Clinical trial NCT05984121: Comparison of the Effectiveness of Local Ozone Injection and Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis
Official title: Which is Outstanding, Local Ozone Injection or Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis?: a Randomised Controlled Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: Local Ozon therapy
Rehabilitation
Dextroz prolotherapy
Ultrasonography
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with a conventional therapy control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 0. week
measure: Visual analogue scale (VAS)
timeFrame: 2. week
measure: Visual analogue scale (VAS)
timeFrame: 4. week
measure: Visual analogue scale (VAS)
timeFrame: 12.week
measure: Foot Function Index (FFI)
timeFrame: 0. week
measure: Foot Function Index (FFI)
timeFrame: 2. week
measure: Foot Function Index (FFI)
timeFrame: 4. week
measure: Foot Function Index (FFI)
timeFrame: 12.week
Secondary outcomes:
measure: plantar fascia thickness measurement
timeFrame: 0. week
measure: plantar fascia thickness measurement
timeFrame: 12. week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran Üniversitesi
Study officials:
References: