NCT05684809

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

January 5, 2023

Last Update Submit

March 23, 2023

Conditions

Mechanical Neck Pain

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Range of Motion

    The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device

    3 Weeks

  • Pain Pressure Threshold

    The Pain Pressure Threshold (PPT) was assessed using an algometer algometer

    3 Weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Post Isometric relaxation Technique (PIR)Other: Cervical Mobilization (CM)Other: conventional treatment

Group B

ACTIVE COMPARATOR

in addition to Conventional treatment, PIR were given

Other: Post Isometric relaxation Technique (PIR)Other: conventional treatment

Interventions

Post Isometric relaxation Technique (PIR)OTHER

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.

Group AGroup B
Cervical Mobilization (CM)OTHER

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.

Group A
conventional treatmentOTHER

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.

Group AGroup B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hashim Ahmed

Najrān, Najran Region, 1988, Saudi Arabia

Location

Hashim Ahmed

Najrān, Najran Region, 66262, Saudi Arabia

Location

Study Officials

  • Hashim Ahmed, PhD

    Najran University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

October 30, 2022

Primary Completion

January 28, 2023

Study Completion

February 15, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(2)