Shoe Insert and Physical Therapy for Lateral Hip Pain

DC
DM
Overseen ByDaniel McGurren, Doctorate of Physical Therapy
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special shoe insert, combined with physical therapy, might reduce hip pain and improve function. Researchers are comparing three groups: one receiving only physical therapy, another with physical therapy plus a placebo insert, and a third with physical therapy plus a real insert on the painful side. The trial targets individuals who have experienced pain on one side of their hip for more than three months and feel discomfort during certain movements or when the area is pressed. The study aims to determine if the shoe insert can immediately improve movement and comfort when standing on one leg. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance hip pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have had certain treatments like corticosteroid injections at the hip within the last 12 months.

What prior data suggests that this shoe insert is safe for use in physical therapy?

Studies have shown that shoe inserts, like those used in this trial, are generally easy to use. Previous research found that people using shoe inserts did not report any serious side effects. The main focus has been on comfort and fit rather than negative effects. Research indicates that while some people might notice changes in their gait, these inserts are designed to support the foot without causing harm. They aim to improve foot and leg movement, potentially reducing pain. Overall, studies have found that shoe inserts are safe, with most users finding them a helpful part of their treatment.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different combinations of physical therapy and shoe inserts to relieve lateral hip pain. Unlike standard treatments like medication or surgery, these approaches are non-invasive and focus on biomechanical adjustments. The trial investigates whether adding a unilateral shoe insert — or using shoe inserts bilaterally — alongside physical therapy enhances pain relief more effectively than physical therapy alone. This could offer a simple, drug-free alternative to existing treatments, potentially reducing side effects and improving patient comfort and mobility.

What evidence suggests that this trial's treatments could be effective for lateral hip pain?

Research has shown that using a shoe insert can help reduce hip pain and improve mobility. In studies, participants who used special shoe inserts, called foot orthoses, experienced less hip pain and an improved quality of life. These inserts improve alignment and reduce stress on the hip joint. In this trial, one group will receive physical therapy alone, while other groups will combine physical therapy with either a unilateral or bilateral shoe insert. Evidence suggests that combining these inserts with physical therapy can enhance pain relief and movement. Overall, adding a shoe insert to physical therapy might offer extra benefits for those experiencing hip pain.13678

Are You a Good Fit for This Trial?

This trial is for individuals with unilateral hip pain lasting over three months, a pain score of at least 3/10 on the VAS localized to the lateral hip, and discomfort during certain hip tests. It's not suitable for those who don't meet these specific criteria.

Inclusion Criteria

I feel pain on the side of my hip when it's pressed.
I have had hip pain on one side for over three months.
I have hip pain rated at least 3 out of 10 on the pain scale.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive physical therapy with or without shoe inserts to assess improvements in pain and function

12 weeks
Regular visits for physical therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Unilateral neutral shoe insert

Trial Overview

The study is testing if adding a special shoe insert to standard physical therapy can improve pain and function better than just physical therapy alone or with sham inserts. The effects will be measured after 12 weeks and again at 6 months.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Physical Therapy Plus Unilateral Shoe InsertExperimental Treatment1 Intervention
Group II: Physical TherapyActive Control1 Intervention
Group III: Physical Therapy Plus Bilateral Shoe InsertPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Shoe Insert and Physical Therapy for Lateral Hip Pain

The study is testing if adding a special shoe insert to standard physical therapy can improve pain and function better than just physical ...

The Utilization of a Shoe Insert on Individuals ...

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain ...

Effects of foot orthoses and footwear interventions on ...

Single-group pre-post study designs describe positive relationships between foot orthoses and footwear use and improvements in hip pain, function, and QoL.

LONG-TERM EFFECTS OF LATERAL WEDGE ORTHOTICS ...

By 36 months, there was statistically significant joint space narrowing at the hip joints in both the lateral wedge and the neutral orthotics groups. This ...

The Utilization of a Shoe Insert on Individuals ...

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain ...

The Utilization of a Shoe Insert on Individuals ...

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain ...

Foot Orthotics - Medical Clinical Policy Bulletins

However, compared with control inserts (neutral soles), lateral wedge insoles provided no clinically significant improvement in pain in patients with medial ...

Lateral Wedge Insoles: Treatment for Medial Knee Osteoarthritis

For unilateral pain: wedge plus neutral insole; bilateral pain: wedge times 2. In the treatment group, 87.8% reported permanently wearing insoles; control ...