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

NCT03731897 | Completed

• 1 other identifier: E171615
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline of pain on 1st and 3th months after treatment: VAS

  Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.

  Pre-treatment, 1st and 3th months after treatment

Secondary Outcomes (2)

• Change from baseline in activity and functional status on 1st and 3th months after treatment.

  Pre-treatment, 1st and 3th months after treatment

• Change from baseline in thickness of proximal plantar fascia on 1st and 3th months after treatment.

  Pre-treatment, 1st and 3th months after treatment treatment

Study Arms (2)

prolotherapy

EXPERIMENTAL

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.

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

control

PLACEBO COMPARATOR

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.

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

Interventions

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

Plantar fascia will be injected to the places where it adheres to the bone.

prolotherapy

9 cc salin + 1cc 2% lidocaine. OTHER

Plantar fascia will be injected to the places where it adheres to the bone.

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Education and Research Hospital: lead

Study Sites (1)

Basak Mansiz-Kaplan

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Glucose; Lidocaine

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Basak Mansiz-Kaplan

  Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: November 12, 2018
• Primary Completion: March 12, 2019
• Study Completion: June 12, 2019
• Last Updated: June 18, 2020

Record last verified: 2019-07

Locations

TU (1)