Shock Waves Therapy Combined With Leg Stretching in Patients With Plantar Fasciitis

NCT06466616 | Active Not Recruiting DMC

• 1 other identifier: IDCES-08969382A
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Keywords

shockwave therapy; stretching; pain; disability; activity limitation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Disability

  Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

Other Outcomes (2)

• Activity limitation FFI

  Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

• Activity limitation FAAM

  Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

Study Arms (2)

Real Stretching

EXPERIMENTAL

This group is going to realize 3 sessions of ESWT plus an 8 weeks stretching program.

Other: Real stretching

Placebo Stretching

PLACEBO COMPARATOR

This group is going to realize 3 sessions of ESWT plus an 8 weeks placebo stretching program.

Other: Placebo stretching

Interventions

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.

Also known as: Extracorporeal Shock Wave Threatment

Real Stretching

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.

Also known as: Extrecorporeal Shock Wave Threatment

Placebo Stretching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

University of Alcalá, Faculty of Nursing and Physiotherapy

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (5)

• 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.

  PMID: 31546912 BACKGROUND

• 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.

  PMID: 34947818 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.

  PMID: 21703003 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.

  PMID: 25940060 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.

  PMID: 32877978 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillem Serrabassa Ureña, MSc

  University of Alcalá

  PRINCIPAL INVESTIGATOR

• Tomás Gallego Izquierdo, PhD

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 20, 2024
• Study Start: May 6, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)