- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046160
The Effect of Scapulothoracic Mobilization on Cervical Pain and Range of Motion in Patients With Neck Pain and Scapular Dyskinesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants: Males and females aging between 25 and 50 years referred from orthopedic clinic with chronic neck pain were included in the study. Recruitment extends through the time period extending from April 2016- April 2017) by notices to orthopedics department with measures of inclusion and exclusion. Data is being collected at Dammam Medical Complex.
Sample: 34 participants with non-specific chronic neck pain (≥ 3 months)
Procedures:
Patients were screened for eligibility through inclusion and exclusion criteria. Consent forms were discussed thoroughly by the researcher to the patient and signed before the start of the study. Assessment will include the following: Detailed subjective information, and the data collection sheet demographic data (e.g., name, age, sex and side of scapular dyskinesia) (Appendix 5). Dyskinesia was identified using the Scapular Dyskinesis Test with 5 repetitions of active shoulder flexion and abduction, bilaterally, while holding a weight with either hand (1.4 kg for patients weighing less than 68.1 kg and 2.3 kg for patients weighing more than 68.1 kg). This test has good reliability and validity (McClure, Tate et al. 2009, Tate, McClure et al. 2009). Neck range of motion as well as active, passive and accessory movements were all assessed. Measurements were obtained three times. First time, at baseline from the patient interview and recorded on a data collection sheet and the second one was taken after completion of 3 sessions of treatment. The last measurement was taken at the end of all sessions.
Patients were assigned with random allocation to one of 2 groups using a computer-generated sequence of numbers by an independent therapist. The groups are: 1) Manual therapy (MWM) + tape (postural correction of scapular anterior tilt) and 2) Control (conventional treatment + tape (postural correction of scapular anterior tilt) groups. The manual therapy intervention was of grade III mobilizations with movement, performed by a certified Mulligan practitioner, in sitting for 6-10 repetitions for 3 sets. Home exercises including cervical retraction, scapular retraction, deep neck flexors strengthening and active range of motion exercises of neck in all directions were all done during the session and at home with 10 seconds hold for 10 repetitions for 5 times a day and were added in the same sequence in both groups. When the experimental group showed significantly improved results, some patients in the control group receive 2 extra sessions after all study measurements were obtained. Frequency of the sessions was carried out as 3 sessions/ week/ 30-60 minutes (Miller, Gross et al. 2010).
Manual Therapy Technique: The patient was sitting in a good relaxed posture with the therapist standing at the opposite side of the affected scapula. Reaching across the trunk, the palm of the left hand was over the clavicle with the right hand controlling the scapular glide. Both hands applied corrective gliding force (grade III) to reposition the scapula to the optimal position using an adduction force along with posterior and external rotations of the scapula. While maintaining this position, the subject was asked to move his neck through the restricted movement point of pain onset and return to starting point. When the technique was indicated, the patient was able to achieve a considerably greater range without pain. When needed, further modifications of the humeral head repositioning could be introduced. MWM were repeated 6-10 times before reassessing the movement independent of scapular repositioning. If the pain improved, further 3 sets of 6-10 repetitions were carried out.
Taping technique to correct anterior scapular tilt: A water-resistant active, elastic and adhesive kinesiotape was used I this study. An I-shaped elastic tape was applied over the muscle belly of the upper Trapezius (UT). The tape started with its anchor fixed anteriorly at the coracoid process and travelled posteriorly over the belly of upper Trapezius fibers and along the course of its lower fibers to get its final anchor at the thoracic spine.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Eastern Province
-
Dammam, Eastern Province, Saudi Arabia, 31433
- Recruiting
- Dammam Medical Complex
-
Contact:
- Mohammad A AlSenni, bachelor
- Phone Number: 00966506912312
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age of 25- 50 years.
- A history of neck pain lasting 3 months or more prior to study start.
- A score of greater than or equal to 5/50 on the Neck Disability Index (NDI)(Vernon 2008, Vernon 2008)
- Presence of scapular dyskinesia.
Exclusion Criteria:
- Previous cervical spine or shoulder surgery
- Cervical radiculopathy (compressed cervical nerve root on its way out of the spine, mainly could be manifested by pain, weakness, and sensory deficits (Corey and Comeau 2014)
- Presence of a severe systemic disease (as fibromyalgia, Chronic fatigue syndrome, Diabetes mellitus, Hypertension, Grave's disease, Systemic lupus erythematous, Rheumatoid arthritis, Sickle cell disease) or any other widespread musculoskeletal pain syndromes.
- Participation in an exercise program for the neck or scapular muscles in the 6 months preceding the study.
- Consumption of stimulants (caffeine and nicotine) or analgesic drugs for at least 8 hours before the study.
- Manual therapy contraindications (e.g., inflammatory joint disease, spinal cord pathology, infections, severe osteoporosis, cancer).
- Whiplash injury/fracture.
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: experimental group
where treatment will involve conventional and Manual therapy (Mobilization with movement)+ tape (postural correction of scapular anterior tilt)
|
grade III mobilizations with movement, performed in sitting for 6-10 repetitions for 3 sets
Other Names:
A program of 12 neck and scapular exercises.
elastic tape used to correct the anterior tilt of the scapula
|
|
Active Comparator: control group
treatment will consist of the conventional approach+ tape (postural correction of scapular anterior tilt)
|
A program of 12 neck and scapular exercises.
elastic tape used to correct the anterior tilt of the scapula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neck pain ( centimeters on visual analog scale)
Time Frame: up to 12 months
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scapular rotatory range of motion (degrees)
Time Frame: up to 12 months
|
up to 12 months
|
|
neck disability index (percentage)
Time Frame: up to 12 months
|
up to 12 months
|
|
neck range of motion (degrees)
Time Frame: up to 12 months
|
up to 12 months
|
|
pressure pain threshold (k pascal)
Time Frame: up to 12 months
|
up to 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- IRB-PGS-2015-03-219
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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