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

NCT02701465 | Completed

• 1 other identifier: 666
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Shoulder; Exercise therapy

Outcome Measures

Primary Outcomes (1)

• Time to exhaustion, incremental test

  participants abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. Every minute the load is increased with 250 grams. The test is stopped if participant fails to maintain pace or movement quality, or experiences increased pain. Time at failure is noted as the result.

  Week 0

Secondary Outcomes (14)

• SPADI questionnaire

  Week 0

• SPADI questionnaire

  Pre+post-test (8 weeks in-between)

• Weight

  Week 0

• Height

  Week 0

• Age

  Week 0

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Exercise: local high intensity interval exercise

Control group

ACTIVE COMPARATOR

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).

Other: Exercise: best clinical practice

Interventions

Exercise: local high intensity interval exercise 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.

Intervention group

Exercise: best clinical practice 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).

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

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

Trondheim, Norway

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Hoff, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 8, 2016
• Study Start: January 2, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)