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

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Other: FDM with isometrics; Other: FDM without isometrics

• Registration Number: NCT05021107
• Lead Sponsor: Riphah International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-25
• Primary Completion: 2022-01-30
• Study Completion: 2022-03-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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Exclusion Criteria

• Progressive degeneration of spine (spondylosis)
• Previous cervical spine injuries
• Congenital and developed spine deformities (scoliosis)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	FDM with isometrics	Fascial Distortion Model with neck isometrics
Group B	FDM without isometrics	Fascial Distortion Model with neck isometrics

Primary Outcome Measures

Name	Time	Method
NPRS	4 weeks	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	4 weeks	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	4 weeks	to measure range

Trial Locations

Locations (1)

Sanabil Health Services hospital; 🇵🇰 Lahore, Punjab, Pakistan