Lateral EpicondylitisNCT04395417
Injection Therapy in Patients With Lateral Epicondylitis
A study testing Hyaluronic Acid and Prolotherapy in people with Lateral Epicondylitis and Tennis Elbow, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis is a painful enthesopathy of the common extensor tendon at the lateral part of the elbow, with a prevalence of 1-3 % in the general population. In the treatment of lateral epicondylitis, the role of biological-based therapies has begun to investigate regeneration and optimize tendon healing. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Hyaluronic Acid and Prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2018to 25 Sep 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 20-60 years,
- had a clinical diagnosis of lateral epicondylitis, defined as pain over the lateral humeral epicondyle of at least 6 months' duration,
- provoked by palpation and resisted wrist/middle finger extension or gripping,
- participants needed to score at least 30/100 on Visual analogue scale (VAS),
- be able to understand enough Turkish to complete the outcome questionnaire.
Who cannot join
- Any treatment for their elbow pain by a health care practitioner within the preceding 6 months,
- Concomitant neck or other arm pain causing disability or requiring treatment within the last 6 months,
- Clinical evidence of other primary sources of lateral elbow pain,
- Upper limb fractures within the preceding 10 years,
- Prior elbow surgery
- Elbow steroid injection in the past 3 months
- Systemic inflammatory disorder or malignancy,
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?
Lateral epicondylitis is a painful enthesopathy of the common extensor tendon at the lateral part of the elbow, with a prevalence of 1-3 % in the general population. In the treatment of lateral epicondylitis, the role of biological-based therapies has begun to investigate regeneration and optimize tendon healing. Prolotherapy (PrT) and hyaluronic acid (HA) injections are biological based treatments. Previous studies have shown benefit of PrT in the treatment of tendinopathies. Preliminary findings demonstrated that HA could be clinically effective in the treatment of enthesopathies. Considering the paucity of HA studies (which also lack a control group) and the proposed mechanism of action of both PrT and HA is through cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .
Read the detailed description
Lateral epicondylitis and other chronic tendinopathies are now understood to be non-inflammatory conditions characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration and neovascularization Biological-based treatments can trigger the release of cytokines and growth factors from platelets, leukocytes, macrophages and other inflammatory cells. These growth factors support neovascularization and the chemotaxis of fibroblasts and tenocytes. It stimulates proliferation and collagen remodeling of fibroblasts and tenocytes.
PrT involves multiple injections of a small amount of irritant or sclerosing solution. Common irritants include hypertonic dextrose, phenol-glycerin-glucose and sodium morrhuate. PrT injection mechanism is as follows; while hypertonic dextrose causes cell rupture through osmosis, monosodium morrhuate attracts inflammatory mediators and improves blood flow of the diseased tendon.Previous studies have shown benefit of PrT in the treatment of tendinopathies HA injection is a treatment method that increases the ability of sliding with its viscoelastic properties, reduces tendon surface friction and accelerates regeneration. In vitro models suggest that HA can increase collagen I production and accumulation with a dose-dependent positive collagen I / collagen III ratio. However, controlled randomised studies are still needed.
Mechanism of action of both PrT and HA is cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Hyaluronic Acid, Prolotherapy
- Keywords
- Lateral epicondylitis, Prolotherapy, Hyaluronic acid
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Also called Prostrolane
Patients were infiltrated with injection single dose 30 mg/2 ml 1500 kilodalton high molecular weight hyaluronic acid at the lateral epicondyle according to the standard technique.
ProlotherapyBiological
Patients were infiltrated with 5cc of dextrose 15% at the lateral epicondyle according to the standard technique. For solution, 1 cc 2% lidocaine, 5 cc 30% hypertonic dextrose and 4 cc 0.9 % isotonic were used.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid injection group | Experimental | This is the study group in whom Hyaluronic acid injection was injected at lateral epicondylitis site. Receives: Drug: Hyaluronic Acid |
| Prolotherapy injection group | Active comparator | This is the control group in whom prolotherapy injection was given at lateral epicondyle site. Receives: Biological: Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain via Visual Analogue Scale
Change from baseline at 6 week and at 12 week
Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 6 and 12 weeks of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
Measured: Baseline, 6 week, 12 week
Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Change from baseline at 6 week and at 12 week
The elbow disability scale was assessed using the Quick DASH (disability of arm, shoulder \& hand) questionnaire containing 11 questions with five choices for each question. The final score can range between 0 (best condition) and 100 (worst condition). Participant is asked to answer the Quick DASH at baseline, 6 and 12 weeks of follow-ups
Measured: Baseline, 6 week, 12 week
Secondary outcomes (1)
Grip strength via dynamometer
Change from baseline at 6 week and at 12 week
Pain-free grip strength is a commonly used objective measure of lateral epicondilitis-related disability with high reliability and validity. In the study, we used a hand dynamometer (Baseline® Hydraulic Hand Dynamometer 200 LB Standard). Patients were asked to sit, adduct the shoulder, flex the elbow to 90 degrees and put their forearm in a neutral position, then squeeze the dynamometer for three to five seconds. This test was conducted three times with 60-second intervals for each patient, and the mean patient grip strength was recorded at baseline, 6 and 12 weeks of follow-ups.
