Protocol summary

Summary
The objective of this study was to evaluate the effects of strengthening exercise of the shoulder rotator muscles on the grip strength, pain intensity and functional improvement in people with tennis elbow syndrome. Inclusion criteria were: pain in the lateral elbow; age between 20-50 years; at least 2 positive tests from 4 tennis elbow tests: Cozen's, resistive and passive tennis elbow and chair lift tests. Exclusion criteria were: History of any fracture or Surgery in the upper limb; History of Rheumatoid diseases and Osteoarthritis in the upper extremity joints; any disease or disorder of the central or peripheral nervous system. This study was a single blinded randomized clinical trial. The sample size was 32 (16 patients in each group).The Patients who referred to the physiotherapy clinic of Shiraz school of rehabilitation sciences, recruited by convenience sampling method. The subjects in the control group received routine physiotherapy and the subjects in the intervention group received the strengthening exercises of shoulder internal and external rotator muscles beside routine physiotherapy. Both groups receive 10 treatment sessions for two consecutive weeks. The pain intensity (visual analogue scale), functional improvement (Standardized method for assessment of elbow function), shoulder rotator strength, pain free grip and maximum grip strength measured before and after the intervention protocols in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071615932N5
Registration date: 2014-08-23, 1393/06/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-23, 1393/06/01
Registrant information
Name
Alireza Motealleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
motealleh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-10-11, 1391/07/20
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the shoulder-rotators strengthening exercises on grip strength and pain reduction in patients with tennis elbow.
Public title
The effect of the shoulder muscles strengthening in treatment of patients with tennis elbow.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: pain in the origin of common wrist extensor muscles in the lateral elbow; presence of symptoms exist at least for 2 months; age between 20-50 years; functional assessment scores between 9 to 22 on the base of "standardized method for assessment of elbow function"; at least 2 positive tests from 4 tennis elbow tests: Cozen's, resistive tennis elbow test, passive tennis elbow test and chair lift test. exclusion criteria: surgery on any part of the upper extremity in the past 12 months; history of any fracture or dislocation in the upper limb; history or symptoms of rheumatoid diseases and osteoarthritis in the upper extremity joints; any disease or disorder of the central nervous system including: stroke, MS and ...; any disease of peripheral nervous system which may affect the study results such as: Neuropathies, carpal tunnel syndrome, Guyan tunnel syndrome and cervical Radiculopathy (specially the seventh cervical root)
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz
City
Shiraz
Postal code
Approval date
2012-10-10, 1391/07/19
Ethics committee reference number
90-01-06-4233

Health conditions studied

1

Description of health condition studied
Tennis elbow
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis, Tennis elbow

Primary outcomes

1

Description
pain intensity
Timepoint
before and after intervention
Method of measurement
visual analogue scale

2

Description
strength of shoulder rotator muscles
Timepoint
before and after intervention
Method of measurement
Newton scale with digital dynamometer

3

Description
maximum grip strength
Timepoint
before and after intervention
Method of measurement
Newton scale with digital dynamometer

4

Description
pain free grip strength
Timepoint
before and after intervention
Method of measurement
Newton scale with digital dynamometer

5

Description
Function of upper limb
Timepoint
before and after intervention
Method of measurement
The questionnaire of Standardized method for assessment of elbow function

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group patients receive routine physical therapy treatment protocol for tennis elbow syndrome for 10 sessions over two consecutive weeks. The routine physical therapy treatment protocol contained: Ultrasound: continues mode, 1 MHz frequency, 1.5 W/Cm2 use for 5 min over the origin of common wrist extensor muscles; Transcutaneous electrical nerve stimulation: burst mode, internal frequency 70-100 Hz, 60 μs pulse width, tolerable intensity for 20 min over the pain site, around the elbow joint; Hot pack: for 20 minutes on the common wrist extensor muscles; Friction massage: for 1-2 min applied on the origin of common wrist extensor muscles, Massage apply while the patient's elbow and wrist is in flexion, forearm in pronation, hand in ulnar deviation and fingers in flexion. The friction massage perform in a direction perpendicular to the muscle fibers through the therapists thumb or index finger which support by the middle finger. Eccentric strengthening exercise for extensor muscles was performed in the seated position with elbow extension, forearm pronation, and maximum wrist extension. From this position, the patient slowly lowered wrist into flexion while holding a weight, and then using the contralateral hand to return the wrist to maximum extension (3 sets × 10 reps; 1 min rest btw sets). The forearm muscle stretching was performed while the patient lying in supine position with the shoulder in abduction and then the therapist apply passive stretching to the patients wrist extensors and forearm supinators (through flexing the wrist pronating the forearm). wrist pronating the forearm). The intervention group receive shoulder rotator muscles strengthening exercises (Oxford method) in addition to the routine physical therapy treatment in each session. For strengthening of shoulder external rotators, the subject was positioned side-lying on a bed with involved shoulder up (lying on the healthy side), arm resting on the side of the thorax with a rolled towel under the axilla and the elbow bent at a 90° angle. The patient was instructed to keep the elbow against his side and slowly rotate the arm at the shoulder and raising the weight to a vertical position (rotate the arm toward external rotation). For strengthening of shoulder internal rotators The subject was positioned side-lying on a bed on the involved side, with the arm forward in partial flexion and the elbow bent at a 90° angle. The patient was instructed to Keep the elbow bent and slowly rotate the arm at the shoulder, lift the weight upward off the table to a vertical position (rotate the arm toward internal rotation). It should be stated that a weight cuff that is determined by 10RM for each person, fasten close to the wrist (about 20% of forearm length proximal to the wrist joint).
Category
Rehabilitation

2

Description
Control group: In the control group patients receive routine physical therapy treatment protocol for tennis elbow syndrome for 10 sessions over two consecutive weeks. The routine physical therapy treatment protocol contained: Ultrasound: continues mode, 1 MHz frequency, 1.5 W/Cm2 use for 5 min over the origin of common wrist extensor muscles; Transcutaneous electrical nerve stimulation: burst mode, internal frequency 70-100 Hz, 60 μs pulse width, tolerable intensity for 20 min over the pain site, around the elbow joint; Hot pack: for 20 minutes on the common wrist extensor muscles; Friction massage: for 1-2 min applied on the origin of common wrist extensor muscles, Massage apply while the patient's elbow and wrist is in flexion, forearm in pronation, hand in ulnar deviation and fingers in flexion. The friction massage perform in a direction perpendicular to the muscle fibers through the therapists thumb or index finger which support by the middle finger. Eccentric strengthening exercise for extensor muscles was performed in the seated position with elbow extension, forearm pronation, and maximum wrist extension. From this position, the patient slowly lowered wrist into flexion while holding a weight, and then using the contralateral hand to return the wrist to maximum extension (3 sets × 10 reps; 1 min rest btw sets). The forearm muscle stretching was performed while the patient lying in supine position with the shoulder in abduction and then the therapist apply passive stretching to the patients wrist extensors and forearm supinators (through flexing the wrist pronating the forearm).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation Sciences
Full name of responsible person
Dr. Alireza Motealleh
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Shirzadi
Position
Student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
shirzadi.zeinab@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Motealleh
Position
Ph.D
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
pmotealeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Shirzadi
Position
Student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+7 116271552
Fax
Email
Shirzadi.zeinab@sums.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
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