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Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain (MET&SSinNckp)

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Muscle Enery Techniques
Static Stretching
Sponsored by
Obafemi Awolowo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Static stretching, ,, neck pain,, muscle energy techniques, visual analogue scale,, neck disability index

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:i. Male and female patients with history of mechanical neck pain of more than 3 months

Exclusion Criteria:

  • Patients with acute neck pain
  • Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse.
  • Patients with history of surgery of the cervical spine during the previous 12months

Sites / Locations

  • Obafemi Awolowo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Muscle Energy Technique (MET)

Static stretching (SS)

Arm Description

MET Group received 12 treatment sessions of MET (Nagrale et al, 2010) two times a week in addition to conventional physiotherapy. The procedures employ voluntary muscle contractions by the patient in a precisely controlled direction and intensity against a counterforce applied by the Physiotherapist. The technique requires the therapist to provide stabilization to the segment on which the distal aspect of the muscle attaches. A command for anisometric contraction of the muscle is given that causes accessory movement of the joint. Several specific muscle energy techniques are described for the subcranial region of the cervical spine.

Subjects in SS Group received 12 treatment sessions of static stretching (Dutton et al, 2008) two times a week in addition to conventional physiotherapy. Stretching involves the application of manual or mechanical force to elongate structures that have adaptively shortened and are hypo-mobile (Sullivan, 2007) Static stretching involves stretching a muscle to a point of discomfort and holding the stretch for a length of time, followed by a return to normal resting muscle length (Andrews et al, 2004). Muscles of the neck were stretched in especially in side flexion, extension, flexion and side rotation for 10 seconds and was repeated 10 times for a session.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
VAS is a one-dimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases (Mc Cormack et al, 1988). pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (Aun et al, 1986)

Secondary Outcome Measures

Neck Disability Index (NDI)
The NDI can be scored as a raw score or doubled and expressed as a percent (Vernon, 1991). Each session is scored on a 0 to 5 rating scale, in which zero means 'No Pain' and 5 means 'Worst Imaginable Pain'. All the points can be summarized as a total score. The test can be interpreted as a raw score with a maximum score of 50 or as a percentage.

Full Information

First Posted
April 15, 2020
Last Updated
April 16, 2020
Sponsor
Obafemi Awolowo University
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1. Study Identification

Unique Protocol Identification Number
NCT04350918
Brief Title
Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain
Acronym
MET&SSinNckp
Official Title
Effects Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain: A Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo University

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 becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the patient's daily activities. There is lack of evidence to allow conclusions to be drawn about the effectiveness of MET when compared with stretching exercises for relieving mechanical neck pain. Therefore, this study is designed to examine the effect of MET, static stretching and to compare their effects on pain intensity and functional disability in patient with mechanical neck pain.
Detailed Description
This experimental study purposively recruited 24 subjects (male: n=10, female: n = 14) with mechanical neck pain from the Outpatient Physiotherapy Department of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife. Subjects were randomly allocated into the MET and SS groups. Subjects in MET group received 6 treatment sessions of Muscle Energy Technique in addition to conventional physiotherapy treatments. Patients in SS group received 6 treatment sessions of Static Stretching in addition to conventional physiotherapy treatments. All subjects were treated twice a week for six weeks. Visual Analogue Scale (VAS) and Neck Disability Index (NDI) were used to assess the pain intensity and functional disability at baseline, 3rd week and 6th week of treatment sessions respectively. Descriptive and Inferential statistics were used to analyse the data. Alpha level was set at < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Static stretching, ,, neck pain,, muscle energy techniques, visual analogue scale,, neck disability index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects for this study were patients diagnosed of mechanical neck pain in Physiotherapy Outpatient Department of Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife. Individuals who meet the inclusion criteria were randomly allocated to Muscle Energy Techniques Group and Static Stretching Group using the simple random assignment method without replacement (Fish Bowl).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle Energy Technique (MET)
Arm Type
Experimental
Arm Description
MET Group received 12 treatment sessions of MET (Nagrale et al, 2010) two times a week in addition to conventional physiotherapy. The procedures employ voluntary muscle contractions by the patient in a precisely controlled direction and intensity against a counterforce applied by the Physiotherapist. The technique requires the therapist to provide stabilization to the segment on which the distal aspect of the muscle attaches. A command for anisometric contraction of the muscle is given that causes accessory movement of the joint. Several specific muscle energy techniques are described for the subcranial region of the cervical spine.
Arm Title
Static stretching (SS)
Arm Type
Experimental
Arm Description
Subjects in SS Group received 12 treatment sessions of static stretching (Dutton et al, 2008) two times a week in addition to conventional physiotherapy. Stretching involves the application of manual or mechanical force to elongate structures that have adaptively shortened and are hypo-mobile (Sullivan, 2007) Static stretching involves stretching a muscle to a point of discomfort and holding the stretch for a length of time, followed by a return to normal resting muscle length (Andrews et al, 2004). Muscles of the neck were stretched in especially in side flexion, extension, flexion and side rotation for 10 seconds and was repeated 10 times for a session.
Intervention Type
Device
Intervention Name(s)
Muscle Enery Techniques
Other Intervention Name(s)
MET
Intervention Description
Group of patients that underwent muscle energy technique as a mean of treatment for the complaint
Intervention Type
Device
Intervention Name(s)
Static Stretching
Other Intervention Name(s)
SS
Intervention Description
Set of patients that had static stretching technique for the treatment for the complaint
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
VAS is a one-dimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases (Mc Cormack et al, 1988). pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (Aun et al, 1986)
Time Frame
From March 2019 to November 2019, The treatment for each patient was for 6 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
The NDI can be scored as a raw score or doubled and expressed as a percent (Vernon, 1991). Each session is scored on a 0 to 5 rating scale, in which zero means 'No Pain' and 5 means 'Worst Imaginable Pain'. All the points can be summarized as a total score. The test can be interpreted as a raw score with a maximum score of 50 or as a percentage.
Time Frame
From March 2019 to November 2019, The treatment for each patient was for 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:i. Male and female patients with history of mechanical neck pain of more than 3 months Exclusion Criteria: Patients with acute neck pain Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse. Patients with history of surgery of the cervical spine during the previous 12months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adesola O Ojoawo PhD
Organizational Affiliation
Head, Department of Medical Rehabilitation, Obafemi Awolowo University Ile Ife
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kayode Ijaduola
Organizational Affiliation
Provost, College of Health Sciences, Obafemi Awolowo University
Official's Role
Study Chair
Facility Information:
Facility Name
Obafemi Awolowo University
City
Ile Ife
State/Province
Osun
ZIP/Postal Code
220005
Country
Nigeria

12. IPD Sharing Statement

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Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain

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