Clinical trial NCT06466616: Shock Waves Therapy Combined With Leg Stretching in Patients With Plantar Fasciitis
Official title: Efficacy of Applying Shock Waves Combined With Leg Stretching in Patients With Plantar Fasciitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Keywords: shockwave therapy
stretching
pain
disability
activity limitation
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intenisty VAS
timeFrame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
measure: Pain intensity PSFP
timeFrame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Secondary outcomes:
measure: Disability
timeFrame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Other outcomes:
measure: Activity limitation FFI
timeFrame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
measure: Activity limitation FAAM
timeFrame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcalá, Faculty of Nursing and Physiotherapy
state: Comunidad De Madrid
Study officials:
affiliation: University of Alcalá
name: Guillem Serrabassa Ureña, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alcalá
name: Tomás Gallego Izquierdo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.