Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload

Neck Pain Clinical Trial

Official title:

Effects Of Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021107
• Other study ID #: REC/Lhr/21/0119 Adeel
• Status: Completed
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: March 20, 2022

Study information

• Verified date: April 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 20, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

1. 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)

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• FDM with isometrics
FDM with isometrics will be done
• FDM without isometrics
FDM without isometrics will be done

Locations

Country	Name	City	State
Pakistan	Sanabil Health Services hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. Review. — View 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. — View 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. English, Polish. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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)	4 weeks
Primary	Goniometer	to measure range	4 weeks