NCT05227963

Brief Summary

A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.

Trial Health

100
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 chronic-pain

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable chronic-pain

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

April 4, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2016

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

1 month

First QC Date

October 26, 2021

Last Update Submit

January 27, 2022

Conditions

Keywords

AssessmentNeck painPain measurementsPatient outcome assessmentTreatment outcome

Outcome Measures

Primary Outcomes (3)

  • Numerical pain rating scale (NPRS)

    NPRS was used to assess the pain intensity. The 11-point numeric scale ranging from 0-10; 0 means no pain while 10 means worst possible pain.

    upto 2 weeks

  • Neck disability index (NDI)

    NDI was used to assess the neck-related disability. Of the 50 score, 0-4 means no disability while 35-50 means severe disability.

    upto 2 weeks.

  • Neck range of motion

    Goniometer was used to measure the range of motion of neck.

    upto 2 weeks .

Study Arms (2)

Experimental Group(Group A)

EXPERIMENTAL

Experimental Group received soft tissue mobilization with neck isometric strengthening exercises.

Other: soft tissue mobilizationOther: neck isometric strengthening exercises

Control group (Group B)

OTHER

Control group received neck isometric strengthening exercises alone.

Other: neck isometric strengthening exercises

Interventions

In this group, each participants received 45-minutes long session that includes 25-minutes of soft tissue mobilization and 20-minutes of neck isometric strengthening exercises. In each session, patient was seated on chair and sustained pressure, direct oscillation, perpendicular mobilization, parallel mobilization, and friction massage was applied on the neck musculature for a minute followed by a release for 30 seconds. This protocol was repeated three times in each session. Each session was repeated four-times a week for two-weeks (a total eight sessions).

Experimental Group(Group A)

In this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions).

Control group (Group B)Experimental Group(Group A)

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • :• Age above 30 and below 75 years
  • Patients having local neck pain included
  • Female included
  • With chronic neck syndrome (\> month)

You may not qualify if:

  • Age below 30 and more than 75 years
  • Patients having radiating pain excluded
  • Male excluded.
  • With acute neck syndrome (\< 3 month)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainNeck 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
INVESTIGATOR
Masking Details
Non-probability convenient sampling technique was used to recruit the sample through lottery method into two groups.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

October 26, 2021

First Posted

February 8, 2022

Study Start

April 4, 2016

Primary Completion

May 10, 2016

Study Completion

August 20, 2021

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share