Exercise for Subacromial Pain Syndrome

Heavy Slow Resistance Exercise for Subacromial Pain Syndrome

This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in comparison with traditional supervised exercise as treatment for patients with subacromial shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare its effect to traditional exercise at pain and function of the shoulder. One half will complete the heavy slow resistance exercise, the other will complete the conventional exercise.

Study Overview

• Status: Completed
• Conditions: Subacromial Pain Syndrome
• Intervention / Treatment: Diagnostic test: Different exercise

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450 Oslo
    • Ullevål sykehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Shoulder pain > Three months
• Subacromial pain
• Dysfunction or pain during abduction
• Pain during isometric strength test of abduction or external rotation of the shoulder.
• Positive Hawkins test
• Normal passive range of movement in the glenohumeral joint

Exclusion Criteria:

• Surgery of the affected shoulder
• Patients that are not considered suitable to complete the treatment, or able to answer a Norwegian questionnaire
• Shoulder dislocation or shoulder instability
• Clinical sign of cervical nerve root affection
• Rheumatoid arthritis
• Clinical sign of full rupture of the rotator cuff.
• Pregnancy
• Cortisone injection past six weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heavy slow resistance exercise	Diagnostic test: Different exercise; Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.
Placebo Comparator: Traditional supervised exercise	Diagnostic test: Different exercise; Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline SPADI score at 12- and 24 weeks.	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Both dimensions account for 50% of the overall score, and scores from 0 to 100.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline "Pain in rest last week" score at 12- and 24 weeks.	11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline "Pain in activity last week" score at 12- and 24 weeks.	11 point Likert-type scale, 0 =no pain, 10 = worst possible pain. Measured by marking a clean visual analogue scale, and later transferred to a score.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change From Baseline "The ability to carry a 5kg carry bag" score at 12- and 24 weeks.	11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline DASH score at 12- and 24 weeks.	DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) is a 30 points questionnaire about the disability of the shoulder. Answers from 0 to 5; 0 0 No problem completing the activity, 5 = Impossible to complete the activity. Total score is calculated by a summary of the scores, subtracted by 30 and divided by 1.2.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from Baseline Active range of motion of the shoulder at 12- and 24 weeks.	A total score the flection, abduction and external rotation of the shoulder. Measured by goniometer.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.
Change from "The ability to take something down from a high shelf" score at 12- and 24 weeks.	11 point Likert-type scale, 0 = no problem, 10 = impossible. Measured by marking a clean visual analogue scale, and later transferred to a score.	Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Høiland, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): December 13, 2018

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Syndrome; Somatoform Disorders
• Other Study ID Numbers: 2017/1277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No