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Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy
Sustained Natural Apophyseal Glides and conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring pain, thoracic manipulation, sustained natural epiphyseal glides, neck disability index

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand Cervical Lateral flexion and rotation <60 degree Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60° Hypomobility at T1- T5 thoracic vertebrae on springing test. Exclusion Criteria: Participants with a history of vertebro-basilary artery insufficiency. Patient with history of cervical surgery or arthroplasty Patients with a positive history of trauma, fracture or surgery of the cervical spine Diagnosed cases of Torticollis, and scoliosis History of osteoporosis, Any heart disease

Sites / Locations

  • The Physiotherapy clinic Saidpur Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy

Sustained Natural Apophyseal Glides and conventional therapy

Arm Description

After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland et al

Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).

Outcomes

Primary Outcome Measures

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.
Inclinometer
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.
(Neck Disability Index) Urdu
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. The total scores (ICC = 0.99) of the Neck Disability Index -Urdu.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05749835
Brief Title
Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy
Official Title
Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 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
Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors. Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine
Detailed Description
Patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. Disc herniation accounts for 20-25% of the cases of cervical radiculopathy. Most of the time cervical radiculopathy appears unilaterally; however it is possible for bilateral symptoms to be present if severe bony spurs are present at one level, impinging/irritating the nerve root on both sides. If peripheral radiation of pain, weakness, or pins and needle are present, the location of the pain will follow back to the concerned affected nerve root Manual techniques include positional release technique, muscle energy technique, myofascial release technique, Cyriax technique, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, manual pressure release, proprioceptive neuromuscular facilitation and ischemic compression. Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
pain, thoracic manipulation, sustained natural epiphyseal glides, neck disability index

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy
Arm Type
Experimental
Arm Description
After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland et al
Arm Title
Sustained Natural Apophyseal Glides and conventional therapy
Arm Type
Experimental
Arm Description
Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).
Intervention Type
Other
Intervention Name(s)
Thoracic Manipulation and Sustained Natural Apophyseal Glides and conventional therapy
Intervention Description
After the segmental mobility examination of thoracic spine, the therapist will apply a high-velocity, end range screw thrust to a restricted segment of the thoracic spine as described by Maitland.
Intervention Type
Other
Intervention Name(s)
Sustained Natural Apophyseal Glides and conventional therapy
Intervention Description
Position of therapist: stands beside the patient, while his\her head is cradled between your body and your right forearm (when you stand at his\her right side). Gentle pressure is now applied in a ventral direction on the spinous process of C7 while the skull remains still due to the control of your right forearm. (The really gentle moving force to do this comes from your left arm via the thenar eminence over the little finger on the spine of C7).
Primary Outcome Measure Information:
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.
Time Frame
four weeks
Title
Inclinometer
Description
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.
Time Frame
four weeks
Title
(Neck Disability Index) Urdu
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. The total scores (ICC = 0.99) of the Neck Disability Index -Urdu.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand Cervical Lateral flexion and rotation <60 degree Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60° Hypomobility at T1- T5 thoracic vertebrae on springing test. Exclusion Criteria: Participants with a history of vertebro-basilary artery insufficiency. Patient with history of cervical surgery or arthroplasty Patients with a positive history of trauma, fracture or surgery of the cervical spine Diagnosed cases of Torticollis, and scoliosis History of osteoporosis, Any heart disease
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
The Physiotherapy clinic Saidpur Road
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy

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