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Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Post Isometric relaxation Technique (PIR)
Cervical Mobilization (CM)
conventional treatment
Sponsored by
Najran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hashim Ahmed
  • Hashim Ahmed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

in addition to Conventional treatment, PIR and cervical mobilization were given

in addition to Conventional treatment, PIR were given

Outcomes

Primary Outcome Measures

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
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
Range of Motion
The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device
Pain Pressure Threshold
The Pain Pressure Threshold (PPT) was assessed using an algometer algometer

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
March 23, 2023
Sponsor
Najran University
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1. Study Identification

Unique Protocol Identification Number
NCT05684809
Brief Title
Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points
Official Title
Efficacy of Cervical Mobilization With Post Isometric Relaxation in Managing Mechanical Neck Pain Associated With Myofascial Trigger Points: a Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
January 28, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Najran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
in addition to Conventional treatment, PIR and cervical mobilization were given
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
in addition to Conventional treatment, PIR were given
Intervention Type
Other
Intervention Name(s)
Post Isometric relaxation Technique (PIR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical Mobilization (CM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
3 Weeks
Title
Neck Disability Index
Description
The Neck Disability was assessed using a neck disability index (NDI) questionnaire, the minimum value 0- and the maximum value is 50
Time Frame
3 Weeks
Title
Range of Motion
Description
The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device
Time Frame
3 Weeks
Title
Pain Pressure Threshold
Description
The Pain Pressure Threshold (PPT) was assessed using an algometer algometer
Time Frame
3 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim Ahmed, PhD
Organizational Affiliation
Najran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hashim Ahmed
City
Najrān
State/Province
Najran
ZIP/Postal Code
1988
Country
Saudi Arabia
Facility Name
Hashim Ahmed
City
Najrān
State/Province
Najran
ZIP/Postal Code
66262
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points

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