Measured: Baseline, 6 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start2 May 2018
- Primary completion15 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilan Bazancir Apaydın, Hacettepe University
- Investigators
- Zuhal Altay, MD, Study director, Inonu University Faculy of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395417
- Sponsor's protocol ID
- 2018/12
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Publications
Apaydin H, Bazancir Z, Altay Z. Injection Therapy in Patients with Lateral Epicondylalgia: Hyaluronic Acid or Dextrose Prolotherapy? A Single-Blind, Randomized Clinical Trial. J Altern Complement Med. 2020 Dec;26(12):1169-1175. doi: 10.1089/acm.2020.0188. Epub 2020 Sep 15.
PubMed 32931308
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?
- ClinicalTrials.gov ID
- NCT04395417
- Acronym / sponsor ID
- 2018/12
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- Lateral epicondylitis, Prolotherapy, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 20 May 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 is a painful enthesopathy of the common extensor tendon at the lateral part of the elbow, with a prevalence of 1-3 % in the general population. In the treatment of lateral epicondylitis, the role of biological-based therapies has begun to investigate regeneration and optimize tendon healing. Prolotherapy (PrT) and hyaluronic acid (HA) injections are biological based treatments. Previous studies have shown benefit of PrT in the treatment of tendinopathies. Preliminary findings demonstrated that HA could be clinically effective in the treatment of enthesopathies. Considering the paucity of HA studies (which also lack a control group) and the proposed mechanism of action of both PrT and HA is through cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .
Detailed description
Lateral epicondylitis and other chronic tendinopathies are now understood to be non-inflammatory conditions characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration and neovascularization Biological-based treatments can trigger the release of cytokines and growth factors from platelets, leukocytes, macrophages and other inflammatory cells. These growth factors support neovascularization and the chemotaxis of fibroblasts and tenocytes. It stimulates proliferation and collagen remodeling of fibroblasts and tenocytes.
PrT involves multiple injections of a small amount of irritant or sclerosing solution. Common irritants include hypertonic dextrose, phenol-glycerin-glucose and sodium morrhuate. PrT injection mechanism is as follows; while hypertonic dextrose causes cell rupture through osmosis, monosodium morrhuate attracts inflammatory mediators and improves blood flow of the diseased tendon.Previous studies have shown benefit of PrT in the treatment of tendinopathies HA injection is a treatment method that increases the ability of sliding with its viscoelastic properties, reduces tendon surface friction and accelerates regeneration. In vitro models suggest that HA can increase collagen I production and accumulation with a dose-dependent positive collagen I / collagen III ratio. However, controlled randomised studies are still needed.
Mechanism of action of both PrT and HA is cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid injection group | Experimental | Drug: Hyaluronic AcidThis is the study group in whom Hyaluronic acid injection was injected at lateral epicondylitis site. |
| Prolotherapy injection group | Active comparator | Biological: ProlotherapyThis is the control group in whom prolotherapy injection was given at lateral epicondyle site. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 20-60 years,
- had a clinical diagnosis of lateral epicondylitis, defined as pain over the lateral humeral epicondyle of at least 6 months' duration,
- provoked by palpation and resisted wrist/middle finger extension or gripping,
- participants needed to score at least 30/100 on Visual analogue scale (VAS),
- be able to understand enough Turkish to complete the outcome questionnaire.
Key exclusion criteria (8 listed)
- Any treatment for their elbow pain by a health care practitioner within the preceding 6 months,
- Concomitant neck or other arm pain causing disability or requiring treatment within the last 6 months,
- Clinical evidence of other primary sources of lateral elbow pain,
- Upper limb fractures within the preceding 10 years,
- Prior elbow surgery
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 |
|---|---|---|
| Hyaluronic AcidAlso: ProstrolanePatients were infiltrated with injection single dose 30 mg/2 ml 1500 kilodalton high molecular weight hyaluronic acid at the lateral epicondyle according to the standard technique. | Drug | Hyaluronic acid injection group |
| ProlotherapyPatients were infiltrated with 5cc of dextrose 15% at the lateral epicondyle according to the standard technique. For solution, 1 cc 2% lidocaine, 5 cc 30% hypertonic dextrose and 4 cc 0.9 % isotonic were used. | Biological | Prolotherapy injection group |
Primary outcome
Pain via Visual Analogue Scale
Time frame: Baseline, 6 week, 12 week
Change from baseline at 6 week and at 12 week Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 6 and 12 weeks of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: Baseline, 6 week, 12 week
Change from baseline at 6 week and at 12 week The elbow disability scale was assessed using the Quick DASH (disability of arm, shoulder \& hand) questionnaire containing 11 questions with five choices for each question. The final score can range between 0 (best condition) and 100 (worst condition). Participant is asked to answer the Quick DASH at baseline, 6 and 12 weeks of follow-ups
1 secondary outcome
Grip strength via dynamometer
Time frame: Baseline, 6 week, 12 week
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 20 May 2020.
- Derived from this study: PubMed 32931308Apaydin H, Bazancir Z, Altay Z. Injection Therapy in Patients with Lateral Epicondylalgia: Hyaluronic Acid or Dextrose Prolotherapy? A Single-Blind, Randomized Clinical Trial. J Altern Complement Med. 2020 Dec;26(12):1169-1175. doi: 10.1089/acm.2020.0188. Epub 2020 Sep 15.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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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.
Zuhal Altay, MD study director
Inonu University Faculy of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid and Prolotherapy in people with Lateral Epicondylitis and Tennis Elbow, run by Hacettepe University 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 8 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 20 May 2020. 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?
Pain via Visual Analogue Scale (time frame: Baseline, 6 week, 12 week). 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?
On the ClinicalTrials.gov record for NCT04395417, which also lists 1 linked publication.
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 20 May 2020.