An interventional study of 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. and 9 cc salin + 1cc 2% lidocaine. in Plantar Fascitis, sponsored by Ankara Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by Ankara Education and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
Ankara Education and Research Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Plantar fascia will be injected to the places where it adheres to the bone.
Plantar fascia will be injected to the places where it adheres to the bone.
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.
Time frame: Pre-treatment, 1st and 3th months after treatment
Change from baseline in activity and functional status on 1st and 3th months after treatment.
Using the Foot Function Index (FFI) to measure the activity and functional status before treatment and multiple time frame after treatment. . The FFI consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. The higher scores indicate worse pain. Both total and subcategory scores are calculated.
Time frame: Pre-treatment, 1st and 3th months after treatment
Change from baseline in thickness of proximal plantar fascia on 1st and 3th months after treatment.
Using the musculoskeletal sonogram to measure the proximal plantar fascia thickness.
Time frame: Pre-treatment, 1st and 3th months after treatment treatment
Ran from Nov 2018 to primary completion in Mar 2019, 4 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Ankara Education and Research Hospital