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

Shoulder Pain Clinical Trial

Official title:

The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02304003
• Other study ID #: BergenUC
• Secondary ID: 2012/2134
• Status: Recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 2022

Study information

• Verified date: August 2018
• Source: Bergen University College
• Contact: Jan Magnus Bjordal, Professor
• Phone: 55 58 60 37
• Email: Jan.Bjordal[@]igs.uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )

1. Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.

2. Symptom duration of minimum 3 months.

3. 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)

Exclusion Criteria:

1. Shoulder pain due to trauma, e.g. fall.

2. Reduced ROM consistent with adhesive capsulitis/frozen shoulder

3. History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability

4. Full thickness rupture of rotator cuff tendon

5. 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.

6. Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine

7. Subjects suffering from serious psychiatric illness.

8. Subjects unable to understand English or Norwegian.

9. Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Shoulder Pain
• Subacromial Impingement
• Tendinopathy

Intervention

Other:
• Structured Physiotherapy Regimen
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.
• Standard Care
Standard follow up in primary care.

Locations

Country	Name	City	State
Norway	Department of Physiotherapy, Hillevaag General Practitioner Practice	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Bergen University College	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for surgery	Dichotomised questionnaire yes or no	12 weeks (end of treatment) and 6 months post treatment
Primary	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
Primary	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
Primary	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	Rotator cuff force	Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .	12 weeks ( end of treatment)
Secondary	Tendon pain pressure threshold	Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.	12 weeks ( end of treatment )
Secondary	Analgesics and corticosteroid injections	Analgesics consumption and corticosteroids injections registered on questionaire.	4 weeks , 12 weeks and 6 months
Secondary	Tendon thickness	Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )	12 weeks ( end of treatment )
Secondary	Patient global impression of change	To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.	4 weeks, 12 weeks & 6 months