Clinical Trial: The Effectiveness of a Treatment for Posterior Shoulder Tightness: A Feasibility Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effectiveness of Treatment for Posterior Shoulder Tightness in Combination With 'Best Care' Compared With 'Best Care' Alone in Individuals With Shoulder Impingement Syndrome<

Brief Summary:

Shoulder impingement syndrome is a very common cause of shoulder pain and normally treated with physiotherapy or surgery. Research has shown that physiotherapy is as effective as surgery, however, the incidence of surgery for this condition is on the rise internationally, nationally and locally. The most effective form of physiotherapy, however, is not known. Laboratory studies have suggested that posterior shoulder tightness may contribute to irritation of the soft tissue around the shoulder joint and perpetuate pain from shoulder impingement syndrome. There is a lack of good quality evidence to support this perspective. The aim of this study is to assess the feasibility of conducting a randomized controlled trial to evaluate the effectiveness of treatment for posterior shoulder tightness in combination with 'best care' compared with 'best care' alone in individuals with shoulder impingement syndrome.

The study will be a randomised, controlled, double blind (patient and assessor), parallel group, feasibility study with 1:1 allocation ratio. Patients awaiting surgery will be assessed for inclusion/exclusion criteria and then randomly allocated into one of two groups. 60 patients will be assigned to receive 'best care' physiotherapy, with or without treatment for posterior shoulder tightness.

Physiotherapy treatment will be delivered over 13-15 weeks and outcomes will be assessed at 0, 6-8, 13-15, 26 and 52 weeks. The results will help us to understand if this is an important part of physiotherapy treatment, which might help reduce patient's pain and disability as well as reduce the cost of treatment for the National Health Service.


Detailed Summary:

The study will be a randomised, controlled, double blind (patient and assessor), parallel group, feasibility study with 1:1 allocation ratio. The patients will be assessed for inclusion/exclusion criteria and then randomly allocated into one of two groups. Both groups will receive the same exercise and educational interventions. The treatment group will also receive specific intervention for posterior shoulder tightness; the placebo group will receive placebo posterior shoulder tightness intervention.

Study setting

The study will take place in secondary care environment. Subjects will be recruited from the outpatient orthopaedic clinics at Worthing and Southlands Hospitals, part of Western Sussex Hospitals NHS Foundation Trust.

Recruitment

Recruitment will be promoted with fliers and research posters in the outpatients department. The chief investigator or a research assistant will attend the orthopaedic shoulder clinics and will approach patients in the waiting area to introduce the study and hand out fliers. The orthopaedic team will also introduce the study to patients where appropriate and introduce the patient to the chief investigator or the research assistant if the patient expresses an interest in receiving more information relating to the study.

Where appropriate the chief investigator or the research assistant will ask the patient if they would be willing to be contacted by the chief investigator the following day to discuss the study further. If so the patient details will be passed to the chief investigator who will call the patient at least 24 hours after the introduction of the study. The chief investigator will call to discuss the study further and if the patie
Sponsor: Western Sussex Hospitals NHS Trust

Current Primary Outcome: Shoulder Pain and Disability Index (Change) [ Time Frame: Baseline, 6-8, 13-15, 26 and 52 weeks. ]

Questionnaire relating to pain and disability


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • EQ-5D-5L (Change) [ Time Frame: Baseline, 6-8, 13-15, 26 and 52 weeks. ]
    Health related quality of life questionnaire
  • Range of motion; glenohumeral internal rotation, low flexion, horizontal adduction (Change). Range will be assessed using purpose built brace (with built in digital inclinometer) and range will be measured in degrees. [ Time Frame: Baseline, 6-8, 13-15 weeks ]
    Measurement of shoulder movements.


Original Secondary Outcome: Same as current

Information By: Western Sussex Hospitals NHS Trust

Dates:
Date Received: October 1, 2015
Date Started: September 2016
Date Completion: October 2019
Last Updated: November 7, 2016
Last Verified: November 2016