Protocol summary

Summary
(1)Objectives: investigate the effectiveness of acupressure on pain, stiffness and physical function of knee among nursing home residents with osteoarthritis. (2) Design: the study population consisted all the elderly with osteoarthritis of the knee settled in nursing homes. The sample volume size included 51 cases that resident in three nursing home centers. Before sampling each centers were randomly allocated to one of the three groups; tow intervention (real and placebo) and a control group. (3) Setting and conduct: After each center was allocated to a various groups, participants were selected from these centers based on inclusion criteria and entered to specified group. (4) Participants including major eligibility criteria: having osteoarthritis, no history of disease-related surgery on the knee, according to case documents, non-acupressure contraindications (such as the open wounds, cancer and signs of serious psychological disorders), non-severe chronic diseases such as insulin-dependent diabetes and lupus, non-Injection the knee joint, non-drug addiction. (5) Intervention: massaged acupoints for real and non-acupoints for placebo every three days a week during the 10 sessions of 15 minutes and the control group continued their usual treatment. (6) Main outcome measures: Main outcome measures included pain, stiffness and physical function that was measured with the WOMAC.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015041521758N2
Registration date: 2015-10-12, 1394/07/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Nabi Akbarnezhad
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7123
Email address
na.akbarnezhad@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on pain, stiffness and physical function of knee among nursing home residents with osteoarthritis
Public title
Effect of acupressure on knee Arthroses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:The elder over 60 years old; Having one or both knee osteoarthritis knee pain that they have at least 6 months of diagnosis; No pain severe that above score of 90% based on Visual Analogue Scale; No history of disease-related surgery (replacement and repair) on the knee joint; Having of consciousness, hearing ability and speech acceptable on the basis of Abbreviated Mental test Score; According to case documents, non-acupressure contraindications, such as: the open wounds, cancer and signs of serious psychological disorders; Non-severe chronic diseases such as insulin-dependent diabetes, cancer, lupus, according to the case documents; Non-Injection the knee joint during the 30 days prior to the intervention or plan to inject until the end of the study period; Non drug addiction; Satisfaction to participate in the study. exclusion criteria: Lack of interest in continuing to work for any reason; Leaving the institution, died or exacerbation leading to hospitalization; Acute disease or condition that is contrast with the intervention; Injected into the knee joint during the intervention period.
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization method: It was possible residents in nursing homes have to meet and discuss about intervention way might causes bias, therefore all of elder in those each centers were randomly allocated to one of the under study groups. In this way a code assigned to each of the under study centers and using a random number table to extract codes. The extracted first code was assigned to the main intervention, the second to the placebo and third to control groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar deadlock, Daneshjo blvd, Evin, Tehran, Iran
City
Tehran
Postal code
1985713834
Approval date
2015-01-23, 1393/11/03
Ethics committee reference number
IR.USWR.REC.1394.9

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis

Primary outcomes

1

Description
Pain
Timepoint
Preintervention and postintervention
Method of measurement
WOMAC

2

Description
Stiffness
Timepoint
preintervention and postintervention
Method of measurement
WOMAC

3

Description
Function
Timepoint
Preintervention and postintervantion
Method of measurement
WOMAC

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Sham group received massage on non-specific acupoints in Knee every other day during 10 sessions.
Category
Placebo

2

Description
Intervention group 2: Acupressure for 10 sessions every other day, just one minute on any of the 8-acupoint on the knee(ST34,ST35,ST36,SP9,SP10,GB34,EX-LE2,EX-LE4) performed.
Category
Rehabilitation

3

Description
control group: without intervention, only continued to current nursing home treatments
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Touhid Nurising Home
Full name of responsible person
Mr. Behrouz Hosseini
Street address
No. 137, Zahedi Alley, West Nosrat Street, Tohid Square
City
Tehran

2

Recruitment center
Name of recruitment center
Mehraban Nurising Home
Full name of responsible person
Ms. Khani
Street address
No. 21, Corner of North Kamali, West Faheemi Street, Behnam street, Kashani Street, The second Sadeghieh Square
City
Tehran

3

Recruitment center
Name of recruitment center
Ibn Sina Nurising Home
Full name of responsible person
Mr. Heydar Qaderinia
Street address
No. 14, Lale Blvd, Tehransar
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamid reza khankeh
Street address
Kodakyar deadlock,Daneshjo blvd,Evin
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nabi Akbarnezhad
Position
Master of Geriatric Nursing
Other areas of specialty/work
Street address
Kodakyar deadlock,Daneshjo blvd,Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7123
Fax
Email
nabiakbarnajad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Farahnaz Mohammadi Shahboulaghi
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
Kodakyar deadlock, Daneshjo blvd, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
F_mohammadi_2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nabi Akbarnezhad
Position
Master of Geriatric Nursing
Other areas of specialty/work
Street address
Kodakyar deadlock, Daneshjo blvd, Evin, Tehran, Iran
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Fax
+98 21 8977 0483
Email
nabiakbarnajad@yahoo.com
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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