Lateral Epicondylitis Clinical Trial
Official title:
Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?
NCT number | NCT04395417 |
Other study ID # | 2018/12 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | September 25, 2018 |
Verified date | May 2020 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 32 |
Est. completion date | September 25, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. aged 20-60 years, 2. had a clinical diagnosis of lateral epicondylitis, defined as pain over the lateral humeral epicondyle of at least 6 months' duration, 3. provoked by palpation and resisted wrist/middle finger extension or gripping, 4. participants needed to score at least 30/100 on Visual analogue scale (VAS), 5. be able to understand enough Turkish to complete the outcome questionnaire. Exclusion Criteria: 1. Any treatment for their elbow pain by a health care practitioner within the preceding 6 months, 2. Concomitant neck or other arm pain causing disability or requiring treatment within the last 6 months, 3. Clinical evidence of other primary sources of lateral elbow pain, 4. Upper limb fractures within the preceding 10 years, 5. Prior elbow surgery 6. Elbow steroid injection in the past 3 months 7. Systemic inflammatory disorder or malignancy, 8. Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
Turkey | Hakan Apaydin | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baseline, 6 week, 12 week | |
Primary | 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 |
Baseline, 6 week, 12 week | |
Secondary | 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. |
Baseline, 6 week, 12 week |
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