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

NCT ID: NCT06466616

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2025-07-01

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.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real Stretching

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

Group Type: EXPERIMENTAL

Real stretching

Intervention Type: 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.

Placebo Stretching

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

Group Type: PLACEBO_COMPARATOR

Placebo stretching

Intervention Type: 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.

Interventions

Real stretching

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.

Intervention Type: OTHER

Placebo stretching

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.

Intervention Type: OTHER

Other Intervention Names

Extracorporeal Shock Wave Threatment; Extrecorporeal Shock Wave Threatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Guillem Serrabassa Ureña

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillem Serrabassa Ureña, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Tomás Gallego Izquierdo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Locations

University of Alcalá, Faculty of Nursing and Physiotherapy

Alcalá de Henares, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 31546912 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34947818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21703003 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25940060 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32877978 (View on PubMed)

Other Identifiers

IDCES-08969382A

Identifier Type: -

Identifier Source: org_study_id