The POST Study; POsterior Shoulder Tightness in Rotator Cuff Related Disorders

NCT02598947 | Completed

• 1 other identifier: CDRF-2014-05-003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome

Keywords

posterior shoulder tightness; shoulder impingement syndrome; Glenohumeral joint; exercise

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index (Change)

  Questionnaire relating to pain and disability

  Baseline, 6-8, 13-15, 26 and 52 weeks.

Secondary Outcomes (2)

• EQ-5D-5L (Change)

  Baseline, 6-8, 13-15, 26 and 52 weeks.

• 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.

  Baseline, 6-8, 13-15 weeks

Study Arms (2)

Posterior shoulder tightness group

EXPERIMENTAL

As well as receiving a strengthening program for the scapular and rotator cuff musculature, subjects allocated to the 'posterior shoulder tightness' treatment group will also receive specific manual therapy and home stretches to address stiffness of the posterior shoulder

Other: Manual therapy

Posterior shoulder tightness sham group

SHAM COMPARATOR

The 'sham posterior shoulder tightness' group will receive the same strengthening program for the scapular and rotator cuff musculature, in addition they 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

Other: Manual therapy

Interventions

Manual therapy OTHER

Exercise, behaviour change interventions and manual therapy

Also known as: Exercise, Education, Behaviour change interventions

Posterior shoulder tightness group; Posterior shoulder tightness sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Listed for subacromial decompression surgery by a consultant orthopaedic surgeon
• Presence of posterior shoulder tightness, based on a positive result in 2 of 3 clinical tests (see below for explanation)
• Comprehensive in spoken and written English
• Site of mechanical pain consistent with shoulder impingement syndrome
• At least 3 months duration of shoulder pain
• A minimum SPADI score of 20
• Clinical examination revealing a positive tests for pain with either Neer's test or Hawkins-Kennedy test
• Using the SEM values obtained from the recent reliability study conducted at the University of Brighton (see appendix 1), side-to-side differences of more than 2×SEM are associated with a 95% probability that the difference is not caused by the inaccuracy of the clinical test. Using the SEM values obtained from this study, it is possible to be 95% confident that the difference identified is not due to an error of measurement when the side-to-side difference is greater than;
• degrees for horizontal adduction
• degrees for internal rotation in abduction
• degrees for low flexion
• Based on these results a side-to-side difference of 10 degrees or more on two out of three clinical tests will be considered positive for the presence of posterior shoulder tightness.
• Clustering tests enables the clinician to overcome the inherent weaknesses of individual tests. Making a decision relating to the presence of posterior shoulder tightness on the outcome of a cluster of tests may better reflect the complex anatomy of the posterior shoulder and the multiple layers of connective tissue and muscle acting as passive restraint to movement.

You may not qualify if:

• Clinically detectable large full thickness rotator cuff tear
• Recent trauma (last 3 months) involving the shoulder
• Clinical and radiologically evidence of osteoarthritis of the glenohumeral joint
• Symptomatic osteoarthritis of the acromioclavicular joint
• Adhesive capsulitis (50% deficit of range of movement in 2 or more directions)
• Malignancy
• Previous fracture or surgery of the symptomatic shoulder
• Polyarthritis
• Past diagnosis of fibromyalgia
• Rheumatiod arthritis
• Cervical source of shoulder pain; somatic or radicular (reproduction of familiar shoulder pain during a clinical examination of the cervical spine)
• Ipsilateral shoulder dislocation in last 2 years
• Multidirectional instability

Sponsors & Collaborators

• Western Sussex Hospitals NHS Trust: lead
• University of Brighton: collaborator

Study Sites (1)

Kevin Hall

Shoreham-by-Sea, Sussex, BN43 6TQ, United Kingdom

Location

Related Publications (2)

• Bernhardsson S, Klintberg IH, Wendt GK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil. 2011 Jan;25(1):69-78. doi: 10.1177/0269215510376005. Epub 2010 Aug 16.

  PMID: 20713438 BACKGROUND

• Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.

  PMID: 25213604 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Motor Activity

Interventions

Musculoskeletal Manipulations; Exercise; Educational Status

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Kevin Hall, MSc

  Western Sussex Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: November 6, 2015
• Study Start: September 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

GB (1)