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Effects of Autogenic and Reciprocal Inhibition on Trapezitis

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
autogenic inhibition
reciprocal inhibition
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring trapezitis, Disability, neck pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mobile phone users age between 20 -40 years old. Both gender male and female included. Neck pain (Numeric Pain Rating Scale >3) With limited Neck ROMs. NDI scoring 15-24points (30-48%) moderate disability Exclusion Criteria: Neck pain with whiplash or headache, neurological disorder. History of previous head, neck, cervical spine or shoulder surgery. Infection or inflammatory arthritis in the cervical spine. Trigger point of Upper trapezius will be excluded. History of cervical radiculopathy. Diagnosed fibromyalgia and myopathy. History of cancer.

Sites / Locations

  • Nusrat Rashid Medical ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

autogenic inhibition

reciprocal inhibition

Arm Description

isometric of muscles and stretching of the same side

isometric of muscles and stretching of the opposite side

Outcomes

Primary Outcome Measures

Goniometry
The art and science of measuring the joint ranges in each plane of the joint are called goniometry. The term 'goniometry' has its origin from two Greek words, gonia, which means angle, and metron, which means to measure. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. A universal goniometer has three parts. The fulcrum and the body are placed over the joint being measured. The stationary arm is the arm of the goniometer that aligns with the inactive part of the joint measured. It is structurally a part of the body and is not movable independently of the body. The moving arm is the arm of the goniometer, which aligns with the mobile part of the joint measured. Neck flexion, extension, side bending and rotation will be assessed through it

Secondary Outcome Measures

NPRS (numeric pain rating scale)
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain. Reliability of NPRS is (r=0.96 and 0.95) and validity is from 0.86 to 0.95
NDI (neck disability index)
The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index). This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. Scoring for each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. The maximum score is 50 (20). Reliability of NDI is 0.50 and 0.98

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06086782
Brief Title
Effects of Autogenic and Reciprocal Inhibition on Trapezitis
Official Title
Comparative Effects of Autogenic and Reciprocal Inhibition Techniques on Pain, Disability and Range of Motion Among Smart Phone User With Trapezitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 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
Aim of my study is to compare two techniques of METS i.e., autogenic and reciprocal inhibition techniques on pain, disability and Range of motion among smart phone user with trapezitis.
Detailed Description
Study focuses trapezitis in smart phone users. There are many different causes of neck pain, but one common factor is upper trapezitis. This refers to pain and spasms in the neck caused by inflammation of the trapezius muscle. The aim of this study is to compare the effects of autogenic and reciprocal inhibition techniques on pain, range of motion and disability among smart phone user with trapezitis. This study will be randomized clinical trial and 40 patients male and female with age 20 to 40 years having NPRS >3 according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability convenience sampling technique. Group A will receive autogenic inhibition technique with conventional physical therapy while Group B will receive reciprocal inhibition technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Total 12 sessions, 3 sessions per week for 4 weeks were provided. Each session was 45 minutes long and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
trapezitis, Disability, neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autogenic inhibition
Arm Type
Experimental
Arm Description
isometric of muscles and stretching of the same side
Arm Title
reciprocal inhibition
Arm Type
Experimental
Arm Description
isometric of muscles and stretching of the opposite side
Intervention Type
Other
Intervention Name(s)
autogenic inhibition
Intervention Description
Group 1 will receive AI-MET with conventional treatment. AI include stretching of the affected muscle and performing isometric contraction with 50% of the total patient's effort in the same muscle that will being stretched and position hold for 10 seconds, with 5 seconds of rest after every repetition. This procedure will repeat 5 times.
Intervention Type
Other
Intervention Name(s)
reciprocal inhibition
Intervention Description
Group 2 receive RI-MET with conventional treatment. The RI also include stretching of the affected muscle but contrary to AI, isometric contraction of the antagonist muscles with the 50% of total patient's effort will follow. This position holds for 10 seconds, while agonist's muscle will still in the stretched position, with 5 seconds of rest after every repetition. This procedure will repeat 5 times too.
Primary Outcome Measure Information:
Title
Goniometry
Description
The art and science of measuring the joint ranges in each plane of the joint are called goniometry. The term 'goniometry' has its origin from two Greek words, gonia, which means angle, and metron, which means to measure. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. A universal goniometer has three parts. The fulcrum and the body are placed over the joint being measured. The stationary arm is the arm of the goniometer that aligns with the inactive part of the joint measured. It is structurally a part of the body and is not movable independently of the body. The moving arm is the arm of the goniometer, which aligns with the mobile part of the joint measured. Neck flexion, extension, side bending and rotation will be assessed through it
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
NPRS (numeric pain rating scale)
Description
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain. Reliability of NPRS is (r=0.96 and 0.95) and validity is from 0.86 to 0.95
Time Frame
4 weeks
Title
NDI (neck disability index)
Description
The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index). This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. Scoring for each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. The maximum score is 50 (20). Reliability of NDI is 0.50 and 0.98
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mobile phone users age between 20 -40 years old. Both gender male and female included. Neck pain (Numeric Pain Rating Scale >3) With limited Neck ROMs. NDI scoring 15-24points (30-48%) moderate disability Exclusion Criteria: Neck pain with whiplash or headache, neurological disorder. History of previous head, neck, cervical spine or shoulder surgery. Infection or inflammatory arthritis in the cervical spine. Trigger point of Upper trapezius will be excluded. History of cervical radiculopathy. Diagnosed fibromyalgia and myopathy. History of cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Humera Mubashar, MS
Phone
+92 308 4157979
Email
humera.mubashar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Humera Mubashar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nusrat Rashid Medical Complex
City
Lahore
State/Province
Punjab
ZIP/Postal Code
16454
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haroon Rashid Rashid, MBBS
Phone
03060063311
Email
info@nusratrashidmedicalcomplex.com
First Name & Middle Initial & Last Name & Degree
Muhammad Awais Hassan, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Autogenic and Reciprocal Inhibition on Trapezitis

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