- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301871
The Effect of Soft Tissue Mobilization in Myofascial Neck Pain
Efficacy of Muscle Energy Technique and Deep Neck Flexors Training in Mechanical Neck Pain- A Randomized Clinical Trial
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Haryana
-
Ambala, Haryana, India, 133207
- Harshita Yadav
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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).
|
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:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional disabilities (Neck Disability Index (NDI)
Time Frame: 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. |
2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Visual Analogue Scale (VAS)
Time Frame: 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. |
2 Weeks
|
Range of Motion (ROM)
Time Frame: 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. |
2 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Harshita Yadav, M.P.T, Maharishi Markandeshwar University, Mullana-Ambala
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N44-449
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Static stretching and Cervical non thrust manipulation
-
Alabama Physical Therapy & AcupunctureLong Island UniversityCompletedCervicogenic HeadacheUnited States
-
Goethe UniversityCompletedRandomized Controlled Trial | Fascia | Myofascial | StretchingGermany
-
University of JaenCompletedLow Back Pain | Neck PainSpain
-
Foundation University IslamabadActive, not recruiting
-
Walsh UniversityYoungstown State University; Des Moines UniversityUnknown
-
Walsh UniversityCompleted
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosCompletedCervicogenic HeadachesUnited States
-
Bradley UniversityUniversity of Nevada, Las Vegas; Nova Southeastern UniversityCompletedTemporomandibular DisorderUnited States
-
Nova Southeastern UniversityUniversity of Nevada, Las Vegas; DeRosa Physical TherapyCompleted
-
Federal University of Health Science of Porto AlegreTerminatedLow Back Pain | Mechanical Low Back Pain | BackacheBrazil