Lateral EpicondylitisPhase 4NCT04680936
Low and High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis
A Phase 4 study testing Dextrose 5% in water, Dextrose 15 % in Water and Isotonic sodium chloride solution in people with Lateral Epicondylitis, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis (tennis elbow) is an enthesopathy seen in 1-2% of the population aged 30-65 years, which can occur in the lateral epicondyle origo of the extensor carpi radialis brevis and longus muscles, after frequently repetitive activities and can lead to limitations in the daily life activities of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Dextrose 5% in water, Dextrose 15 % in Water and Isotonic sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 21 May 2022
- Phase
- Phase 4
- 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
- Those who admit Kirsehir Ahi Evran University Hospital and is diagnosed with lateral epicondylitis,
- Participants with unilateral or bilateral lateral epicondylitis and pain and functional limitations due to this condition,
- who can read and write in Turkish,
- participant's admission participating in the study,
- participants who do not have exclusion criteria,
Who cannot join
- receiving any injection therapy to the elbow area in the last 3 months,
- participants with complaints less than 3 months(acute lateral epicondylitis)
- previously surgery on the elbow area,
- having a history of acute trauma or fracture in the elbow area,
- have local dermatological problems,
- have a local infection in the treatment area,
Show all 19Show fewer
- those who are allergic to dextrose,
- with coagulation disorders or using anticoagulant drugs,
- with an autoimmune disease,
- with type 1 or type 2 diabetes mellitus,
- have unregulated hypertension,
- have immune dysfunction,
- with malignancy or diagnosed with a malignancy in the last 5 years,
- pregnancy or lactation,
- having cervical radiculopathy in the same extremity,
- with cognitive dysfunction,
- patients with paralysis in the same extremity,
- lack of cooperation due to cognitive impairment,
- participant's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirsehir Ahi Evran University Hospital
Kırşehir
About this study
Official title: Is Low Dose Dextrose Prolotherapy as Effective as High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis?- A Double Blind- Ultrasound Guided- Randomized Controlled Study
Lateral epicondylitis (tennis elbow) is an enthesopathy seen in 1-2% of the population aged 30-65 years, which can occur in the lateral epicondyle origo of the extensor carpi radialis brevis and longus muscles, after frequently repetitive activities and can lead to limitations in the daily life activities of the patients. The diagnosis is made by anamnesis and clinical examination, cases that last more than 3 months are defined as chronic lateral epicondylitis. Treatment options are analgesics, non-steroidal anti-inflammatory drugs, hand-wrist splints, eccentric strengthening exercises for forearm muscles and wrist dorsiflexors, injection therapies, physical therapy agents such as therapeutic ultrasound, ESWT(extracorporeal shockwave therapy), low-level laser therapy, and surgery. Prolotherapy is a treatment method that is performed with repetitive injections of a small amount of irritant or sclerosing solutions such as hypertonic dextrose, phenol-glycerin-glucose, or sodium morrhuate and aims to activate the healing process by increasing the blood flow around the damaged tendinopathy or enthesopathy area with the effect of these solutions. Hypertonic dextrose solutions in concentrations ranging from 12.5-20% are frequently used in prolotherapy. Prolotherapy can be done with ultrasound guidance or by determining anatomical landmarks. The injection is applied to the annular ligament, lateral epicondyle, and supracondylar area where the forearm extensor muscles adhere. Injection side effects and complications are pain, bruising, muscle spasm, nerve or vessel damage at the injection site. Based on previous studies, the low dose of dextrose solutions (1%, 5%, and 10%) may have a similar effect with fewer side effects than higher concentrations of dextrose solutions (15%, 20%, 25%) and the low dose may have fewer cell damage. Thus, it may be possible to apply an effective treatment method with fewer side effects in the treatment of lateral epicondylitis. Also, in this study, the effect of inflammation created by injection of saline in one group and the inflammatory, proliferative and angiogenic effects of dextrose injected in other groups at different concentrations on the treatment outcome will be compared.
