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

Primary Purpose

Plantar Fascitis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Local ozon injections
Local dextroz prolotherapy injections
Exercise Group
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring Local Ozon therapy, Rehabilitation, Dextroz prolotherapy, Ultrasonography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kırşehir Ahi Evran ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Local ozon injections

Local dextroz prolotherapy injections

Exercise Group (Control Group)

Arm 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)

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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

Secondary Outcome Measures

plantar fascia thickness measurement
plantar fascia thickness measurement will be performed by ultrasonography
plantar fascia thickness measurement
plantar fascia thickness measurement will be performed by ultrasonography

Full Information

First Posted
August 2, 2023
Last Updated
August 14, 2023
Sponsor
Ahi Evran University Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05984121
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
Local Ozon therapy, Rehabilitation, Dextroz prolotherapy, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups with a conventional therapy control group
Masking
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
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local ozon injections
Arm Type
Active Comparator
Arm 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)
Arm Title
Local dextroz prolotherapy injections
Arm Type
Active Comparator
Arm 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.
Arm Title
Exercise Group (Control Group)
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Local ozon injections
Intervention Description
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
Intervention Name(s)
Local dextroz prolotherapy injections
Intervention Description
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
Other
Intervention Name(s)
Exercise Group
Intervention Description
Patients will receive a conventional therapy program consisting of exercises
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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
Time Frame
0. week
Title
Visual analogue scale (VAS)
Description
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
Time Frame
2. week
Title
Visual analogue scale (VAS)
Description
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
Time Frame
4. week
Title
Visual analogue scale (VAS)
Description
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
Time Frame
12.week
Title
Foot Function Index (FFI)
Description
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
Time Frame
0. week
Title
Foot Function Index (FFI)
Description
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
Time Frame
2. week
Title
Foot Function Index (FFI)
Description
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
Time Frame
4. week
Title
Foot Function Index (FFI)
Description
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
Time Frame
12.week
Secondary Outcome Measure Information:
Title
plantar fascia thickness measurement
Description
plantar fascia thickness measurement will be performed by ultrasonography
Time Frame
0. week
Title
plantar fascia thickness measurement
Description
plantar fascia thickness measurement will be performed by ultrasonography
Time Frame
12. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Figen TUNCAY, Prof.Dr.
Phone
5353046401
Ext
+90
Email
figentuncay3206@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dogus Gümüsay, Ass.Dr.
Phone
5556502708
Ext
+90
Facility Information:
Facility Name
Kırşehir Ahi Evran Üniversitesi
City
Kırşehir
ZIP/Postal Code
40100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Figen Tuncay, Prof.Dr.
Phone
5353046401
Ext
+90
Email
figentuncay3206@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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