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Effects of Cervical Spine Manipulation

Primary Purpose

Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cervical spine manipulation
traction
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Pain

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1.presence MTrps in upper trapezius
  • limited side bending and rotation
  • both gender
  • age between 25 to 45

Exclusion Criteria:

  • Malignancy, infection, trauma, bone deformities.
  • Acute Disc Protrusion
  • Positive VBI
  • Positive Sharp purser test
  • History of whiplash injury

Sites / Locations

  • Dr. Abdul Gaffoor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cervical spine manipulation

traction

Arm Description

In spinal manipulation, the velocity, magnitude and direction of the impulse are controlled to encourage relaxation and comfort of muscle and connective tissue.

aimed to relieve pressure on the spine

Outcomes

Primary Outcome Measures

changes from the baseline in Algometer values
It is a device used to identify the pressure and force eliciting a pressure pain threshold. The hand held algometer 1 cm round rubber surface which applies force and display for readings in newtons or kilograms.Sustained force is usually applied at the right angle to the soft tissue. Estimated pressure application rates have ranged from 0.05 to 20N/s. it has a high validity and reliability for measuring pain pressure threshold in patients of myofascial trigger points.
changes from the baseline in Inclinometer values
It is a device used to measure neck ranges of motion.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2022
Last Updated
October 12, 2022
Sponsor
University of Lahore
Collaborators
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05582733
Brief Title
Effects of Cervical Spine Manipulation
Official Title
Effects of Cervical Spine Manipulation on Upper Trapezius Active Versus Conventional Techniques.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
Collaborators
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
No

5. Study Description

Brief Summary
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.
Detailed Description
To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method. Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used for pre and post assessment. Outcomes were measured by algometry and inclinometer before and after the application of respective techniques. The data was analyzed at baseline and immediately after the intervention on IBM SPSS-21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.
Masking
Participant
Masking Description
Free envelop method
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical spine manipulation
Arm Type
Experimental
Arm Description
In spinal manipulation, the velocity, magnitude and direction of the impulse are controlled to encourage relaxation and comfort of muscle and connective tissue.
Arm Title
traction
Arm Type
Experimental
Arm Description
aimed to relieve pressure on the spine
Intervention Type
Other
Intervention Name(s)
Cervical spine manipulation
Intervention Description
hot pack for 10 minutes will be applied followed by cervical manipulation (chin hold kaltenborn) once and then stretching
Intervention Type
Other
Intervention Name(s)
traction
Intervention Description
Hot pack will be applied followed by sustained pressure or MPR for 90 sec and then stretching.
Primary Outcome Measure Information:
Title
changes from the baseline in Algometer values
Description
It is a device used to identify the pressure and force eliciting a pressure pain threshold. The hand held algometer 1 cm round rubber surface which applies force and display for readings in newtons or kilograms.Sustained force is usually applied at the right angle to the soft tissue. Estimated pressure application rates have ranged from 0.05 to 20N/s. it has a high validity and reliability for measuring pain pressure threshold in patients of myofascial trigger points.
Time Frame
Baseline and 3 weeks
Title
changes from the baseline in Inclinometer values
Description
It is a device used to measure neck ranges of motion.
Time Frame
Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1.presence MTrps in upper trapezius limited side bending and rotation both gender age between 25 to 45 Exclusion Criteria: Malignancy, infection, trauma, bone deformities. Acute Disc Protrusion Positive VBI Positive Sharp purser test History of whiplash injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, PHD*
Organizational Affiliation
ghafoor.sajjad@riphah.edu.pk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Abdul Gaffoor
City
Islamabad
ZIP/Postal Code
00430
Country
Pakistan

12. IPD Sharing Statement

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Effects of Cervical Spine Manipulation

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