- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086782
Effects of Autogenic and Reciprocal Inhibition on Trapezitis
Comparative Effects of Autogenic and Reciprocal Inhibition Techniques on Pain, Disability and Range of Motion Among Smart Phone User With Trapezitis
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Humera Mubashar, MS
- Phone Number: +92 308 4157979
- Email: humera.mubashar@riphah.edu.pk
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 16454
- Recruiting
- Nusrat Rashid Medical Complex
-
Contact:
- Haroon Rashid Rashid, MBBS
- Phone Number: 03060063311
- Email: info@nusratrashidmedicalcomplex.com
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Principal Investigator:
- Muhammad Awais Hassan, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: autogenic inhibition
isometric of muscles and stretching of the same side
|
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.
|
Experimental: reciprocal inhibition
isometric of muscles and stretching of the opposite side
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goniometry
Time Frame: 4 weeks
|
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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NPRS (numeric pain rating scale)
Time Frame: 4 weeks
|
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
|
4 weeks
|
NDI (neck disability index)
Time Frame: 4 weeks
|
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
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Humera Mubashar, MS, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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