- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649397
Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain
Effects of Cervical Spine Manipulation on Proprioception, Blood Pressure and Respiratory Rate in Patients With Mechanical Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck pain can over time negatively affect the central processing of any afferent input received because it can create a disturbance in the proprioceptive input to the Central Nervous System. Vuillerme stated that cervical muscle proprioceptors are stimulated by painful electrical stimuli. Therefore, joint proprioception can be affected in patients with mechanical neck pain .
The conservative management of mechanical neck pain includes many treatment options like electrotherapy which includes moist heat, Transcutaneous Electrical Nerve Stimulation therapy and different manual therapy options like cervical and thoracic mobilization and manipulation, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, Cyriax technique, manual pressure release, ischemic compression and proprioceptive neuromuscular facilitation. Postural reeducation and strength training of weak muscle group has beneficial effects. Joint mobilization and manipulation are widely used as a treatment for mechanical neck pain, as cervical mobilizations which are low velocity passive oscillatory movements are used by 90% of physiotherapist and chiropractors to treat people with neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Islamabad, Punjab, Pakistan
- Riphah international hospital Sihala
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS)
- Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
- Patients who have cervical joint position error greater than 7.1 cm or 4.5 degrees
Exclusion Criteria:
- Patients with a positive history of trauma, fracture or surgery of the cervical spine .
- anatomical cervical spine abnormality
- presented with any neurological signs
- history of benign paroxysmal positional vertigo
- Neck pain with radiation to the arm and upper extremity .
- Diagnosed cases of torticollis, and scoliosis
- History of osteoporosis, Any cardiac disorder
- had participated in a neck exercise program in the past 6 months .
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: cervical manipulation
in the cervical manipulation, provide a high velocity, low-amplitude manipulation to each subject's cervical spine.
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provide a high velocity, low-amplitude manipulation to each subject's cervical spine.
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Active Comparator: conventional therapy
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15 mins moist hot pack Neck Isometric exercise hold for 5-8 seconds and repeat 10 times Cervical range of motion 10 repetitions of movement in rotation within pain free range
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint position sense test
Time Frame: four weeks
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A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting.
The target is typically 40cm in diameter with concentric circles in 1cm increments.
A laser pointer or similar targeting device is mounted onto a lightweight headband is then placed on the patient's head.
The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the center or "bullseye" of the target.
With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible.
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four weeks
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Digital sphygmomanometer
Time Frame: four weeks
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It is the most technologically advanced sphygmomanometer.
It consists of an electronic sensor to measure the blood pressure and the readings are displayed on the digital monitor.
To measure the blood pressure, the instrument measures the fluctuations of arteries
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four weeks
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Respiratory rate measurement
Time Frame: four weeks
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To measure the respiratory rate of a person, ask the person to rest quietly for a moment.
Start a timer for 60 seconds and count every time they breathe.
Use the second hand on your watch or a timer on your phone to keep track of the person's breathing for exactly 1 minute.
Once the minute starts, count every time you see their chest rise .
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four weeks
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NPRS (Numeric Pain Rating Scale).
Time Frame: four weeks
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The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain.
The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability
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four weeks
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NDI (U) (Neck Disability Index)
Time Frame: four weeks
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The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points.
An Urdu version of neck disability index will be used in this study.
An intra-class correlation coefficient (ICC) revealed excellent test-retest reliability for all items (ICC = 0.86-0.98)
and total scores (ICC = 0.99) of the NDI-U
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four weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: maria Khalid, MSOMPT, Riphah International University
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- 01395 Hafsa Bint Bilal
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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