Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis
Condition: Plantar Calcaneal Spur; Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar; Heel Spur
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): algometer
Intervention type(s): Device
Intervention description(s): Pressure algometer (Algometry) - This is an instrument that measures pain threshold (the minimum pressure required to produce pain). The instrument consists of a flat disk size centimeter square attached to pressure transducer and measuring electrodes. The disk is placed vertically on the point of pain and therapist increases the intensity of the pressure until initial pain appears (when sense of pressure becomes sense of pain.) Score is determined by average of three repeated measurements with 30 seconds break between each.
The algometer allows an objective assessment of pain in addition to LEFS score which is a subjective tool. The algometer test was found to be valid and reliable in repeated measurements (interrater, intrarater) by Andrew A. Fischerin 1987 with healthy people [Andrew 1987]. In another study high reliability was found for averaging between three repeated tests: ICC = 0.91 (CI 0.82; 0.97 95%). [Linda et al 2007]
Other intervention name(s): SBMEDIC Electronics
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: plantar fasciitis; heel pain; manual treatment; dorsi flexion