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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05684809
Other study ID # 444-42-20993-DS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2022
Est. completion date February 15, 2023

Study information

Verified date March 2023
Source Najran University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

purpose of the study: to determine the effectiveness of cervical mobilization with PIR in reducing pain and improving neck ROM and function in people with mechanical neck pain associated with MTrPs


Description:

This study will be based on a randomized controlled design which will be comparative in nature. Participants will be recruited using the convenience sampling method and will be randomly divided into two groups A and B respectively. Thirty participants of mechanical neck pain associated with upper Trapezius trigger point pain will be recruited from the Physiotherapy department, at the Najran University, Saudi Arabia. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly assigned into two equal groups A and B. Group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and PIR technique while group B will receive the hot pack, active Stretching, isometric exercise intervention, and cervical Mobilization.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date February 15, 2023
Est. primary completion date January 28, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - age 20-40 years, - having mechanical neck pain located in the neck or scapular regions along with 1-2 MTrPs which, - on palpation replicated their chief complaints in the upper Trapezius muscle (unilateral). Exclusion Criteria: - known cases of fibromyalgia syndrome, - cervical radiculopathy or myelopathy, - history of cervical spine surgery, - congenital or acquired postural deformity, presence of MTrPs in bilateral upper Trapezius muscles, - patients who received any treatment for their pain one month prior to the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Post Isometric relaxation Technique (PIR)
In PIR intervention, the patients were requested to lie down in a supine position and their neck was in a lateral flexion to the opposite side so that the target upper Trapezius muscle fibers would be in a lengthened position. The therapist performed a moderate isometric contraction (approximately 75% of maximal) of upper Trapezius muscles, held it for 5 seconds, then relaxed for 3 seconds before moving the cervical spine into the new barrier. In each session, this technique was repeated for four times, on alternate days for three weeks.
Cervical Mobilization (CM)
Cervical Mobilization was delivered in prone lying with their foreheads resting comfortably on his hands, and the chin was tucked in.The treatment session was done on alternate days (3 days a week) for 3 weeks, hence the total number of sessions were 9.
conventional treatment
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10-second relaxation) were given, and isometric exercise of the neck((10 repetitions of two sets with 10 seconds hold) alternate days for three weeks.

Locations

Country Name City State
Saudi Arabia Hashim Ahmed Najran Najran
Saudi Arabia Hashim Ahmed Najran Najran

Sponsors (1)

Lead Sponsor Collaborator
Najran University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity The pain intensity was assessed Using a numeric pain rating scale (NPRS), Its a 11 point scale, where zero indicates no pain and 10 indicates severe pain 3 Weeks
Primary Neck Disability Index The Neck Disability was assessed using a neck disability index (NDI) questionnaire, the minimum value 0- and the maximum value is 50 3 Weeks
Primary Range of Motion The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device 3 Weeks
Primary Pain Pressure Threshold The Pain Pressure Threshold (PPT) was assessed using an algometer algometer 3 Weeks
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