Evaluation of Deltoid Exercises on Injection Site Pain After (BNT162b2) COVID - 19 Vaccination

Evaluation of Deltoid Muscle Exercises on Injection Site and Arm Pain After Pfizer - BioNTech (BNT162b2) COVID - 19 Vaccination, A Randomized Controlled Study

Pfizer - BioNTech (BNT162b2) COVID - 19 vaccine is the first vaccine to be approved for emergency use by FDA. The most commonly reported side effect of the BNT162b2 vaccination is mild-to-moderate pain at injection site, i.e. deltoid muscle. Injection site pain may be observed during and after vaccine injection, and severity of pain may vary according to the type of vaccine, patients age, sex, level of anxiety, needle size, injection site and technique and patient positioning. Vaccination pain is one of the reasons of vaccine hesitancy and World Health Organization (WHO) recommended various measures to mitigate pain at the time of vaccination.

Exercise is one of the suggested methods to relieve the pain and anxiety in various conditions including vaccination site pain. However, we found no studies addressing injection site pain after the vaccination and pain associated with BNT162b2 vaccine. Aim of our study is to evaluate effectiveness of deltoid muscle exercises to relieve injection site pain observed after BNT162b2 vaccination.

Study Overview

• Status: Completed
• Conditions: Injection Site Reaction; Vaccines, Adverse Effects
• Intervention / Treatment: Behavioral: exercise

Detailed Description

The study was started at the designated COVID - 19 vaccination department of Bursa Yuksek Ihtisas research and training hospital Approvals was obtained from Republic of Turkey Ministry of Health and institutional review board and ethics committee and the study was conducted in concordance with Declaration of Helsinki.

Volunteers were selected among the healthy persons who admitted to our vaccination department to have BNT162b2 vaccine. Selection criteria were age being over 18, having no physical disability to perform the physical exercises given and willingness to participate in the study and sign an informed consent. People under the age of 18, patients with conditions that prevent them doing the exercises given and who did not want to participate in the study were excluded from the study.

Volunteers who accept to participate in the study, were randomized in to exercise vs. no-exercise groups according to a previously formed online randomization list. All volunteer's demographic data and vaccination status (first or second dose) were recorded. Both groups were asked to keep a five - day pain diary using numeric rating scale (NRS) and to also record any use of analgesics, any hospital admissions, any side effects other than injection site and arm pain and the time of cessation of pain.

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16000
    • BursaYuksek Ihtisas Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• vaccination with Bnt162b2
• having no physical disability to perform the physical exercises given
• willingness to participate in the study and sign the informed consent form

Exclusion Criteria:

• vaccination with vaccines other than Bnt162b2
• having physical disability to perform the physical exercises given
• not willing to participate in the study and sign the informed consent form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise; volunteers in this group do shoulder/arm exercises after vaccine injection and fill in the pain diary	Behavioral: exercise; volunteers in the exercise arm instructed to do three basic deltoid muscle exercises 3 times daily at least 20 repetitions for each exercise for five days. exercises were side lateral shoulder raises, front shoulder raises with hyperextension and mid range arm circles.
No Intervention: no-exercise; volunteers in this arm only completed the pain diary without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to no pain at injection site or arm	time frame between the time of vaccination and self reported time of being pain free	within 5 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
use of analgesics	self reported use of any analgesics	within 5 days after vaccination
hospital admission	self reported admission to hospital for reasons related to vaccination	within 5 days after vaccination
mean daily pain score	difference in mean daily pain score in numeric rating scale	within 5 days after vaccination

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Zulfi Engindeniz, MD, Bursa Yuksek Ihtisas Reseach and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: December 11, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: exercise; Pain Management; Injection Site Reaction; BNT162B2
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Extravasation of Diagnostic and Therapeutic Materials; Injection Site Reaction
• Other Study ID Numbers: 2021-KAEK-25 2021/08-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No