An interventional study of Z-track method and TPR method in Muscle Pain and Injection Site Pain, sponsored by Cumhuriyet University. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Cumhuriyet University · Not applicable, Interventional, and Prevention
This randomized, triple-blind clinical trial compares the effectiveness of Z-track and TPR (traction-pressure-release) techniques in reducing pain and medication leakage during ventrogluteal intramuscular injections. Pain is measured using VAS, and leakage is assessed with a millimeter scale. The study aims to identify a more efficient, less painful injection method.
Introduction: Intramuscular (IM) injections are widely used for delivering medications due to their high bioavailability and quick absorption. However, they can cause significant local complications, especially pain, which may affect patient compliance. Various non-pharmacological techniques have been developed to reduce injection pain, including the Z-track method and the more recent TPR (traction-pressure-release) technique, based on the gate control theory of pain. While both aim to minimize pain, TPR has shown promise but lacks research regarding its effect on drug leakage.
Objective: The study aims to compare the effectiveness of TPR and Z-track techniques in reducing pain and drug leakage during IM injections in the ventrogluteal site.
Method: This study is a triple-blind, randomized, two-group clinical trial with a parallel design. A total of 76 patients aged 16-40, prescribed with intramuscular diclofenac sodium, will be recruited. Each participant will receive both techniques-TPR and Z-track-in randomly assigned ventrogluteal muscles. Pain intensity will be measured using a Visual Analog Scale (VAS), and drug leakage will be assessed using millimetric paper and a ruler. All injections will be administered by the same nurse, and evaluation will be performed by blinded assessors.
Conclusion: This research seeks to provide evidence on the efficacy of the TPR technique as a potentially time- and cost-effective alternative to Z-track, particularly in minimizing injection-related pain and leakage, thereby improving patient comfort and treatment adherence.
256 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 76 is above the median of 44 across 216 interventional studies indexed under Myalgia.
Browse Myalgia studies →Cumhuriyet University is the lead sponsor of 133 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention Type: Intramuscular drug administration with TPR technique Intervention Name: Diclofenac Sodium TPR method, while the needle is inserted at a 90-degree angle, deep pressure will be applied to the muscle, then rapidly released to create a snapping motion that facilitates the injection. This technique relies on rapid muscle relaxation rather than needle movement by the dominant hand.
Other: TPR method
Intervention Type: Intramuscular drug administration with Z-track method Intervention Name: Diclofenac Sodium Z-track method, the skin will be pulled laterally by 2.5-3.5 cm before needle insertion at a 90-degree angle. After aspiration and injection, the needle will be withdrawn and the skin released immediately.
Other: Z-track method
Z-track method, the skin will be pulled laterally by 2.5-3.5 cm before needle insertion at a 90-degree angle. After aspiration and injection, the needle will be withdrawn and the skin released immediately.
TPR method, while the needle is inserted at a 90-degree angle, deep pressure will be applied to the muscle, then rapidly released to create a snapping motion that facilitates the injection. This technique relies on rapid muscle relaxation rather than needle movement by the dominant hand.
Pain with visual analog scale
Pain intensity measured with the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
Time frame: Within 5 minutes after intramuscular injection
Drug leakage
millimeter ruler to assess medication leakage
Time frame: Time Frame: Immediately after injection (within 1 minute)Description: Drug leakage will be observed immediately after intramuscular injection by checking the injection site for any visible medication leakage.
Plan to share: No — I would like to share the research after it is completed.
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Start is estimated for Jun 2025; primary completion for Aug 2025, 2 months later.
Of 101 non-industry interventional studies with no phase under Myalgia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's planned 2 months is below that.
Counting every sponsor, half of 111 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
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