Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?

NCT ID: NCT02701465

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-02
• Study Completion Date: 2018-04-30

Brief Summary

The purpose of this randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function.

Conditions

Chronic Pain

Study Design

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

Study Groups

Intervention group

The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.

Group Type: EXPERIMENTAL

Exercise: local high intensity interval exercise

Intervention Type: OTHER

The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.

Control group

The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).

Group Type: ACTIVE_COMPARATOR

Exercise: best clinical practice

Intervention Type: OTHER

The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).

Interventions

Exercise: local high intensity interval exercise

The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.

Intervention Type: OTHER

Exercise: best clinical practice

The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• shoulder pain for longer than three months
• clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test)
• normal passive range of motion of the shoulder

Exclusion Criteria

• subjects unable to provide an informed consent
• lack of ability to complete the intervention
• full rupture of the tendon of m. supraspinatus
• planned shoulder surgery, or previous shoulder surgery on affected shoulder
• other musculoskeletal problem that could explain the symptoms
• adhesive capsulitis
• pregnancy
• rheumatoid arthritis
• symptomatic osteoarthritis of the shoulder/shoulder girdle
• glenohumeral instability
• widespread pain syndrome
• unstable underlying heart disease
• cortisone injections in the shoulder the last month
• allergies
• other serious mental or somatic disease (i.e. psychosis or active cancer disease).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Hoff, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic

Trondheim, , Norway

Countries

Norway

Other Identifiers

666

Identifier Type: -

Identifier Source: org_study_id