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

A

Ahi Evran University Education and Research Hospital

Status

Completed

Conditions

Plantar Fascitis

Treatments

Drug: Local ozon injections
Other: Exercise Group
Drug: Local dextroz prolotherapy injections

Study type

Interventional

Funder types

Other

Identifiers

NCT05984121
AEU-FTR-DG-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Local ozon injections
Active Comparator group
Description:
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)
Treatment:
Drug: Local ozon injections
Local dextroz prolotherapy injections
Active Comparator group
Description:
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.
Treatment:
Drug: Local dextroz prolotherapy injections
Exercise Group (Control Group)
Other group
Description:
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.
Treatment:
Other: Exercise Group
Drug: Local ozon injections
Drug: Local dextroz prolotherapy injections

Trial contacts and locations

1

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Central trial contact

Dogus Gümüsay, Ass.Dr.; Figen TUNCAY, Prof.Dr.

Data sourced from clinicaltrials.gov

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