Comparison of Effect of Swedish Massage and Hip Strengthening Exercises on Pain, Range of Motion and Daily Life Function in The Elderly with Knee Osteoarthritis
Determining the comparative effect of Swedish massage and hip strengthening exercises on pain, range of motion and daily life function in the elderly with knee osteoarthritis.
Design
75 eligible seniors will be divided into two intervention groups and one control group using a simple random division method using a random number table, and the type of intervention will be determined again by random division.
Settings and conduct
The intervention is carried out on elderly people with knee osteoarthritis who refer to the outpatient clinic of Rafsanjan city. Both interventions are done individually at home.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 60 to 70 years, mentally alert, suffering from knee osteoarthritis according to a rheumatologist's diagnosis, presence of pain along with at least 3 out of 6 clinical criteria of the American Rheumatology Association and suffering from this disease duration of at least 6 months and at most 5 years, having chronic pain, having a basic score of 40-70 for knee pain on the VAS scale, Absence of skin problems at the massage site, No history of other autoimmune diseases and chronic neuropathic diseases, no intra-articular injection in the past three months, no history of knee surgery and severe knee injury and Non-entry criteria: having health problems affecting exercise and massage and chronic use of knee braces, crutches and having a regular exercise program
Intervention groups
Both intervention groups participate in two training sessions with one of their family members, and the Swedish massage protocol and hip strengthening exercises are taught in each group by the researcher using a training booklet and pictures. Then both trained groups perform the interventions for 8 weeks and 3 sessions of 30 minutes per week at home.
Main outcome variables
Pain, range of motion and daily life function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N33
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect of Swedish Massage and Hip Strengthening Exercises on Pain, Range of Motion and Daily Life Function in The Elderly with Knee Osteoarthritis
Public title
Comparison of Effect of Swedish Massage and Hip Strengthening Exercises on Pain, Range of Motion and Daily Life Function in The Elderly with Knee Osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 60 to 70 years
People who are mentally alert and able to answer the questions of the questionnaires
Patients with osteoarthritis of the knee according to the diagnosis of a rheumatologist, the presence of pain along with at least 3 of the 6 clinical criteria of the American Rheumatology Association and suffering from this disease for a minimum of 6 months and a maximum of 5 years
Having pain for more than three months (chronic pain)
Have a basic score of 40-70 (out of 100) for knee pain on the VAS scale.
Absence of local skin infections or open skin in massage areas
No history of other autoimmune diseases such as lupus erythematosus, rheumatoid arthritis and chronic neuropathic diseases such as diabetes
No intra-articular injection during the last three months
No history of knee surgery and severe injury to the knee
Exclusion criteria:
Having health problems that affect Swedish massage and exercises, such as heart and brain disorders
chronic use of knee braces, crutches, and walkers
having a regular exercise program in the previous 6 months
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the samples, the data will be divided into 3 groups A, B, and C according to age and sex, in such a way that the first data in one of the 3 groups will be divided by a simple random method and using the "Random allocation software" are selected and and in the next 2 groups, the data is allocated in the same way based on the software. After allocating the data equally to 3 groups, treatment methods were written on 3 separate sheets and a method will be assigned to each group by lottery, and the intervention groups of Swedish massage and Hip Strengthening Exercises and the Control group will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Rafsanjan University of Medical Sciences
Street address
School of Nursing and Midwifery, Nurse avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2023-08-08, 1402/05/17
Ethics committee reference number
IR.RUMS.REC.1402.068
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
pain
Timepoint
All participants will complete the visual analog scale before the intervention and immediately after the end of the intervention.
Method of measurement
Visual Analogue Scale
2
Description
Range of motion
Timepoint
The range of motion of all participants will be measured by a goniometer before the intervention and immediately after the end of the intervention.
Method of measurement
goniometer
3
Description
daily life function
Timepoint
All participants will complete the sub-scale of daily life function from Knee Injuries and Osteoarthritis Outcome Questionnaire (KOOS) before the intervention and immediately after the end of the intervention.
Method of measurement
sub-scale of daily life function knee Injury and Osteoarthritis Outcome Score (KOOS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Swedish massage intervention group participates in two face-to-face educational sessions with one of their family members, and the massage protocol is taught by the researcher using a training booklet and pictures, and at the end of the sessions, all the elderly are taught one by one. They are evaluated in terms of performing the massage correctly around their knee joint. Then, for 8 weeks, 3 sessions a week and each session for 30 minutes at home, according to the training method, they apply Swedish massage on their knee joint. They are also provided with educational booklets and pictures. During the study, all participants are monitored through telephone follow-ups and can raise their questions and problems, and they are also reminded to perform massage in each session.
Category
Treatment - Other
2
Description
Intervention group: The intervention group of hip strengthening exercises together with one of their family members participates in two face-to-face training sessions and the protocol of doing the exercises is taught by the researcher using training booklets and pictures, and at the end of the sessions, all the elderly are taught one by one. They are evaluated in terms of doing the exercises correctly. Then, for 8 weeks, 3 sessions per week and each session for 30 minutes, they perform hip strengthening exercises at home according to the training method. They are also provided with educational booklets and pictures. During the study, all participants are monitored through telephone follow-ups and can raise their questions and problems, and are also reminded to do the exercises of each session.
Category
Treatment - Other
3
Description
Control group: The control group receives routine treatment, which includes conventional drugs and treatments under the supervision of a rheumatology specialist, and the researcher does not intervene on them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient rheumatology clinic of Rafsanjan city
Full name of responsible person
Dr. Ali Ravari
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Reza Vazirinejad
Street address
Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
rvazirinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.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