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Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A (Control Group - Static Stretching + Standard Treatment)
Group B (Autogenic Inhibition - PIR + Standard treatment)
Group C (Reciprocal Inhibition - RI + Standard treatment)
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Muscle Energy Techniques, Autogenic Inhibition, Reciprocal Inhibition, Stretching, Range of Motion, Muscle Strength, VAS, Neck Disability Index, NDI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group A (Control Group - Static Stretching)

Group B (Autogenic Inhibition MET)

Group C (Reciprocal Inhibition MET)

Arm Description

(Control Group - Static Stretching + Standard Treatment)

(Autogenic Inhibition - PIR + Standard treatment)

(Reciprocal Inhibition - RI + Standard treatment)

Outcomes

Primary Outcome Measures

Pain (Numeric Pain Rating Scale) - Change is being assessed
To measure the pre and post patient's perception of pain
Cervical Range of Motion (CROM) - Change is being assessed
To measure patient's improvement in cervical range of motion
Neck Disability Index (NDI) - Change is being assessed
to measure patient's pre and post functional disability
Cervical Isometric Muscle Strength (Modified Sphygmomanometer dynamometry) - Change is being assessed
To measure patient's improvement in Isometric Muscle Strength

Secondary Outcome Measures

Full Information

First Posted
April 10, 2017
Last Updated
February 7, 2018
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT03136250
Brief Title
Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain
Official Title
Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Muscle Energy Techniques, Autogenic Inhibition, Reciprocal Inhibition, Stretching, Range of Motion, Muscle Strength, VAS, Neck Disability Index, NDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized Controlled trial will be conducted in order to find and compare the effectiveness of conventional stretching and MET 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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participant, investigator and outcome assessor are not aware of which treatment group the participant/patient is placed in.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Control Group - Static Stretching)
Arm Type
Active Comparator
Arm Description
(Control Group - Static Stretching + Standard Treatment)
Arm Title
Group B (Autogenic Inhibition MET)
Arm Type
Experimental
Arm Description
(Autogenic Inhibition - PIR + Standard treatment)
Arm Title
Group C (Reciprocal Inhibition MET)
Arm Type
Experimental
Arm Description
(Reciprocal Inhibition - RI + Standard treatment)
Intervention Type
Other
Intervention Name(s)
Group A (Control Group - Static Stretching + Standard Treatment)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group B (Autogenic Inhibition - PIR + Standard treatment)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Group C (Reciprocal Inhibition - RI + Standard treatment)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pain (Numeric Pain Rating Scale) - Change is being assessed
Description
To measure the pre and post patient's perception of pain
Time Frame
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Title
Cervical Range of Motion (CROM) - Change is being assessed
Description
To measure patient's improvement in cervical range of motion
Time Frame
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Title
Neck Disability Index (NDI) - Change is being assessed
Description
to measure patient's pre and post functional disability
Time Frame
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Title
Cervical Isometric Muscle Strength (Modified Sphygmomanometer dynamometry) - Change is being assessed
Description
To measure patient's improvement in Isometric Muscle Strength
Time Frame
Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, DPT, MS-OMPT, CHPE
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain

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