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

University of Alcala

Status: Active, not recruiting

Conditions: Plantar Fascitis

Treatments: Other: Placebo stretching; Other: Real stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT06466616

IDCES-08969382A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Real Stretching

Experimental group

Description:

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

Treatment:

Other: Real stretching

Placebo Stretching

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo stretching