NCT04716192

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

January 19, 2021

Last Update Submit

May 31, 2022

Conditions

Keywords

Positional release therapytrapezitissubacute, paincervical ROM

Outcome Measures

Primary Outcomes (3)

  • 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.

    2 weeks

  • 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.

    2 weeks

  • 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)

    2 weeks

Study Arms (2)

Positional release technique

EXPERIMENTAL

Positional release technique, Mayofascial release technique and ultrasound

Other: Positional release techniqueOther: Myofascial release technique & Ultrasound

Mayofascial release technique and ultrasound

ACTIVE COMPARATOR

Mayofascial release technique and ultrasound

Other: Myofascial release technique & Ultrasound

Interventions

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

Positional release technique

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.

Mayofascial release technique and ultrasoundPositional release technique

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Met Life Rehab center

Lahore, Punjab Province, 38000, Pakistan

Location

Related Publications (4)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Myofascial Release TherapyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Saima Zahid, 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

January 19, 2021

First Posted

January 20, 2021

Study Start

January 25, 2021

Primary Completion

May 25, 2021

Study Completion

July 25, 2021

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations