The effect of proprioception training on pain, grip force, dexterity and proprioception of elbow joint in patients with chronic tennis elbow
Design
This study is a randomized controlled clinical trial with parallel, double blind, randomized block design with Block Randomization. The sample size is 22 persons in each group
Settings and conduct
The study will be conducted in Shiraz University of Rehabilitation Sciences and the study population (n = 44) will be randomly divided in 2 groups . Groups will do exercises for 6 weeks.This is a double-blinded study.The assessor and paitens will be blinded to participants group.
Participants/Inclusion and exclusion criteria
Inclusion criteria is: presence of symptoms exist at least for 3 months and up to 36 months; Feeling of pain and burning in the lateral elbow; at least 2 positive tests from 4 tennis elbow tests: A) Thomson test B) Maudsely test C) Mills tset D) Dynamometer test.The exclusion criteria is: 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.
Intervention groups
The first group patients receives routine physical therapy treatment protocol include ultrasound (puls mode, 1 MHz frequency, 1 W/Cm2) at origin of extensor muscles of forearm and fingers, friction massage for 5 minutes and strengthening with stretching exercises. The second group receives proprioception training beside routine physiotherapy. The duration of treatment is six week, three sessions per week.
Main outcome variables
Proprioception ; Pain and Function ; Dexterity ; Grip strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211010052722N1
Registration date:2021-10-26, 1400/08/04
Registration timing:prospective
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Nastaran Mollazehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 2018
Email address
nstrn.mollazehi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of proprioception training on pain, grip force and proprioception in patients with tennis elbow
Public title
The effect of muscles strengthening on treatment of patients with tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of symptoms exist at least for 3 months and up to 36 months;
Feeling of pain and burning in the lateral elbow
Feeling pain greater than 3 and less than 8 on the VAS criteria when touched lateral epicondyle by physiotherapist
At least 2 positive tests from 4 tennis elbow tests: A) Thomson test B) Maudsely test C) Mills tset D) Dynamometer test.
Exclusion criteria:
History of fracture or dislocation at shoulder or elbow
The history of surgery at shoulder or elbow for reasons other than fracture or dislocation
Degenerative changes at elbow or shoulder
Untreated infection or tumors at elbow or shoulder
Pressure on the cervical nerve roots
Person with radial tunnel syndrome or carpal tunnel syndrome
Impingement nerves at arm and forearm
History or symptoms of rheumatoid diseases
History of getting Gout
History of Diabetic neuropathy
Any disease or disorder of the central nervous system including: stroke, head injury, MS and .....
Any injury at elbow that interferes with use physiotherapy modalities
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Samples via Block randomizer application and Block size=4 will be placed in one of the two groups of routine physical therapy and routine physical therapy plus proprioception training.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blind to group therapy
assessments and treatment will be performed by two independent individuals, and the assessor is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz Univercity of Medical Siences
Street address
Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.SUMS.REHAB.REC.1400.029
Health conditions studied
1
Description of health condition studied
Choronic Tennis elbow
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
Proprioception
Timepoint
Before and after intervention; one month after the end intervention
Method of measurement
Biodex system isokinetic dynamometer
Secondary outcomes
1
Description
Pain and function
Timepoint
Before and after intervention; one month after the end intervention
Method of measurement
Patient rate elbow evaluation questionnaire
2
Description
Dexterity
Timepoint
Before and after intervention; one month after the end intervention
Method of measurement
Purduepeg Bord test
3
Description
Grip strength
Timepoint
Before and after intervention; one month after the end intervention
Method of measurement
Hand dynamometer
Intervention groups
1
Description
Intervention group:The first group patients receive routine physical therapy treatment protocol include ultrasound (puls mode, 1 MHz frequency, 1 W/Cm2) use for 5 min over the origin of common wrist extensor muscles, friction massage for 5 min applied on the origin of common wrist extensor muscles and strengthening (concentric and eccentric) and stretching exercises 3 sessions per week for 6 weeks.
Category
Rehabilitation
2
Description
Intervention group: The second group receive proprioception training exercises in addition to the routine physical therapy treatment in each session for 3 sessions per week for 6 weeks. proprioception training include: week 1: 30 seconds hold Rhythmic stabilization plus 30 seconds hold Quadruped position; week 2 : 1 min hold Rhythmic stabilization plus 1 min hold Quadruped position plus 30 seconds hold kneel push up position plus 30 seconds hold prone on elbows position; week 3: 2 min hold Rhythmic stabilization plus 2 min hold Quadruped position plus 1 min hold kneel push up position plus 1min hold prone on elbows plus 30 seconds hold push up position plus 30 seconds hold Full push up feet elevated position; week 4: 2 min hold kneel push up position plus 2 min hold prone on elbows plus 1 min hold push up position plus 1min hold Full push up feet elevated position plus 30 seconds hold Hands on wobble board plus 30 seconds hold Hands on bosu ball position; week 5: 2 min hold push up position plus 2 min hold Full push up feet elevated position plus 1 min hold Hands on wobble board plus 1 min hold Hands on bosu ball position plus 1 min hold elbows on gym ball; week 6: 2 min hold Hands on wobble board plus 2 min hold Hands on bosu ball position plus 2 min hold elbows on gym ball plus 1 min hold Hands on gym ball
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences
Full name of responsible person
Nastaran Mollazehi
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
nstrn.mollazehi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Qasemi
Street address
Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
دانشگاه علوم پزشکی شیراز
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Nastaran Mollazehi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Email
nstrn.mollazehi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohsen Razeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Email
razeghm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nastaran Mollazehi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Email
nstrn.mollazehi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available