlled trial by lization and manipulation improved the All patients signed an informed-consent
Renan-Ordine et al,28 manual tech- range of ankle DF.2 Despite the evidence form prior to participation, and the rights
niques for soft tissue release combined that limited ankle DF may be a contribut- of the subjects were protected. The study
with stretching exercises were compared ing factor to PF,22,25,33 no interventional was registered at ClinicalTrials.gov (reg-
with stretching exercise alone. It was as- study has examined the direct correlation istration number NCT01439932).
sumed that the presence of myofascial between increase in ankle DF following
trigger points in the calf muscles would treatment and decrease in PF symptoms. Sample-Size Estimation
create stiffness and therefore reduce the The aim of this study was to evaluate The sample-size calculation was per-
effectiveness of the stretching exercises. the effect of ankle, subtalar, and midfoot formed by using an online power/
They used trigger point pressure-release joint mobilizations on pain and function sample-size calculator (http://stat.ubc.
and neuromuscular techniques over the in patients with PF. We hypothesized that ca/~rollin/stats/ssize/n2.html). Calcu-
0.93. The number of subjects in each Tinel sign was found to be positive in tar-
group, according to this calculation, was sal tunnel syndrome and medial plantar
20. Due to the possibility of dropouts, 50 nerve entrapment by Schon and Baxter
participants were recruited to provide in 1990.32 The modified straight leg raise
approximately 25 participants per group. test with ankle DF/eversion was found to
be a valuable tool to differentiate plan-
Allocation tar heel pain of neural origin from other
Participants were randomly assigned to common conditions such as PF.1,23 Be-
groups following a simple randomization cause none of these tests can provide an
procedure. Fifty opaque, sealed envelopes accurate answer, any participant with a
were prepared in advance, containing positive test of tarsal tunnel syndrome
FIGURE 1. Methods of ankle dorsiflexion evaluations.
cards with the name of the study group, of was excluded.
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
which 25 were for the control group and Dorsiflexion range of motion was
25 for the intervention group. All sealed measured in both legs (FIGURE 1). Mea- volving everyday functional activities and
envelopes were thoroughly mixed. At the surement was performed in the lunge is used to assess lower extremity disor-
end of baseline evaluation, the examiner position. The patient stood against the ders. The questionnaire was developed by
randomly picked up the consequent en- wall with the measured leg in front and Binkley et al in 19994 and found to have
velope and gave it to the physical thera- toes pointing to the wall. The patient was high reliability and validity (test-retest
pist who performed the treatment. Cards asked to maximally bend the knee toward reliability, 0.94; 95% lower-limit con-
with a group name were returned to the the first toe without lifting the heel. An fidence interval [CI]: 5.89 and correla-
examiner at the end of the study, after all inclinometer was placed on the anterior tion with the quality-of-life questionnaire
Journal of Orthopaedic & Sports Physical Therapy®
evaluations were completed. The exam- aspect of the tibia, and the recorded angle Medical Outcomes Study 36-Item Short-
iner was blinded to patient allocation. to the vertical was the ankle DF. The high Form Health Survey, 0.8; 95% lower-
reliability (intraclass correlation coeffi- limit CI: 5.73). The maximum score
Outcome Measures cient [ICC] = 0.96-0.99) of this method indicating a high functional level was 80,
Baseline and final assessments were per- has been previously demonstrated, with and the MCID was 9 points (90% CI).4
formed by a physical therapist (A.S., the a minimal clinically important difference The questionnaire was translated into
examiner) who was blinded to the study (MCID) of 3.7° to 3.8°.24 Hebrew and validated as part of a com-
group. Finally, the 3 outcome measures—the puterized adaptive evaluation system.11,12
Baseline evaluation included demo- NPRS, LEFS, and algometry—were con- The LEFS score was measured 4 times
graphic data collection, medical history, ducted. The NPRS is a valid and reliable during the study: at baseline, after 4 ses-
and physical examination. Demographic tool for assessing pain intensity20,21,27 and sions, at the end of all treatment sessions,
data included age, sex, weight, height, is a common outcome in PF studies.7,13,34 and after a 6-week follow-up.
