Effect of Manual Therapy and Inmediately Application of Plantar Orthoses

NCT ID: NCT05847972

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2023-12-11

Brief Summary

Limitation of ankle dorsiflexion is directly related to pronated foot. For its treatment, plantar orthoses and manual therapy are used. There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.

Detailed Description

The popularity of long-distance running has increased because it can be practised in many settings, the low cost and the links to prevention of health problems. In running between 19-79% of runners may suffer a running-related overuse injury each year. Pronated feet have been identified as a risk factor for lower limb overuse injury, and several studies have found that ankle dorsiflexion limitation is related to pronated feet.

There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.

The main objective is to compare the effect of manipulation with motion (MWM) performed immediately prior to casting for plantar orthoses (PO) with the effect of manipulation with motion performed one week prior to casting for plantar orthoses on ankle dorsiflexion (ankle DF) and foot pronation in runners with hyper pronator feet secondary to a limited ankle DF.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 18 and 45.

They will be randomised into two groups; group A, which will undergo MWM and have the moulds taken in phenolic foam immediately after the manipulation. The other group will be group B, which will undergo the MWM, and the moulds will be taken one week after the manipulation.

Conditions

Ankle Injuries and Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

A will undergo MWM and have their moulds taken in phenolic foam immediately after the musculoskeletal manipulation.

Group Type: EXPERIMENTAL

MWM (Mobilization with movement)

Intervention Type: PROCEDURE

This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Plantar orthoses

Intervention Type: DEVICE

Procedure: MWM All participants will undergo MWM. This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Procedure: Plantar orthoses The moulds will be taken immediately after the manipulation. The PO will be made of resin (0.8mm +1.2mm), 2mm hard EVA heel stabiliser, 3mm semi-hard EVA cover. The PO should be worn for 3 months to obtain the results of the study.

Control Group

Participants will undergo MWM and moulds will be taken one week after the musculoskeletal manipulation.

Group Type: PLACEBO_COMPARATOR

MWM (Mobilization with movement)

Intervention Type: PROCEDURE

This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Plantar orthoses

Intervention Type: DEVICE

Procedure: MWM All participants will undergo MWM. This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Procedure: Plantar orthoses The moulds will be taken immediately after the manipulation. The PO will be made of resin (0.8mm +1.2mm), 2mm hard EVA heel stabiliser, 3mm semi-hard EVA cover. The PO should be worn for 3 months to obtain the results of the study.

Interventions

MWM (Mobilization with movement)

This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Intervention Type: PROCEDURE

Plantar orthoses

Procedure: MWM All participants will undergo MWM. This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Procedure: Plantar orthoses The moulds will be taken immediately after the manipulation. The PO will be made of resin (0.8mm +1.2mm), 2mm hard EVA heel stabiliser, 3mm semi-hard EVA cover. The PO should be worn for 3 months to obtain the results of the study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Runners who run on asphalt.
• Individuals who run at least >6 hours per week for 6 months prior to study participation.
• Participants with hyperpronated feet secondary to ankle ROM limitation.
• Runners with an ankle DF difference of >1.5cm in both feet or an ankle DF of less than 11.5cm according to the Lunge Test.

Exclusion Criteria

• Individuals who have suffered a major injury in the previous two months.
• FPI less than 6.
• Runners wearing minimalist footwear into which PO cannot be inserted.
• Individuals already undergoing treatment with plantar supports.
• Chronic widespread pain, including fibromyalgia.
• Systemic rheumatic pathologies.
• History of recent trauma or surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Universidad Católica de Valencia San Vicente Mártir

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Juan Vicente-Mampel

Torrent, Valencia, Spain

Countries

Spain

Other Identifiers

UCV/2022-2023/093

Identifier Type: -

Identifier Source: org_study_id