Back to resultsThe Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
Primary Purpose
Tendinopathy, Shoulder Impingement Syndrome, Shoulder Pain
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Structured Physiotherapy Regimen
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring Shoulder tendinopathy, Subacromial impingement syndrome, Rotator cuff tendinopathy, Supraspinatus tendinopathy
Eligibility Criteria
Inclusion Criteria:
Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
- Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
- Symptom duration of minimum 3 months.
Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
- Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop & Veer, 2003)
- Painful arc during active abduction (Ombregt, Bisschop & Veer, 2003)
- Positive Neers sign (Neer, 1972 ; Tennent, Beach & Meyers, 2003)
- Positive Jobes test (Jobe & Moynes, 1982 ; Tennent, Beach & Meyers, 2003)
- Positive Hawkins-Kennedy impingement test (Hawkins & Kennedy, 1980)
Exclusion Criteria:
- Shoulder pain due to trauma, e.g. fall.
- Reduced ROM consistent with adhesive capsulitis/frozen shoulder
- History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
- Full thickness rupture of rotator cuff tendon
- OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
- Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
- Subjects suffering from serious psychiatric illness.
- Subjects unable to understand English or Norwegian.
- Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.
Sites / Locations
- Department of Physiotherapy, Hillevaag General Practitioner PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Structured Physiotherapy regimen
Standard care
Arm Description
Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy
Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options.
Outcomes
Primary Outcome Measures
Need for surgery
Dichotomised questionnaire yes or no
Shoulder function
Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
Shoulder Pain
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Generic health status
EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
Secondary Outcome Measures
Rotator cuff force
Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
Tendon pain pressure threshold
Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.
Analgesics and corticosteroid injections
Analgesics consumption and corticosteroids injections registered on questionaire.
Tendon thickness
Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
Patient global impression of change
To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.
Full Information
NCT ID
NCT02304003
First Posted
November 26, 2014
Last Updated
August 22, 2018
Sponsor
Bergen University College
Collaborators
University of Bergen
1. Study Identification
Unique Protocol Identification Number
NCT02304003
Brief Title
The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
Official Title
The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bergen University College
Collaborators
University of Bergen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.
Detailed Description
There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Shoulder Impingement Syndrome, Shoulder Pain, Subacromial Impingement
Keywords
Shoulder tendinopathy, Subacromial impingement syndrome, Rotator cuff tendinopathy, Supraspinatus tendinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structured Physiotherapy regimen
Arm Type
Experimental
Arm Description
Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy
Arm Title
Standard care
Arm Type
Other
Arm Description
Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options.
Intervention Type
Other
Intervention Name(s)
Structured Physiotherapy Regimen
Intervention Description
Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard follow up in primary care.
Primary Outcome Measure Information:
Title
Need for surgery
Description
Dichotomised questionnaire yes or no
Time Frame
12 weeks (end of treatment) and 6 months post treatment
Title
Shoulder function
Description
Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
Time Frame
4 weeks , 12 weeks and 6 months
Title
Shoulder Pain
Description
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Time Frame
4 weeks , 12 weeks and 6 months
Title
Generic health status
Description
EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
Time Frame
12 weeks and 6 months
Secondary Outcome Measure Information:
Title
Rotator cuff force
Description
Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
Time Frame
12 weeks ( end of treatment)
Title
Tendon pain pressure threshold
Description
Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.
Time Frame
12 weeks ( end of treatment )
Title
Analgesics and corticosteroid injections
Description
Analgesics consumption and corticosteroids injections registered on questionaire.
Time Frame
4 weeks , 12 weeks and 6 months
Title
Tendon thickness
Description
Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
Time Frame
12 weeks ( end of treatment )
Title
Patient global impression of change
Description
To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.
Time Frame
4 weeks, 12 weeks & 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
Symptom duration of minimum 3 months.
Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop & Veer, 2003)
Painful arc during active abduction (Ombregt, Bisschop & Veer, 2003)
Positive Neers sign (Neer, 1972 ; Tennent, Beach & Meyers, 2003)
Positive Jobes test (Jobe & Moynes, 1982 ; Tennent, Beach & Meyers, 2003)
Positive Hawkins-Kennedy impingement test (Hawkins & Kennedy, 1980)
Exclusion Criteria:
Shoulder pain due to trauma, e.g. fall.
Reduced ROM consistent with adhesive capsulitis/frozen shoulder
History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
Full thickness rupture of rotator cuff tendon
OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
Subjects suffering from serious psychiatric illness.
Subjects unable to understand English or Norwegian.
Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Magnus Bjordal, Professor
Phone
55 58 60 37
Ext
0047
Email
Jan.Bjordal@igs.uib.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sturla Haslerud, Msc
Phone
93424347
Ext
0047
Email
shas@hib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Magnus Bjordal, Professor
Organizational Affiliation
University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physiotherapy, Hillevaag General Practitioner Practice
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sturla Haslerud, Msc
Phone
93424347
Ext
0047
Email
shas@hib.no
First Name & Middle Initial & Last Name & Degree
Jon Joensen, PhD
Phone
55 58 72 31
Ext
0047
Email
jon.joensen@hib.no
12. IPD Sharing Statement
Learn more about this trial
The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
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