Orthopaedic Treatment in Propulsive Metatarsalgia

Status Completed

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia. The main question it aims to answer are: - To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia. - To determinate the influence of clinical and radiographical characteristics in pain improvement. Participants will wear the treatment for 3 months . Researchers will compare polypropylene and EVA insoles and Fixtoe Device® to see if a foot pain improvement is achieved.

Clinical Trial Description

Type of Study: Randomised Clinical Trial. Aim: To compare the effect of orthopedic treatment on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia. Study Protocol Description: Prior to the start of the study, a calculation of the sample size will be made using the GRANMO Sample Size Calculator, version .12 April 2012, with an error of 5%, assuming a confidence level of 95% and values of ß that establish an analysis power of 80%. The study population will be randomly divided into two treatment groups, which, in turn, will be subdivided into two groups. Said randomization will be carried out using an online tool (www.randomization.com). Treatment groups are: - Group A: Treatment by custom insoles made of 4.5mm polypropylene, balanced in inversion 0-4º, MLA of the patient, 4mm-heel rise and metatarsal dome. - Group A1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device. - Group A2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks). - Group B: Treatment by custom insoles made of 45º shore A E.V.A with the patient's MLA, 4mm- heel rise and metatarsal dome. - Group B1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device. - Group B2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks). Visits protocol is as follows: - Day 1: inclusion, clinical and radiographical evaluation. Pain questionnaires fulfillment.Treatment group allocation. - Day 2 (3 weeks after Day 1): Pain questionnaires fulfillment. Starts insoles treatment. - Day 3 (6 weeks after Day 2): Pain questionnaires fulfillment (telephone). - Day 4 (6 weeks after Day 3): Pain questionnaires fulfillment. Clinical evaluation. End of study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05713175
Study type	Interventional
Source	Universidad Complutense de Madrid
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2022
Completion date	January 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05864833` - METabolism After Orthopedic Surgery
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Recruiting	`NCT05461326` - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT	N/A
Completed	`NCT06080685` - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents	N/A
Not yet recruiting	`NCT06326827` - In'Oss™ (MBCP® Putty) Ortho
Not yet recruiting	`NCT06002009` - SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Completed	`NCT04730115` - Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis
Withdrawn	`NCT03436667` - Perioperative Factors Impacting Surgical Risk and Outcomes in Children
Completed	`NCT03299920` - Opioid Consumption After Knee Arthroscopy	N/A
Active, not recruiting	`NCT05075525` - EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME	N/A
Completed	`NCT06158165` - Evaluating The Cardiovascular Effects of Tourniquet Application
Recruiting	`NCT04891549` - Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures	N/A
Recruiting	`NCT04676841` - Wound Contamination During Orthopaedic Surgery
Not yet recruiting	`NCT03899298` - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions	Phase 1
Completed	`NCT04514601` - A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
Not yet recruiting	`NCT04546594` - Epidemiological Data on Pain
Completed	`NCT05396924` - Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy	N/A
Active, not recruiting	`NCT06438835` - Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO)	N/A
Active, not recruiting	`NCT05795127` - Risk for Reoperation After First MTP Joint Arthrodesis
Completed	`NCT04481711` - Total Knee Arthroplasty and Clinical Findings	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.