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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] 283930 0
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 290946 0
Condition category
Condition code
Musculoskeletal 291294 291294 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291322 291322 0 0
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] 288625 0
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] 291288 0
The shoulder pain and disability index (SPADI)
Timepoint [1] 291288 0
Baseline, after treatment and one month later.
Primary outcome [2] 291290 0
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] 291290 0
Baseline, after treatment and one month later
Primary outcome [3] 291291 0
Symptomatic onset range in active scaption.The angle of abduction where the patient first reports their symptom onset on the affected arm measured in degrees with an inclinometer.
Timepoint [3] 291291 0
Baseline, after treatment and one month later
Secondary outcome [1] 306434 0
Scapula co ordinates (in centimetres from the y axis of the centre of the spine to the x axis of the inferior scapula angle, medial scapula angle and lateral scapula angle) at rest, 90 degrees and end range of motion abduction will be measured bilaterally with a tape measure.
Timepoint [1] 306434 0
Baseline, after treatment and one month later
Secondary outcome [2] 306435 0
The visual analogue scale (VAS) of pain intensity
Timepoint [2] 306435 0
Baseline, after treatment and one month later
Secondary outcome [3] 313333 0
Surface electromyography on upper and lower trapezius
Timepoint [3] 313333 0
Baseline, after treatment and one month later
Secondary outcome [4] 313334 0
Tampa kinesiophobia scale
Timepoint [4] 313334 0
Baseline

Eligibility
Key inclusion criteria
Presence of shoulder pain in the anterior , lateral and posterior aspects of the shoulder.
Episode with a minimum duration of 4 weeks.
Participants aged between 18 and 55 years
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent shoulder dislocation, any recent fractures around the shoulder, systemic illnesses such as rheumatoid arthritis, acute phase of adhesive capsulitis, shoulder pain that is deemed to be originating from the neck or if there is a neurological impairment, osteoporosis, haemophilia and/or malignancies, any treatment of shoulder pain by a health care practitioner within the last six weeks and /or a corticosteroid injection to the shoulder joint in the last six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers who are referred by a medical practitioner or health care professional, will undergo a phone screening and baseline physical assessment to determine eligibility by a trial assessor. Eligible volunteers who consent to participate will complete baseline outcome measures prior to being randomised to one of the three interventions, using sealed opaqued envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated with a web-based randomisation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming that differences between basal and final values of SPADI in the best treatment option will be of 15 points, and taking into account that the standard deviation most likely will be around 11 (Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM, 2013), our calculations indicate that the power to detect these minimum differences on SPADI in a sample of 96 subjects (allocated proportionally among the four groups) would be of 80% for an alpha of 5% and a drop-out rate of 5%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
31/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 5761 0
Spain
State/province [1] 5761 0
Malaga

Funding & Sponsors
Funding source category [1] 288580 0
University
Name [1] 288580 0
University of Malaga
Country [1] 288580 0
Spain
Primary sponsor type
University
Name
University of Malaga
Address
Paseo del Parque, s/n
29009 Malaga
Spain
Country
Spain
Secondary sponsor category [1] 287290 0
None
Name [1] 287290 0
Address [1] 287290 0
Country [1] 287290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290444 0
Ethics Committee Carlos Haya Hospital, Malaga, Spain
Ethics committee address [1] 290444 0
Ethics committee country [1] 290444 0
Spain
Date submitted for ethics approval [1] 290444 0
27/01/2014
Approval date [1] 290444 0
31/01/2014
Ethics approval number [1] 290444 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45678 0
Dr Alejandro Luque Suarez
Address 45678 0
Faculty of Health Sciences, University of Malaga
Calle Francisco Penalosa, 3
29071 Malaga, Spain
Country 45678 0
Spain
Phone 45678 0
+34 951952853
Fax 45678 0
Email 45678 0
aluques@uma.es
Contact person for public queries
Name 45679 0
Alejandro Luque Suarez
Address 45679 0
Faculty of Health Sciences, University of Malaga
Calle Francisco Penalosa, 3
29071 Malaga, Spain
Country 45679 0
Spain
Phone 45679 0
+34 951952853
Fax 45679 0
Email 45679 0
aluques@uma.es
Contact person for scientific queries
Name 45680 0
Alejandro Luque Suarez
Address 45680 0
Faculty of Health Sciences, University of Malaga
Calle Francisco Penalosa, 3
29071 Malaga, Spain
Country 45680 0
Spain
Phone 45680 0
+34 951952853
Fax 45680 0
Email 45680 0
aluques@uma.es

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIs coracohumeral distance associated with pain-function, and shoulder range of movement, in chronic anterior shoulder pain?.2017https://dx.doi.org/10.1186/s12891-017-1498-0
N.B. These documents automatically identified may not have been verified by the study sponsor.