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Plantar FasciitisPhase 4NCT00222911

Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports

A Phase 4 study testing dorsiflexion night splint and medial arch support in people with Plantar Fasciitis, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall purpose of this study is to examine the combined effect of both dorsiflexion night splints and medial arch supports and compare it to the effect of these interventions each by itself in the treatment of plantar fasciitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plantar Fasciitis
What is being tested?
dorsiflexion night splint and medial arch support
Type of treatment
Medical device
How many people
75 participants
Where
1 siteUnited States
Study dates
Aug 2005to Nov 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • plantar heel pain
  • pain is provoked by taking the first few steps in the morning, by standing after prolonged sitting, and/or by prolonged standing
  • tenderness localized to the origin of the plantar fascia on the medial calcaneal tubercle

Who cannot join

  • previous foot surgery
  • foot trauma within the previous three months
  • tarsal tunnel syndrome
  • loss of plantar foot sensation
  • foot pathology other than plantar fasciitis including tendonitis, bursitis, or calcaneus fracture
  • generalized inflammatory disorders associated with the diagnosis of plantar fasciitis including rheumatoid arthritis, ankylosing spondylitis, Reiter's disease, gout, or lupus
Show all 10Show fewer
  • previous treatment of plantar fasciitis with dorsiflexion night splints and/or medial arch supports
  • inability or unwillingness to discontinue current treatment modalities that are used for the purpose of plantar fasciitis
  • participation in a worker's compensation program
  • age of less than 18 years

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: Conservative Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports: a Prospective Randomized Study

The overall purpose of this study is to examine the combined effect of both dorsiflexion night splints and medial arch supports and compare it to the effect of these interventions each by itself in the treatment of plantar fasciitis.

Read the detailed description

Plantar fasciitis is an overuse injury causing inflammation at the origin of the plantar fascia and is characterized by plantar heel pain that is provoked by taking the first few steps in the morning and by prolonged standing. It is the most common clinical problem that causes inferomedial heel pain in adults. It is estimated that more than two million people receive treatment for plantar fasciitis in the United States each year. Despite its familiarity to physicians, the exact etiology of plantar fasciitis remains obscure. The variety of treatments noted in the literature attests to the uncertainty of the etiology and pathogenesis of plantar fasciitis. It has been suggested that the success of conservative care for the treatment of patients with plantar fasciitis requires a combination of treatment modalities. Although many authors have stated that mechanical therapy should be considered a cornerstone of any effective treatment plan, some debate remains regarding the most effective form of mechanical treatment. The literature provides evidence to support the use of dorsiflexion night splints and medial arch supports in the treatment of plantar fasciitis. A night splint is used to address early morning pain by preventing contracture of the plantar fascia and Achilles tendon overnight. An arch support, on the other hand, addresses the end of the day pain by preventing overstretch of the plantar fascia during prolonged weight bearing. Therefore, both night splints and arch supports may be necessary to treat plantar fasciitis as they complement each other by both controlling nocturnal contracture of the plantar fascia and Achilles tendon and reducing stresses imposed on the plantar fascia during the day, respectively. This prospective randomized study, to the best of our awareness, is the first that addresses this problem by examining the combined effect of these treatment modalities and comparing it to the effect of a night splint or arch support each by itself. We hypothesize that the night splint and arch support together will be more effective in the treatment of plantar fasciitis than night splint or arch support alone in terms of increasing the range of pain-free passive ankle dorsiflexion, relieving heel tenderness and pain, and reducing disability imposed by the heel pain/plantar fasciitis. A secondary hypothesis of this study is that those with limited passive dorsiflexion of the ankle will benefit from a night splint more than those with normal passive dorsiflexion of the ankle and those with a low medial longitudinal arch will benefit from an arch support more than those with a normal medial longitudinal arch in terms of the previously mentioned outcomes. The range of motion will be measured with a goniometer; heel tenderness will be measured with a pressure algometer; and pain and disability will be measured by the Foot Function Index.

Being tested
dorsiflexion night splint, medial arch support
Keywords
plantar fasciitis, heel pain, heel spur, night splint, arch support, foot orthosis, physical therapy
Medical subject headings
Fasciitis, Plantar, Heel Spur

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dorsiflexion night splintDevice

  • medial arch supportDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the range of pain-free passive ankle joint dorsiflexion at baseline and 6 weeks

  2. plantar heel tenderness at baseline and 6 weeks

  3. plantar heel pain at baseline and 6 weeks

  4. disability imposed by the heel pain/plantar fasciitis at baseline and 6 weeks

Secondary outcomes (1)
  1. medial longitudinal arch height at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startAug 2005
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00222911
Sponsor's protocol ID
0506173
Status last verified
May 2008
First submitted
20 Sep 2005
Last updated
20 May 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dorsiflexion night splint and medial arch support in people with Plantar Fasciitis, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the range of pain-free passive ankle joint dorsiflexion at baseline and 6 weeks. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.

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