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The Effect of Soft Tissue Mobilization in Myofascial Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Dr. Gene's Health and Wellness
Muscle Energy Technique
Static stretching and Cervical non thrust manipulation
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring MNP, MET, Soft tissue mobilization, DNF, Static Stretching

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 45 years
  • Neck pain of minimum duration of six weeks
  • Both males and females
  • Signed informed consent form
  • Tightness of upper trapezius, levator scapulae, scalene muscles on painful side
  • Should not be recieving any other therapeutic intervention
  • Should not be on medication
  • Willing to participate

Exclusion Criteria:

  • Inflammatory, Malignant and Neurological conditions
  • Metabolic disease
  • Neck pain radiating into arms and upper extremity
  • Neck pain associated with headaches or facial pain
  • Recent major trauma or fracture of the cervical spine
  • Referred pain
  • History of surgery of cervical spine

Sites / Locations

  • Harshita Yadav

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional group

DNF Group

MET Group

Arm Description

The treatment was given for 5 days per week for 2 weeks such as MHP (Moist Heat Pack) for 20 minutes, Static Stretching exercises for upper trapezius, levator scapulae and scalene muscle which is held for 10-30 seconds- repeated 3-5 times, Cervical spine non-thrust mobilization (Grade 3) was given to each segment from C2-C7 was oscillated for 10 repetitions, followed by a 10 seconds rest between segments, Cervical spine active ROM (Range of Motion) exercises with 10 repetitions- 2-3 times a day and Postural exercises were given as home programme.

DNF training along with conventional treatment. In this programme, emphasis was placed on first attaining the correct craniocervical flexion action, with minimal activity of the superficial cervical flexor muscles. The craniocervical flexion action involves a specific craniocervical movement (nodding - "yes" movement) of head such that it remains in contact with the supporting surface. Once the correct action had been achieved, participants were instructed in the use of the sphygmomanometer to guide the training of the CCF muscle contraction at the various incremental levels of pressure (22 to 30 mmHg, progressively inner range positions).

MET in additional to conventional treatment. MET was applied to Upper trapezius, Levator scapulae and Scalene Following the 7-10 seconds isometric contraction and complete relaxation of all elements, the stretch is maintained for 30 seconds. The effort and the counter-pressure should be modest (20% of available strength) and painless. The process is repeated 3-5 times.

Outcomes

Primary Outcome Measures

Functional disabilities (Neck Disability Index (NDI)
Neck Disability Index (NDI): It is a self reported ten-item scale. Each item assess different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating highest disability. The total score ranges from 0 to 50. The scale was measured at baseline, 7th day and 14th day.

Secondary Outcome Measures

Pain (Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS): It was use assess the severity of pain. A 10 cm horizontal line was drawn, with 0 means no pain and 10 means the worst possible pain. The patient was asked to mark a point the scale representing their intensity of pain. The scale was measured at baseline, 7th day and 14th day.
Range of Motion (ROM)
Goniometric measurement: Active range of motion was assessd using universal standard goniometer for cervical flexion, extension, side flexion (left and right), rotation (left and right). All ranges were assessed in sitting position and the data was collected at baseline, 7th day and 14th day.

Full Information

First Posted
November 22, 2014
Last Updated
November 25, 2014
Sponsor
Maharishi Markendeswar University (Deemed to be University)
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1. Study Identification

