- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136250
Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain
February 7, 2018 updated by: Foundation University Islamabad
Neck pain is among the most common musculoskeletal disorders worldwide and is an important public health issue in terms of personal wellbeing.
Prevalence of neck pain show excessive variations, with a point prevalence varying between 6% and 22%, and one year prevalence ranging between 1.5-75%.
Neck pain like all other mechanical disorders leads to pain, disability and decreased range of motion (ROM).
Stretching is a very common exercise performed by sportsmen, elderly, in physical therapy and rehabilitation patients, thus practiced in all sorts of fitness programs.
The major types of stretching included in the literature are static, dynamic and pre-contraction stretching; of which static stretching is the conventional type of stretching.
The different types of pre-contraction stretching include Proprioceptive Neuromuscular Facilitation (PNF) stretching, Post Isometric Relaxation (PIR), Post Facilitation stretch (PFS) and Active Isolated Stretch (AIS).
Pre-contraction stretching is also considered a part of Muscle Energy Technique (MET).
Recently MET and pre-contraction stretching have been shown to have significant superiority over conventional stretching in management of mechanical neck pain, but the evidence is currently lacking regarding which of the two pre-contraction stretching protocols, namely autogenic and reciprocal inhibition is more effective than the other.
A RCT will be conducted in order to find and compare the effectiveness of conventional stretching and pre-contraction stretching (autogenic inhibition and reciprocal inhibition).
One Control group (conventional group) and two Experimental groups (Experimental Group A - Autogenic Inhibition & Experimental Group B - Reciprocal Inhibition) will be formed.
The participants will be recruited in the study if they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital and randomized into the three respective groups.
All the groups will receive the gold standard treatment for chronic neck pain including mobilization and modalities.
In addition to the gold standard treatment the participants will receive specific stretching protocol based on their interventional group
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Islamabad, Pakistan
- Foundation university institute of rehabilitation sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 70 years;
- Neck pain on NPRS 4 to 8 (moderate cases);
- Subacute or chronic cases (4 to 12 weeks).
- Decreased or painful Cervical range of motion (CROM)
Exclusion Criteria:
- Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
- History of cervical spine surgery in previous 12 months;
- History of trauma or fractures in cervical spine;
- Signs of cervical radiculopathy or myelopathy; and
- Vascular syndromes such as VBI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A (Control Group - Static Stretching)
(Control Group - Static Stretching + Standard Treatment)
|
o Conventional Gold Standard treatment (Manual Therapy + Modalities) Conventional Static Stretching 15-30 seconds hold 3-5 repetitions (Page P, 2012) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles.
|
Experimental: Group B (Autogenic Inhibition MET)
(Autogenic Inhibition - PIR + Standard treatment)
|
o Conventional Gold Standard treatment (Manual Therapy + Modalities) Post Isometric Relaxation MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles.
(Chaitow L, 2006)
|
Experimental: Group C (Reciprocal Inhibition MET)
(Reciprocal Inhibition - RI + Standard treatment)
|
o Conventional Gold Standard treatment (Manual Therapy + Modalities) Reciprocal Inhibition MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid,Levator Scapulae and Upper Trapezius Muscles (Chaitow L, 2006)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Numeric Pain Rating Scale) - Change is being assessed
Time Frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
To measure the pre and post patient's perception of pain
|
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
Cervical Range of Motion (CROM) - Change is being assessed
Time Frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
To measure patient's improvement in cervical range of motion
|
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
Neck Disability Index (NDI) - Change is being assessed
Time Frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
to measure patient's pre and post functional disability
|
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
Cervical Isometric Muscle Strength (Modified Sphygmomanometer dynamometry) - Change is being assessed
Time Frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
To measure patient's improvement in Isometric Muscle Strength
|
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Osama, DPT, MS-OMPT, CHPE, Foundation University Islamabad
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2017
Primary Completion (Actual)
November 30, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
April 10, 2017
First Submitted That Met QC Criteria
April 27, 2017
First Posted (Actual)
May 2, 2017
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
February 7, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2017/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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