Read the detailed description
Lateral epicondylitis (tennis elbow) is an enthesopathy seen in 1-2% of the population aged 30-65 years, which can occur in the lateral epicondyle origo of the extensor carpi radialis brevis and longus muscles, after frequently repetitive activities and can lead to limitations in the daily life activities of the patients.
The diagnosis is made by anamnesis and clinical examination, cases that last more than 3 months are defined as chronic lateral epicondylitis.
Treatment options are analgesics, non-steroidal anti-inflammatory drugs, hand-wrist splints, eccentric strengthening exercises for forearm muscles and wrist dorsiflexors, injection therapies, physical therapy agents such as therapeutic ultrasound, ESWT(extracorporeal shockwave therapy), low-level laser therapy, and surgery.
Prolotherapy is a treatment method that is performed with repetitive injections of a small amount of irritant or sclerosing solutions such as hypertonic dextrose, phenol-glycerin-glucose, or sodium morrhuate and aims to activate the healing process by increasing the blood flow around the damaged tendinopathy or enthesopathy area with the effect of these solutions. Hypertonic dextrose solutions in concentrations ranging from 12.5-20% are frequently used in prolotherapy.
Dextrose is an ideal proliferant agent due to its ability to dissolve in water, exists in the blood chemically, and to led safely apply to more than one place. It is known that hypertonic dextrose solutions dehydrate the cells in the injection area, cause local tissue trauma, attracts granulocytes and macrophages to the damaged area, and triggers healing. Prolotherapy can be done with ultrasound guidance or by determining anatomical landmarks. The injection is applied to the annular ligament, lateral epicondyle, and supracondylar area where the forearm extensor muscles adhere. Injection side effects and complications are pain, bruising, muscle spasm, nerve or vessel damage at the injection site.
Based on previous studies, the low dose of dextrose solutions (1%, 5%, and 10%) may have a similar effect with fewer side effects than higher concentrations of dextrose solutions (15%, 20%, 25%) and the low dose may have fewer cell damage. Thus, it may be possible to apply an effective treatment method with fewer side effects in the treatment of lateral epicondylitis. Also, in this study, the effect of inflammation created by injection of saline in one group and the inflammatory, proliferative and angiogenic effects of dextrose injected in other groups at different concentrations on the treatment outcome will be compared.
- Conditions
- Lateral Epicondylitis
- Being tested
- Dextrose 5% in water, Dextrose 15 % in Water, Isotonic sodium chloride solution
- Keywords
- prolotherapy, dextrose prolotherapy, tennis elbow, chronic lateral epicondylitis, dextrose therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 5% in waterDrug
Also called 5% dextrose solution
low dose dextrose solution
Dextrose 15 % in WaterDrug
Also called 15%dextrose solution
high dose dextrose solution
Isotonic sodium chloride solutionDrug
Also called 0.9% NaCl solution
isotonic saline solution
| Study group | Role | What they receive |
|---|---|---|
| low dose dextrose arm (5% dextrose) | Active comparator | Prolotherapy injection will be made with 5% dextrose solution for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded. Receives: Drug: Dextrose 5% in water |
| high dose dextrose arm (15% dextrose) | Active comparator | Prolotherapy injection will be made with 15% dextrose solution for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded. Receives: Drug: Dextrose 15 % in Water |
| Isotonic saline arm (0.9% NaCl) | Active comparator | Prolotherapy injection will be made with isotonic saline for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded. Receives: Drug: Isotonic sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of prolotherapy injection on hand grip strength.
Evaluation of the effect of prolotherapy injection on hand grip strength Hand grip strength will be measured with Hand-Dynamometer, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Measured: Change of the hand grip strength at baseline, 3 weeks and after the injection treatment (12th week).
Evaluation of elbow pain that develops at rest and movement before, during and after injection treatment.
Elbow pain at rest and movement will be assessed by Visual Analogue Scale, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Measured: Change in elbow pain at baseline, 3 weeks and after the injection treatment (12th week).
