Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age38+
SponsorNational and Kapodistrian University of Athens
About this trial
The aim of this study is to test whether the addition of dextrose to perineural injections is superior to local anesthetic alone, as some initial data have indicated. To enhance the potential therapeutic effect, we will proceed to a 4-point injection technique, targeting 4 genicular nerves (superomedial, superolateral, inferomedial, recurrent peroneal genicular nerve) in a randomized controlled trial with two arms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of both sexes
Age >38 years
Body Mass Index (BMI) up to 42 kg/m2
Chronic knee pain on the Numerical Rating Scale (NRS) > 5 for at least 3 months prior to the study
Disqualifiers
Any infection of the skin of the knee joint, such as cellulitis, or periarticular or intraarticular infection during the last 3 months
Poorly controlled diabetes mellitus or connective tissue disease affecting the knee joint
History of previous total knee arthroplasty or other knee surgery.
History of periarticular or intraarticular injection of corticosteroids, local anesthetic, hyaluronic acid, platelet-rich plasma, radiofrequency, prolotherapy within the last trimester
Trial design
Design model
Parallel
Treatments tested in this trial
Dextrose 5% and Lidocaine
DrugIn the Dextrose + Lidocaine group (group D+L) a perineural infusion of a total volume of 8 ml of DW 5% and lidocaine 1% will be performed at the 4 genicular nerves (2ml per nerve), which will be prepared as follows: 4 ml of lidocaine 2%, with 1.2 ml of DW 35% and 2.8 ml of NaCl 0.9%. All perineural injections will be executed under ultrasound guidance 3 times (in 3 consecutive sessions): at their first assessment, 2 and 4 weeks later.
Lidocaine
DrugIn the Lidocaine group (group L) the respective infusion of a solution of 8 ml of lidocaine 1% at the 4 genicular nerves (2ml per nerve) will be prepared as follows: 4 ml of lidocaine 2% with 4 ml of NaCl 0.9%. The perineural injections in each group will be executed 3 times (in 3 consecutive sessions): at their first assessment, 2 and 4 weeks later.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Dextrose + Lidocaine group (group D+L)Active comparator 1 intervention
Group B: Lidocaine group (group L)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Severity Score (PSS) at 15 days after the 3rd (last) infiltration
The primary outcome will be estimated by the Brief Pain Inventory (BPI) score, a numerical scale used to assess pain. This score is the arithmetic average of four items related to pain intensity: worst pain, least pain, average pain, and current pain (SCORE RANGE: 0= No pain, 1-3= Mild pain, 4-6= Moderate pain, 7-10= Severe pain).
Time frame
15 days after the 3rd infiltration of the first participant up to 15 days after the 3rd infiltration of the last participantSecondary outcomes
1
Pain Severity Score (PSS) at baseline, 30 and 90 days after the 3rd infiltration
It will be estimated by the Brief Pain Inventory (BPI) score. This score is the arithmetic average of four items related to pain intensity: worst pain, least pain, average pain, and current pain (SCORE RANGE: 0= No pain, 1-3= Mild pain, 4-6= Moderate pain, 7-10= Severe pain).
Time frame
A measurement before the first infiltration of the first participant up to 90 days after the 3rd infiltration of the last participant.2
Pain Interference Score (PIS)
Pain Interference Score from the relevant items of the Brief Pain Inventory (BPI) Score at baseline, 15, 30 and 90 days after the last infiltration. This score is the arithmetic average of seven items that assess how pain interferes with daily functions: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life (SCORE RANGE: 0= No interference, 1-3= Mild interference, 4-6= Moderate interference, 7-10= Severe interference).
Time frame
From before the first infiltration of the first participant up to 3 months after the last infiltration of the last participant.3
Short-term changes 24h after the first infiltration
Pain intensity at the affected knee during movement will be assessed, according to Numerical Rating Scale (NRS), where patients assign a number from 0 to 10 to describe their pain level, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable". Furthermore, the duration of the analgesia provided by the perineural injection will be recorded, along with the patient's level of optimism regarding the treatment's effectiveness and its impact on improving daily life.
Time frame
24 hours after the first infiltration of the first participant up to 24 hours after the first infiltration of the last participant.4
WOMAC Questionnaire
Patients physical function will be evaluated by WOMAC questionnaire, which is divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The 24-item questionnaire uses a 0-4 scale (None to Extreme), where scores are summed for each subscale (Pain 0-20, Stiffness 0-8, Function 0-68). Higher WOMAC scores indicate worse symptoms and greater functional limitations. Measurement will be made at: baseline, 15, 30 and 90 days after completion of the therapy. Further subitems of WOMAC questionnaire might also be evaluated.
Time frame
Baseline, 15, 30 and 90 days after completion of the therapy of the first participant until 90 days after completion of therapy of the last participant.Other outcomes
1
Subanalyses of the scales used
Subanalyses of questions, eg. usage of analgesics
Time frame
Baseline, 15, 30 and 90 days after completion of the therapy of the first participant until 90 days after completion of therapy of the last participantSponsors and contacts
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Source ClinicalTrials.gov