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

Ankara Education and Research Hospital

Status: Completed

Conditions: Plantar Fascitis

Treatments: Other: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.; Other: 9 cc salin + 1cc 2% lidocaine.

Study type: Interventional

Funder types: Other

Identifiers

NCT03731897

E171615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-65 year-old.
• Heel pain for at least 3 months
• Plantar fasciitis which diagnosed clinically and confirmed using ultrasonography (plantar fascia thickness > 4mm)

Exclusion criteria

• History of chronic pain syndromes
• Patients undergoing steroid injections for the treatment of plantar fasciitis in the last 6 months
• Rheumatic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

prolotherapy

Experimental group

Description:

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.

Treatment:

Other: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.

control

Placebo Comparator group

Description:

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.

Treatment:

Other: 9 cc salin + 1cc 2% lidocaine.