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Effects of Post Isometric Relaxation With Scapular Stabilization Exercises

Primary Purpose

Upper Cross Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Post-isometric relaxation and Conventional treatment
Conventional Physical Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Cross Syndrome focused on measuring Neck muscles, Neck Pain, levator scapulae, Range of Motion

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both Males and females Age range of 18-40 years Neck and medial border scapular pain for at least 3months Examination - Increased muscle tone and tenderness at neck Reduced Side flexion and Rotation of neck Positive Levator Scapular length Test Exclusion Criteria: Neuropathies Vertebral fractures Pregnancy Previous cognitive and functional disorders Traumatic neck injury Fibromyalgia cancer

Sites / Locations

  • Tehsil Headquarter Hospital Sharqpur ShareefRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: post isometric relaxation and ConVentional treatment.

Group B: Conventional treatment

Arm Description

Post Isometric Relaxation: The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec.

hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient

Outcomes

Primary Outcome Measures

Universal Goniometer (UG)
Universal Goniometer (UG) used to measure ROM of cervical Spine A goniometer is an instrument that measures the available range of motion at a joint. Physical therapists commonly use a goniometer to measure the range of motion. The therapist can use a goniometer to assess the range of motion at the initial assessment. In this study range of motion of the neck will be measured. The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.
Numeric pain rate scale (NPRS)
The numeric pain rate scale (NPRS) measures the pain at the neck region in patients with mechanical neck pain. The patient's level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst pain. NPRS is categorized into mild, moderate and severe pain. Mild pain value 1 to 3 Moderate pain value 4 to 7 Severe pain value 8 to 10
Neck Disability index (NDI)
Neck Disability index (NDI) measures the disability of the neck region in patients with mechanical pain. NDI questionnaire will be used to assess disability. It comprises 10 items; 7 related to daily living activities, 2 related to pain and 1 to concentration. Each item is scored from 0 to 5. The total score is a percentage, with higher scores related to more significant disability. 0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete

Secondary Outcome Measures

Full Information

First Posted
June 27, 2023
Last Updated
July 25, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05973682
Brief Title
Effects of Post Isometric Relaxation With Scapular Stabilization Exercises
Official Title
Effects of Post Isometric Relaxation With Scapular Stabilization Exercises on Pain, Range of Motion and Disability With Levator Scapulae Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

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
The levator scapulae is an important postural muscle that tends to shorten or become tight because of overactivity and bad posture, leading to neck and shoulder pain. Levator scapulae syndrome is usually caused by the poor shoulders posture as rounded shoulders as sitting at a computer hunched. It is exacerbated by sustained neck postures, neck movements or levator scapulae muscle palpation. The aim of study will be to determine the effects of post isometric relaxation with scapular stabilization exercises on pain, disability and range of motion in patients with levator scapulae syndrome.
Detailed Description
A Randomized Controlled Trial will be conducted at Tehsil Headquarter Hospital Sharqpur Shareef, Sheikhupura through consecutive sampling technique on 30 patients with levator scapulae syndrome which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with post isometric relaxation, scapular stabilization exercises along with baseline treatment. Group B will be treated with post isometric relaxation along with baseline treatment. Baseline treatment includes hot pack, TENS, upper trapezius stretch, levator scapular stretch and pectoralis major stretch. Both groups will come thrice per week for a total of 4 weeks. Outcome measures are NPRS, universal goniometer and NDI. Data will be analysed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Keywords: Disability, Levator Scapulae, Range of Motion, Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Cross Syndrome
Keywords
Neck muscles, Neck Pain, levator scapulae, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: post isometric relaxation and ConVentional treatment.
Arm Type
Experimental
Arm Description
Post Isometric Relaxation: The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec.
Arm Title
Group B: Conventional treatment
Arm Type
Active Comparator
Arm Description
hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient
Intervention Type
Other
Intervention Name(s)
Post-isometric relaxation and Conventional treatment
Intervention Description
The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec. + hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30 second hold. static stretching exercises two sessions per week for 3 weeks were given to each patient
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Conventional Physical Therapy; hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient
Primary Outcome Measure Information:
Title
Universal Goniometer (UG)
Description
Universal Goniometer (UG) used to measure ROM of cervical Spine A goniometer is an instrument that measures the available range of motion at a joint. Physical therapists commonly use a goniometer to measure the range of motion. The therapist can use a goniometer to assess the range of motion at the initial assessment. In this study range of motion of the neck will be measured. The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.
Time Frame
upto 4 weeks
Title
Numeric pain rate scale (NPRS)
Description
The numeric pain rate scale (NPRS) measures the pain at the neck region in patients with mechanical neck pain. The patient's level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst pain. NPRS is categorized into mild, moderate and severe pain. Mild pain value 1 to 3 Moderate pain value 4 to 7 Severe pain value 8 to 10
Time Frame
upto 4 weeks
Title
Neck Disability index (NDI)
Description
Neck Disability index (NDI) measures the disability of the neck region in patients with mechanical pain. NDI questionnaire will be used to assess disability. It comprises 10 items; 7 related to daily living activities, 2 related to pain and 1 to concentration. Each item is scored from 0 to 5. The total score is a percentage, with higher scores related to more significant disability. 0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete
Time Frame
upto 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both Males and females Age range of 18-40 years Neck and medial border scapular pain for at least 3months Examination - Increased muscle tone and tenderness at neck Reduced Side flexion and Rotation of neck Positive Levator Scapular length Test Exclusion Criteria: Neuropathies Vertebral fractures Pregnancy Previous cognitive and functional disorders Traumatic neck injury Fibromyalgia cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samrood Akram, MPhil
Phone
92-3324806143
Email
samrood.akram@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Samrood Akram, Mphil
Phone
92-3324806143
Email
samrood.akram@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, Mphil
Organizational Affiliation
Riphah International University,Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehsil Headquarter Hospital Sharqpur Shareef
City
Sheikhupura
State/Province
Punjab
ZIP/Postal Code
39460
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, Mphil
Phone
92-3324806143
Email
samrood.akram@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31773477
Citation
Mahmoud NF, Hassan KA, Abdelmajeed SF, Moustafa IM, Silva AG. The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. Curr Rev Musculoskelet Med. 2019 Dec;12(4):562-577. doi: 10.1007/s12178-019-09594-y.
Results Reference
background
PubMed Identifier
30759118
Citation
Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
Results Reference
background
PubMed Identifier
34682453
Citation
Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
Results Reference
background
PubMed Identifier
33187167
Citation
Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.
Results Reference
background
PubMed Identifier
31971759
Citation
Henry JP, Munakomi S. Anatomy, Head and Neck, Levator Scapulae Muscles. 2022 Aug 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553120/
Results Reference
background
PubMed Identifier
31060367
Citation
Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
Results Reference
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Effects of Post Isometric Relaxation With Scapular Stabilization Exercises

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