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Cervical SpondylosisNCT05916794

Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises in Cervical Spondylosis

A study testing Modified Cervical Retraction Exercises (MCRE) in people with Cervical Spondylosis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Cervical Spondylosis
What is being tested?
Modified Cervical Retraction Exercises (MCRE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
3 Mar 2023to 2 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah Rehabilitation Clinic

    Lahore, Punjab Province, 54700

Other trials in Pakistan

About this study

Official title: Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises on Pain, Range of Motion and Functional Disability in Patients With Cervical Spondylosis

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

Read the detailed description

Cervical spondylosis is a chronic degenerative process of the cervical spine which affects the vertebral bodies and intervertebral discs and causes herniated intervertebral discs, osteophytes, and ligament hypertrophy. It is commonly seen in patients between the ages of 40 and 60. Neck pain not only imposes a notable burden on individuals in the society, but also affects families, the healthcare and economic systems of countries. In 2017, age-standardized prevalence, annual incidence, and years lived with disability from neck pain were estimated at 3551, 807, and 352 per 100,000 population worldwide, respectively Patients seeking medical help for this condition primarily complain of neck pain and/or stiffness. This pain is considered the second most common complaint post low back pain and increased by neck movements especially hyperextension and side bending Currently, there are several therapeutic approaches, either pain relievers or non-medicinal treatments for the management of cervical spondylosis and its associated pain and disability Pain medications mainly include non-steroids anti-inflammatory drugs and narcotics with exercise therapy, massage, physiotherapy, and local injections are among the most common non-medicinal therapies. Evidence suggests that exercise therapy plays a role in improving neck pain and disability of patients with cervical spondylosis. Besides, thanks to being non-invasive and profitable, exercise therapy is commonly used in patient rehabilitation Therapeutic exercises include various workouts such as proprioceptive exercises, stability exercises, strength exercises (dynamic and isometric) and endurance exercises. Neck retraction helps recover the lordotic curve in the lower cervical portion, but kyphotic changes may occur at the upper cervical level. The motor control exercises are the therapeutic approach which mainly focuses on motor control, activation of deep cervical muscles, and aims to retrain the optimal control and coordination of the cervical muscles Apart from the fact that clinical guidelines suggest therapeutic exercises as an integral part of managing neck pain and disability, prescribing the most advantageous exercise therapy has yet been controversial and even current guidelines do not offer specific recommendations on the preferred type and dosage of exercises

Being tested
Modified Cervical Retraction Exercises (MCRE), Motor Control therapeutic exercise(MCTE)
Medical subject headings
Spondylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Cervical Retraction Exercises (MCRE)Other

    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

  • Motor Control therapeutic exercise(MCTE)Other

    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

Study groups in NCT05916794
Study groupRoleWhat they receive
: Modified Cervical Retraction Exercises (MCRE)ExperimentalThe 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
Receives: Other: Modified Cervical Retraction Exercises (MCRE)
Motor Control therapeutic exercise(MCTE)ExperimentalThe MCTE will used is based on retraining the cervical muscles and included four exercises
Receives: Other: Motor Control therapeutic exercise(MCTE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. . 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)

    Measured: 6th week

  2. 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

    Measured: 6th weeks

  3. 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

    Measured: 6th weeks

Secondary outcomes (4)
  1. ROM cervical spine (flexion)

    The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor for measuring range of cervical flexion

    Measured: 6th weeks

  2. ROM cervical spine (extension)

    the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck, for measuring the cervical extension ROM.

    [Time Frame: 6th week] The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and pati

    Measured: 6th weeks

  3. ROM cervical spine (side flexion)

    the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for side flexion [Time Frame: 6th week] The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for sid

    Measured: 6th weeks

  4. ROM cervical spine (Rotation)

    the center of the goniometer is placed Over center of cranial aspect of head, proximal arm is placed Parallel to imaginary line between the two acromial processes and distal arm With the tip of the nose. If using the tongue depressor, parallel to the longitudinal axis of tongue depressor for cervical rotation ROM

    Measured: 6th weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start3 Mar 2023
  3. Primary completion28 Sep 2023
  4. Study completion2 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916794
Sponsor's protocol ID
: REC/RCR & AHS/23/0123
Status last verified
Nov 2023
First submitted
14 Jun 2023
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30205836
  • 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.

    PubMed 31350584
  • 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.

    PubMed 32927858
  • 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.

    PubMed 26618067
  • 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.

    PubMed 29021908
  • 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.

    PubMed 28369946
  • 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.

    PubMed 30099210

Questions about this trial

What is this clinical trial studying?

A study testing Modified Cervical Retraction Exercises (MCRE) in people with Cervical Spondylosis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

. Numerical Rating Scale (NPRS) (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916794, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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