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Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises

Primary Purpose

Shoulder Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypergravity
isometric load
normal gravity
Sponsored by
Carrick Institute for Graduate Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring balance, postural, postural equilibrium, pain scale, range of motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)

Exclusion Criteria:

  • adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption

Sites / Locations

  • FIFE Therapy
  • Optim Orthopedics - DeRenne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

hypergravity WITH isometric load

hypergravity WITHOUT isometric load

normal gravity WITH isometric load

normal gravity WITHOUT isometric load

Arm Description

Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats

Patient performing rehabilitation exercises under hypergravity

Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats

Patient performing rehabilitation exercises under normal gravity

Outcomes

Primary Outcome Measures

Changes in pain level
The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.

Secondary Outcome Measures

Changes in Stability Score
The Stability Score is calculated as percentage ratio of the actual sway and the theoretical limit of stability. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Changes in shoulder range of motion
It is measured as shoulder abduction through "Scaption Range", external / internal rotation in abduction at 90 degrees, and single arm overhead press motion. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
A 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Test of Sustained Selective Attention (TOSSA)
An 8-minute computerized auditory sustained attention test. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.

Full Information

First Posted
October 23, 2015
Last Updated
February 16, 2017
Sponsor
Carrick Institute for Graduate Studies
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1. Study Identification

Unique Protocol Identification Number
NCT02589184
Brief Title
Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
Official Title
Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Logistics reason at the data collection site
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carrick Institute for Graduate Studies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.
Detailed Description
Standard rehabilitation protocols will be used with every subject, depending on the cause of their shoulder pain. The treating clinician will determine the appropriate therapy protocol for each subject. During the treatment sessions, subjects will wear a very comfortable waist belt attached with rubber band to anchor points on the ground (the rubber bands will be tighten to simulate the extra-gravity). Upon enrollment, the treating clinician will randomly assign the subject to one of four groups depending on the type of loading and exercise typology. The hyper-gravity will be simulated as an additional 50% of subject's body weight. The frequency and duration of each therapy session will be determined by the treating clinician (usually 45 minutes of therapy twice a week for 4 weeks). Before, after and 24h post therapy session, the subject will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). As part of the rehabilitation therapy procedure, subjects will undergo shoulder range of motion evaluations (done by a trained clinician in approximately 3 minutes) and Computer Dynamic Posturography (CDP) testing on a 4" tall foam cushion with eyes closed (PSEC test - less than 1 minute of testing) before and after each therapy session. Subjects will complete the DASH and TOSSA questionnaires (the total amount of time required to complete these assessment is ~20 minutes), and will be tested using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol (the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally, less than 2 minutes testing time) at the time of enrollment and at the end of the 4 week therapy program. Subjects will be asked to come back for two more evaluations (questionnaires, range of motion assessment, and CDP testing) one month and three months after the end of the 4 week therapy program to identify possible long term effects of the "hyper-gravity/accentuated vertical loading" therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
balance, postural, postural equilibrium, pain scale, range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypergravity WITH isometric load
Arm Type
Experimental
Arm Description
Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats
Arm Title
hypergravity WITHOUT isometric load
Arm Type
Experimental
Arm Description
Patient performing rehabilitation exercises under hypergravity
Arm Title
normal gravity WITH isometric load
Arm Type
Experimental
Arm Description
Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats
Arm Title
normal gravity WITHOUT isometric load
Arm Type
Active Comparator
Arm Description
Patient performing rehabilitation exercises under normal gravity
Intervention Type
Other
Intervention Name(s)
Hypergravity
Intervention Description
the rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing
Intervention Type
Other
Intervention Name(s)
isometric load
Intervention Description
at the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load
Intervention Type
Other
Intervention Name(s)
normal gravity
Intervention Description
the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity
Primary Outcome Measure Information:
Title
Changes in pain level
Description
The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Changes in Stability Score
Description
The Stability Score is calculated as percentage ratio of the actual sway and the theoretical limit of stability. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Time Frame
three months
Title
Changes in shoulder range of motion
Description
It is measured as shoulder abduction through "Scaption Range", external / internal rotation in abduction at 90 degrees, and single arm overhead press motion. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Time Frame
three months
Title
Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Description
A 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Time Frame
three months
Title
Test of Sustained Selective Attention (TOSSA)
Description
An 8-minute computerized auditory sustained attention test. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear) Exclusion Criteria: adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick R Carrick, PhD
Organizational Affiliation
Carrick Institute for Graduate Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
FIFE Therapy
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Optim Orthopedics - DeRenne
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States

12. IPD Sharing Statement

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Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises

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