The POST Study; POsterior Shoulder Tightness in Rotator Cuff Related Disorders
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

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 description: 
      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 patient is happy to
      participate an appointment will be arranged for the patient to attend the physiotherapy
      department of either Worthing or Southlands hospital. At this time informed consent,
      eligibility assessment and baseline outcome measurement will be performed. In addition
      baseline characteristics will be recorded in an attempt to minimize selection bias. The
      estimated time for this visit is 90 minutes.

      Randomisation and Blinding

      Prior to subject randomisation, sealed envelopes will be prepared containing the treatment
      manual for the two treatment arms. The assessor will assign consenting participants a unique
      study number and the anonymised data will be forwarded to the named research officer at the
      Brighton and Sussex Clinical Trials Unit (B&S CTU). The officer will enter the data into the
      software package 'sealed envelope' that will process the data and assign the subject to the
      treatment or placebo group. An E-mail containing group allocation will then be sent to the
      assessor. The patient will then be transferred to the reception of the physiotherapy
      department where the appropriately numbered envelop will be placed with the physiotherapy
      notes and the patient booked for their initial physiotherapy session. The group allocation of
      each patient will only be available to the treating physiotherapist when the envelope
      containing the manual is opened at the initial physiotherapy consultation. The
      physiotherapist will be instructed not to advise the patient to which group they have been
      allocated.

      Data collection

      Data collection will take place prior to random allocation, half way through the intervention
      (6-8 weeks) and at the end of the intervention (13-15 weeks). At 26 and 52 weeks a telephone
      follow-up interview will repeat collection of Shoulder pain and Disability Index (SPADI) and
      the EuroQol questionnaire (EQ-5D-5L) and evaluate the surgical outcome. The chief
      investigator will perform data collection, an assistant will accompany to assist with
      measurement of posterior shoulder tightness. The assessor will be blind to the group
      allocation of participants. Where possible the participants will complete questionnaires
      unassisted, where assistance is required additional explanation will be provided by the
      research assistant. Physical data will be collected in the form of a clinical examination at
      baseline, 6-8 weeks and at 13-15 weeks. The examination will involve measurement of posterior
      shoulder tightness through the use of three clinical tests. These tests will be performed
      with measurement brace and digital inclinometer. A reliability study of these three clinical
      tests has been performed by the chief investigator at the University of Brighton following
      approval by the Faculty of Health Sciences Research Ethics and Governance Committee. The
      three clinical tests to identify patients with posterior shoulder tightness are; horizontal
      adduction, internal rotation in 90 degrees abduction and low flexion.

      Physiotherapy intervention

      The treatment intervention will be delivered in the physiotherapy outpatient departments of
      Worthing Hospital or Southlands Hospital. Treatment will be delivered by NHS physiotherapists
      over 13-15 weeks and consist of 6-8 sessions of physiotherapy. The first 4 sessions will be
      delivered weekly and the subsequent 4 sessions will be delivered every 2 weeks. This
      treatment dose and duration is consistent with previous high quality studies (Holmgren et al.
      2014, Bernhardsson et al. 2011). The intervention will be delivered while patients are on the
      surgical waiting list for subacromial decompression surgery. The current waiting times for
      surgery vary considerably between consultants, from 18-28 weeks. This means the intervention
      can be fully completed during the waiting time for surgery.

      All treatment will be provided by NHS physiotherapist as part of their daily caseload. They
      will be allocated 45 minutes for initial assessment and 30 minutes for subsequent treatment
      sessions, in line with current departmental procedure. All therapists will be recruited for
      the trial on a voluntary basis. Appropriate training will be provided to all
      physiotherapists. It is estimated that 2 physiotherapists from each of the three
      physiotherapy sites will be required to deliver the physiotherapy interventions.

      For both groups, physiotherapy treatment will consist of education regarding the nature of
      the patients condition, and the prescription of an exercise program to be performed once a
      day at home. Each group will perform three strengthening exercises to address the muscular
      systems of the scapular and rotator cuff musculature and a stretching exercise for the
      anterior shoulder. The exercises have been selected based on review of the available
      literature relating to muscular dysfunction in shoulder impingement, electromyography (EMG)
      studies of shoulder exercises and RCTs where the interventions have been adequately
      described. The exercises with be taught by the physiotherapist and reviewed at each session
      where the exercises will be progressed or regressed depending on the patients response since
      the last visit.

      In addition subjects allocated to the 'posterior shoulder tightness' treatment group will
      also receive specific manual therapy during each physiotherapy session. The treatment has
      been designed to mobilise the structures of the posterior shoulder. They will be prescribed
      home stretches to address stiffness of the posterior shoulder.

      The 'sham posterior shoulder tightness' group will receive home stretches and manual therapy
      of similar durations to the 'posterior shoulder tightness' group, but delivered to structures
      that have no known direct structural influence on the posterior shoulder. The intention is
      for subjects to receive a similar dose of manual therapy to control for the generic effects
      of manual therapy, which may have pain relieving mechanisms. The sham intervention will be
      controlled for time and attention in order to create a comparable attention-control group.
      Using this design it may be possible to determine if there is any additional benefit to
      treating posterior shoulder tightness in combination with high quality rehabilitation for
      patients with shoulder impingement syndrome.

      All subjects will be asked to perform 4 strengthening exercises each day and 2 stretches each
      day as well as attending 6-8 physiotherapy treatments over a 13-15 week period. The exercises
      will take approximately 10-15 minutes to perform.

      The study has been designed as a feasibility study as there are believed to be too many
      unknown factors to proceed directly to definitive randomised controlled study design. These
      are outlined in full in section 11A. It is predicted recruitment will begin in May 2016 and
      continue until November 2018. Final follow-up assessment will occur one year after initial
      outcome assessment. So it is predicted that final patient contact will occur in
      October/November 2019.

      The study design was discussed in depth with a user group at its conception in June 2013 and
      two patient representatives have continued to assist throughout the study design. Patients
      have reviewed the recruitment strategy, patient information literature and consent forms.
      They have agreed to participate in an informed consent rehearsal and appraisal prior to the
      start of recruitment to ensure informed consent is thorough and easy for the patient to
      comprehend and allows sufficient time for questions.

      The study steering committee will meet every 6 months to ensure the study is running
      smoothly. The steering committee will include; Kevin Hall (lead researcher), Chris Mercer
      (Physiotherapy Consultant, physiotherapy clinical lead), Professor Ann Moore (academic
      supervisor, or a member of the academic supervisory team), Mr Nurang (Orthopaedic Shoulder
      Consultant), Richard Brunton (service user), Pamela Clarke (service user), Clare Meachin
      (Research and Innovation Department) and Physiotherapist (to be confirmed).

      Progress reports will be submitted to the National Institute of Health Research (NIHR) at 6
      months and then annually for the 5 year duration of the study.
    

Intervention name(s): Manual therapy
Intervention type(s): Other
Intervention description(s): Exercise, behaviour change interventions and manual therapy
Other intervention name(s): Exercise; Education; Behaviour change interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: posterior shoulder tightness; shoulder impingement syndrome; Glenohumeral joint; exercise