Positional Release Technique in Patients With Unilateral Subacute Trapezitis
Primary Purpose
Cervical Spine Disease
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Positional release technique
Myofascial release technique & Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spine Disease focused on measuring Positional release therapy, trapezitis, subacute, pain, cervical ROM
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Met Life Rehab center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Positional release technique
Mayofascial release technique and ultrasound
Arm Description
Positional release technique, Mayofascial release technique and ultrasound
Mayofascial release technique and ultrasound
Outcomes
Primary Outcome Measures
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.
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.
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04716192
First Posted
January 19, 2021
Last Updated
May 31, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04716192
Brief Title
Positional Release Technique in Patients With Unilateral Subacute Trapezitis
Official Title
Effects of Positional Release Technique on Pain, Range of Motion and Function in Patients With Unilateral Subacute Trapezitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
July 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spine Disease
Keywords
Positional release therapy, trapezitis, subacute, pain, cervical ROM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positional release technique
Arm Type
Experimental
Arm Description
Positional release technique, Mayofascial release technique and ultrasound
Arm Title
Mayofascial release technique and ultrasound
Arm Type
Active Comparator
Arm Description
Mayofascial release technique and ultrasound
Intervention Type
Other
Intervention Name(s)
Positional release technique
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Myofascial release technique & Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
UNIVERSAL GONIOMETER
Description
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.
Time Frame
2 weeks
Title
NUMERIC PAIN RATING SCALE
Description
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.
Time Frame
2 weeks
Title
NECK DISABILITY INDEX
Description
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)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saima Zahid, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Met Life Rehab center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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).
Results Reference
background
Citation
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.
Results Reference
background
Learn more about this trial
Positional Release Technique in Patients With Unilateral Subacute Trapezitis
We'll reach out to this number within 24 hrs