Shock Waves Combined With Leg Stretches in Patients With Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Efficacy of Applying Shock Waves Combined With Leg Stretches in Patients With Plantar Fasciitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06466616
• Other study ID #: IDCES-08969382A
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	University of Alcalá, Faculty of Nursing and Physiotherapy	Alcalá De Henares	Comunidad De Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity limitation	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 %, the highest the % is the worst.; The Foot and Ankle Ability Measures is also goint 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 %. The highest the % is, the better.	Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Primary	Pain intenisty	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, We are also going to use the Pain Scale for Plantar Fasciitis in their seccion for pain masure. 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	Disability	To evaluate the difference in disability after the intervention. The Foot Function Index is going to be used in order to evaluate the disability, in its section intended for this. This scale gives a result in %, the highest the % is the worst.	Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention