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Comparison of the Effectiveness of Local Ozone Injection and Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis

Which is Outstanding, Local Ozone Injection or Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis?: a Randomised Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05984121
Enrollment
60
Registered
2023-08-09
Start date
2023-08-05
Completion date
2024-03-15
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fascitis

Keywords

Local Ozon therapy, Rehabilitation, Dextroz prolotherapy, Ultrasonography

Brief summary

The aim of our study was to investigate the effect of local ozone injection and dextrose prolotherapy applications on pain and foot functions to compare the efficacy and to evaluate the thickness of the plantar fascia.

Detailed description

In this study, 60 plantar fasciitis patients aged between 18 and 75 years admitted to Kırşehir Ahi Evran University Training and Research Hospital were examined. Plantar fasciitis (PF) is a common cause of heel pain associated with gait disorders. is one of the causes and has a significant negative impact on quality of life. The diagnosis is usually made by clinical assessment and no additional investigations are required. Treatment with non-steroidal anti-inflammatory drugs, night splints and therapeutic exercises are the first choice extracorporeal shock wave therapy and plasma-rich Minimally invasive treatments such as platelet (prp) can also be applied.Plantar dextrose prolotherapy, which is another treatment method in fasciitis, improves the ligament structure strengthens and reduces pain.In 2022, Chutumstid T et al. conducted a meta-analysis and found that dextrose prolotherapy reduces pain, increases functionality and increases plantar fascia thickness in chronic plantar fasciitis. decreased the risk of complications. Seyam Omar et al. concluded that ozone therapy can be applied subcutaneously, periarticularly and intraarticularly. It can be preferred due to its low risk and high chance of success. is a treatment method.

Interventions

DRUGLocal ozon injections

Local ozone therapy is approximately 2-3 cc of medical ozone, ozone-resistant is realised by injecting subcutaneously or intramuscularly with injectors. Local ozone injection group at 0., 2. and 4. weeks with ultrasound guided medial Firstly 1.5 cc with a 25 gauge needle into the plantar fascia insertion in the plantar region 02 lidocaine injection in a sterile way and then (according to the weeks 3 cc ozone injection of 10, 15 and 20 pyg/ml will be made respectively.

DRUGLocal dextroz prolotherapy injections

Dextrose prolotherapy injection group under ultrasound guidance at weeks 0, 2 and 4 1.5 cc 30% dextrose solution and 1.5 cc 2 lidocaine mixture with a 25 gauge needle into the medial plantar region cc 2 lidocaine mixture will be made sterile with 3 cc 15% dextrose.

OTHERExercise Group

Patients will receive a conventional therapy program consisting of exercises

Sponsors

Ahi Evran University Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Patients will be randomly divided into 3 groups. (They will be selected by simple random sampling using the closed envelope method). They will be divided into Group 1 (local ozon injections and exercise) and group 2 (local dextroz prolotherapy and exercise) and group 3 (exercise) Outcome evalutions in the stduy will be carried out by a researcher who is blind to group allocation

Intervention model description

Three groups with a conventional therapy control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 18-75 years old, both sexes * Pain in the plantar medial calcaneal tubercle on palpation for more than 3 months * Accepting to participate in the study * Heel pain, especially in the first few steps in the morning, increasing with loading during the day * Patients with an initial VAS assessment of 4 or more on a 10 cm scale

Exclusion criteria

* Hyperthyroidism * Glucose6 phosphate dehydrogenase deficiency * Ozone allergy * Acute metabolic disease comorbidity (acute MI, acute hyperglycaemia, diabetic ketoacidosis, acute cerebrovascular disease etc.) * Pregnancy and breastfeeding * Malignite * Epilepsy * Tipl, having a history of type 2 diabetes * History of inflammatory rheumatic disease * History of bleeding disorders * Use of anticoagulants other than aspirin * Local corticosteroid injection into the plantar fascia within the last 3 months to have a story * ESWT treatment of the plantar fascia in the last 3 months * To have received physiotherapy to the foot, ankle area within the last 3 months * History of foot and ankle surgery * Active infection at the application site (cellulitis, erysipelas, etc.) * Allergy to dextrose * History of peripheral neuropathy * SI radiculopathy

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale (VAS)0. weekA Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Foot Function Index (FFI)0. weekFoot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems

Secondary

MeasureTime frameDescription
plantar fascia thickness measurement0. weekplantar fascia thickness measurement will be performed by ultrasonography

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026