body mass index (kg/m2), history, physi- Pain score according to the NPRS (0-10), Algometry measures the minimum
cal activity (participation, type of activ- taken during the first steps in the morn- pressure required to produce pain and
ity, and hours per week), occupation, and ing, was the primary outcome (0 as “no consists of a flat, 1-cm2 disc connected
general health of the patient. Physical pain” and 10 as “very severe pain”). The to a manometer. The disc was placed
examination included observation of gait MCID has been shown to vary between vertically on the point of pain, with the
pattern (categorized as normal, limp- 1.7 points14 and 2 points31 for chronic therapist increasing the pressure inten-
ing, toe touch, or other). Palpation was musculoskeletal pain. Pain score was sity until the initial pain appeared (when
performed for local heat or swelling and measured 4 times during the study: at the feeling of pressure became painful).
for local pain at the medial calcaneal tu- baseline, after 4 sessions, at the end of all The score was determined by averaging
berosity. Participants with clinical symp- treatment sessions, and after a 6-week 3 repeated measurements, with a 30-sec-
toms of pain in the middle of the heel follow-up. ond break between each. Algometry fa-
that were aggravated by walking on hard The LEFS consists of 20 questions in- cilitates an objective assessment of pain
firmed that data were missing at random, 6 of 8 sessions (2 patients from each improved significantly in both groups
and the missing values were replaced by group), and 2 other patients attended 5 (P<.001 and P = .001, respectively). No
predicted values using the expectation of 8 sessions (1 patient from each group). difference was found in algometry in both
maximization technique. The reasons for not attending all sessions groups. Dorsiflexion range of motion was
were unavailability, satisfactory improve- measured twice during the study, before
RESULTS ment, or lack of improvement. intervention and at the end of all treat-
Initially, baseline data were compared, ment sessions. Both groups significantly
S
eventy-eight patients with PF and no differences were found between improved in DF range of motion in the
were screened during the study pe- groups in all baseline characteristics reference leg (intervention group, 2.16°;
riod. Twenty-five did not meet the (TABLE 1). P = .006; control group, 2.96°; P = .023).
inclusion criteria and 3 refused to partici- In the group-by-time interaction, no
pate. Fifty patients (15 men, 35 women; significant difference was found in any of DISCUSSION
age range, 23-73 years; mean SD age, the 3 outcomes, as well as in DF range of
M
51.32 12.58 years) met the inclusion motion (TABLE 2). obilization of the ankle, sub-
criteria and were included in the study. In the comparison between patients talar, and midfoot joints, in
Duration of symptoms ranged from 1 whose DF range of motion was initially conjunction with conventional
to 24 months (mean SD, 5.91 5.13 limited (less than 35°) and patients with physical therapy, did not improve pain
months). Forty-six patients completed a DF range of motion of 35° or greater, and function more than conventional
the study and 4 dropped out (1 man and 1 a significant difference was found in the treatment alone in patients with PF. Both
woman from the intervention group and relative change of the DF range of mo- the NPRS and LEFS showed continuous
2 women from the control group) (FIGURE tion in favor of the limited patients (P improvement throughout all measure-
2). The age range of the dropouts was = .021). No difference was found in the ment points in both groups, with no
29 to 45 years (younger on average than relative change in NPRS and LEFS scores difference between them. Although the
other participants). No differences were between these subgroups. intervention group demonstrated greater
Intervention group 7.76 2.03 7.16 2.36 5.6 3.3 4.68 3.38
Control group 8.12 1.77 6.68 1.89 5.28 2.88 4.76 3.41
LEFS (0-80) 5.89 (–3.69, 15.47) P = .161 (0.105) P<.001 (0.508)
Intervention group 40.00 16.48 43.12 18.47 47.6 19.38 55.96 19.45
Control group 48.16 17.06 51.88 17.35 52.32 19.69 57.88 18.03
Algometry, Pa 61.74 (–42.71, 166.18) P = .828 (0.001) P = .072 (0.069)
Intervention group 423.17 176.43 ... 461.74 184.98 ...
Control group 365.52 200.66 ... 395.92 198.94 ...
Dorsiflexion, deg§ 0.2 (–4.03, 4.43) P = .573 (0.007) P = .001 (0.216)
Intervention group 39.88 8.96 ... 42.04 8.83 ...
