NCT04557904

Brief Summary

The aim of this research is to compare the effects of craniocervical flexion exercises and scapular stabilization exercises in reducing neck pain and forward head posture among females wearing head scarves. Quasi experimental trials done at Akhtar Saeed Trust hospital, Falah o Behbud Associations and Medicare Hospital (Lahore, Pakistan). A sample size of 50 patients was taken using non-probability purposive sampling technique. Subjects were randomly divided into 2 groups. Subjects in group A were treated with craniocervical flexion exercises and the subjects in group B were treated with scapular stabilization exercises with 25 subjects in each group. Pretreatment evaluation was done using numeric pain rating scale (NPRS) and neck disability index (NDI) as subjective measurement and Goniometry for assisted range of motion (AROM) and plumb line method for measuring head posture as objective measurement. The baseline values for all dependent variables were recorded on day one and at the end of 4th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

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

Study Start

First participant enrolled

June 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 16, 2020

Last Update Submit

September 16, 2020

Conditions

Keywords

Forward head posture, Craniocervical flexion exercises

Outcome Measures

Primary Outcomes (9)

  • Neck disability index

    Changes from base line Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section was missing in all the female patients, total score was considered as 45 instead of 50

    4th week

  • Numeric Pain Rating Scale

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

    4th week

  • ROM Cervical Spine ( Flexion)

    Changes from the Baseline ROM range of Motion of Cervical spine flexion was taken with the Help of Goniometer

    4th week

  • ROM Cervical Spine ( extension)

    Changes from the Baseline ROM range of Motion of Cervical spine extension was taken with the Help of Goniometer

    4th week

  • ROM Cervical Spine ( Right side flexion)

    Changes from the Baseline ROM range of Motion of Cervical spine right side flexion was taken with the Help of Goniometer

    4th week

  • ROM Cervical Spine ( left side Flexion)

    Changes from the Baseline ROM range of Motion of Cervical spine left side flexion was taken with the Help of Goniometer

    4th week

  • ROM Cervical Spine ( right rotation)

    Changes from the Baseline ROM range of Motion of Cervical spine right rotation was taken with the Help of Goniometer

    4th week

  • ROM Cervical Spine ( left rotation)

    Changes from the Baseline ROM range of Motion of Cervical spine left rotation was taken with the Help of Goniometer

    4th week

  • Plumb Line

    Participants were requested to wear the suitable attire to properly expose the areas being examined e.g thoracic \& cervical spine. The lobe of ear, the seventh cervical vertebra, acromion process, the thoracic spine and lateral malleolus were used as landmarks for measuring the head posture

    4th week

Study Arms (2)

Group A: Craniocervical flexion exercises

EXPERIMENTAL

Exercise protocol were performed over a 4 week duration under the command of a supervisor. Subjects were asked not to obtain any other particular intervention for cervical ache. Command the subject to be in crook lying position. Lock their finger to place their finger below the skull and retract the lower jaw and retract chin as far as possible.

Other: Craniocervical flexion exercises

Group B: Scapular stabilization exercises

EXPERIMENTAL

Group B performed scapular stabilization workout for 30 minutes per session, three days a week for four weeks. The scapular stabilization exercises were made up of four stages

Other: Scapular stabilization exercises

Interventions

Command the subject to be in crook lying position. Lock their finger to place their finger below the skull and retract the lower jaw and retract chin as far as possible. Subject has to slightly raise his/he skull a few centimeters. Fingers should be touching the cranium but not supporting it. Subject had to respire and hold the position. Subject has the move out the chin. Stop exercise and restart again. Perform this exercise for 10 times by holding this position for 20 sec at the start of the exercise, increasing it by 10 seconds every session commonly underwent pectoralis minor stretching before every session of exercise of 4 sets with 30 second's hold

Group A: Craniocervical flexion exercises

The scapular stabilization exercises were made up of four stages: (1) In supine position, the patient was commanded to deep respire for the sake of relaxation by maintain the cervical and shoulder in relaxing position to take a deep breath to relax the body while holding her shoulders and neck in relaxing position. (2) The patient then flex her knees and placed her feet flat on the plinth, and maintain the pose without any cervical movement. Then the patient asked to raise her dominant arm to 90° shoulder flexion with full elbow extension and scapular protraction. This position was sustained for 10 seconds before going to initial position. Three laps of 10 repetitions with one-minute interval in between were performed. (3) In quadruped position, the patient raise her arms alternatively with shoulder abduction and 120 ° flexion. That posture was held for 10 seconds before returning to the starting position. (4) In sitting position

Group B: Scapular stabilization exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Forward-head-posture
  • Duration of wearing-the headscarf/hijab for a minimum of 5-years
  • Females ho start wearing headscarf before or at the age of-20. Females having neck-pain for less-than-six-months or if they had any muscular spasm \& tenderness in the neck region.
  • Pain being experienced in cervical spine area, which started from-superior-nuchal line-to the first thoracic vertebra.
  • Pain radiating with or without any extensive radicular-symptoms towards other areas of body such as head and upper extremities.
  • Restricted range-of-motion of cervical-spine.

You may not qualify if:

  • Any red flags (tumor, osteoporosis, metabolic disorders, fracture, rheumatoid arthritis, resting-blood-pressure higher than 140/90 mmHg, prolonged-history of steroids abuse, continuous nerve root entrapment with two-or more-positive-neurologic-signs (muscle weakness involving cervical myotomes, abnormal upper limb deep-tendon-reflexes, or- -abnormal cervical dermatome.
  • Already diagnosed with cervical spine-stenosis, showed bilateral upper limb symptoms.
  • Any six weeks prior history of whiplash-injury or engaged in any type of treatment regarding neck pain from any-practitioner within the last month.
  • History-of any previous-cervical or thoracic-spine-surgery-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akhtar Saeed Trust hospital, Falah o Behbud Associations and Medicare Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (16)

  • Nejati P, Lotfian S, Moezy A, Moezy A, Nejati M. The relationship of forward head posture and rounded shoulders with neck pain in Iranian office workers. Med J Islam Repub Iran. 2014 May 3;28:26. eCollection 2014.

    PMID: 25250268BACKGROUND
  • Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.

    PMID: 26957772BACKGROUND
  • Lopez-de-Uralde-Villanueva I, Beltran-Alacreu H, Paris-Alemany A, Angulo-Diaz-Parreno S, La Touche R. Relationships between craniocervical posture and pain-related disability in patients with cervico-craniofacial pain. J Pain Res. 2015 Jul 30;8:449-58. doi: 10.2147/JPR.S84668. eCollection 2015.

    PMID: 26261425BACKGROUND
  • Dunleavy K, Goldberg A. Comparison of cervical range of motion in two seated postural conditions in adults 50 or older with cervical pain. J Man Manip Ther. 2013 Feb;21(1):33-9. doi: 10.1179/2042618612Y.0000000017.

    PMID: 24421611BACKGROUND
  • Benatto MT, Florencio LL, Bragatto MM, Dach F, Fernandez-de-Las-Penas C, Bevilaqua-Grossi D. Neck-specific strengthening exercise compared with sham ultrasound when added to home-stretching exercise in patients with migraine: study protocol of a two-armed, parallel-groups randomized controlled trial. Chiropr Man Therap. 2020 May 19;28(1):22. doi: 10.1186/s12998-020-00313-w.

    PMID: 32423454BACKGROUND
  • Blomgren J, Strandell E, Jull G, Vikman I, Roijezon U. Effects of deep cervical flexor training on impaired physiological functions associated with chronic neck pain: a systematic review. BMC Musculoskelet Disord. 2018 Nov 28;19(1):415. doi: 10.1186/s12891-018-2324-z.

    PMID: 30486819BACKGROUND
  • Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.

    PMID: 30881101BACKGROUND
  • Rudolfsson T, Bjorklund M, Svedmark A, Srinivasan D, Djupsjobacka M. Direction-Specific Impairments in Cervical Range of Motion in Women with Chronic Neck Pain: Influence of Head Posture and Gravitationally Induced Torque. PLoS One. 2017 Jan 18;12(1):e0170274. doi: 10.1371/journal.pone.0170274. eCollection 2017.

    PMID: 28099504BACKGROUND
  • Yang CC, Su FC, Yang PC, Lin HT, Guo LY. Characteristics of the Motor Units during Sternocleidomastoid Isometric Flexion among Patients with Mechanical Neck Disorder and Asymptomatic Individuals. PLoS One. 2016 Dec 12;11(12):e0167737. doi: 10.1371/journal.pone.0167737. eCollection 2016.

    PMID: 27941995BACKGROUND
  • Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.

    PMID: 28826164BACKGROUND
  • Coulter ID, Crawford C, Vernon H, Hurwitz EL, Khorsan R, Booth MS, Herman PM. Manipulation and Mobilization for Treating Chronic Nonspecific Neck Pain: A Systematic Review and Meta-Analysis for an Appropriateness Panel. Pain Physician. 2019 Mar;22(2):E55-E70.

    PMID: 30921975BACKGROUND
  • Groeneweg R, van Assen L, Kropman H, Leopold H, Mulder J, Smits-Engelsman BCM, Ostelo RWJG, Oostendorp RAB, van Tulder MW. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial. Chiropr Man Therap. 2017 Apr 28;25:12. doi: 10.1186/s12998-017-0141-3. eCollection 2017.

    PMID: 28465824BACKGROUND
  • Groeneweg R, Kropman H, Leopold H, van Assen L, Mulder J, van Tulder MW, Oostendorp RA. The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT). BMC Musculoskelet Disord. 2010 Jan 24;11:14. doi: 10.1186/1471-2474-11-14.

    PMID: 20096136BACKGROUND
  • Price J, Rushton A, Tyros I, Tyros V, Heneghan NR. Effectiveness and optimal dosage of exercise training for chronic non-specific neck pain: A systematic review with a narrative synthesis. PLoS One. 2020 Jun 10;15(6):e0234511. doi: 10.1371/journal.pone.0234511. eCollection 2020.

    PMID: 32520970BACKGROUND
  • Damgaard P, Bartels EM, Ris I, Christensen R, Juul-Kristensen B. Evidence of Physiotherapy Interventions for Patients with Chronic Neck Pain: A Systematic Review of Randomised Controlled Trials. ISRN Pain. 2013 Apr 15;2013:567175. doi: 10.1155/2013/567175. eCollection 2013.

    PMID: 27335877BACKGROUND
  • Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.

    PMID: 32723399BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rabiya Noor, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

June 15, 2018

Primary Completion

February 20, 2019

Study Completion

March 15, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations