Clinical Trial: Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis, a Randomized Control Trial
Brief 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 rec
Detailed Summary:
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 sw
Sponsor: Meir Medical Center
Current Primary Outcome: Numeric Pain Rating Scale 0-10 [ Time Frame: one year and two months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Meir Medical Center
Dates:
Date Received: September 20, 2011
Date Started: October 2011
Date Completion:
Last Updated: February 17, 2013
Last Verified: September 2011
