NCT05916794

Brief Summary

Cervical spondylosis is a general term for age-related wear and tear in the cervical spine that can lead to neck pain, stiffness and other symptoms. Sometimes this condition is called arthritis or osteoarthritis of the neck. The spine likely begins this wearing-down process sometime in your 30s. By age 60, almost nine in 10 people have cervical spondylosis .Objective of this study is to compare the effects of Modified cervical retraction Motor control therapeutic exercises on pain, ROM and functional disability in patients with cervical spondylosis

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 Mar 2023

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

March 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 14, 2023

Last Update Submit

November 10, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • . Numerical Rating Scale (NPRS)

    Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)

    6th week

  • Neck Disability Index (NDI)

    The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain. Points summed to a total score The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.,0 points or 0% means : no activity limitations .50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. For patients' understanding, the URDU version is used. A clinically important change was calculated as 5 points, with a sensitivity of 0.78 and a specificity of 0.80

    6th weeks

  • Handheld dynamometry (HHD)

    A small portable device is held by the examiner and placed against the patient's limb during a maximal isometric contraction. The device can be used to test both proximal and distal muscles in all extremities. Specific dynamometers are used to test grip strength. The Strength measure is more sensitive to change than MMT and correlates well with fixed dynamometry up to 30-kg force. Reliability coefficients for HHD ranged from -0.19 to 0.99, with the majority surpassing 0.70. HHD readings obtained by multiple raters may be up to 53% more variable than those obtained by a single rater

    6th weeks

Secondary Outcomes (4)

  • ROM cervical spine (flexion)

    6th weeks

  • ROM cervical spine (extension)

    6th weeks

  • ROM cervical spine (side flexion)

    6th weeks

  • ROM cervical spine (Rotation)

    6th weeks

Study Arms (2)

: Modified Cervical Retraction Exercises (MCRE)

EXPERIMENTAL

The patient is in sitting OR standing position and faces the physical therapist. The MCRE program consisted of alternating head positions. Hold each position for 20 sec with 8 to 10 repetitions

Other: Modified Cervical Retraction Exercises (MCRE)

Motor Control therapeutic exercise(MCTE)

EXPERIMENTAL

The MCTE will used is based on retraining the cervical muscles and included four exercises

Other: Motor Control therapeutic exercise(MCTE)

Interventions

Group A includes Modified cervical retraction exercise The patient is in sitting OR standing position and faces the physical therapist. The MCRE program consisted of alternating head position( neutral, side bending and rotation) while pushing their chin backward patients maintained an upright posture and tried to pull back their shoulders while maintaining this retracted position patient side bend OR rotate their head respectively hold the position for 20 sec.subject performed 5 sets of 10 repetition for 3-4 days per week. Rest intervals of 30 seconds were provided after the completion of 10 repetitions for each pattern and between sets, respectively. The total duration of MCRE will be of approximately 15-20 minutes

: Modified Cervical Retraction Exercises (MCRE)

Motor control therapeutic exercises will be guided for the retraining of cervical muscles.it include craniocervical flexor exercise,craniocervical extensor exercise, co-contraction of flexors and extensor, a synergy exercise for retraining the strength of the deep neck flexors. Each of these four exercises will be performed for 3 sets of 8 to 10 repetitions, taking an approximate total duration of 15-20 minutes for, 3 days a week

Motor Control therapeutic exercise(MCTE)

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45 -65 years
  • Both. male and female,
  • Patient with pain NPRS 4-7
  • Subject radiological diagnosed
  • Cervical spondylosis (With or without Radiculopathy

You may not qualify if:

  • Cervical fracture or injury
  • Cervical spine osteoporosis,
  • Cervical myelopathy \& Cervical canal stenosis,
  • Cervical Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (7)

  • Lv Y, Tian W, Chen D, Liu Y, Wang L, Duan F. The prevalence and associated factors of symptomatic cervical Spondylosis in Chinese adults: a community-based cross-sectional study. BMC Musculoskelet Disord. 2018 Sep 11;19(1):325. doi: 10.1186/s12891-018-2234-0.

    PMID: 30205836BACKGROUND
  • Bernabeu-Sanz A, Molla-Torro JV, Lopez-Celada S, Moreno Lopez P, Fernandez-Jover E. MRI evidence of brain atrophy, white matter damage, and functional adaptive changes in patients with cervical spondylosis and prolonged spinal cord compression. Eur Radiol. 2020 Jan;30(1):357-369. doi: 10.1007/s00330-019-06352-z. Epub 2019 Jul 26.

    PMID: 31350584BACKGROUND
  • Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.

    PMID: 32927858BACKGROUND
  • Hidalgo-Perez A, Fernandez-Garcia A, Lopez-de-Uralde-Villanueva I, Gil-Martinez A, Paris-Alemany A, Fernandez-Carnero J, La Touche R. EFFECTIVENESS OF A MOTOR CONTROL THERAPEUTIC EXERCISE PROGRAM COMBINED WITH MOTOR IMAGERY ON THE SENSORIMOTOR FUNCTION OF THE CERVICAL SPINE: A RANDOMIZED CONTROLLED TRIAL. Int J Sports Phys Ther. 2015 Nov;10(6):877-92.

    PMID: 26618067BACKGROUND
  • Suni JH, Rinne M, Tokola K, Manttari A, Vasankari T. Effectiveness of a standardised exercise programme for recurrent neck and low back pain: a multicentre, randomised, two-arm, parallel group trial across 34 fitness clubs in Finland. BMJ Open Sport Exerc Med. 2017 Aug 6;3(1):e000233. doi: 10.1136/bmjsem-2017-000233. eCollection 2017.

    PMID: 29021908BACKGROUND
  • Lima LV, Abner TSS, Sluka KA. Does exercise increase or decrease pain? Central mechanisms underlying these two phenomena. J Physiol. 2017 Jul 1;595(13):4141-4150. doi: 10.1113/JP273355. Epub 2017 May 26.

    PMID: 28369946BACKGROUND
  • Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.

    PMID: 30099210BACKGROUND

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sana hafeez, phD*

    Riphah International University Lahore Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

March 3, 2023

Primary Completion

September 28, 2023

Study Completion

October 2, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations