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Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cervical manipulation
conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring pain, proprioception, blood pressure, respiratory rate, cervical manipulation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Riphah international hospital Sihala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cervical manipulation

conventional therapy

Arm Description

in the cervical manipulation, provide a high velocity, low-amplitude manipulation to each subject's cervical spine.

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

Outcomes

Primary Outcome Measures

Joint position sense test
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.
Digital sphygmomanometer
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
Respiratory rate measurement
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 .
NPRS (Numeric Pain Rating Scale).
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
NDI (U) (Neck Disability Index)
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

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
July 25, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05649397
Brief Title
Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain
Official Title
Effects of Cervical Spine Manipulation on Proprioception, Blood Pressure and Respiratory Rate in Patients With Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Mechanical neck pain is known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Neck pain is defined by the international association for the study of pain as: "Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck" . There are variable causes of neck pain like trauma, infections, inflammatory conditions, musculoskeletal conditions, rheumatic diseases, and congenital diseases . There are varying degrees of disability and activity limitation caused by neck pain, like work productivity reduction and decrease quality of life . People who have a sedentary lifestyle, poor occupational postures, students with poor posture, people involved in occupation like computer programming, clerical job workers and desk job works are more likely to suffer from mechanical neck pain . Most common cause of mechanical neck pain is muscle tightness, Upper trapezius and levator scapulae are the most involved muscles
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
pain, proprioception, blood pressure, respiratory rate, cervical manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical manipulation
Arm Type
Experimental
Arm Description
in the cervical manipulation, provide a high velocity, low-amplitude manipulation to each subject's cervical spine.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
cervical manipulation
Intervention Description
provide a high velocity, low-amplitude manipulation to each subject's cervical spine.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Joint position sense test
Description
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.
Time Frame
four weeks
Title
Digital sphygmomanometer
Description
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
Time Frame
four weeks
Title
Respiratory rate measurement
Description
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 .
Time Frame
four weeks
Title
NPRS (Numeric Pain Rating Scale).
Description
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
Time Frame
four weeks
Title
NDI (U) (Neck Disability Index)
Description
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
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maria Khalid, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international hospital Sihala
City
Islamabad
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain

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