Effects of Scapular Stabilization Program in Patients Chronic Non-specific Neck Pain

March 31, 2023 updated by: Riphah International University

Effects of Scapular Stabilization Program on Pain, Range of Motion and Disability in Patients With Chronic Non- Specific Neck Pain

The aim of this study is to determine the effects of scapular stabilization program on pain, range of motion and disability in patients with chronic non- specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using non- probability purposive sampling technique. Experimental group will receive relaxation exercises for the cervico-scapular region combined with SSP(scapular stabilization program). The Control group will receive relaxation exercises only. Outcome measure: Numeric Pain Rating Scale, Goniometer, and Neck Disability Index will measure pain, range of motion, and disability. The experimental group will receive a total of 45 minutes sessions, thrice a week on alternate days for 3 weeks. The Control group will receive relaxation exercises in cervico-scapular region including neck stretches, stretches of scapular muscles, and myofascial release 3 times a week for 3 weeks on alternate days. Measurements will be taken at the baseline, at the end of 3rd week and for long term effects follow- up at 6 weeks. Data will be analyzed by SPSS version 20.

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.

Detailed Description

This study will provide evidence for management strategies of chronic NNP (nonspecific neck pain) solely focusing on a well-designed SSP (scapular stabilization program). The study will enable physiotherapists to induct this exercise program (Scapular stabilization program) in their treatment regimens to manage NNP. Some studies have used these exercises in combination to treat people with chronic neck pain. It is hypothesized that adding a scapular stabilization program will increase treatment efficacy. This study will enable us to solely evaluate the effects of SSP on NNP without adding other treatment strategies. This study aims to determine the effects of a scapular stabilization program on pain, range of motion and disability in patients with chronic non-specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using the non-probability purposive sampling technique. The experimental group will receive relaxation exercises for the cervico-scapular region combined with SSP(scapular stabilization program). The Control group will receive relaxation exercises only. Outcome measure: Numeric Pain Rating Scale, Goniometer and Neck Disability Index will measure pain, range of motion, and disability. The experimental group will receive a total of 45 minutes sessions, thrice a week on alternate days for 3 weeks. The Control group will receive relaxation exercises in the cervico-scapular region including neck stretches, stretches of scapular muscles, and myofascial release 3 times a week for 3 weeks on alternate days. Measurements will be taken at the baseline, at the end of the 3rd week and for long-term effects follow up at the 6th week. Data will be analyzed by SPSS version 20.

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.
28

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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Riphah Rehabilitation Center

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of age between 18-35 years

    • NPRS value more than or equal to 4
    • Chronic nonspecific neck pain for more than 3 months
    • Shoulder flexion 130˚ or more

Exclusion Criteria:

  • Structural abnormalities like fractures/spondylosis

    • Any other musculoskeletal problem
    • Neurological problems
    • H/o cervical or thoracic surgery Psychological disorders

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: Group A
Scapular Stabilization exercise program
Other: Relaxation Exercises and Scapular Stabilization exercise program
Scapular Stabilization Program (3 sets of 10 reps each/day). This exercise program is for muscles affecting scapular alignment due to chronic neck pain. A specialized program of non-resistive scapular upward rotation, wall facing arm lift, backward rolling arm lift, overhead arm raise, shoulder abduction in scapular plane above 120˚, shoulder shrugs, levator scapulae and pectoralis minor stretching. Hot pack (10 min) and relaxation exercises including myofascial release and stretching of neck and scapular region muscles. A total of 45 minutes session three times a week on alternate days for 3 weeks. Assessment will be done at baseline, on the end of 3rd week and for long-term effects at the end of 6th week.
Other: Group B
Relaxation Exercises of cervico- scapular region
Other: Relaxation Exercises of cervico- scapular region
Relaxation exercises of the cervico-scapular region including neck stretches of scapular muscles and myofascial release will be given to patients three times a week on alternate days for 3 weeks. Assessment will be done at baseline, at the end of the 3rd week, and for long-term effects at the end of the 6th week.

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
NPRS
Time Frame: 3rd day
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
3rd day
Goniometer
Time Frame: 3rd day
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Thoracic flexion and extension will be assessed through it.
3rd day
NDI
Time Frame: 3rd day
It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability.
3rd day

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.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
May 30, 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.
December 30, 2022

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 30, 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).
May 23, 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.
May 23, 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.
May 26, 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.
April 3, 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.
March 31, 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.
March 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.
  • REC/RCR & AHS/22/0143 Moeen

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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