Evaluation of elbow pain threshold, before, during and after injection treatment.
Elbow pain threshold will be assessed by Pain Algometer, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Measured: Change in elbow pain threshold at baseline, 3 weeks and after the injection treatment (12th week).
Assessment of the effect of elbow pain on daily life activities.
Daily life activities will be measured with Quick-DASH(Disabilities of Arm, Shoulder and Hand) Questionnaire, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Measured: Change of the effect of elbow pain on daily life activities at baseline, 3 weeks and after the injection treatment (12th week).
Secondary outcomes (2)
Evaluation of the clinical improvement.
Clinical improvement of the patients will be evaluated subjectively with the Global Disease Assessment Questionnaire, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Measured: week 3 and 12
Evaluation of the injection side effects and complications.
Side effects and complications that may occur after injection treatments will be evaluated and compared between groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jan 2021
- Primary completion1 May 2022
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YILDIZ GONCA DOGRU, Ahi Evran University Education and Research Hospital
- Investigators
- FIGEN TUNCAY, PROF.,M.D., Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680936
- Sponsor's protocol ID
- 14
- Status last verified
- May 2022
- First submitted
- 13 Dec 2020
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
PubMed 27429562Tsai SW, Hsu YJ, Lee MC, Huang HE, Huang CC, Tung YT. Effects of dextrose prolotherapy on contusion-induced muscle injuries in mice. Int J Med Sci. 2018 Jul 30;15(11):1251-1259. doi: 10.7150/ijms.24170. eCollection 2018.
PubMed 30123064Sims SE, Miller K, Elfar JC, Hammert WC. Non-surgical treatment of lateral epicondylitis: a systematic review of randomized controlled trials. Hand (N Y). 2014 Dec;9(4):419-46. doi: 10.1007/s11552-014-9642-x.
PubMed 25414603Ciftci YGD, Tuncay F, Kocak FA, Okcu M. Is Low-Dose Dextrose Prolotherapy as Effective as High-Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis? A Double-Blind, Ultrasound Guided, Randomized Controlled Study. Arch Phys Med Rehabil. 2023 Feb;104(2):179-187. doi: 10.1016/j.apmr.2022.09.017. Epub 2022 Oct 13.
PubMed 36243123
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Low Dose Dextrose Prolotherapy as Effective as High Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis?- A Double Blind- Ultrasound Guided- Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04680936
- Acronym / sponsor ID
- 14
- Conditions
- Lateral Epicondylitis
- Keywords
- prolotherapy, dextrose prolotherapy, tennis elbow, chronic lateral epicondylitis, dextrose therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 23 Dec 2020 (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.
Lateral epicondylitis (tennis elbow) is an enthesopathy seen in 1-2% of the population aged 30-65 years, which can occur in the lateral epicondyle origo of the extensor carpi radialis brevis and longus muscles, after frequently repetitive activities and can lead to limitations in the daily life activities of the patients. The diagnosis is made by anamnesis and clinical examination, cases that last more than 3 months are defined as chronic lateral epicondylitis. Treatment options are analgesics, non-steroidal anti-inflammatory drugs, hand-wrist splints, eccentric strengthening exercises for forearm muscles and wrist dorsiflexors, injection therapies, physical therapy agents such as therapeutic ultrasound, ESWT(extracorporeal shockwave therapy), low-level laser therapy, and surgery. Prolotherapy is a treatment method that is performed with repetitive injections of a small amount of irritant or sclerosing solutions such as hypertonic dextrose, phenol-glycerin-glucose, or sodium morrhuate and aims to activate the healing process by increasing the blood flow around the damaged tendinopathy or enthesopathy area with the effect of these solutions. Hypertonic dextrose solutions in concentrations ranging from 12.5-20% are frequently used in prolotherapy. Prolotherapy can be done with ultrasound guidance or by determining anatomical landmarks. The injection is applied to the annular ligament, lateral epicondyle, and supracondylar area where the forearm extensor muscles adhere. Injection side effects and complications are pain, bruising, muscle spasm, nerve or vessel damage at the injection site. Based on previous studies, the low dose of dextrose solutions (1%, 5%, and 10%) may have a similar effect with fewer side effects than higher concentrations of dextrose solutions (15%, 20%, 25%) and the low dose may have fewer cell damage. Thus, it may be possible to apply an effective treatment method with fewer side effects in the treatment of lateral epicondylitis. Also, in this study, the effect of inflammation created by injection of saline in one group and the inflammatory, proliferative and angiogenic effects of dextrose injected in other groups at different concentrations on the treatment outcome will be compared.
