The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy

NCT02304003 | Unknown DMC

• 2 other identifiers: BergenUC2012/2134
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.

Conditions

Tendinopathy; Shoulder Impingement Syndrome; Shoulder Pain; Subacromial Impingement

Keywords

Shoulder tendinopathy; Subacromial impingement syndrome; Rotator cuff tendinopathy; Supraspinatus tendinopathy

Outcome Measures

Primary Outcomes (4)

• Need for surgery

  Dichotomised questionnaire yes or no

  12 weeks (end of treatment) and 6 months post treatment

• Shoulder function

  Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.

  4 weeks , 12 weeks and 6 months

• Shoulder Pain

  Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .

  4 weeks , 12 weeks and 6 months

• Generic health status

  EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

  12 weeks and 6 months

Secondary Outcomes (5)

• Rotator cuff force

  12 weeks ( end of treatment)

• Tendon pain pressure threshold

  12 weeks ( end of treatment )

• Analgesics and corticosteroid injections

  4 weeks , 12 weeks and 6 months

• Tendon thickness

  12 weeks ( end of treatment )

• Patient global impression of change

  4 weeks, 12 weeks & 6 months

Study Arms (2)

Structured Physiotherapy regimen

EXPERIMENTAL

Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy

Other: Structured Physiotherapy Regimen

Standard care

OTHER

Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options.

Other: Standard Care

Interventions

Structured Physiotherapy Regimen OTHER

Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.

Structured Physiotherapy regimen

Standard Care OTHER

Standard follow up in primary care.

Standard care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
• Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
• Symptom duration of minimum 3 months.
• Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
• Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop \& Veer, 2003)
• Painful arc during active abduction (Ombregt, Bisschop \& Veer, 2003)
• Positive Neers sign (Neer, 1972 ; Tennent, Beach \& Meyers, 2003)
• Positive Jobes test (Jobe \& Moynes, 1982 ; Tennent, Beach \& Meyers, 2003)
• Positive Hawkins-Kennedy impingement test (Hawkins \& Kennedy, 1980)

You may not qualify if:

• Shoulder pain due to trauma, e.g. fall.
• Reduced ROM consistent with adhesive capsulitis/frozen shoulder
• History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
• Full thickness rupture of rotator cuff tendon
• OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
• Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
• Subjects suffering from serious psychiatric illness.
• Subjects unable to understand English or Norwegian.
• Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.

Sponsors & Collaborators

• Bergen University College: lead
• University of Bergen: collaborator

Study Sites (1)

Department of Physiotherapy, Hillevaag General Practitioner Practice

Stavanger, 4016, Norway

RECRUITING

MeSH Terms

Conditions

Tendinopathy; Shoulder Impingement Syndrome; Shoulder Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Joint Diseases; Shoulder Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jan Magnus Bjordal, Professor

  University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.

  STUDY CHAIR

Central Study Contacts

Jan Magnus Bjordal, Professor

CONTACT

55 58 60 37; Jan.Bjordal@igs.uib.no

Sturla Haslerud, Msc

CONTACT

93424347; shas@hib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sturla Haslerud , PT , Msc Orthopedics & Reumatology , PhD candidate

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 1, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

NO (1)