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

NCT ID: NCT02589184

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-01-31

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypergravity WITH isometric load

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

Group Type: EXPERIMENTAL

Hypergravity

Intervention Type: OTHER

the rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing

isometric load

Intervention Type: OTHER

at the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load

hypergravity WITHOUT isometric load

Patient performing rehabilitation exercises under hypergravity

Group Type: EXPERIMENTAL

Hypergravity

Intervention Type: OTHER

the rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing

normal gravity WITH isometric load

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

Group Type: EXPERIMENTAL

isometric load

Intervention Type: OTHER

at the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load

normal gravity

Intervention Type: OTHER

the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity

normal gravity WITHOUT isometric load

Patient performing rehabilitation exercises under normal gravity

Group Type: ACTIVE_COMPARATOR

normal gravity

Intervention Type: OTHER

the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity

Interventions

Hypergravity

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

isometric load

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

normal gravity

the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carrick Institute for Graduate Studies

OTHER

Sponsor Role: lead

Responsible Party

Frederick Carrick, PhD, FACCN

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederick R Carrick, PhD

Role: PRINCIPAL_INVESTIGATOR

Carrick Institute for Graduate Studies

Locations

FIFE Therapy

Savannah, Georgia, United States

Optim Orthopedics - DeRenne

Savannah, Georgia, United States

Countries

United States

Other Identifiers

CI-IRB-20150818006A

Identifier Type: -

Identifier Source: org_study_id