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
improvement in LEFS scores, no statis- in some patients with PF the pain area effect of mobilization on pain and func-
tical or clinical differences were found; may slightly vary, algometry might not be tion outcomes in patients with PF and
therefore, we assume that the lower the an applicable outcome for PF. found that patients treated with joint
Journal of Orthopaedic & Sports Physical Therapy®
baseline functional score, the greater the Out of 46 patients who completed the mobilization had a positive outcome;
potential for improvement favoring the study, 29 improved in pain intensity and however, due to the abundance of tech-
intervention group in this case. 18 improved in function. These findings niques and joints involved, they could not
In algometry, which also measured are consistent with previous studies dem- determine which technique was superior
pain intensity, no difference was found onstrating the effectiveness of this conven- and which joint was the most relevant.
between or within groups. This finding tional treatment, stretching exercises, and In the present study, we chose to fo-
is not consistent with a previous study of therapeutic ultrasound in treating PF.7,25,28 cus on mobilization of the ankle and foot
PF that found an association between im- Previous studies (mainly case-control joints, based on the assumption that lim-
provement in algometry and in the Medi- designs) have found an association be- ited DF is a contributing factor. Dorsi-
cal Outcomes Study 36-Item Short-Form tween DF range of motion and PF.19,29 flexion range of motion increased in both
Health Survey quality-of-life score.28 Pos- Because the temporal relationship be- groups. Because there was no difference
sible reasons for this finding may be due tween DF range of motion and PF was between the groups, we assume that the
to difficulty in focusing on the specific not examined, it is unclear whether their mobilizations did not affect DF range of
pain point of the patient. findings of limited DF were a cause or motion.
In the present study, according to the consequence. On the other hand, to our Bennell et al3 defined limited DF in
patient’s subjective report, the most pain- knowledge to date, no study has assessed the lunge position as less than 35°. Ac-
ful point occurred at the medial anterior the outcome effect of increased DF range cording to this definition, 10 patients in
heel, near the medial calcaneal tuberos- of motion on pain and function of pa- this study had limited DF range of mo-
ity. It is possible that in some patients, the tients with PF. Though stretching ex- tion and 40 had normal DF range of mo-
sensitivity at that point decreased during ercises—a common treatment in many tion at baseline. In independent-sample
treatment and the second measurement studies—can affect DF range of motion, t tests, the NPRS, LEFS, and DF range
was performed at a different point. In a correlation between this effect and the of motion showed a significantly greater
addition, we used a 1-cm2 pressure disc, change in outcome measures was not ex- improvement in the patients with lim-
which required a precise point. Because amined.7,25,28 Cleland et al7 examined the ited DF. A significant difference was also
A
NPRS and LEFS scores. with PF had limited DF. A possible ex- nkle and foot joint mobiliza-
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
There is conflicting evidence as to the planation for this contradiction may be tion aimed at improving DF range
association between limited DF and heel that in previous studies9,22,25,29 DF was of motion is not more effective than
pain. In a systematic review by Irving et measured in non–weight bearing with ultrasound and stretching alone in treat-
al,18 the association between chronic heel the knee extended. Thus, full dynamic ing PF. The association between limited
pain and possible etiological factors was range of motion at the ankle joint could DF and PF most probably is based on calf
examined. No conclusive proof was found not be achieved due to gastrocnemius muscle shortening (mainly of the gastroc-
to support the association between lim- tension, which limits movement. There- nemius) and not on ankle or foot joint
ited DF and PF. Only 1 of the 3 studies fore, it may be assumed that muscular limitation. t
included in the review found a significant tension of the gastrocnemius, rather than
Journal of Orthopaedic & Sports Physical Therapy®
The Lower Extremity Functional Scale (LEFS): man PT. Randomized controlled trial of calcaneal 2003;85-A:872-877.
scale development, measurement properties, taping, sham taping, and plantar fascia stretching 30. Rome K, Howe T, Haslock I. Risk factors associ-
and clinical application. North American Ortho- for the short-term management of plantar heel ated with the development of plantar heel pain
paedic Rehabilitation Research Network. Phys pain. J Orthop Sports Phys Ther. 2006;36:364- in athletes. Foot. 2001;11:119-125.
