Fasciitis, Plantar Clinical Trial
Official title:
Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis, a Randomized Control Trial
Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the
population during life. This is a degenerative condition of the plantar fascia at its
insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning
or after prolonged lack of weight bearing. The pain intensity can be very high and this can
cause functional limitations and reduce quality of life.
Despite the high prevalence of the PF, treatment is controversial and not supported by
extensive research. Review of the previous studies on various treatments, mentioned steroid
injections, shock waves, night splint, orthotics, heel padding and stretching exercises.
Limitation of ankle dorsi flexion is a common finding and thought to be a contributing
factor to the development of pathology. So far, this issue had been addressed mainly by soft
tissue therapy techniques to improve ankle range of motion in patients with PF. Only one
study (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However,
in this study mobilizations were part of complex therapy and therefore the effect of
treatment cannot be attributed solely to them.
The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints
mobilization on pain and function of patients with PF.
The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to
conventional physical therapy will improve pain and function significantly more than
conventional treatment, in patients with PF.
Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will
be recruited and randomly divided into two groups. Both groups will receive commonly
accepted physical therapy treatment that includes stretching exercise of the plantar fascia
and triceps surae muscles and ultrasound therapy at the site of symptoms. The study group
will receive in addition manual mobilizations to the ankle and midfoot joints. The
procedures will take place at the physiotherapy clinic Bat-Yamon of General Health Services
and will last four weeks, twice a week.
A prospective randomized double-blinded controlled clinical trial. Setting: Bat-Yamon
physical therapy clinic of Clalit health services in Bat Yam.
Ethical considerations: The research proposal will be submitted for the approval of the
Helsinki Committee at Meir Hospital in Kefar Saba. All patients will sign informed consent
form according to the laws of medical ethics.
Subjects will be recruited from all the population of patients who are referred to physical
therapy for the treatment of PF with diagnosis of plantar fasciitis or calcaneal spur.
Randomization will be carried out using envelopes that will be prepared in advance. Each
patient will receive at the end of the baseline examination envelope with the type of
treatment for which will be delivered only to the therapist so that the examiner and the
patient will be blind to the treatment group.
Baseline and final evaluations will be performed by the examiner-therapist and treatments
performed by three physical therapists at the Bat-Yamon clinic with experience of at least 3
years which will receive proper instruction and training.
Baseline examination will be performed after completing informed consent form and will
include demographic information to be filled by patient, clinical interview and examination
by the examiner. Demographic information includes age, gender, weight, BMI (calculated by
the examiner), history of the problem, habits related to physical activity and occupation
and general health.
The interview will refer to etiology and nature of symptoms. The clinical examination will
include observation of foot structure and gait pattern, the presence of hit or swelling.
Palpation for pain location and for ruling out fat pad Syndrome, clunk test and neurodynamic
of tibial nerve will be performed to rule out tarsal tunnel syndrome (TTS). Patients with
suspicion for one of these diagnoses will not be recruited. Dorsi flexion range of motion in
both legs will be measured and compared to the range at the end of treatment. Measurement
will be taken in two ways, once weight bearing with inclinometer - the patient stands in
lounge position while tested leg in front and asked to bend the knee of this leg as possible
without lifting the heel off the floor. The angle measured is the angle between the tibia
and a vertical line to the floor.Second time without weight bearing with Goniometer- the
patient lies on his back with a pillow under the tested knee , the therapist performs
maximum dorsi flexion passively and asks the patient to add an active movement in the same
direction. The angle measured is between fibula and fifth metatarsus
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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