Detailed description
Lateral epicondylitis (tennis elbow) is an enthesopathy seen in 1-2% of the population aged 30-65 years, which can occur in the lateral epicondyle origo of the extensor carpi radialis brevis and longus muscles, after frequently repetitive activities and can lead to limitations in the daily life activities of the patients.
The diagnosis is made by anamnesis and clinical examination, cases that last more than 3 months are defined as chronic lateral epicondylitis.
Treatment options are analgesics, non-steroidal anti-inflammatory drugs, hand-wrist splints, eccentric strengthening exercises for forearm muscles and wrist dorsiflexors, injection therapies, physical therapy agents such as therapeutic ultrasound, ESWT(extracorporeal shockwave therapy), low-level laser therapy, and surgery.
Prolotherapy is a treatment method that is performed with repetitive injections of a small amount of irritant or sclerosing solutions such as hypertonic dextrose, phenol-glycerin-glucose, or sodium morrhuate and aims to activate the healing process by increasing the blood flow around the damaged tendinopathy or enthesopathy area with the effect of these solutions. Hypertonic dextrose solutions in concentrations ranging from 12.5-20% are frequently used in prolotherapy.
Dextrose is an ideal proliferant agent due to its ability to dissolve in water, exists in the blood chemically, and to led safely apply to more than one place. It is known that hypertonic dextrose solutions dehydrate the cells in the injection area, cause local tissue trauma, attracts granulocytes and macrophages to the damaged area, and triggers healing. Prolotherapy can be done with ultrasound guidance or by determining anatomical landmarks. The injection is applied to the annular ligament, lateral epicondyle, and supracondylar area where the forearm extensor muscles adhere. Injection side effects and complications are pain, bruising, muscle spasm, nerve or vessel damage at the injection site.
Based on previous studies, the low dose of dextrose solutions (1%, 5%, and 10%) may have a similar effect with fewer side effects than higher concentrations of dextrose solutions (15%, 20%, 25%) and the low dose may have fewer cell damage. Thus, it may be possible to apply an effective treatment method with fewer side effects in the treatment of lateral epicondylitis. Also, in this study, the effect of inflammation created by injection of saline in one group and the inflammatory, proliferative and angiogenic effects of dextrose injected in other groups at different concentrations on the treatment outcome will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose dextrose arm (5% dextrose) | Active comparator | Drug: Dextrose 5% in waterProlotherapy injection will be made with 5% dextrose solution for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded. |
| high dose dextrose arm (15% dextrose) | Active comparator | Drug: Dextrose 15 % in WaterProlotherapy injection will be made with 15% dextrose solution for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded. |
| Isotonic saline arm (0.9% NaCl) | Active comparator | Drug: Isotonic sodium chloride solutionProlotherapy injection will be made with isotonic saline for 3 sessions with 3 weeks intervals. 1ml solution will be given with 27 Gauge 1/2 inch needles in the sessions. Before the treatment, the examination and questionnaire data of the patient will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Those who admit Kirsehir Ahi Evran University Hospital and is diagnosed with lateral epicondylitis,
- Participants with unilateral or bilateral lateral epicondylitis and pain and functional limitations due to this condition,
- who can read and write in Turkish,
- participant's admission participating in the study,
- participants who do not have exclusion criteria,
Key exclusion criteria (19 listed)
- receiving any injection therapy to the elbow area in the last 3 months,
- participants with complaints less than 3 months(acute lateral epicondylitis)
- previously surgery on the elbow area,
- having a history of acute trauma or fracture in the elbow area,
- have local dermatological problems,
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 |
|---|---|---|
| Dextrose 5% in waterAlso: 5% dextrose solutionlow dose dextrose solution | Drug | low dose dextrose arm (5% dextrose) |
| Dextrose 15 % in WaterAlso: 15%dextrose solutionhigh dose dextrose solution | Drug | high dose dextrose arm (15% dextrose) |
| Isotonic sodium chloride solutionAlso: 0.9% NaCl solutionisotonic saline solution | Drug | Isotonic saline arm (0.9% NaCl) |
Primary outcome
Evaluation of the effect of prolotherapy injection on hand grip strength.
