ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000144617

Ethics application status

Approved

Date submitted

20/01/2014

Date registered

5/02/2014

Date last updated

2/03/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of manual therapy, exercise and elastic taping on shoulder pain: A double-blind, randomized clinical trial.

Scientific title

The effect of three different programs of rehabilitation for shoulder pain on pain and disability

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1152-3173

Trial acronym

The PHYSHO study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

shoulder pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention 1: manual therapy + therapeutic exercise

Manual therapy. 10 sessions will be applied by a physiotherapist. One per day. Duration of each session: 15 min. Duration of treatment: 2 weeks.
a. 3 sets of 12 repetitions for lower gliding (supine position) and posterior gliding (sitting position) on humeral head, slow velocity and amplitude.
b. 3 sets of 12 repetitions for upward scapular rotation (side lying position)

Exercise therapy at physiotherapy clinic. 10 sessions (one per day). Duration of each session: 20 min. Total duration: 2 weeks. Comprised of:
a. 5 sessions of isometric and isotonic strengthening exercises for scapula stabilizers, rotator cuff muscles and posterior deltoids. From 0 to 45 degrees of abduction.
b. 5 sessions of isometric and isotonic strengthening exercises for scapula stabilizers, rotator cuff muscles and posterior deltoids. From 45 to 90 degrees of abduction.
c. One session per day during 10 days of stretching exercises for posterior capsula and shoulder internal rotators. 3 repetitions of 30 seconds for each muscular group.

Note: manual therapy session (15 min) will be applied firstly, and, afterwards, an exercise therapy session of 20 min, at the same physiotherapy clinic, by the same physiotherapist. Hence, the duration of the session will be 35 min. 10 sessions (see above) will be performed in this way.
After that, an extra set of 20 exercise therapy sessions (same exercises as described above) will be prescribed by the physiotherapist for the patient to be done at home, as described below.

Exercise therapy at home. 20 sessions (one per day). Duration of each session: 20 min. Total duration: one month. Comprised of:

a. Isometric and isotonic strengthening exercises for scapula stabilizers, rotator cuff muscles and posterior deltoids. From 45 to 90 degrees of abduction.
b. Stretching exercises for posterior capsula and shoulder internal rotators. 3 repetitions of 30 seconds for each muscular group.
In order to monitor the adherence to exercise therapy at home, a participant daily exercise diary will be used.

Summary intervention 1:
Week 1-2: Manual therapy + Exercise therapy (clinic)
Week 3-6: Exercise therapy (Home)

Intervention 2: manual therapy + therapeutic exercise + elastic taping

Manual therapy: same as intervention 1.
Exercise therapy: same as intervention 1.
Elastic tape: A single strip will be applied with the subject in erect standing, with the shoulder in maximal external rotation, palm facing forward. The tape was applied from the coracoid process anteriorly to the superior scapular angle posteriorly, to maintain shoulder external rotation. The tape will be stretched to 100% and immediately applied to the skin. Once applied, the adhesion of the tape to the skin was enhanced by rubbing the surface of the tape three times in an anterior to posterior direction. The strip will be maintained during 5 consecutive days and replaced for the next 5 therapy sessions. While wearing elasting taping, manual therapy will be applied and exercises will be executed. The overall duration of the taping application will be 2 weeks.
Due to the tape will be worn for 5 consecutive days at the same time as manual therapy is applied, the physiotherapist will check each session that the tape has not been removed. In this case, the old one has been replaced by a new strip.

Summary intervention 2:
Week 1-2: Manual therapy + Exercise therapy (clinic) + elastic taping
Week 3-6: Exercise therapy (Home)

Intervention 3: manual therapy + elastic taping
Same interventions as intervention 1 and 2

Summary intervention 3:
Week 1-2: Manual therapy + Elastic taping (clinic)

All the interventions will be carried out in 4 physiotherapy clinics.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Manual therapy. 10 sessions will be applied by a physiotherapist. One per day. Duration of each session: 15 min. Duration of treatment: 2 weeks.
a. 3 sets of 12 repetitions for lower gliding (supine position) and posterior gliding (sitting position) on humeral head, slow velocity and amplitude.
b. 3 sets of 12 repetitions for upward scapular rotation (side lying position)

Control group

Active

Outcomes

Primary outcome [1]

The shoulder pain and disability index (SPADI)

Timepoint [1]

Baseline, after treatment and one month later.

Primary outcome [2]

Acromiohumeral distance (AHD) measured by ultrasound imaging.
Outcome data will be collected for all participants. The ultrasound examinations will be carried out measuring AHD at 0 degrees and 60 degrees of shoulder elevation in the scapular plane, with the participant seated in an upright position. To achieve an upright position, with shoulder retraction and cervical and thoracic extension, subjects will be instructed to sit against the back rest of the chair, sit up straight, pull their shoulders back and look straight ahead. A hydrogoniometer placed on the participant’s arm will be used to position the arm at 0 degrees and 60 degrees of scapular plane elevation. To assist in positioning arm elevation in the scapular plane, a room divider will be positioned at an angle of 30 degrees forward from the subject’s frontal plane, which will be marked with tape on the floor. The participants will be asked to maintain their arm elevated actively with enough tension to maintain the position of the hydrogoniometer. Between measurements, participants will be instructed to bring their arm down to a resting position to minimise shoulder fatigue. To measure the AHD in 0 degrees and 60 degrees the ultrasound transducer was positioned along the major axis of the humerus and parallel to the flat superior aspect of the acromion, so that both the acromion and humerus can be visualised. The AHD will be measured going straight down (vertically) from the acromion to the humeral head. Measurements of the AHD will be made at two locations: (1) at the most anterior part of the acromial arch and (2) 1 cm behind the first measure.

Timepoint [2]