Evaluation of the Efficacy of Prolotherapy Treatment in Patients With

Status Completed

Clinical Trial Summary

Plantar fasciitis is the most common cause of heel pain and it is diagnosed by clinically.

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.

Clinical Trial Description

After obtaining written informed consent, patients of clinically and sonographically diagnosed with plantar fasciitis were randomized into intervention and control group. Participants in intervention group received two-session prolotherapy injection and control group received two-session 9cc salin + 1 cc 2% lidocaine injection in 3 weeks interval. Stretching and range of motion exercises were prescribed after treatment.

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03731897
Study type	Interventional
Source	Ankara Education and Research Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 12, 2018
Completion date	June 12, 2019

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See also
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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.

Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms