Effectiveness of high-energy extracorporeal shockwave therapy along with routine physical therapy on subjective and objective measures in patients with calcified rotator cuff tendinopathy; a randomized controlled trial
1. To determine the effectiveness of high-energy extracorporeal shockwave therapy along with routine physical therapy on pain intensity, range of motion, functional activity and radiological outcomes in patients with calcified rotator cuff tendinopathy.
Design
Parallel group, single blinded, randomized controlled trial
Settings and conduct
Physiotherapy department, Lifeline Health Care and Pain Centre, Lahore Pakistan
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with calcified rotator cuff tendinopathy referred by orthopedic surgeons or rheumatologists
Either gender, age ranges from 30-55 years
Radiological evidence of type A or B calcification(≥1cm or 10mm)
Exclusion Criteria:
• Patients having primary joint trauma or infection in shoulder region
• Frozen shoulder or symptoms from cervical spine, glenohumeral osteoarthritis
• Shoulder instabilities, malignancies and nerve injuries
Intervention groups
Randomly, treatment will be assigned to patients in this study.
Group-A (Experimental group): It will receive routine physical therapy treatment and high-energy extra-corporeal shockwave therapy. Routine physiotherapy treatment will be administered to the patients.
Group B (Control group): In this group, routine physical therapy will be given to treat calcifies tendinopathy. For routine treatment, same interventions will be administered to the patients as given to group A.
Main outcome variables
Numeric Pain Rating Scale
Constant and Murley Score
Western Ontario Rotator Cuff Index
Radiological outcomes
General information
Reason for update
Acronym
CRCTT
IRCT registration information
IRCT registration number:IRCT20200204046373N1
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Arooj Fatima
Name of organization / entity
The University Of Lahore
Country
Pakistan
Phone
+92 42 35414221
Email address
aruj43@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-10, 1399/01/22
Expected recruitment end date
2020-09-30, 1399/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of high-energy extracorporeal shockwave therapy along with routine physical therapy on subjective and objective measures in patients with calcified rotator cuff tendinopathy; a randomized controlled trial
Public title
High-energy extracorporeal shockwave therapy in patients with calcified rotator cuff tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with calcified rotator cuff tendinopathy referred by orthopedic surgeons or rheumatologists ofeither gender, age ranges from 30-55 years
Having at least 3 months history of shoulder pain located in the proximal lateral aspect of the upper arm
Radiological evidence of type A or B calcification(≥1cm or 10mm)
2 of 3 impingement test positive - Neer’s test, Hawkins tests and/or Jobe test
Exclusion criteria:
Patients having primary joint trauma or infection in shoulder region•
Frozen shoulder or symptoms from cervical spine, glenohumeral osteoarthritis
History of Shoulder instabilities, malignancies and nerve injuries, Chronic diabetic patients, diabetic neuropathy
Patients with metallic implant, Pregnant female, Severe renal or cardiovascular diseases
Patients having clotting disorders or having anticoagulant treatment
History of any fracture or surgery in the shoulder complex or Full thickness rupture in the rotator cuff tendon
Age
From 30 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The patients having diagnosed calcified rotator cuff tendinopathy will be recruited in the study by convenient sampling, and the patients who fulfilled the inclusion and exclusion criteria will be selected, with similar baseline characteristics. The consent will be taken from the subjects to participate in the study.
It will be a single blinded trial in which the assessor will be kept blind. The subjects will be randomly assigned to one of two groups by using a table of random numbers generated the randomization sequence, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups will be ensured, from all study personnel and participants by entry of data into computer randomization program immediately.
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be a single blinded trial in which the assessor will be kept blind. Assessor will be senior physiotherapist who will take measurements after giving consent to participate in study. He will be blind; not confirmed about the group of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Parallel groups, single blinded, single setting
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board Committee
Street address
1 km, Bhobatiyan chowk, Raiwind road
City
Lahore
Postal code
0544
Approval date
2641-06-20, 2020/03/30
Ethics committee reference number
IRB-UOL-FAHS/693/2020
Health conditions studied
1
Description of health condition studied
Rotator cuff tendinopathy
ICD-10 code
M75
ICD-10 code description
Shoulder lesions
Primary outcomes
1
Description
Pain intensity
Timepoint
Baseline, 6th and 12th week
Method of measurement
Numeric Pain Rating Scale
Secondary outcomes
1
Description
Functional mobility
Timepoint
Baseline, 6 and 12 week
Method of measurement
Constant and Murley score
Intervention groups
1
Description
Intervention group: Shockwave therapy along with routine physical therapy. It will receive routine physical therapy treatment and high-energy extra-corporeal shockwave therapy. Routine physiotherapy treatment will be administered to the patients which includes these: ⦁ General exercise plan (range of motion, strengthening, and stretching exercises of shoulder abductors and flexors). Each exercise will be performed once a day with ten repetitions, three times a week.32⦁ Advice rest, avoiding overuse or heavy weight lifting⦁
Category
Treatment - Devices
2
Description
Control group: It will be give same routine treatment methods given generally to treat such patients for same time
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy department, Lifeline Health Care and Pain Centre, Lahore Pakistan
Full name of responsible person
Tehreem Niazi
Street address
Johar town
City
Lahore
Postal code
0544
Phone
Email
tehreemkhan.tk@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Ashfaq Ahmad
Street address
1 km, Raiwind road
City
Lahore
Postal code
0544
Phone
Email
ashfaaqpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Arooj Fatima
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, Raiwind road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 341 4391882
Email
aruj43@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Arooj Fatima
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, raiwind road
City
Lahore
Province
Punjab
Postal code
54000
Phone
0923414391882
Email
aruj43@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Arooj Fatima
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, raiwind road
City
Lahore
Province
Punjab
Postal code
54000
Phone
0923414391882
Email
aruj43@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected IPD for all outcome measures
When the data will become available and for how long
starting in November 2020
6 months after publication
To whom data/document is available
persons in academic institutes
Under which criteria data/document could be used
it could be used on request
From where data/document is obtainable
03414391882
What processes are involved for a request to access data/document