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

NCT05984121 | Completed

• 1 other identifier: AEU-FTR-DG-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Keywords

Local Ozon therapy; Rehabilitation; Dextroz prolotherapy; Ultrasonography

Outcome Measures

Primary Outcomes (8)

• Visual analogue scale (VAS)

  A 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

  0. week

• Visual analogue scale (VAS)

  A 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

  2. week

• Visual analogue scale (VAS)

  A 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

  4. week

• Visual analogue scale (VAS)

  A 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

  12.week

• Foot Function Index (FFI)

  Foot 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

  0. week

• Foot Function Index (FFI)

  Foot 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

  2. week

• Foot Function Index (FFI)

  Foot 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

  4. week

• Foot Function Index (FFI)

  Foot 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

  12.week

Secondary Outcomes (2)

• plantar fascia thickness measurement

  0. week

• plantar fascia thickness measurement

  12. week

Study Arms (3)

Local ozon injections

ACTIVE COMPARATOR

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)

Drug: Local ozon injections

Local dextroz prolotherapy injections

ACTIVE COMPARATOR

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.

Drug: Local dextroz prolotherapy injections

Exercise Group (Control Group)

OTHER

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.

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

Interventions

Local ozon injections 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.

Exercise Group (Control Group); Local ozon injections

Local dextroz prolotherapy injections 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); Local dextroz prolotherapy injections

Exercise Group OTHER

Patients will receive a conventional therapy program consisting of exercises

Exercise Group (Control Group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kırşehir Ahi Evran Üniversitesi

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation

Model Details: Three groups with a conventional therapy control group

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: August 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)