Shock Waves Therapy Combined With Leg Stretching in Patients With Plantar Fasciitis
- Conditions
- Plantar Fascitis
- Interventions
- Other: Placebo stretchingOther: Real stretching
- Registration Number
- NCT06466616
- Lead Sponsor
- University of Alcala
- Brief Summary
The aim of this study is to evaluate the efficacy of a combination treatment consisting of ESWT and stretching of different muscles in the lower body compared to ESWT treatment alone in patients with plantar fasciitis.
- Detailed Description
Background: Plantar fasciitis is the most common cause of pain in the heel of the foot, manifested by the presence of pain in the antero-internal part of the calcaneus. Currently, there is ample evidence of the efficacy of both shock waves and stretching in their treatment, however, no study has proven what results are obtained by combining the application of shock waves with stretching in different leg muscles.
Objectives: The main objective of the study is to compare the effects of OC treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with PF. The secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term.
Materials and Methods: A double-blind randomized clinical trial will be conducted. A total of 52 subjects (26 in each group) will participate in the study, divided into one group that will undergo shockwave therapy plus real stretching (experimental group) and another that will undergo shockwave therapy plus placebo stretching (control group). The primary variable of the study will be pain, and secondary variables will include changes in disability and activity limitation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- Presence of pain in the medial area of the sole of the foot lasting 3 or more months.
- Being diagnosed with plantar fasciitis by one of the physical therapists participating in the study.
- Have a pain level equal to or greater than 3 on the Visual Analogue Scale (VAS).
- Presence of bilateral plantar fasciitis.
- Signs of neurological abnormalities.
- Infections and malignant tumors.
- History of presence of dysfunction in the lower extremity.
- Pregnant women
- Have been treated with shock waves in the previous 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Stretching Placebo stretching This group is going to realize 3 sessions of ESWT plus an 8 weeks placebo stretching program. Real Stretching Real stretching This group is going to realize 3 sessions of ESWT plus an 8 weeks stretching program.
- Primary Outcome Measures
Name Time Method Pain intenisty VAS Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention To evaluate the difference in pain after the intervention. We are going to use the Visual Analogue Scale, being 0 the better result and 10 the worst possible.
Pain intensity PSFP Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention We are also to use the Pain Scale for Plantar Fasciitis in their section for pain measure. The minimum score is 0 (better) and the maximum 100 (worst).
- Secondary Outcome Measures
Name Time Method Disability Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention To evaluate the difference in disability after the intervention. The Foot Function Index is going to be used to evaluate the disability, in its section intended for this. This scale gives a result in percent, the highest the percent is the worst.
Trial Locations
- Locations (1)
University of Alcalá, Faculty of Nursing and Physiotherapy
🇪🇸Alcalá De Henares, Comunidad De Madrid, Spain