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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Stretching | Experimental | This group is going to realize 3 sessions of ESWT plus an 8 weeks stretching program. |
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| Placebo Stretching | Placebo Comparator | This group is going to realize 3 sessions of ESWT plus an 8 weeks placebo stretching program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real stretching | Other | Aplying 3 sesions of ESWT in patients with plantar fasciitis in the zone of pain. Futhermore they are going to do a program of 8 weeks stretching of plantar fascia, gastrocnemius and hamstring muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intenisty VAS | 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. | Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention |
| Pain intensity PSFP | 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). | Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | 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. | Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Activity limitation FFI | To evaluate the difference in activity limitation after the intervention. The Foot Function Index is going to be used in order to evaluate the activity limitation, in its section intended for this. This scale gives a result in percent, the highest the percent is, the worst. | Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillem Serrabassa Ureña, MSc | University of Alcalá | Principal Investigator |
| Tomás Gallego Izquierdo, PhD | University of Alcalá | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alcalá, Faculty of Nursing and Physiotherapy | Alcalá de Henares | Madrid | 28805 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31546912 | Background | Wang YC, Chen SJ, Huang PJ, Huang HT, Cheng YM, Shih CL. Efficacy of Different Energy Levels Used in Focused and Radial Extracorporeal Shockwave Therapy in the Treatment of Plantar Fasciitis: A Meta-Analysis of Randomized Placebo-Controlled Trials. J Clin Med. 2019 Sep 19;8(9):1497. doi: 10.3390/jcm8091497. | |
| 34947818 | Background |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo stretching | Other | Aplying 3 sesions of ESWT in patients with plantar fasciitis in the zone of pain. Futhermore they are going to do a program of 8 weeks placebo stretching of plantar fascia, gastrocnemius and hamstring muscle. |
|
|
| Activity limitation FAAM | The Foot and Ankle Ability Measures is going to be used to evaluate activity limitation. It's section destinated to evaluate this item fives a number that goes from 0 to 84. This number must be divided by 100 to get de final percent. The highest the percent is, the better. | Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention |
| Rhim HC, Kwon J, Park J, Borg-Stein J, Tenforde AS. A Systematic Review of Systematic Reviews on the Epidemiology, Evaluation, and Treatment of Plantar Fasciitis. Life (Basel). 2021 Nov 24;11(12):1287. doi: 10.3390/life11121287. |
| 21703003 | Background | Sweeting D, Parish B, Hooper L, Chester R. The effectiveness of manual stretching in the treatment of plantar heel pain: a systematic review. J Foot Ankle Res. 2011 Jun 25;4:19. doi: 10.1186/1757-1146-4-19. |
| 25940060 | Background | Rompe JD, Furia J, Cacchio A, Schmitz C, Maffulli N. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg. 2015 Dec;24(Pt B):135-42. doi: 10.1016/j.ijsu.2015.04.082. Epub 2015 May 1. |
| 32877978 | Background | Boonchum H, Bovonsunthonchai S, Sinsurin K, Kunanusornchai W. Effect of a home-based stretching exercise on multi-segmental foot motion and clinical outcomes in patients with plantar fasciitis. J Musculoskelet Neuronal Interact. 2020 Sep 1;20(3):411-420. |