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

NCT ID: NCT05021107

Last Updated: 2022-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2022-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neck Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Fascial Distortion Model with neck isometrics

Group Type EXPERIMENTAL

FDM with isometrics

Intervention Type OTHER

FDM with isometrics will be done

Group B

Fascial Distortion Model with neck isometrics

Group Type ACTIVE_COMPARATOR

FDM without isometrics

Intervention Type OTHER

FDM without isometrics will be done

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FDM with isometrics

FDM with isometrics will be done

Intervention Type OTHER

FDM without isometrics

FDM without isometrics will be done

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad Salman Bashir, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanabil Health Services hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17514162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32158655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21393647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25659245 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/Lhr/21/0119 Adeel

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.