Ther. 1999;79:371-383. 371. http://dx.doi.org/10.2519/jospt.2006.2078 31. Salaffi F, Stancati A, Silvestri CA, Ciapetti A,
5. Bolívar YA, Munuera PV, Padillo JP. Relationship 18. Irving DB, Cook JL, Menz HB. Factors associ- Grassi W. Minimal clinically important changes
between tightness of the posterior muscles of ated with chronic plantar heel pain: a system- in chronic musculoskeletal pain intensity mea-
the lower limb and plantar fasciitis. Foot Ankle atic review. J Sci Med Sport. 2006;9:11-22; sured on a numerical rating scale. Eur J Pain.
Int. 2013;34:42-48. discussion 23-24. http://dx.doi.org/10.1016/j. 2004;8:283-291. http://dx.doi.org/10.1016/j.
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Interrater reliability of algometry in measur- 19. Irving DB, Cook JL, Young MA, Menz HB. 32. Schon LC, Baxter DE. Neuropathies of the
ing pressure pain thresholds in healthy Obesity and pronated foot type may in- foot and ankle in athletes. Clin Sports Med.
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AJP.0b013e318154b6ae culoskelet Disord. 2007;8:41. http://dx.doi. The diagnosis and treatment of heel pain: a
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physical therapy and exercise versus electrophys- 20. Jensen MP, Karoly P, Braver S. The measure- Foot Ankle Surg. 2010;49:S1-S19. http://dx.doi.
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plantar heel pain: a multicenter randomized clini- of six methods. Pain. 1986;27:117-126. http:// 34. Young B, Walker MJ, Strunce J, Boyles R. A
cal trial. J Orthop Sports Phys Ther. 2009;39:573- dx.doi.org/10.1016/0304-3959(86)90228-9 combined treatment approach emphasizing
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EXERCISE PROGRAM
Exercise Description Dosage Illustration
Gastrocnemius muscle stretch Step position against the wall with the refer- 2 stretches for 30
ence leg behind and the knee and foot facing seconds each,
straight forward. Lean forward toward the wall 3 times a day
while keeping the knee straight and the heel
on the floor until you feel tension at your calf
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Soleus muscle stretch Step position against the wall with the refer- 2 stretches for 30
ence leg behind and the knee and foot facing seconds each,
straight forward. Lean forward toward the wall 3 times a day
while keeping the knee bent and the heel on
the floor until you feel tension at your calf
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Plantar fascia stretch Sitting, put your reference leg across the other 2 stretches for 30
leg. Hold the toes with one hand and pull seconds each,
toward your shin until you feel tension along 3 times a day
your foot
Journal of Orthopaedic & Sports Physical Therapy®
APPENDIX B
MOBILIZATION TECHNIQUES
Mobilization Description Illustration
Non–weight-bearing AP The patient lies prone, the reference leg in 90° of knee flexion. The therapist
ankle joint mobilization stands at the reference leg’s side while one hand stabilizes the tibia and fibula
behind the ankle toward the malleoli and the second hand grasps the midfoot
and performs AP movement. If the patient cannot lie prone, the technique will
be performed supine, with the foot out of bed. The therapist stabilizes the tibia
and fibula behind the ankle toward the malleoli with one hand while the other
hand grasps around the talus and performs AP movement
Eversion/inversion of First option: the patient lies prone, the reference leg in 90° of knee flexion. The
subtalar joint therapist stands at the reference leg’s side, grasps the foot around the cal-
caneus, and performs inversion and eversion movements by moving the calf
close and away while maintaining the foot parallel to the ceiling
Second option: the patient lies on the reference leg’s side while the foot, distal to
the talus, is out of bed. The therapist stabilizes the distal calf with one hand
and with the other hand grasps around the calcaneus and performs eversion
and inversion by movements toward the floor and the ceiling
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
Pronation/supination of The patient lies prone, the reference leg in 90° of knee flexion. The therapist
mid-tarsal joints stands at the reference leg’s side and stabilizes the calcaneus and talus with
one hand while the other hand twists the mid-tarsal joints toward pronation
and supination
Journal of Orthopaedic & Sports Physical Therapy®