- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916794
Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises in Cervical Spondylosis
Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises on Pain, Range of Motion and Functional Disability in Patients With Cervical Spondylosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54700
- Riphah Rehabilitation Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 45 -65 years
- Both. male and female,
- Patient with pain NPRS 4-7
- Subject radiological diagnosed
- Cervical spondylosis (With or without Radiculopathy
Exclusion Criteria:
- Cervical fracture or injury
- Cervical spine osteoporosis,
- Cervical myelopathy & Cervical canal stenosis,
- Cervical Malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: : Modified Cervical Retraction Exercises (MCRE)
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
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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
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Experimental: Motor Control therapeutic exercise(MCTE)
The MCTE will used is based on retraining the cervical muscles and included four exercises
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
. Numerical Rating Scale (NPRS)
Time Frame: 6th week
|
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)
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6th week
|
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Neck Disability Index (NDI)
Time Frame: 6th weeks
|
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
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6th weeks
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Handheld dynamometry (HHD)
Time Frame: 6th weeks
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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
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6th weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM cervical spine (flexion)
Time Frame: 6th weeks
|
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
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6th weeks
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ROM cervical spine (extension)
Time Frame: 6th weeks
|
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 |
6th weeks
|
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ROM cervical spine (side flexion)
Time Frame: 6th weeks
|
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
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6th weeks
|
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ROM cervical spine (Rotation)
Time Frame: 6th weeks
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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
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6th weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sana hafeez, phD*, Riphah International University Lahore Campus
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Int J Sports Phys Ther. 2015 Dec;10(7):1074.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- : REC/RCR & AHS/23/0123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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