NCT05618964

Brief Summary

Deep cervical flexor and extensor muscles show decreased strength in patients with Mechanical neck pain. Exercises involving deep cervical muscles has improved coordination and motor control. This study aim to determine the effects of deep flexor muscle exercises along with deep extensor muscle exercises on pain, range of motion and muscle strength in mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 18, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

November 8, 2022

Last Update Submit

February 20, 2023

Conditions

Keywords

Neck musclesNeck PainMuscle strengthRange of Motion

Outcome Measures

Primary Outcomes (4)

  • Numerical 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 on 4th week

  • Manual Muscle Testing (MMT)

    Muscle strength will be assessed by Manual muscle testing. Which is scored using a 0-5 points Medical Research Council muscle strength scale. MMT is the most commonly used method for documenting impairments in muscle strength in both spine and periphery with a kappa value 0.88.

    followup on 4th week

  • Universal Goniometer (UG)

    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. The range of motion of neck including flexion and extension will be measured by using universal goniometer that has an inter-rater reliability (ICC2, 2 = 0.79 to 0.92) for cervicle region.

    follow up on 4th week

  • Pressure Biofeedback unit

    Pressure biofeedback unit if placed under the suboccipital region and the pressure cuff is inflated to a pressure of 20 mmHg in order to fill the space of the cervical lordosis and the subject asked to perform a gentle head-nodding action of craniocervical flexion (indicating yes). Maximum pressure increase above the baseline upto 10 mmHg achieved and held for 10 seconds is defined as strength of deep cervical flexors.

    follow up on 4th week

Study Arms (2)

Group A: Deep Neck Flexors & Extensors exercises

EXPERIMENTAL

Group A Patients will receive: Deep neck flexor exercises (2 set of 10 repetitions) that includes: * Contraction of deep neck flexor muscle in supine * Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: * Contraction of deep neck extensors in quadruped position * Segmented extension movement with the head bent down onto their chest in a horizontal direction,

Other: Deep Neck Flexors & Extensors exercises

Group B: Standardized Physical Therapy

NO INTERVENTION

Standardized Physiotherapy treatment will be: * Hot pack for 10 minutes, * SNAG manual therapy at Cervical spine 6 repetitions for 60 seconds. * Superficial neck muscles (upper trapezius, Levator scapulae, Pect.Major) stretching for 3 times with 30 seconds and * Neck isometrics 10 times with 6 seconds hold. Both groups will come thrice per week for a total of 4 weeks. Pre and post treatment values of both groups will be analyzed

Interventions

Deep neck flexor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,

Group A: Deep Neck Flexors & Extensors exercises

Eligibility Criteria

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

You may qualify if:

  • Males and Females
  • and 40 years of age
  • Forward Head Posture
  • Manual Muscle testing (MMT) grade less than 6
  • Deep Flexor strength measured by pressure biofeedback unit (20 mmHg), patients who cannot hold craniocervical flexion (indicating yes) for 10 seconds

You may not qualify if:

  • Cervical radiculopathy
  • History of whiplash injury
  • History of cervical and thoracic spine surgery
  • Neck pain associated with vertigo
  • History of spinal osteoporosis
  • Vertebral Fractures
  • Tumors
  • Diagnosed psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (11)

  • Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.

    PMID: 34980079BACKGROUND
  • Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.

    PMID: 33234017BACKGROUND
  • Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.

    PMID: 28870191BACKGROUND
  • 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
  • Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.

    PMID: 34900443BACKGROUND
  • 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
  • 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
  • Alghadir AH, Iqbal ZA. Effect of Deep Cervical Flexor Muscle Training Using Pressure Biofeedback on Pain and Forward Head Posture in School Teachers with Neck Pain: An Observational Study. Biomed Res Int. 2021 May 22;2021:5588580. doi: 10.1155/2021/5588580. eCollection 2021.

    PMID: 34095302BACKGROUND
  • Gimenez-Costa M, Schomacher J, Murillo C, Blanco-Hernandez T, Falla D, Lluch E. Specific versus non-specific exercises for the neck extensor muscles in women with chronic idiopathic neck pain: A randomized controlled trial. Musculoskelet Sci Pract. 2022 Aug;60:102561. doi: 10.1016/j.msksp.2022.102561. Epub 2022 Apr 6.

    PMID: 35421696BACKGROUND
  • Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.

    PMID: 33521131BACKGROUND
  • Sikka I, Chawla C, Seth S, Alghadir AH, Khan M. Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly. Biomed Res Int. 2020 Oct 5;2020:8327565. doi: 10.1155/2020/8327565. eCollection 2020.

    PMID: 33083487BACKGROUND

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

November 8, 2022

First Posted

November 16, 2022

Study Start

October 18, 2022

Primary Completion

January 18, 2023

Study Completion

February 1, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations