Lateral EpicondylitisNCT05066451

5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

A study testing %5 dextrose prolotherapy and %15 dextrose prolotherapy in people with Lateral Epicondylitis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

In the treatment of lateral epicondylitis, 5% dextrose prolotherapy is aimed to be more reliable than 15% prolotherapy in terms of side effects and to show that it is similar in terms of efficacy in treatment. Read more about this study

Who is it for?: Ages 20 to 60 years
Conditions the study is for: Lateral Epicondylitis
What is being tested?: %5 dextrose prolotherapy and %15 dextrose prolotherapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Feb 2021to 25 Feb 2022
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

Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint
tenderness on palpation over the lateral epicondyle
Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test),
> 20 years old , < 60 years old

Who cannot join

Patients who received physical therapy modalities and/or steroid injections in the last 3 months,
Having a history of malignancy,
Pregnant cases,
Those who have bone and joint diseases in the neck, shoulder and elbow,
Patients with infection in the treatment area,
Patients with arrhythmia or pacemaker in the heart,

Show all 12Show fewer

Patients receiving coagulation disorder or anticoagulant therapy,
Those with local dermatological problems,
Patients with a history of surgery in the elbow joint,
Having a tendon tear
Presence of nerve involvement
Lack of cooperation and refusal to participate in the study due to cognitive dysfunction

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

İstanbul physical medicine rehabilitation training &research hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Demonstration and Comparison of 5% Dextrose Prolotherapy and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

Read the detailed description

For this prospective randomized controlled study, volunteer patients who met the inclusion criteria and applied to the Health Sciences University, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic will be included in the study. Participants who volunteered for the study will be divided into study groups and control groups by stratified randomization. A total of 26 volunteers will be recruited.

A solution to be used for prolotherapy is containing 30% dextrose, 2% lidocaine, and physiological saline.

In the beginning, all patients were asked about gender, age, body mass index, education level, occupation, duration of complaint, dominant side and affected extremity, previous treatments, and when the last treatment was applied.

Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.

Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.

Patients in the control group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose, initially (0.) Week 3 and Week 6. The injection will be made with the same method as the study group.

Measurements; will be evaluated at baseline (week 0), immediately after treatment at Week 3, Week 6, and Week 12.

Patients; In the evaluation of the visual analog scale (VAS), quick Disabilities of the Arm, Shoulder and Hand (QDASH), Grip strength, hand dynamometer measurements, and adverse events during the study period will be noted.

Conditions: Lateral Epicondylitis
Being tested: %5 dextrose prolotherapy, %15 dextrose prolotherapy
Keywords: lateral epicondylitis, dextrose prolotherapy, pain, injection
Medical subject headings: Tennis Elbow, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

%5 dextrose prolotherapyOther
Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.
Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.
%15 dextrose prolotherapyOther
Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose at the beginning(0.) 3rd week and 6th week.
Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.

Study groups in NCT05066451
Study group	Role	What they receive
%5 dextrose prolotherapy	Experimental	A total of 3 sessions of prolotherapy solution containing 5% dextrose will be applied at the beginning, 3rd week, and the 6th week. Receives: Other: %5 dextrose prolotherapy
%15 dextrose prolotherapy	Active comparator	A total of 3 sessions of prolotherapy solution containing 15% dextrose will be applied at the beginning, 3rd week, and the 6th week. Receives: Other: %15 dextrose prolotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

The upper extremity disability level
The upper extremity disability level will be evaluated by using the Quick Disabilities of Arm, Shoulder and Hand (QDASH) scale. The maximum score is 100 points. A higher score indicates a worse disability level.
Measured: Change from baseline upper extremity disability level at 3, 6, and 12 weeks
Pain intensity
Pain intensity will be evaluated by using a visual analog scale (VAS). The maximum score is 10 points. A higher score indicates a worse pain level.
Measured: Change from baseline pain intensity at 3, 6, and 12 weeks

Secondary outcomes (1)

Hand grip strength
The standard evaluation tool (a hand dynamometer) will used for measuring grip and squeeze strength minimum value 0 and there is not maximum value, bigger values mean better outcome
Measured: Change from baseline hand grip strength at 3, 6, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202125 Feb 2022

First posted4 Oct 2021
Study start1 Feb 2021
Primary completion1 Feb 2022
Study completion25 Feb 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05066451
Sponsor's protocol ID: FTRTEZTASKIN
Status last verified: Feb 2022
First submitted: 20 Sep 2021
Last updated: 2 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fornalski S, Gupta R, Lee TQ. Anatomy and biomechanics of the elbow joint. Tech Hand Up Extrem Surg. 2003 Dec;7(4):168-78. doi: 10.1097/00130911-200312000-00008.
PubMed 16518218
Kahlenberg CA, Knesek M, Terry MA. New Developments in the Use of Biologics and Other Modalities in the Management of Lateral Epicondylitis. Biomed Res Int. 2015;2015:439309. doi: 10.1155/2015/439309. Epub 2015 May 31.
PubMed 26114106
Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013.
PubMed 20188998
Jensen KT, Rabago DP, Best TM, Patterson JJ, Vanderby R Jr. Early inflammatory response of knee ligaments to prolotherapy in a rat model. J Orthop Res. 2008 Jun;26(6):816-23. doi: 10.1002/jor.20600.
PubMed 18240327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

All Lateral Epicondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demonstration and Comparison of 5% Dextrose Prolotherapy and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis
ClinicalTrials.gov ID: NCT05066451
Acronym / sponsor ID: FTRTEZTASKIN
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis, dextrose prolotherapy, pain, injection
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
Study start: 1 Feb 2021 (actual)
Primary completion: 1 Feb 2022 (actual)
Study completion: 25 Feb 2022 (actual)
First posted: 4 Oct 2021 (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.

Detailed description

A solution to be used for prolotherapy is containing 30% dextrose, 2% lidocaine, and physiological saline.

Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.

Measurements; will be evaluated at baseline (week 0), immediately after treatment at Week 3, Week 6, and Week 12.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
%5 dextrose prolotherapy	Experimental	Other: %5 dextrose prolotherapyA total of 3 sessions of prolotherapy solution containing 5% dextrose will be applied at the beginning, 3rd week, and the 6th week.
%15 dextrose prolotherapy	Active comparator	Other: %15 dextrose prolotherapyA total of 3 sessions of prolotherapy solution containing 15% dextrose will be applied at the beginning, 3rd week, and the 6th week.

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint
tenderness on palpation over the lateral epicondyle
Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test),
> 20 years old , < 60 years old

Key exclusion criteria (12 listed)

Patients who received physical therapy modalities and/or steroid injections in the last 3 months,
Having a history of malignancy,
Pregnant cases,
Those who have bone and joint diseases in the neck, shoulder and elbow,
Patients with infection in the treatment area,

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
%5 dextrose prolotherapyPatients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.	Other	%5 dextrose prolotherapy
%15 dextrose prolotherapyPatients in the study group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.	Other	%15 dextrose prolotherapy

Primary outcome

The upper extremity disability level
Time frame: Change from baseline upper extremity disability level at 3, 6, and 12 weeks
The upper extremity disability level will be evaluated by using the Quick Disabilities of Arm, Shoulder and Hand (QDASH) scale. The maximum score is 100 points. A higher score indicates a worse disability level.
Pain intensity
Time frame: Change from baseline pain intensity at 3, 6, and 12 weeks
Pain intensity will be evaluated by using a visual analog scale (VAS). The maximum score is 10 points. A higher score indicates a worse pain level.

1 secondary outcome

Hand grip strength
Time frame: Change from baseline hand grip strength at 3, 6, and 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 2 Mar 2022.
Background: PubMed 16518218Fornalski S, Gupta R, Lee TQ. Anatomy and biomechanics of the elbow joint. Tech Hand Up Extrem Surg. 2003 Dec;7(4):168-78. doi: 10.1097/00130911-200312000-00008.
Background: PubMed 26114106Kahlenberg CA, Knesek M, Terry MA. New Developments in the Use of Biologics and Other Modalities in the Management of Lateral Epicondylitis. Biomed Res Int. 2015;2015:439309. doi: 10.1155/2015/439309. Epub 2015 May 31.
Background: PubMed 20188998Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013.
Background: PubMed 18240327Jensen KT, Rabago DP, Best TM, Patterson JJ, Vanderby R Jr. Early inflammatory response of knee ligaments to prolotherapy in a rat model. J Orthop Res. 2008 Jun;26(6):816-23. doi: 10.1002/jor.20600.
Individual participant dataSharing planned: No

Related trials for Lateral Epicondylitis

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

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.

Gokhan Taskin, MD principal investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospita

Fatma Nur Kesiktas, Prof study chair

Istanbul Physical Medicine Rehabilitation Training and Research Hospita

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 12 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 2 Mar 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.

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?

The upper extremity disability level (time frame: Change from baseline upper extremity disability level at 3, 6, and 12 weeks). 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 NCT05066451, 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 2 Mar 2022.