Time frame: Change of the hand grip strength at baseline, 3 weeks and after the injection treatment (12th week).
Evaluation of the effect of prolotherapy injection on hand grip strength Hand grip strength will be measured with Hand-Dynamometer, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Evaluation of elbow pain that develops at rest and movement before, during and after injection treatment.
Time frame: Change in elbow pain at baseline, 3 weeks and after the injection treatment (12th week).
Elbow pain at rest and movement will be assessed by Visual Analogue Scale, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Evaluation of elbow pain threshold, before, during and after injection treatment.
Time frame: Change in elbow pain threshold at baseline, 3 weeks and after the injection treatment (12th week).
Elbow pain threshold will be assessed by Pain Algometer, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
Assessment of the effect of elbow pain on daily life activities.
Time frame: Change of the effect of elbow pain on daily life activities at baseline, 3 weeks and after the injection treatment (12th week).
Daily life activities will be measured with Quick-DASH(Disabilities of Arm, Shoulder and Hand) Questionnaire, before injection treatment (pre-intervention), at the 3rd week (2nd session of treatment) and after the injection treatment (12th week).
2 secondary outcomes
Evaluation of the clinical improvement.
Time frame: week 3 and 12
Evaluation of the injection side effects and complications.
Time frame: 12 weeks
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 26 May 2022.
- Background: PubMed 27429562Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
- Background: PubMed 30123064Tsai SW, Hsu YJ, Lee MC, Huang HE, Huang CC, Tung YT. Effects of dextrose prolotherapy on contusion-induced muscle injuries in mice. Int J Med Sci. 2018 Jul 30;15(11):1251-1259. doi: 10.7150/ijms.24170. eCollection 2018.
- Background: PubMed 25414603Sims SE, Miller K, Elfar JC, Hammert WC. Non-surgical treatment of lateral epicondylitis: a systematic review of randomized controlled trials. Hand (N Y). 2014 Dec;9(4):419-46. doi: 10.1007/s11552-014-9642-x.
- Derived from this study: PubMed 36243123Ciftci YGD, Tuncay F, Kocak FA, Okcu M. Is Low-Dose Dextrose Prolotherapy as Effective as High-Dose Dextrose Prolotherapy in the Treatment of Lateral Epicondylitis? A Double-Blind, Ultrasound Guided, Randomized Controlled Study. Arch Phys Med Rehabil. 2023 Feb;104(2):179-187. doi: 10.1016/j.apmr.2022.09.017. Epub 2022 Oct 13.
- Individual participant dataSharing planned: No
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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.
FIGEN TUNCAY, PROF.,M.D. principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextrose 5% in water, Dextrose 15 % in Water and Isotonic sodium chloride solution in people with Lateral Epicondylitis, run by Ahi Evran University Education 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 5 inclusion and 19 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 26 May 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of the effect of prolotherapy injection on hand grip strength. (time frame: Change of the hand grip strength at baseline, 3 weeks and after the injection treatment (12th week).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680936, which also lists 4 linked publications.
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 26 May 2022.