Trial record 4 of 190 for:    Open Studies | "Shoulder"

SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Linkoeping University
Sponsor:
Collaborators:
Primary care units and
Linköping University hospital (Orthopedic clinic)
The County council of Östergötland, Sweden
Information provided by (Responsible Party):
Kajsa Johansson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01885377
First received: June 18, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

Objective: A randomized clinical trial in order to evaluate the efficacy of a specific exercise strategy for patients with subacromial pain.

Hypothesis:

H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder function and/or shoulder pain.

H0 - No difference between the two exercise strategies (specific exercise strategy and active control exercises).

Method: Patients attending primary care with subacromial pain are offered participation. If accepted, they will participate in a three month rehabilitation program. The duration of symptoms can vary from 2 weeks and longer. The patients will be randomized to either rehabilitation; the specific exercise strategy or active control exercises. All patients has an equal number of sessions with the physical therapist (PT) to offer similar attention and support with exercise performance. A blinded physical therapist evaluates the following outcomes at baseline and after three-, six and twelve months:

Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes; Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound to reveal the status of the rotator cuff.

Additional to the analysis of treatment effect on shoulder function and pain, factors influencing and explaining the CM-score at follow-ups will be analyzed.

This study is warranted in order to evaluate if an earlier reported positive effect on shoulder function and pain with the specific exercise strategy, in patients on waiting list for subacromial decompression, can be repeated in the primary care population of patients with subacromial pain. There is no consensus about first-line exercises for patients with subacromial pain, and these positive results on pain and shoulder function need to be reproduced in primary care before they can be recommended and implemented. Further, knowledge about which factors that can be used in prediction rules for patients that will respond to the exercises or needs surgery is lacking.


Condition Intervention
Shoulder Pain
Shoulder Impingement Syndrome
Disorder of Rotator Cuff
Subacromial Bursitis
Other: Specific exercise group
Other: Control exercise group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • The Constant-Murley shoulder assessment [ Time Frame: Baseline and change 3-, 6- and 12 months ] [ Designated as safety issue: No ]

    Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.

    The score is summarized to a maximum of 100 for best available shoulder function.



Secondary Outcome Measures:
  • Euro Qol 5D index (EQ 5D) [ Time Frame: Baseline and change 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    Health Related Quality of Life by EuroQol 5 dimensions and index. Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.

  • Disabilities of the arm, shoulder and hand [ Time Frame: Baseline and change 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity.

  • VAS for pain [ Time Frame: Baseline and change 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    Self-assessed for pain at rest, in activity and at night if it disturbs sleeping

  • Patients Global Impression of Change (PGIC) [ Time Frame: At follow-up: 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    The patients are asked to assess change. A scale ranging from getting worse by the intervention to be recovered.

  • The Patient Specific functional Scale [ Time Frame: Baseline and change 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    Self-selected functional activities to relate efficacy to during follow-ups.

  • Euro Qol VAS (EQ VAS) [ Time Frame: Baseline and change 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    In EQ VAS the patients assess their health state on a vertical line valued from 0-100.


Other Outcome Measures:
  • Hospital Anxiety and Depression Scale (HAD) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To screen mental health (depression and/or anxiety) in all included patients. Maximum score is 21 points for the depression and anxiety part respectively. The higher score, the higher risk of a depression and/or anxiety.

  • Sick-leave and return to work or working status [ Time Frame: Baseline, 3-, 6- and 12 months ] [ Designated as safety issue: No ]
    Patient reported can be double checked by the Swedish Social Insurance Agency.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Specific exercise group
A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed
Other: Specific exercise group
A program where exercise load is individually adjusted and the exercises progressed during a 3 month period. The 'pain monitoring model' were used to find the individual resistance. Several exercises are performed eccentrically in order to load more. Initially the exercises were PT-tutored every week and then every other week.
Other Names:
  • •Strength-endurance exercises
  • •Rotator cuff
  • •Scapular stabilization
  • •Eccentric
  • •Posture
Active Comparator: Control exercise group
General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period.
Other: Control exercise group
A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
Other Names:
  • •Movement exercises
  • •Stretching
  • •Posture

  Eligibility

Ages Eligible for Study:   30 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 2 weeks of symptom duration
  • Typical history and pain location (C5 dermatome)

Three of these four must be positive:

  • Neer impingement sign
  • Hawkins-Kennedy impingement sign
  • Jobe supraspinatus test
  • Patte maneuver

Exclusion Criteria:

  • Polyarthritis or fibromyalgia
  • Pathological hyper-laxity or dislocation of the any of the shoulder joints
  • Cervical spine pathology
  • Lack of communication skills that prevent the use of outcome measures
  • Signs in ultrasound of bone spurs i.e. Acromio-Clavicular joint, that will affect the subacromial space
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885377

Contacts
Contact: Jenny Nordqvist, MSc, RPT +46 10 103 78 22 jenny.nordqvist@liu.se
Contact: Kajsa Johansson, PhD, RPT +46 10 103 74 89 kajsa.johansson@liu.se

Locations
Sweden
Primary Care unit "Rörelse & Hälsa" Recruiting
Linköping, Sweden, 581 85
Principal Investigator: Jenny Norqvist, MSc, RPT         
Sponsors and Collaborators
Linkoeping University
Primary care units and
Linköping University hospital (Orthopedic clinic)
The County council of Östergötland, Sweden
Investigators
Study Chair: Birgitta Öberg, Professor Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
Study Director: Lars Adolfsson, Professor Dept. of Orthopaedics, University Hospital Linköping & Linköping University
Principal Investigator: Kajsa Johansson, PhD Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University
  More Information

No publications provided

Responsible Party: Kajsa Johansson, Senior Lecturer, Linkoeping University
ClinicalTrials.gov Identifier: NCT01885377     History of Changes
Other Study ID Numbers: 8820 PV-JN-1
Study First Received: June 18, 2013
Last Updated: June 20, 2013
Health Authority: Sweden: Swedish Board of Health and Welfare
Sweden: Linköping university

Keywords provided by Linkoeping University:
Subacromial pain
Impingement
Exercises
Physical therapy
Primary care

Additional relevant MeSH terms:
Bursitis
Shoulder Pain
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Arthralgia
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014