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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

ABRAR I ALSADIQ, MASTER STUDENT contact

00966566115689

challen1319@me.com

ALI M ALSHAMI, PHD contact

00966552225548

alshami@uod.edu.sa

Saudi Arabia1 site, 1 recruiting
  • Dammam Medical Complex

    Dammam, Eastern Province, 31433

    Mohammad A AlSenni, bachelor, 00966506912312

    Recruiting

Other trials in Saudi Arabia

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 groups in NCT03046160
Study groupRoleWhat they receive
experimental groupExperimentalwhere 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 groupActive comparatortreatment 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.

  1. Neck pain ( centimeters on visual analog scale)

    Measured: up to 12 months

Secondary outcomes (4)
  1. Scapular rotatory range of motion (degrees)

    Measured: up to 12 months

  2. neck disability index (percentage)

    Measured: up to 12 months

  3. neck range of motion (degrees)

    Measured: up to 12 months

  4. 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.

  1. First posted8 Feb 2017 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

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)
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

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.

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