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

• ClinicalTrials.gov Identifier: NCT05984121
• Recruitment Status: Completed
• First Posted: August 9, 2023
• Last Update Posted: April 25, 2024
• Sponsor: Ahi Evran University Education and Research Hospital
• Information provided by (Responsible Party): Figen Tuncay, Ahi Evran University Education and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plantar Fascitis	Drug: Local ozon injections; Drug: Local dextroz prolotherapy injections; Other: Exercise Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three groups with a conventional therapy control group
• 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
• Primary Purpose: Treatment
• Official Title: Which is Outstanding, Local Ozone Injection or Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis?: A Randomised Controlled Study"
• Actual Study Start Date: July 17, 2023
• Actual Primary Completion Date: December 31, 2023
• Actual Study Completion Date: March 15, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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)	Drug: 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.
Active Comparator: 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.	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.
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.	Drug: 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.; 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.; Other: Exercise Group; Patients will receive a conventional therapy program consisting of exercises

Outcome Measures

Primary Outcome Measures :

1. Visual analogue scale (VAS) [ Time Frame: 0. week ]
   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. Visual analogue scale (VAS) [ Time Frame: 2. week ]
   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
3. Visual analogue scale (VAS) [ Time Frame: 4. week ]
   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. Visual analogue scale (VAS) [ Time Frame: 12.week ]
   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
5. Foot Function Index (FFI) [ Time Frame: 0. week ]
   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
6. Foot Function Index (FFI) [ Time Frame: 2. week ]
   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
7. Foot Function Index (FFI) [ Time Frame: 4. week ]
   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
8. Foot Function Index (FFI) [ Time Frame: 12.week ]
   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

Secondary Outcome Measures :

1. plantar fascia thickness measurement [ Time Frame: 0. week ]
   plantar fascia thickness measurement will be performed by ultrasonography
2. plantar fascia thickness measurement [ Time Frame: 12. week ]
   plantar fascia thickness measurement will be performed by ultrasonography

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Kırşehir Ahi Evran Üniversitesi

Kırşehir, Turkey, 40100

Sponsors and Collaborators

Ahi Evran University Education and Research Hospital

More Information

• Responsible Party: Figen Tuncay, Physical Medicine and Rehabilitation, Ahi Evran University Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT05984121
• Other Study ID Numbers: AEU-FTR-DG-01
• First Posted: August 9, 2023
• Last Update Posted: April 25, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Figen Tuncay, Ahi Evran University Education and Research Hospital:

Local Ozon therapy; Rehabilitation; Dextroz prolotherapy; Ultrasonography

Additional relevant MeSH terms:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases