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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 70 years;
  2. Neck pain on NPRS 4 to 8 (moderate cases);
  3. Subacute or chronic cases (4 to 12 weeks).
  4. Decreased or painful Cervical range of motion (CROM)

Exclusion Criteria:

  1. Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
  2. History of cervical spine surgery in previous 12 months;
  3. History of trauma or fractures in cervical spine;
  4. Signs of cervical radiculopathy or myelopathy; and
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A (Control Group - Static Stretching)
(Control Group - Static Stretching + Standard Treatment)
Other: Group A (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)
Other: Group B (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)
Other: Group C (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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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