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OpenTrials
Completed

NCT Number: NCT05021107

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

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.

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Key information

Conditions

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

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanabil Health Services hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

FDM with isometrics

Other

FDM with isometrics will be done

FDM without isometrics

Other

FDM without isometrics will be done

Primary outcomes

  1. NPRS

    Time frame: 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.

  2. NDI

    Time frame: 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)

  3. Goniometer

    Time frame: 4 weeks

    to measure range

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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