Chronic Plantar Fasciitis Musculoskeletal Diseases Plantar fascial fibromatosis
Conditions
Interventions
Patients are randomised to two groups:
1. Shockwave therapy
1.1. Patient lying down in supine position at the stretcher, without shoes, with ear plugs, with feet towar
Sponsors
Funding Authority for Studies and Projects, Ministry of Science and Technology (Financiadora de Estudo e Projetos) (Brazil)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Older than 40 years, for both sexes 2. Patient with unilateral chronic plantar fasciitis, diagnosed by clinical examination 3. Symptoms of heel pain in the region of plantar fascia insertion, for more than 6 weeks 4. History of unsuccessful previous conservative treatment, including one, or an association of, the following therapeutic methods: NSAID (non-steroidal anti-inflammatory drugs), rest, heat, ice, ultrasound, massage, orthoses, plaster immobilization, taping, change of footwear and use of night orthosis. 5. Physical examination with pain to palpation of the plantar fascia insertion in the unilateral calcaneus inferomedial region 6. Ultrasound examination of affected foot showing inflammatory process in the plantar fascia insertion region, in the calcaneus inferior part
Exclusion criteria
Exclusion criteria: 1. History or documented evidence of autoimmune or peripheral vascular disease 2. History or documented evidence of type 1 or type 2 Diabetes mellitus (possibility of diabetic peripheral neuropathy) 3. History or documented evidence of peripheral neuropathy (Nerve Compression Syndrome, Tarsal Tunnel Syndrome) 4. History or documented evidence of systemic inflammatory disease (reumathoid arthritis, ankylosing spondylitis, Reiter?s Syndrome, etc.) 5. History or documented evidence of loss of feeling in foot or ankle 6. Pregnancy 7. Reflex sympathetic dystrophy 8. Congenital club foot 9. History or documented evidence of blood coagulation disorders (treatment with anticoagulant, except for aspirin) 10. Treatment with corticosteroid injection in less than 30 days 11. Previous surgical treatment for plantar fasciitis 12. Use of cardiac pacemaker 13. Allergy or known allergic sensitivity to lidocaine or corticosteroids 14. Active infectious process (superficial on the skin and cellular subcutaneous tissue or deep in the bone) in the region to be treated 15. Nonpalpable posterial tibial pulse or pedal pulse, or abnormal capillary refill 16. Tumoral (main or secondary tumors), traumatic (fracture) or infectious (osteomyelitis) lesions 17. Stress fracture 18. Radiographic examination of the affected foot, in profile and axial position of the calcaneus with infectious (osteomyelitis) or neoplastic (bone tumor or metastatic tumor) processes. Repeat radiographic examinations after last re-evaluation in 12 weeks. 19. Ultrasound examination of affected foot showing local infectious process of soft tissues, or neoplastic process of soft tissues. Repeat radiographic examinations after last re-evaluation in 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain evaluation in all cases will be carried out by an evaluator according to the visual and analogical scale for pain in the foot with plantar fasciitis after any intervention (Shock waves Therapy or corticosteroids infiltration). This scale was described by Revill et col. (1976); in it, the patient marks the intensity of his pain in a blank sheet of paper, with an ?X? alongside a 10 cm line, measuring the distance from zero to X with a millimeter rule and the value written down in centimeters, with one decimal place. Zero is absence of pain and 10 cm is maximum pain. 2. The hindfoot function of the patient with plantar fasciitis, after treatment with Shock waves Therapy or corticosteroids, will be evaluated through the AOFAS questionnaire. 3. Quality of life of the patient with plantar fasciitis after treatment with Shock waves Therapy or corticosteroids will be evaluated through the SF-36 questionnaire.Use of a quality of life evaluation questionnaire is required to correlate specific aspects of an illness with the overall health condition of the person. SF-36 (The Medical Outcomes Study 36-item Short-Form Health Survey) questionnaire is a generic tool for evaluating quality of life, i. e., it may be used for any illness, age or treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrence of inflammatory or infectious process in the region of local anesthesia or corticoid infiltration. 2. Necrosis of skin in the region of anesthetic block or corticoid infiltration. 3. Use of rescue medication (dipyrone). 4. Relation of B.M.I. with the post-intervention evolution. Evaluation of Outcomes: Use of analgesics post-application (rescue) 1. If pain gets worse soon after any of the established treatments, the patient will be allowed to use an analgesic (dipyrone) for a period of 5 days. Medication will be provided to the patient after intervention with instructions about how and in what situation it must be used. 2. After the 5-day period of analgesia, in case of persistent pain, the patient will be re-evaluated, and the need for change of medication will be checked. 3. After the second evaluation (in 6 weeks), if pain is worse than it was before the treatment, it will be proposed to the patient the change of treatment for the other method (infiltration of shock waves) or his exclusion from the work, if the patient so wants. 4. It will be excluded from the study the patient who receives another type of treatment, on his own, during the study. 5. Criteria for worsening: VAS higher than initial evaluation. SF-36 and AOFAS lower than initial evaluation. Worsening referred by the patient. 6. Criteria for unchanged situation: VAS, SF-36 and AOFAS unchanged in relation to the initial evaluation. 7. Criteria for improvement: VAS lower than initial evaluation. SF-36 and AOFAS higher than initial evaluation. | — |
Countries
Brazil
Outcome results
None listed