NCT04801732

Brief Summary

This study was conducted to investigate the effect of mulligan thoracic sustained natural apophyseal glide on patients diagnosed as sub acromial impingement syndrome and its effect on shoulder range of motion, pain, function and disability of affected shoulder joint and size of sub acromial space, Half of the patients will treated with traditional treatment and mulligan thoracic SNAGS technique, while the other half will treated with traditional treatment only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 7, 2021

Last Update Submit

March 4, 2023

Conditions

Keywords

SUBACROMIAL IMPINGEMENT SYNDROMEmulligan thoracic sustained natural apophyseal glidesAcromiohumeral distance or subacromial space

Outcome Measures

Primary Outcomes (4)

  • Pain by Visual analogue scale

    the patient asked to choose from scale from zero (no pain) to 10 (worst pain) to detect his/her intensity of pain.

    changes from baseline to before treatment and changes before treatment to immediately after treatment

  • Range of motion of shoulder joint by universal goniometer.

    for flexion stationary Arm of the goniometer was aligned with the lateral border of the scapula (mid axillary arm), and the moving arm was aligned with the humerus. for abduction the fulcrum was placed at the mid point of the posterior aspect of the glenohumeral joint, stationary arm was parallel to the trunk, and the moving arm was parallel to the longitudinal axis of the humerus. for internal and external rotation patient was in supine with the hips and knees flexed approximately 45°.The tested arm was supported on the table in 90° of abduction, elbow flexed 90°, and the wrist in neutral position. the fulcrum was placed on the olecranon, stationary arm Placed perpendicular to the floor, and the moving arm parallel with the forearm.

    changes from baseline to before treatment and changes before treatment to immediately after treatment

  • Shoulder pain and disability index

    the patients will asked to answer the questions on index . And then creating a percentage of pain and disability with higher scores indicating more severe limitation. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst). Minimum Detectable Change (90% confidence) = 13 points

    changes from baseline to before treatment and changes before treatment to immediately after treatment

  • The sub-acromial space by radiograph X ray

    measure the size of sub-acromial space

    changes from baseline to before treatment and changes before treatment to immediately after treatment

Study Arms (2)

mulligan group

EXPERIMENTAL

Patients in the study group will treated with SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) for 3 times/week for one month.

Other: mulligan thoracic Sustained Natural Apophyseal Glides

exercising group

ACTIVE COMPARATOR

will receive only traditional treatment (ice application and supervised exercise ) for 3 times/week for one month.

Other: traditional treatments

Interventions

Extension Thoracic Sustained Natural Apophyseal Glides : Patient position: The patient sits astride the end of the table with hands placed behind the neck to protract the scapulae allowing access to the mid thoracic spine for the therapist's hand. Therapist position: Therapist stands on their most efficient side for a centrally applied Sustained Natural Apophyseal Glides. Therapist grasp: The therapist's mobilizing hand (ulnar border) will apply a cephalad glide in line with the facet joint plane of the involved spinal level and the other arm holds the thoracic wall above the level to be mobilized. Traction is applied prior to glide, which is achieved by therapist knee extension Repetitions: Three sets of ten repetitions will be done after a trial for the patient to be familial with the technique. and traditional treatment.

mulligan group

includes: Ice pack and Pendulum exercise and shoulder range of motion (elevation, depression, flexion, abduction, rotations).Stretching exercise for internal rotators and posterior capsule. Strengthening exercise will be isometric in nature include external shoulder rotators, internal rotators, biceps, deltoid, and scapular stabilizers (rhomboids, trapezius, serratus anterior, Latissimus Dorsi , and pectoralis major muscles).

exercising group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification.
  • Have +ve Neer's sign, +ve Hawkins and Kennedy test and +ve Empty and full can tests.
  • selected from both genders.
  • Aged from 25 to 40 years old.
  • Have restricted thoracic extension motion ( +ve occiput to wall test).

You may not qualify if:

  • History of shoulder adhesive capsulitis
  • Rotator cuff tendon tear/rupture (stage 3).
  • Shoulder dislocation, subluxation and fractures.
  • History of cervical, shoulder, upper back surgery.
  • Any spinal deformities such as scoliosis, kyphosis and rounded shoulder.
  • Diabetes mellitus.
  • Radiculopathy.
  • History of breast cancer.
  • Previous stroke or Shoulder hand syndrome.
  • Ligamentous Laxity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy - Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Shimaa T Abu EL-Kasem, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will randomly assigned into two groups without being informed whether they are in the control or the study(experimental) group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study design were the recruited patients will randomly allocated into two groups control group and study group by Closed Envelope method of randomization. The treatment for all patients in both groups will conducted 3 times per week for one month .The study group (A): will receive SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) and the study group(B) will receive only traditional treatment (ice or application and supervised exercise). All patients will be diagnosed as stage II according to Neer's classification recruited from orthopedic clinic from both sexes who met all the inclusion criteria and will be informed about the study procedure and signed the informed consent prepared for this study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 17, 2021

Study Start

August 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

These data are case sensitive and considered confidential regarding my supervisors' and study directors' opinion, So, upon their request i prefer to not share individual participant data with other researchers

Locations