Clinical trial NCT05021107: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: NPRS
timeFrame: 4 weeks
measure: NDI
timeFrame: 4 weeks
measure: Goniometer
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sanabil Health Services hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Salman Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.