Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000287235
Ethics application status
Approved
Date submitted
24/02/2009
Date registered
18/05/2009
Date last updated
18/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of medical exercise therapy in patients with long lasting unilateral shoulder pain: a randomized controlled trial with one year follow-up.
Scientific title
The Trondheim Shoulder Pain study: A study on the effectiveness of medical exercise therapy on pain reduction in patients with long lasting unilateral shoulder pain.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder subacromial impingement 4380 0
Condition category
Condition code
Musculoskeletal 4627 4627 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical exercise therapy:
Type of exercises completed: shoulder range of motion exercises.
High repetition group.
Eight shoulder range of motion exercises were completed each treatment session, with three sets of 30 repetitions for each exercise. The approximate duration of each treatment session was one hour.

Low repetition group.
Five shoulder range of motion exercises were completed each treatment session, with three sets of 30 repetitions for each exercise. The approximate duration of each treatment session was thirty minutes.
For both groups, patient history, symptoms, and clinical findings were the basis for choosing starting positions, range of motion, and weight resistance for the patient being able to do three sets of 30 repetitions. Each exercise was tested using a specific clinical test procedure developed in medical exercise therapy (Torstensen 1999, Torstensen 2004). Thus, each patient had an individual tailored exercise program. The patient exercised within the comfortable range of motion with normal humeroscapular rhythm, and in the early phase the weight from the pulley apparatus was used to deload some of the weight of the arm, making it possible to perform the high number of repetitions in sets (three sets of 30 repetitions) with good kinetic control. As the patient improved, experiencing less pain, the range of motion and weight resistance were increased and the starting position was changed according to the progression ladder developed in medical exercise therapy (Torstensen 1999). The number of repetitions and sets was kept constant for both intervention groups during the treatment period, which involved three treatments a week for 12 weeks. The effect of the program is a combination of the global aerobic exercises using a stationary bike, treadmill, or step machine, and the semiglobal and local exercises using such medical exercise therapy equipment, as a wall pulley apparatus, lateral pulley apparatus, incline board, angle bench, multiple purpose bench, shoulder rotator, dumbbells or barbells.
Intervention code [1] 4112 0
Rehabilitation
Comparator / control treatment
Type of exercises completed: shoulder range of motion exercises.
High repetition group.
Eight shoulder range of motion exercises were completed each treatment session, with three sets of 30 repetitions for each exercise. The approximate duration of each treatment session was one hour.

Low repetition group.
Five shoulder range of motion exercises were completed each treatment session, with three sets of 30 repetitions for each exercise. The approximate duration of each treatment session was thirty minutes.
For both groups, patient history, symptoms, and clinical findings were the basis for choosing starting positions, range of motion, and weight resistance for the patient being able to do three sets of 10 repetitions. Each exercise was tested using a specific clinical test procedure developed in medical exercise therapy (Torstensen 1999, Torstensen 2004). Thus, each patient had an individual tailored exercise program. The patient exercised within the comfortable range of motion with normal humeroscapular rhythm, and in the early phase the weight from the pulley apparatus was used to deload some of the weight of the arm, making it possible to perform the high number of repetitions in sets (three sets of 10 repetitions) with good kinetic control. As the patient improved, experiencing less pain, the range of motion and weight resistance were increased and the starting position was changed according to the progression ladder developed in medical exercise therapy (Torstensen 1999). The number of repetitions and sets was kept constant for both intervention groups during the treatment period, which involved three treatments a week for 12 weeks. The effect of the program is a combination of the global aerobic exercises using a stationary bike, treadmill, or step machine, and the semiglobal and local exercises using such medical exercise therapy equipment, as a wall pulley apparatus, lateral pulley apparatus, incline board, angle bench, multiple purpose bench, shoulder rotator, dumbbells or barbells.
Control group
Active

Outcomes
Primary outcome [1] 5497 0
Shoulder pain assessed by mean visual analogue scale score
Timepoint [1] 5497 0
Timepoint: at baseline and at 3, 6 and 12 weeks after intervention
commencement
Secondary outcome [1] 9258 0
Mean function score, assesed by isometric strength test and active range of motion test.
Timepoint [1] 9258 0
Timepoint: at baseline and at 3, 6 and 12 weeks after intervention
commencement

Eligibility
Key inclusion criteria
positive subacromial impingement test
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous shoulder surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1600 0
Norway
State/province [1] 1600 0
Country [2] 1601 0
Norway
State/province [2] 1601 0

Funding & Sponsors
Funding source category [1] 4555 0
University
Name [1] 4555 0
Sor-Trondelag University College
Country [1] 4555 0
Norway
Primary sponsor type
Government body
Name
Department of Physical Therapy
Address
Ranheimsvn 10
7004 Trondheim
Country
Norway
Secondary sponsor category [1] 4111 0
None
Name [1] 4111 0
Address [1] 4111 0
Country [1] 4111 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29321 0
Address 29321 0
Country 29321 0
Phone 29321 0
Fax 29321 0
Email 29321 0
Contact person for public queries
Name 12568 0
Havard Osteras
Address 12568 0
Sor-Trondelag University College, Faculty of Health Education and Social Work, Department of Physical Therapy, Ranheimsv 10, N-7004 Trondheim
Country 12568 0
Norway
Phone 12568 0
+4773559305
Fax 12568 0
Email 12568 0
[email protected]
Contact person for scientific queries
Name 3496 0
Tom Torstensen
Address 3496 0
Holten Institute, BOX 6038 Lidingo, Sweden
Country 3496 0
Sweden
Phone 3496 0
+46707344102
Fax 3496 0
Email 3496 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.