Clinical trial NCT03731897: Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study
Official title: to Evaluate the Efficacy of Prolotherapy Treatment and Compare the Control Group in Patients With Plantar Fasciitis: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of pain on 1st and 3th months after treatment: VAS
timeFrame: Pre-treatment, 1st and 3th months after treatment
Secondary outcomes:
measure: Change from baseline in activity and functional status on 1st and 3th months after treatment.
timeFrame: Pre-treatment, 1st and 3th months after treatment
measure: Change from baseline in thickness of proximal plantar fascia on 1st and 3th months after treatment.
timeFrame: Pre-treatment, 1st and 3th months after treatment treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Basak Mansiz-Kaplan
Study officials:
affiliation: Physical Medicine and Rehabilitation
name: Basak Mansiz-Kaplan
role: PRINCIPAL_INVESTIGATOR
References: