Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
FDM with isometrics
FDM without isometrics
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
- Trigger band pain pattern
- Age limit 20 to 30 years.
- Male and female
- Pain in the cervical spine
- Limited cervical ROM
- Uneasiness while working in a sitting posture for 4 hours but no abnormal neurological findings
Exclusion Criteria:
- Progressive degeneration of spine (spondylosis)
- Previous cervical spine injuries
- Congenital and developed spine deformities (scoliosis)
Sites / Locations
- Sanabil Health Services hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Fascial Distortion Model with neck isometrics
Fascial Distortion Model with neck isometrics
Outcomes
Primary Outcome Measures
NPRS
will be used for pain measurement. It is a unitdimensional 11 point scale (0-10) with measure of pain intensity with High test-retest reliability of r = 0.96 and validity correlations range from 0.86 to 0.95.
NDI
will be used to check neck disability. Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)
Goniometer
to measure range
Secondary Outcome Measures
Full Information
NCT ID
NCT05021107
First Posted
August 23, 2021
Last Updated
April 21, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05021107
Brief Title
Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload
Official Title
Effects Of Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
March 20, 2022 (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 spine pain is the one the most common musculoskeletal disorder and spinal overload is one of the major causes. Forward tilting of every inch of head increases load on the cervical spine and is referred as cervical spine overload. Persistent overloading and overburdening results in radiation of pain, weakness of muscles and limitation in joint range.
Psychological factors are also play role in acute, sub-acute or chronic neck pain. Treatment commonly used for this pain is NSAID, physiotherapy interventions (mobilisation, manipulation, TENS, ultrasound, stretching, isometrics and FDM) and awareness about posture. FDM was established in 1991 by Stephan Typaldos and it recommends that musculoskeletal ailments are due to disruption in fascia. There are 6 diverse proposed facial distortions and diagnosis in this model i.e., trigger band, herniated trigger band, folding distortion, continuum distortion, tectonic fixation and cylinder distortion. Main purpose of this randomised clinical trial will be to find out the effects of fascial distortion model with and without neck isometrics in patients with cervical spine overload.
Patients will be recruited into study by consecutive sampling technique and after that patients will be allocated to the groups by random sampling assignment. NPRS, NDI and goniometer will be used as data measuring tool. Treatment will be given to 2 groups. One group will get treatment of only FDM and other group will get treatment of FDM and neck isometrics as well. Treatment will be given two times a week for 4weeks and duration of the session will be of 30 minutes. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Fascial Distortion Model with neck isometrics
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Fascial Distortion Model with neck isometrics
Intervention Type
Other
Intervention Name(s)
FDM with isometrics
Intervention Description
FDM with isometrics will be done
Intervention Type
Other
Intervention Name(s)
FDM without isometrics
Intervention Description
FDM without isometrics will be done
Primary Outcome Measure Information:
Title
NPRS
Description
will be used for pain measurement. It is a unitdimensional 11 point scale (0-10) with measure of pain intensity with High test-retest reliability of r = 0.96 and validity correlations range from 0.86 to 0.95.
Time Frame
4 weeks
Title
NDI
Description
will be used to check neck disability. Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)
Time Frame
4 weeks
Title
Goniometer
Description
to measure range
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
Trigger band pain pattern
Age limit 20 to 30 years.
Male and female
Pain in the cervical spine
Limited cervical ROM
Uneasiness while working in a sitting posture for 4 hours but no abnormal neurological findings
Exclusion Criteria:
Progressive degeneration of spine (spondylosis)
Previous cervical spine injuries
Congenital and developed spine deformities (scoliosis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanabil Health Services hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17514162
Citation
Sipko T, Biec E, Demczuk-Wlodarczyk E, Ciesielska B. Mobility of cervical spine and postural equilibrium in patients with spinal overload syndrome. Ortop Traumatol Rehabil. 2007 Mar-Apr;9(2):141-8. English, Polish.
Results Reference
background
PubMed Identifier
32158655
Citation
Dasgupta S, Rozario JE. Troika of Posture, Occlusion and Airway. Indian J Otolaryngol Head Neck Surg. 2020 Mar;72(1):49-54. doi: 10.1007/s12070-019-01734-7. Epub 2019 Sep 11.
Results Reference
background
PubMed Identifier
21393647
Citation
Mysliwiec A, Saulicz E, Kuszewski M, Kokosz M, Wolny T. Assessment of the influence of Saunders traction and transcutaneous electrical nerve stimulation on hand grip force in patients with neck pain. Ortop Traumatol Rehabil. 2011 Jan-Feb;13(1):37-44. doi: 10.5604/15093492.933786. English, Polish.
Results Reference
background
PubMed Identifier
25659245
Citation
Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
Results Reference
background
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Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload
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