NCT03317808

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

October 15, 2017

Last Update Submit

January 23, 2019

Conditions

Subacromial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change from Baseline "Pain in rest last week" score at 12- and 24 weeks.

    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.

    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.

    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.

    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.

    Measured three times. Firstly at the baseline. Secondly at the 12-week follow up (after finished intervention). Lastly at the 24-week follow up.

  • +1 more secondary outcomes

Study Arms (2)

Heavy slow resistance exercise

ACTIVE COMPARATOR
Diagnostic Test: Different exercise

Traditional supervised exercise

PLACEBO COMPARATOR
Diagnostic Test: Different exercise

Interventions

Different exerciseDIAGNOSTIC_TEST

Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.

Heavy slow resistance exerciseTraditional supervised exercise

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevål Sykehus

Oslo, 0450 Oslo, Norway

Location

Study Officials

  • Høiland

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stud.med

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 23, 2017

Study Start

October 16, 2017

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

NO(1)