The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee PainNCT06345222
Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain
A study testing Prolotherapy in people with The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain
- What is being tested?
- Prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who suffer from primary knee osteoarthritis
Who cannot join
- Inflammatory knee pain
- Cellulitis
- Septic arthritis
- Local abscess
- Bleeding disorders
- Patient on anticoagulant medication
Show all 11Show fewer
- Patients allergic to dextrose
- Diabetes Mellitus
- breathing problems
- Electrolyte imbalance
- Kidney or liver disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Türkiye, 16310
About this study
92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month.
- Being tested
- Prolotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyProcedure or surgery
The "Modified Prolotherapy" technique was applied in the study and 0.5cc 5% Dextrose injection was applied per injection to the tendon entesis and/or tendon of the patient's non-rheumatic chronic, myoskeletal knee-induced, pain-inducing sensation. The follow-up period was determined as 1 month after the last injection. The ligaments to be injected within the scope of the research (context knee pain) were determined as Lateral Collateral Ligament (LCL), AnteroLateral Collateral Ligament (ALL), Medial Collateral Ligament (MCL), Pes Anserius and Patellar Ligament.
| Study group | Role | What they receive |
|---|---|---|
| Prolotherapy | Experimental | Patients to whom prolotherapy treatment applied (n=32). Receives: Procedure: Prolotherapy |
| Control | Other | Patients to whom no prolotherapy applied. No intervention with their treatment (n=33). Receives: Procedure: Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in knee pain with prolotherapy application
Visual Analog Scale (VAS) scores determines pain relief. VAS scale use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.
Measured: 1 month
change in quality of life
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.SF-36 Scale scores determines change in quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 May 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case control study
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hakan Demirci, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Hakan Demirci, Professor, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345222
- Sponsor's protocol ID
- GETAT 23/05
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on demand. Sharing data identifying patients is forbidden in Türkiye.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain
- ClinicalTrials.gov ID
- NCT06345222
- Acronym / sponsor ID
- GETAT 23/05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case control study
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy | Experimental | Procedure: ProlotherapyPatients to whom prolotherapy treatment applied (n=32). |
| Control | Other | Procedure: ProlotherapyPatients to whom no prolotherapy applied. No intervention with their treatment (n=33). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who suffer from primary knee osteoarthritis
Key exclusion criteria (11 listed)
- Inflammatory knee pain
- Cellulitis
- Septic arthritis
- Local abscess
- Bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProlotherapyThe "Modified Prolotherapy" technique was applied in the study and 0.5cc 5% Dextrose injection was applied per injection to the tendon entesis and/or tendon of the patient's non-rheumatic chronic, myoskeletal knee-induced, pain-inducing sensation. The follow-up period was determined as 1 month after the last injection. The ligaments to be injected within the scope of the research (context knee pain) were determined as Lateral Collateral Ligament (LCL), AnteroLateral Collateral Ligament (ALL), Medial Collateral Ligament (MCL), Pes Anserius and Patellar Ligament. | Procedure or surgery | Control, Prolotherapy |
Primary outcome
change in knee pain with prolotherapy application
Time frame: 1 month
Visual Analog Scale (VAS) scores determines pain relief. VAS scale use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.
change in quality of life
Time frame: 1 month
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.SF-36 Scale scores determines change in quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared on demand. Sharing data identifying patients is forbidden in Türkiye.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Demirci, Professor study chair
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolotherapy in people with The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in knee pain with prolotherapy application (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.