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

NCT ID: NCT05984121

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-05
• Study Completion Date: 2024-03-15

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.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local ozon injections

Local ozone therapy consists of 95-99% oxygen, 1-5% medical ozone mixture and is obtained from medical ozone generators. Medical ozone therapy contains at least 95% oxygen and at most 5% ozone. (Bocci, Velio Alvaro. 2006)

Group Type: ACTIVE_COMPARATOR

Local ozon injections

Intervention Type: DRUG

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.

Local dextroz prolotherapy injections

Hypertonic dextrose prolotherapy stimulates the cells at the injection site dehydrates, causing local tissue trauma, and increases macrophage and attracts granulocytes to that area and provides tissue healing. (Hauser, Ross and et al, 2016). Kesikburun Serdar et al. in 2022 with plantar fasciitis prolotherapy injection 3 times at 2 weeks intervals in their study "They used a 15% dextrose prolotherapy solution.

Group Type: ACTIVE_COMPARATOR

Local dextroz prolotherapy injections

Intervention Type: DRUG

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.

Exercise Group (Control Group)

Patients in the exercise group were treated as in the other groups during the treatment period.

plantar fascia stretching exercises, gastrocsoleus stretching exercises, foot intrinsic muscle strengthening exercises will be taught 2 times a day 10 times each will be asked to do so. In a systematic review by Siriphorn et al. fascia stretching exercises and gastrocsoleus stretching exercises in plantar fasciitis There is evidence that it is effective. The control group was given exercise therapy We aimed to ensure that the control group was not left untreated. in case of cold application and NSAIDs other than paracetamol will be asked not to take medication.

Group Type: OTHER

Local ozon injections

Intervention Type: DRUG

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.

Local dextroz prolotherapy injections

Intervention Type: DRUG

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.

Exercise Group

Intervention Type: OTHER

Patients will receive a conventional therapy program consisting of exercises

Interventions

Local 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.

Intervention Type: DRUG

Local 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.

Intervention Type: DRUG

Exercise Group

Patients will receive a conventional therapy program consisting of exercises

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Figen Tuncay

Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kırşehir Ahi Evran Üniversitesi

Kırşehir, Kırşehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AEU-FTR-DG-01

Identifier Type: -

Identifier Source: org_study_id