- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350918
Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain (MET&SSinNckp)
Effects Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain: A Randomized Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Osun
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Ile Ife, Osun, Nigeria, 220005
- Obafemi Awolowo University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 |
---|---|
Experimental: Muscle Energy Technique (MET)
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.
|
Group of patients that underwent muscle energy technique as a mean of treatment for the complaint
Other Names:
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Experimental: Static stretching (SS)
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. |
Set of patients that had static stretching technique for the treatment for the complaint
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: From March 2019 to November 2019, The treatment for each patient was for 6 weeks
|
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)
|
From March 2019 to November 2019, The treatment for each patient was for 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index (NDI)
Time Frame: From March 2019 to November 2019, The treatment for each patient was for 6 weeks
|
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.
|
From March 2019 to November 2019, The treatment for each patient was for 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adesola O Ojoawo PhD, Head, Department of Medical Rehabilitation, Obafemi Awolowo University Ile Ife
- Study Chair: Kayode Ijaduola, Provost, College of Health Sciences, Obafemi Awolowo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- OJO/2020/01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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