1. Home
  2. Approved trials
  3. » فارسی

The beneficial effects of combined low level laser, ultrasound and exercise therapy on Iranian women with shoulder tendinitis: a randomized clinical trial

Protocol summary

Summary
The aim of this study was to assess the effect of combination of low level laser therapy (LLLT), ultrasound and exercise therapy on shoulder tendinitis. 62 female patients with shoulder tendinitis (35-65 years) participated in this study and were randomly assigned into 3 groups. All groups completed 10 sessions, 3 sessions per week, of treatment as following: Group A (ultrasound plus exercise), Group B (830 nm laser, ultrasound plus exercise), Group C (780nm laser, ultrasound plus exercise). Outcome measures: Clinical assessments such as pain severity through visual analogue scale (VAS), Tenderness, Functional Recovery (FR) and Manual Muscle Testing (MMT) were performed at the baseline, before treatment, and at the end of treatment. Follow-up were done, one and three months after treatment period based on the degree of recovery and satisfaction of patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138712101719N1
Registration date: 2009-03-19, 1387/12/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-03-19, 1387/12/29
Registrant information
Name
khadije Otadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 6134
Email address
k_otadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS), Iran
Expected recruitment start date
2005-04-20, 1384/01/31
Expected recruitment end date
2007-04-20, 1386/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The beneficial effects of combined low level laser, ultrasound and exercise therapy on Iranian women with shoulder tendinitis: a randomized clinical trial
Public title
Effects of combined physical therapy protocols on shoulder tendonitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female patients with local pain in supraspinatus and /or long head of biceps tendons, painful arc in abduction movement, pain in isometric resistance and passive stretch in supraspinatus and biceps, tenderness over the involved tendons, and positive speed's sign or impingement test. Exclusion criteria: Any history of steroid injection to the tendon, rupture of the tendons, calcification in the tendons, bursitis, previous operation in shoulder region, neck and shoulder OA and Thoracic outlet
Age
From 35 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Center for Medical Ethics
Street address
No 21, 4th floor, Poorsina St.
City
Tehran
Postal code
14167
Approval date
2005-01-17, 1383/10/28
Ethics committee reference number
132/8367

Health conditions studied

1

Description of health condition studied
Shoulder tendinitis
ICD-10 code
M75.2,M75.
ICD-10 code description
Bicipital tendinitis,Impingement syndrome of shoulder

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, and end of 10 sessions of treatment.
Method of measurement
Visual Analogue Scale

2

Description
Tenderness
Timepoint
Before intervention, and end of 10 sessions of treatment.
Method of measurement
Manual test and palpation

3

Description
Functional movement
Timepoint
Before intervention, and end of 10 sessions of treatment.
Method of measurement
Constant-Murley score

4

Description
Muscle strength
Timepoint
Before intervention, and end of 10 sessions of treatment.
Method of measurement
Manual Muscle Testing

Secondary outcomes

1

Description
Satisfaction
Timepoint
1 and 3 months after the end of 10 sessions treatment
Method of measurement
quetion by phone

2

Description
Recovery of functional movement
Timepoint
1 and 3 months after the end of 10 sessions treatment
Method of measurement
question by phone

Intervention groups

1

Description
Low level Laser therapy(830nm,1 J/point) + Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions
Category
Rehabilitation

2

Description
Low level Laser therapy(780 nm,1 J/point) + Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions
Category
empty

3

Description
Control :Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Out patient clinic of Rehabilitation Faculty
Full name of responsible person
Khadije otadi
Street address
Pich e shemiran- Enghlab st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences (Primary sponsor)
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshvarz.BLV,Kods street.central organization of TUMS
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences (Primary sponsor)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Rehabilitation
Full name of responsible person
Khadije Otadi
Position
MS PT , Post Graduate Department, Instructor
Other areas of specialty/work
Street address
Pich e shemiran- Enghlab st.
City
Tehran
Postal code
1148965141
Phone
Fax
Email
k-otadi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Rehabilitation, Tehran University of Medical Sciences, TUMS
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Ph.D. Professor, Faculty of Rehabilitation, Imam komeini Hospital
Other areas of specialty/work
Street address
Pich e shemiran- Enghlab st.
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
hadianrs@sina.tums.ac.ir hadian_ras@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Rehabilitation, TUMS
Full name of responsible person
Khadije Otadi
Position
Instructor ,Post Graduate Department.
Other areas of specialty/work
Street address
Pich e shemiran- Enghlab st.
City
Tehran
Postal code
1148965141
Phone
+98 219124486726
Fax
Email
k-otadi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...