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

NCT05021107 | Completed DMC

• 1 other identifier: REC/Lhr/21/0119 Adeel
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Goniometer

  to measure range

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Fascial Distortion Model with neck isometrics

Other: FDM with isometrics

Group B

ACTIVE COMPARATOR

Fascial Distortion Model with neck isometrics

Other: FDM without isometrics

Interventions

FDM with isometrics OTHER

FDM with isometrics will be done

Group A

FDM without isometrics OTHER

FDM without isometrics will be done

Group B

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Sanabil Health Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 17514162 BACKGROUND

• 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.

  PMID: 32158655 BACKGROUND

• 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.

  PMID: 21393647 BACKGROUND

• 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.

  PMID: 25659245 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Muhammad Salman Bashir, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 25, 2021
• Study Start: August 10, 2021
• Primary Completion: January 30, 2022
• Study Completion: March 20, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)