Neck PainNCT03046160
The Effect of Scapulothoracic Mobilization on Cervical Pain and Range of Motion in Patients With Neck Pain and Scapular Dyskinesia
A study testing Manual therapy (Mobilization with movement), neck and scapular exercises. and corrective tape in people with Neck Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
Background: Dyskinesia has been referred to as a major manifestation of affected muscle performance and neuromuscular control of the scapular stabilizers. Alterations around the scapula with muscular imbalances could facilitate or emphasize dysfunction in its surrounding structures through compressive and shear… Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual therapy (Mobilization with movement), neck and scapular exercises. and corrective tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Dammam Medical Complex
Dammam, Eastern Province, 31433
Mohammad A AlSenni, bachelor, 00966506912312
About this study
Background: Dyskinesia has been referred to as a major manifestation of affected muscle performance and neuromuscular control of the scapular stabilizers. Alterations around the scapula with muscular imbalances could facilitate or emphasize dysfunction in its surrounding structures through compressive and shear stresses created by abnormal pull through attachments. No studies have investigated the effect of scapular mobilization with movement on neck mobility and pain. Objective: To quantify the effects of utilizing a scapular mobilization with movement on cervical pain and range of motion as compared to conventional treatment under the presence of scapular dyskinesia. Design: an experimental case-control study. Setting: Dammam Medical Complex. Methods: thirty-four patients with chronic non-specific neck pain. Participants will be allocated to one of two groups: experimental group where treatment will involve conventional and manual interventions or the control group where treatment will consist of the conventional approach only. The manual intervention will consist of a sustained corrective scapular glide during neck movement in all directions. Measurements will include: Visual Analog Scale, pressure pain threshold, neck range of motion, scapular rotation measure and Neck Disability Index. Statistical analysis: all will be done using SPSS version 22.0 for Mac. Means and standard deviations will be given as descriptive statistics. Paired t-test will be used to study the effects of scapulothoracic mobilization and exercises on neck range of motion and pain intensity. Independent t-test will be used to compare the effects of the two interventions on pain intensity Key words: Pressure pain threshold; Scapula; Intervention, Manual therapy, mobilization.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Manual therapy (Mobilization with movement), neck and scapular exercises., corrective tape
- Keywords
- PPT, Scapula, Intervention, Manual therapy, mobilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy (Mobilization with movement)Other
Also called MWM
grade III mobilizations with movement, performed in sitting for 6-10 repetitions for 3 sets
neck and scapular exercises.Other
A program of 12 neck and scapular exercises.
corrective tapeOther
elastic tape used to correct the anterior tilt of the scapula
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | where treatment will involve conventional and Manual therapy (Mobilization with movement)+ tape (postural correction of scapular anterior tilt)
1. The Manual therapy (Mobilization with movement)intervention was of grade III mobilizations with movement performed in sitting for 6-10 repetitions for 3 sets
2. tape (postural correction of scapular anterior tilt)
3. A program of 12 neck and scapular exercises. Receives: Other: Manual therapy (Mobilization with movement); Other: neck and scapular exercises.; Other: corrective tape |
| control group | Active comparator | treatment will consist of the conventional approach+ tape (postural correction of scapular anterior tilt)
1. tape (postural correction of scapular anterior tilt)
2. A program of 12 neck and scapular exercises. Receives: Other: neck and scapular exercises.; Other: corrective tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain ( centimeters on visual analog scale)
Measured: up to 12 months
Secondary outcomes (4)
Scapular rotatory range of motion (degrees)
Measured: up to 12 months
neck disability index (percentage)
Measured: up to 12 months
neck range of motion (degrees)
Measured: up to 12 months
pressure pain threshold (k pascal)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrar AlSadiq, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046160
- Sponsor's protocol ID
- IRB-PGS-2015-03-219
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scapulothoracic Mobilization on Cervical Pain and Range of Motion in Patients With Neck Pain and Scapular Dyskinesia
- ClinicalTrials.gov ID
- NCT03046160
- Acronym / sponsor ID
- IRB-PGS-2015-03-219
- Conditions
- Neck Pain
- Keywords
- PPT, Scapula, Intervention, Manual therapy, mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Dyskinesia has been referred to as a major manifestation of affected muscle performance and neuromuscular control of the scapular stabilizers. Alterations around the scapula with muscular imbalances could facilitate or emphasize dysfunction in its surrounding structures through compressive and shear stresses created by abnormal pull through attachments. No studies have investigated the effect of scapular mobilization with movement on neck mobility and pain. Objective: To quantify the effects of utilizing a scapular mobilization with movement on cervical pain and range of motion as compared to conventional treatment under the presence of scapular dyskinesia. Design: an experimental case-control study. Setting: Dammam Medical Complex. Methods: thirty-four patients with chronic non-specific neck pain. Participants will be allocated to one of two groups: experimental group where treatment will involve conventional and manual interventions or the control group where treatment will consist of the conventional approach only. The manual intervention will consist of a sustained corrective scapular glide during neck movement in all directions. Measurements will include: Visual Analog Scale, pressure pain threshold, neck range of motion, scapular rotation measure and Neck Disability Index. Statistical analysis: all will be done using SPSS version 22.0 for Mac. Means and standard deviations will be given as descriptive statistics. Paired t-test will be used to study the effects of scapulothoracic mobilization and exercises on neck range of motion and pain intensity. Independent t-test will be used to compare the effects of the two interventions on pain intensity Key words: Pressure pain threshold; Scapula; Intervention, Manual therapy, mobilization.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Manual therapy (Mobilization with movement), Other: neck and scapular exercises., Other: corrective tapewhere treatment will involve conventional and Manual therapy (Mobilization with movement)+ tape (postural correction of scapular anterior tilt) 1. The Manual therapy (Mobilization with movement)intervention was of grade III mobilizations with movement performed in sitting for 6-10 repetitions for 3 sets 2. tape (postural correction of scapular anterior tilt) 3. A program of 12 neck and scapular exercises. |
| control group | Active comparator | Other: neck and scapular exercises., Other: corrective tapetreatment will consist of the conventional approach+ tape (postural correction of scapular anterior tilt) 1. tape (postural correction of scapular anterior tilt) 2. A program of 12 neck and scapular exercises. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy (Mobilization with movement)Also: MWMgrade III mobilizations with movement, performed in sitting for 6-10 repetitions for 3 sets | Other | experimental group |
| neck and scapular exercises.A program of 12 neck and scapular exercises. | Other | control group, experimental group |
| corrective tapeelastic tape used to correct the anterior tilt of the scapula | Other | control group, experimental group |
Primary outcome
Neck pain ( centimeters on visual analog scale)
Time frame: up to 12 months
4 secondary outcomes
Scapular rotatory range of motion (degrees)
Time frame: up to 12 months
neck disability index (percentage)
Time frame: up to 12 months
neck range of motion (degrees)
Time frame: up to 12 months
pressure pain threshold (k pascal)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy (Mobilization with movement), neck and scapular exercises. and corrective tape in people with Neck Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ABRAR I ALSADIQ, MASTER STUDENT (00966566115689, challen1319@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain ( centimeters on visual analog scale) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.