NCT05581667

Brief Summary

Aim: The aim of this study is to investigate the immediate effects of Post Isometric Relaxation (PIR) Technique on pain threshold, pain severity and joint range of motion of the cervical region in healthcare workers with neck pain. Method: A total of 30 male and female participants aged 20-45 were randomly divided into two groups (Post Isometric Relaxation (PIR) Technique and Control Group). PIR group participants were under a single session of PIR application with 10 repetitions to m.supraspinatus, the upper part of the m.trapeze and m.levator scapula in addition to classical Swedish massage for neck and upper thoraric region. Control group participants received only classical Swedish massage to the cervical and upper thoracic region. Pain severity (Visual Analog Scale), Pain threshold (digital algometer), range of servical motion (goniometer) were measured at baseline and immediately after the single-session PIR Techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

October 12, 2022

Last Update Submit

December 27, 2023

Conditions

Keywords

neck painPost isometric relaxationhospital employeespain threshold

Outcome Measures

Primary Outcomes (3)

  • Pain threshold assessment

    Digital algometer (JTECH Commander ™ Algometer with 0.5 cm2 tip) device was used. After training by showing the measuring instrument to the participants, pressure will be applied to a place outside the assessment area to introduce the feeling of pressure. He will be told to give a "stop" command as soon as the pain is first felt. This process will be applied 3 times to ensure that the participants adapt to the pressure to be applied during the evaluation. Before and immediately after the applications, all participants felt the pain for the first time with a speed of 10 N/s over the sensitive points of the m.trapezius pars descendes, m.levator Scapula, m.Rrhomboideus Major, M.Sternocleidomasteideus, suboccipital region, M. Infraspinatus, M. Multifidius muscles. will be increased so far. The measurement was terminated with the "Stop" command and a total of 3 measurements will be made and the average value seen on the screen will be recorded.

    30 min

  • Pain severity assessment

    After explaining that '0 is no pain, 10 is the most severe pain', all participants will be asked to mark the intensity of pain they feel on the 10 cm horizontal Visual Analog Scale (VAS) before and immediately after the application.

    30 min

  • Joint Range of Motion

    In order to evaluate the range of motion of the cervical vertebrae, measurements will be made before and immediately after the applications using a universal goniometer and according to Kendall-Mc Creary criteria. The fixed arm, pivot point and movable arm of the goniometer will be placed in certain reference areas in the measurement that starts when the participant is in a sitting position. Measurements of cervical flexion, extension, right and left lateral flexion, right and left rotation will be recorded after the participant's active movements, the angle value at the end of the movement, the active joint range of motion measurement.

    30 min

Study Arms (2)

PIR Group

EXPERIMENTAL

PIR Group participants will be given a one-time PIR Technique for each of the neck and upper back muscles, right after the classical Swedish massage is applied to the cervical region and upper back area.

Other: post isometric relaxationOther: Swedish Massage

Control Group

EXPERIMENTAL

Control group participants will receive classical Swedish massage only to the cervical and upper thoracic region.

Other: Swedish Massage

Interventions

PIR is performed by first passively lengthening the muscle, then having the patient lightly contract (10-20% of maximum) against resistance for 5 seconds passively before exhaling and relaxing the muscle and repeated. The clinician then takes up the slack within the muscle and repeats the technique 3 to 5 times

PIR Group

classic Swedish massage for the cervical and upper thoracic region. Massage is a method that is applied to superficial soft tissues such as muscles, skin, ligaments and fascia and structures located under the superficial tissues and aims to relax.

Control GroupPIR Group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • be a hospital worker
  • complaining of neck pain for at least 3 months
  • pain intensity at rest is 4 out of 10 according to VAS assessment
  • volunteer to participate in the study

You may not qualify if:

  • Having neck pain after trauma to the neck in the last 6 months
  • presence of neurological signs; neck pain that has spread to the arm and fingers
  • have had spinal surgery
  • shoulder pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (2)

  • Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.

    PMID: 25659245BACKGROUND
  • Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.

    PMID: 22034615BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 14, 2022

Study Start

October 7, 2022

Primary Completion

November 7, 2022

Study Completion

December 10, 2022

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations