NCT04813757

Brief Summary

Altered scapular movement is a common impairment among patients with subacromial impingement syndrome (SAIS). Nevertheless scapular focused interventions have resulted in conflicting findings among this population. One possible reason for this is the inability to identify patients with SAIS who will respond favorably to a scapular focused intervention. The scapular assistance test (SAT) may be one possible indicator of patients most likely to benefit from a scapular focused intervention, particularly one that emphasizes scapular upward rotation. The purpose of this study is to examine targeted upward rotation intervention in patients demonstrating a positive Scapular Assistance test.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

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

July 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

December 20, 2020

Last Update Submit

September 14, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Disability of the Arm, Shoulder and Hand (DASH) questionnaire

    each participant will receive the Disability of the Arm shoulder and hand questioner. score is from 0 -100 a higher score is greater disability

    pre intervention

  • Numeric pain Rating Scale (NPRS), 0 - 10

    each participant will receive the NPRS questioner higher score means greater pain

    pre intervention

Secondary Outcomes (3)

  • Active shoulder flexion

    pre intervention

  • active shoulder abduction

    pre intervention

  • scapular posterior tilt

    pre intervention

Study Arms (2)

intervention group

EXPERIMENTAL

Participants in the intervention group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy. The exercise program will include 2 scapular and rotator cuff strengthening exercises emphasizing scapular upward rotation and posterior tilt and one additional flexibility exercise. These exercise will be repeated at home on the days in between the therapy sessions.

Other: exerciseOther: manual therapy

control group

ACTIVE COMPARATOR

Participants in the control group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy, posterior shoulder stretching, and mobilization-with-movement into shoulder elevation. The exercise program will include 2 exercises focusing on scapular and rotator cuff strengthening without a special emphasis on scapular upward rotation as well as one additional flexibility exercise. These exercises will be performed at home on the days on between the therapy sessions.

Other: exerciseOther: manual therapy

Interventions

each group will perform 2 shoulder strength exercise at the therapy session and 3 exercise at home session-2 strength exercise and one stretching exercise. they will perform the exercises 5 times per week

control groupintervention group

on each treatment session both group will receive 15 minutes of manual therapy which will include: massage,3-4 trigger point treatment posterior capsule stretch and mobilization with movement

control groupintervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral shoulder pain for ≥1 month
  • A diagnosis of SAIS as determined by having 3 or ore positive tests out of: Neer test, Hawkins test, Painful arc, Jobe test, external rotation resistance test.
  • A positive SAT

You may not qualify if:

  • Cervical spine involvement as evidenced by reproduction of symptoms with neck movement
  • Massive rotator cuff tear as evidenced by pseudoparalysis
  • Previous history of a fracture or surgery within the involved shoulder.
  • Limited passive range of motion by ≥50% or more compared with uninvolved side in
  • planes of motion (i.e. flexion, external rotation)
  • A history of shoulder dislocation or subluxation
  • A history of Rheumatoid arthritis, CVA, fibromyalgia
  • Current pregnancy
  • Population with special needs
  • Pending disability claim / litigation procedure associated with shoulder complaint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meuhedet

Ashdod, Israel

RECRUITING

MeSH Terms

Interventions

ExerciseMusculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Andrey Maizles

CONTACT

Alon Rabin, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
We assume participants will not be able to differentiate between the upward rotation focused intervention and the control intervention. Furthermore, the examiner performing baseline and outcome assessment will be unaware of the group allocation while performing these assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

March 24, 2021

Study Start

July 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations