Comparing the Effects of Neck Stabilization Exercises Verses Dynamic Exercises Among Patients Having Nonspecific Neck Pain With Forward Head Posture

May 5, 2023 updated by: Asma Batool, Dow University of Health Sciences

Comparing the Effects of Neck Stabilization Exercises Verses Dynamic Exercises Among Patients Having Nonspecific Neck Pain With Forward Head Posture- A Randomized Clinical Trial

the objective of this randomized clinical trial is to compare the effectiveness of neck stabilization exercises versus neck dynamic exercises in patients having non specific neck pain with forward head posture for pain intensity, correction of forward head posture, increasing Range of movement and decrease functional disability. the study is being conducted at physiotherapy department of institute of physical medicine and rehabilitation (Dow university of health sciences) total 60 patients with non specific neck pain with forward head posture recruited by non-probability sampling technique initially screening done by consultant physicians who is blinded to the treatment given to patients. patient are included in study who fulfill inclusion criteria and sign the consent form. patients then randomly allocated to both treatment groups using computer generated randomization sheet. baseline assessment is taken at first session after providing 9 treatment of stabilizing exercises to group1 and dynamic exercises to group 2 session post assessment will be done on goniometry, NDI, VAS and plumb line at last session at third week.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Aftab Ahmed Mirza Baig, MSAPT
  • Phone Number: +923002739920
  • Email: ab.dptrm@gmail.com

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Sindh Institute of Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with nonspecific neck pain more than 3 weeks less than 6 months.
  • Patients with forward head posture on plumb line assessment.
  • Pain on VAS moderate 4-7
  • NDI score with moderate; 50-64%.
  • Age ranges from 18-40.

Exclusion Criteria:

  • Previous history of any accident (whiplash), fracture, tumor etc.
  • Patients not willing to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group 1: stabilization exercises

stabilization exercises

  1. Chin tuck
  2. Cervical extension
  3. Shoulder shrugs
  4. Shoulder rolls
  5. Scapular retraction (15 repetitions 1 set) with TENS(10 mins before each session for 10 min at the back of the neck), stretching of trapezius, Pectorals minor, sternocleidomastoid, levator scapulae (5 rep 10 sec hold 1 set in both sides ) and cold pack (10 min at the back of neck at the end of each session)
Other: Stabilization exercises
The activation of deep cervical muscle to reduce the activity of surface muscles is known as stabilization exercises
Active Comparator: Treatment group 2: dynamic exercises

dynamic exercises

  1. Cervical extension-dynamic isometric.
  2. Cervical Flexion-Dynamic isometric.
  3. Chest flies exercises (15 repetitions 1 set) with TENS(10 mins before each session for 10 min at the back of the neck), stretching of trapezius, Pectorals minor, sternocleidomastoid, levator scapulae (5 rep 10 sec hold 1 set in both sides ) and cold pack (10 min at the back of neck at the end of each session)
Other: Dynamic exercises
The exercises in which muscle tension remains constant but muscle length changes is known as dynamic exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain intensity with Visual analog scale (VAS) in cm
Time Frame: Baseline and 3 weeks
VAS will be used for assessment of pain intensity on 10 cm straight line with marking from 0 to 10 (0 means no pain and 10 means worst pain possible) patients pain is recorded at baseline at the start of 1st session than change in pain intensity (decrease) will be assessed at the end of 9th session at week 3.
Baseline and 3 weeks
Change in disability with Neck disability index questionnaire (NDI) scores
Time Frame: Baseline and 3 weeks
NDI will be used for the assessment of disability due to neck pain. NDI is a ten item questionnaire each question has 6 responses from 0 no disability to 5 complete disability (score of less than 4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and scores greater than 35 complete disability) used to assess disability associated with neck pain and whiplash injury. patients disability is recorded at baseline at the start of 1st session than change in disability (decrease) will be assessed at the end of 9th session at week 3.
Baseline and 3 weeks
Change in neck range of motions with goniometer in degrees
Time Frame: Baseline and 3 weeks
Goniometry will be used for the assessment of change in available range of motion of around neck joint in degrees. the therapist assess the range of motion using goniometer in flexion, extension, lateral flexion(right), lateral flexion(left), rotation(right), rotation(left). patients ROM is recorded at baseline at the start of 1st session than change in ROM (increase) will be assessed at the end of 9th session at week 3.
Baseline and 3 weeks
Change in ear position with reference to shoulder Plumb line measurement in inches
Time Frame: Baseline and 3 weeks
Plumb line measurement will be used for the assessment of forward head posture using body landmarks such as ear lobe or mastoid process and shoulder alignment in inches. patients forward head is recorded at baseline at the start of 1st session than change in forward head (postural correction) will be assessed at the end of 9th session at week 3.
Baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rabail Rani Soomro, MSPT, Sindh Institute of Physical Medicine and Rehabilitation
  • Study Director: Aftab Ahmed Mirza Baig, MSAPT, Sindh Institute of Physical Medicine and Rehabo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABatool

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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