Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study
NCT ID: NCT03731897
Last Updated: 2020-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-11-12
2019-06-12
Brief Summary
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Resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical therapy methods are used in the treatment. Steroid injection can be applied in patients who do not respond to these treatments. But steroid injection is not a pathology-based treatment, and also can cause serious side effects, such as fat pad atrophy and plantar fascia rupture. At this stage, in patients who do not respond to conservative treatments, new methods such as dextrose prolotherapy and platelet rich plasma may be used instead of steroid injection. In the literature, there is insufficient study showing effect of prolotherapy in patients with plantar fasciitis. Because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trial to assess the effect after prolotherapy injection in patients with plantar fasciitis.
The participants evaluated with clinically and sonographically. The aim of this study is to compare the pain, function and thickness of proximal plantar fascia in prolotherapy or control group.
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Detailed Description
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The primary outcome is visual analog scale (VAS) and secondary outcomes include Foot Function Index , ultrasonographic measurement of proximal plantar fascia. The evaluation was performed pretreatment as well as on the 1st and 3th month the treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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prolotherapy
Experimental: Plantar fasciitis injection with prolotherapy total 5cc. Procedure: Plantar fascia will be injected to the places where it adheres to the bone.
Drug: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. This treatment, known as regenerative injection therapy, stimulates tissue repair and reduces pain.
5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.
Plantar fascia will be injected to the places where it adheres to the bone.
control
Placebo Comparator: Plantar fasciitis injection with 9cc salin + 1 cc 2% lidocaine total 5cc.
Procedure: Plantar fascia will be injected to the places where it adheres to the bone.
Drug: 9 cc salin + 1cc 2% lidocaine. This treatment is safe for Plantar fasciitis injection.
9 cc salin + 1cc 2% lidocaine.
Plantar fascia will be injected to the places where it adheres to the bone.
Interventions
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5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.
Plantar fascia will be injected to the places where it adheres to the bone.
9 cc salin + 1cc 2% lidocaine.
Plantar fascia will be injected to the places where it adheres to the bone.
Eligibility Criteria
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Inclusion Criteria
* Heel pain for at least 3 months
* Plantar fasciitis which diagnosed clinically and confirmed using ultrasonography (plantar fascia thickness \> 4mm)
Exclusion Criteria
* Patients undergoing steroid injections for the treatment of plantar fasciitis in the last 6 months
* Rheumatic diseases
18 Years
65 Years
ALL
No
Sponsors
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Ankara Education and Research Hospital
OTHER_GOV
Responsible Party
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Basak Mansiz-Kaplan
Department of Physical Medicine and Rehabilitation
Principal Investigators
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Basak Mansiz-Kaplan
Role: PRINCIPAL_INVESTIGATOR
Physical Medicine and Rehabilitation
Locations
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Basak Mansiz-Kaplan
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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E171615
Identifier Type: -
Identifier Source: org_study_id
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