Unique Protocol Identification Number
NCT02301871
Brief Title
The Effect of Soft Tissue Mobilization in Myofascial Neck Pain
Official Title
Efficacy of Muscle Energy Technique and Deep Neck Flexors Training in Mechanical Neck Pain- A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A long term habitual posture with abnormal loading of ligaments and muscles, leads to development of neck pain. 33 patients including 18 males and 15 females were selected and randomly allocated into three groups using sealed opaque envelope containing treatment allocation. Group A (n=11) received conventional treatment such as MHP (Moist Heat Pack), Static Stretching exercises, Cervical spine non-thrust mobilization, Cervical spine active ROM (Range of Motion) exercises and Postural exercises. Group B (n=11) received DNF training with conventional treatment. Group C (n=11) received Muscle Energy Technique (MET) in additional to conventional treatment. Primary outcome measure functional disabilities and secondary measure pain and ROM were recorded at baseline, 7th day and 14th day.One-way ANOVA was used for within group analysis. Repeated measure ANOVA followed by post hoc analysis was employed for between group comparisons. The results suggest that there was a significant improvement in mean change scores of Neck Disability Index (NDI), Visual Analogue Scale (VAS) and Range of Motion (ROM) .Both DNF training and MET have additional therapeutic effects over a standard care by reducing functional disabilities, pain and in improving ROM in mechanical neck pain patients.
Detailed Description
According to Janda, postural muscles have tendency to get shorten, in both normal and pathological conditions. Upper trapezius, levator scalpulae and scalene are most common postural muscles. Additionally, longus colli and longus capitis (DNF) have important role in postural support and their impaired activation leads to neck pain. More recently, muscle based treatments approaches for MNP evolved from a passive treatment technique such as myofascial release towards more active treatment technique such as MET and DNF training. Group A (N=11) received conventional treatment for 5 days per week for 2 weeks such as MHP (Moist Heat Pack) for 20 minutes, Static Stretching exercises for upper trapezius, levator scapulae and scalene muscle which is held for 10-30 seconds- repeated 3-5 times, Cervical spine non-thrust mobilization (Grade 3) was given to each segment from C2-C7 was oscillated for 10 repetitions, followed by a 10 seconds rest between segments, Cervical spine active ROM (Range of Motion) exercises with 10 repetitions- 2-3 times a day and Postural exercises were given as home programme. Group B (N=11) received DNF training along with conventional treatment. In this programme, emphasis was placed on first attaining the correct craniocervical flexion action, with minimal activity of the superficial cervical flexor muscles. The craniocervical flexion action involves a specific craniocervical movement (nodding - "yes" movement) of head such that it remains in contact with the supporting surface. Once the correct action had been achieved, participants were instructed in the use of the sphygmomanometer to guide the training of the Craniocervical Flexors muscle contraction at the various incremental levels of pressure (22 to 30 mmHg, progressively inner range positions). Group C (N=11) received MET in additional to conventional treatment. MET was applied to Upper trapezius, Levator scapulae and Scalene Following the 7-10 seconds isometric contraction and complete relaxation of all elements, the stretch is maintained for 30 seconds. The effort and the counter-pressure should be modest (20% of available strength) and painless. The process is repeated 3-5 times.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
MNP, MET, Soft tissue mobilization, DNF, Static Stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
The treatment was given for 5 days per week for 2 weeks such as MHP (Moist Heat Pack) for 20 minutes, Static Stretching exercises for upper trapezius, levator scapulae and scalene muscle which is held for 10-30 seconds- repeated 3-5 times, Cervical spine non-thrust mobilization (Grade 3) was given to each segment from C2-C7 was oscillated for 10 repetitions, followed by a 10 seconds rest between segments, Cervical spine active ROM (Range of Motion) exercises with 10 repetitions- 2-3 times a day and Postural exercises were given as home programme.
Arm Title
DNF Group
Arm Type
Experimental
Arm Description
DNF training along with conventional treatment. In this programme, emphasis was placed on first attaining the correct craniocervical flexion action, with minimal activity of the superficial cervical flexor muscles. The craniocervical flexion action involves a specific craniocervical movement (nodding - "yes" movement) of head such that it remains in contact with the supporting surface. Once the correct action had been achieved, participants were instructed in the use of the sphygmomanometer to guide the training of the CCF muscle contraction at the various incremental levels of pressure (22 to 30 mmHg, progressively inner range positions).
Arm Title
MET Group
Arm Type
Experimental
Arm Description
MET in additional to conventional treatment. MET was applied to Upper trapezius, Levator scapulae and Scalene Following the 7-10 seconds isometric contraction and complete relaxation of all elements, the stretch is maintained for 30 seconds. The effort and the counter-pressure should be modest (20% of available strength) and painless. The process is repeated 3-5 times.
Intervention Type
Device
Intervention Name(s)
Dr. Gene's Health and Wellness
Other Intervention Name(s)
Sphymomanometer
Intervention Description
The device is used to perfom deep neck flexors muscles traning. These low load craniocervical flexion exercise are even in early stages of rehabilitation when pain or pathology might preclude high load exercises and thus gradually reduces the symptoms.
Intervention Type
Procedure
Intervention Name(s)
Muscle Energy Technique
Intervention Description
MET was applied to Upper trapezius, Levator scapulae and Scalene Following the 7-10 seconds isometric contraction and complete relaxation of all elements, the stretch is maintained for 30 seconds. The effort and the counter-pressure should be modest (20% of available strength) and painless. The process is repeated 3-5 times.
Intervention Type
Procedure
Intervention Name(s)
Static stretching and Cervical non thrust manipulation
Intervention Description
conventional treatment for 5 days per week for 2 weeks such as MHP (Moist Heat Pack) for 20 minutes, Static Stretching exercises for upper trapezius, levator scapulae and scalene muscle which is held for 10-30 seconds- repeated 3-5 times, Cervical spine non-thrust mobilization (Grade 3) was given to each segment from C2-C7 was oscillated for 10 repetitions, followed by a 10 seconds rest between segments, Cervical spine active ROM (Range of Motion) exercises with 10 repetitions- 2-3 times a day and Postural exercises were given as home programme.
Primary Outcome Measure Information:
Title
Functional disabilities (Neck Disability Index (NDI)
Description
Neck Disability Index (NDI): It is a self reported ten-item scale. Each item assess different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating highest disability. The total score ranges from 0 to 50. The scale was measured at baseline, 7th day and 14th day.
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Pain (Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS): It was use assess the severity of pain. A 10 cm horizontal line was drawn, with 0 means no pain and 10 means the worst possible pain. The patient was asked to mark a point the scale representing their intensity of pain. The scale was measured at baseline, 7th day and 14th day.
Time Frame
2 Weeks
Title
Range of Motion (ROM)
Description
Goniometric measurement: Active range of motion was assessd using universal standard goniometer for cervical flexion, extension, side flexion (left and right), rotation (left and right). All ranges were assessed in sitting position and the data was collected at baseline, 7th day and 14th day.
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 45 years Neck pain of minimum duration of six weeks Both males and females Signed informed consent form Tightness of upper trapezius, levator scapulae, scalene muscles on painful side Should not be recieving any other therapeutic intervention Should not be on medication Willing to participate Exclusion Criteria: Inflammatory, Malignant and Neurological conditions Metabolic disease Neck pain radiating into arms and upper extremity Neck pain associated with headaches or facial pain Recent major trauma or fracture of the cervical spine Referred pain History of surgery of cervical spine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harshita Yadav, M.P.T
Organizational Affiliation
Maharishi Markandeshwar University, Mullana-Ambala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harshita Yadav
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

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The Effect of Soft Tissue Mobilization in Myofascial Neck Pain

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