The Effect of Soft Tissue Mobilization in Myofascial Neck Pain

Sponsor

Maharishi Markendeswar University (Deemed to be University) (Other)

Overall Status

Completed

CT.gov ID

NCT02301871

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Device: Dr. Gene's Health and Wellness Procedure: Muscle Energy Technique Procedure: Static stretching and Cervical non thrust manipulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Muscle Energy Technique and Deep Neck Flexors Training in Mechanical Neck Pain- A Randomized Clinical Trial

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional group 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.	Procedure: Static stretching and Cervical non thrust manipulation 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.
Experimental: DNF Group 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).	Device: Dr. Gene's Health and Wellness 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. Other Names: Sphymomanometer
Experimental: MET Group 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.	Procedure: Muscle Energy Technique 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.

Arm

Intervention/Treatment

Active Comparator: Conventional group

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.

Procedure: Static stretching and Cervical non thrust manipulation

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.

Experimental: DNF Group

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).

Device: Dr. Gene's Health and Wellness

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.

Other Names:

Sphymomanometer

Experimental: MET Group

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.

Procedure: Muscle Energy Technique

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.

Outcome Measures

Primary Outcome Measures

Functional disabilities (Neck Disability Index (NDI) [2 Weeks]
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) [2 Weeks]
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) [2 Weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harshita Yadav	Ambala	Haryana	India	133207

Sponsors and Collaborators

Maharishi Markendeswar University (Deemed to be University)

Investigators

Principal Investigator: Harshita Yadav, M.P.T, Maharishi Markandeshwar University, Mullana-Ambala

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HARSHITA YADAV, Efficacy of Muscle Energy Technique and Deep Neck Flexors Training in Mechanical Neck Pain- A Randomized Clinical Trial, Maharishi Markendeswar University (Deemed to be University)

ClinicalTrials.gov Identifier:

NCT02301871

Other Study ID Numbers:

N44-449

First Posted:

Nov 26, 2014

Last Update Posted:

Nov 26, 2014

Last Verified:

Nov 1, 2014

Keywords provided by HARSHITA YADAV, Efficacy of Muscle Energy Technique and Deep Neck Flexors Training in Mechanical Neck Pain- A Randomized Clinical Trial, Maharishi Markendeswar University (Deemed to be University)

MNP

MET

Soft tissue mobilization

DNF

Static Stretching

Additional relevant MeSH terms:

Neck Pain

Study Results

No Results Posted as of Nov 26, 2014