NCT05353088

Brief Summary

Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of scapular stabilization versus thoracic spine extension exercises on pain, disability and range of motion in patients with mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

April 21, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

Disability Physicalmuscle strengthrange of motion

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes \<1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; * High test-retest reliability has been (r = 0.96 and 0.95, respectively) * For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.

    follow up at 6th week

  • Neck Disability index (NDI)

    This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Every section is marked in each section only the one box that applies to you. We realise you may consider that two or more statements in any one section relate to you, but please just mark the box that most closely describes your problem. Intended population includes: Chronic neck or upper back pain and musculoskeletal neck pain. Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated.

    follow up at 6th week

  • Range of Motion

    A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error.

    follow up at 6th week

Study Arms (2)

Scapular stabilization exercises

EXPERIMENTAL

Group A performed scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II).

Other: scapular stabilization

Thoracic extension exercises

ACTIVE COMPARATOR

Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs.

Other: Thoracic extension exercises

Interventions

Scapular stabilization exercise aims to restore scapular position, orientations, motor control of muscles, and movement pattern, thereby attaining stability of scapula for better kinematics of shoulder.scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II)

Scapular stabilization exercises

Thoracic extension involves concurrent posterior rotation (external torsion) and depression of the posterior ribs with elevation of the anterior ribs. Bending to the side is a combination of spinal segments side bending, ribs on the same come together while ribs on the opposite side separate.Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs.

Thoracic extension exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females between 18 and 40 years of age with mechanical neck pain. (symptoms provoked by neck movement and/or palpation of musculature of the cervical region)
  • Chronic mechanical neck pain for more than 3 months.

You may not qualify if:

  • Cervical radiculopathy
  • Traumatic neck injury
  • History of cervical and thoracic spine surgery
  • Neck pain associated with vertigo
  • Osteoporosis
  • Vertebral Fractures
  • Tumors
  • Pregnancy
  • Diagnosed psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima memorial hospital - Physical therapy clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.

    PMID: 30586067BACKGROUND
  • Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.

    PMID: 30759118BACKGROUND
  • Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.

    PMID: 33187167BACKGROUND
  • Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.

    PMID: 34682453BACKGROUND
  • 5. Verma CV, Bhosale KS. Evaluation of neck pain and scapular stability in graduate dental students: A cross-sectional study. Indian Journal of Dental Sciences. 2021;13(4):260.

    BACKGROUND
  • Javdaneh N, Ambrozy T, Barati AH, Mozafaripour E, Rydzik L. Focus on the Scapular Region in the Rehabilitation of Chronic Neck Pain Is Effective in Improving the Symptoms: A Randomized Controlled Trial. J Clin Med. 2021 Aug 8;10(16):3495. doi: 10.3390/jcm10163495.

    PMID: 34441791BACKGROUND
  • Yu L-J, Kim T-H. The Effect of Cervical Stabilization Exercises with Thoracic Spine Extension Exercises on Forward Head Posture. 2021.

    BACKGROUND
  • Seo YG, Park WH, Lee CS, Kang KC, Min KB, Lee SM, Yoo JC. Is Scapular Stabilization Exercise Effective for Managing Nonspecific Chronic Neck Pain?: A Systematic Review. Asian Spine J. 2020 Feb;14(1):122-129. doi: 10.31616/asj.2019.0055. Epub 2019 Nov 1.

    PMID: 31668049BACKGROUND
  • Al-Bassiouny HA, Shendy S, El-Khozamy H. Effect of Upper Thoracic Mobilization on Chronic Mechanical Neck Pain. Med J Cairo Univ. 2019;87(3):1449-57.

    BACKGROUND
  • Yildiz TI, Turgut E, Duzgun I. Neck and Scapula-Focused Exercise Training on Patients With Nonspecific Neck Pain: A Randomized Controlled Trial. J Sport Rehabil. 2018 Sep 1;27(5):403-412. doi: 10.1123/jsr.2017-0024. Epub 2018 Jul 25.

    PMID: 28605288BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samrood Akram, MPhil

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 29, 2022

Study Start

April 30, 2022

Primary Completion

October 18, 2022

Study Completion

November 4, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations