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Cervical Spine DiseaseNCT04716192

Positional Release Technique in Patients With Unilateral Subacute Trapezitis

A study testing Positional release technique and Myofascial release technique & Ultrasound in people with Cervical Spine Disease, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the effects of positional release technique to improve the cervical range of motion, relieve pain and function in the patient with unilateral subacute trapezitis. Read more about this study

Who is it for?
Ages 25 to 40 years
Conditions the study is for
Cervical Spine Disease
What is being tested?
Positional release technique and Myofascial release technique & Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
25 Jan 2021to 25 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pain with less than 3 months duration
  • Subjects of sub- acute trapezitis with trigger points
  • Taut band palpable in upper trapezius muscle
  • Excruciating spot tenderness at one point along the length of the taut band of the upper trapezius muscle
  • Restriction in cervical lateral flexion when measured
  • Pain increased by elongating (stretching) the trapezius muscle.

Who cannot join

  • Traumatic Neck Injury
  • Fracture of cervical vertebras
  • Cervical Spinal Cord Compromise
  • Cervical Radiculopathy
  • Spondylolisthesis of the cervical spine
  • A history of heart disease or the presence of a pacemaker

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Met Life Rehab center

    Lahore, Punjab Province, 38000

Other trials in Pakistan

About this study

Official title: Effects of Positional Release Technique on Pain, Range of Motion and Function in Patients With Unilateral Subacute Trapezitis

To assess the effects of positional release technique to improve the cervical range of motion, relieve pain and function in the patient with unilateral subacute trapezitis.

Read the detailed description

Trapezius pain is the most common muscular pain due to increased stress which results in trapezitis. The trapezius muscle is postural muscle diamond shape highly susceptible to overuse. It helps in extension, neck rotation, and side bending. Trapezitis is frequently caused by bad posture, watching TV or working on computer for a long and use of thick pillo. Passive ROM may be painful and restricted due to protective spasm in muscle. This study will be a Randomized controlled study and will be conducted in Met Life Rehablitation center Lahore. The study will be completed within the time duration of six months . Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effect of positional release technique in subacute unilateral trapezitis. Patient will be divided into two groups. Mayoficial release therapy and ultrasound will be given to both groups as a baseline treatment. (Group A will be treated with positional release technique, mayofascial release technique and ultrasound while Group B will be treated with mayofascial release technique and ultrasound). All measurements will be taken at baseline and at the end of 2nd week.Each group will be given 3 sessions per week for 2 weeks. Neck disability index will be used to measure function, Numeric pain rating scale will be used to measure pain intensity and goniometer will be used to measure cervical lateral flexion and extension and rotation range of motion. Data will be analyzed on SPSS 25.

Being tested
Positional release technique, Myofascial release technique & Ultrasound
Keywords
Positional release therapy, trapezitis, subacute, pain, cervical ROM
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positional release techniqueOther

    Positional Release Technique The subject lies supine with therapist standing on the affected side; tender points are located along the upper fibres of the trapezius. Pressure will applied by pinching the muscle between the thumb and fingers. The subject's head is laterally flexed toward the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 90° a slight flexion or extension is added to obtain fine-tune. The ideal position of comfort achieved is held for a period of 90 seconds and followed by a passive return of the body part to an anatomically neutral position continued for 5 minutes.

    Mayofascial Release Technique Therapeutic Ultrasound

  • Myofascial release technique & UltrasoundOther

    Myofascial Release Technique

    • Position of the patient - sitting comfortably with supported back, elbow flexed with forearm placed on a pillow. A low load, long duration stretch is applied along the lines of maximal fascial restrictions. The fascia is palpated and the pressure is applied directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. The pressure will be applied for 90 to120 seconds. This procedure will carried out without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved.
    • Therapeutic ultrasound with the frequency of 3Mhz , with continuous mode and an intensity of 0.1-1.5 W/cm2 for a duration of 5 min will given with the patient position back rest.
Study groups in NCT04716192
Study groupRoleWhat they receive
Positional release techniqueExperimentalPositional release technique, Mayofascial release technique and ultrasound
Receives: Other: Positional release technique; Other: Myofascial release technique & Ultrasound
Mayofascial release technique and ultrasoundActive comparatorMayofascial release technique and ultrasound
Receives: Other: Myofascial release technique & Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UNIVERSAL GONIOMETER

    UG is a reliable device to evaluate cervical ROM. The UG is cheap, easy to use, popular instrument and requires minimum training. Intra-rater reliability is observed for both raters measuring ACROM using UG, with ICC (2,1) ranging from 0.83 to 0.98.

    Measured: 2 weeks

  2. NUMERIC PAIN RATING SCALE

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.

    Measured: 2 weeks

  3. NECK DISABILITY INDEX

    Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI). Face validity was ensured through peer-review and patient feedback sessions. Test-retest reliability was conducted (Pearson's r = 0.89, p ≤ . 05)

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start25 Jan 2021
  3. Primary completion25 May 2021
  4. Study completion25 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716192
Sponsor's protocol ID
REC/LHR/20/1039 Sana Naz
Status last verified
May 2022
First submitted
19 Jan 2021
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parab AA, Pattanshetty R. Effect of myofascial release versus muscle energy technique on trapezius spasm in head and neck cancer patients: A randomized clinical trial. Indian Journal of Physical Therapy and Research. 2019;1(2):114.

  • Chaudhary ES, Shah N, Vyas N, Khuman R, Chavda D, Nambi G. Comparative study of myofascial release and cold pack in upper trapezius spasm. International Journal of Health Sciences & Research. 2013;3(12):20-7.

  • Mishra D, Prakash RH, Mehta J, Dhaduk A. Comparative Study of Active Release Technique and Myofascial Release Technique in Treatment of Patients with Upper Trapezius Spasm. Journal of Clinical & Diagnostic Research. 2018;12(11).

  • Karthick K. A Study on the Effectiveness of Positional Release Therapy in the Management of Trapezitis. Research & Reviews: Journal of Computational Biology. 2018;6(2):19-25.

Questions about this trial

What is this clinical trial studying?

A study testing Positional release technique and Myofascial release technique & Ultrasound in people with Cervical Spine Disease, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UNIVERSAL GONIOMETER (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04716192, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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