NCT03046160

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

January 24, 2017

Last Update Submit

February 7, 2017

Conditions

Keywords

PPTScapulaInterventionManual therapymobilization

Outcome Measures

Primary Outcomes (1)

  • Neck pain ( centimeters on visual analog scale)

    up to 12 months

Secondary Outcomes (4)

  • Scapular rotatory range of motion (degrees)

    up to 12 months

  • neck disability index (percentage)

    up to 12 months

  • neck range of motion (degrees)

    up to 12 months

  • pressure pain threshold (k pascal)

    up to 12 months

Study Arms (2)

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.

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.

Other: neck and scapular exercises.Other: corrective tape

Interventions

grade III mobilizations with movement, performed in sitting for 6-10 repetitions for 3 sets

Also known as: MWM
experimental group

A program of 12 neck and scapular exercises.

control groupexperimental group

elastic tape used to correct the anterior tilt of the scapula

control groupexperimental group

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dammam Medical Complex

Dammam, Eastern Province, 31433, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsMovement

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

ABRAR I ALSADIQ, MASTER STUDENT

CONTACT

ALI M ALSHAMI, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 8, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations