Protocol summary

Summary
This study aimed to compare the effects of action potential simulation with low level LASER in reducing pain and improving function of women with knee osteoarthrosis. This single-blind, randomized clinical trial was carried out in Zahedan University of Medical Sciences, in 2009. Thirty patients with knee Osteoarthrosis were recruited through simple non-probability sampling. Patients were selected based on following inclusion criteria: Age between 14 and 40, having knee pain according to Altman’s classification, lack of regular exercise (non-professional or professional) over the past 10 years, not regular or irregular (5 times per week) of analgesics and steroidal and non-steroidal anti-inflammatory drugs within 2 months prior to study entry. Patients were excluded if they had insufficient treatment, using other therapeutic modalities during the study, trauma, doing surgery during the study, exacerbation of symptoms following the intervention, patients who have had a history of knee surgery, intra-articular injections in the past 6 months; and lower extremity fracture in last 3 months. Patients were randomly assigned to either a low-level LASER group (N=15) or an action potential simulation group (APS) (N=15). In LASER group, a low-level Ga-As LASER was applied with 5 KHz frequency, a 100 mW point probe (average power), wavelength 905 nm, pulse duration 200 ns, 9 J/cm2 dosages per minute, for 6 minutes per session. In action potential simulation group, action potential simulation was applied with intensity of 1mA, 150 Hz frequency, for 16 minutes per session. Both groups received exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles and hot pack. A 16-session treatment program, during 4 weeks, 4 sessions per week was performed for both groups. Before and after intervention, we measured pain through Visual Analog Scale (VAS) (ordinal), function with Knee and Osteoarthritis Outcome Score (KOOS), and range of knee flexion with goniometer (degree), stiffness, pain and physical function with Western Ontario and McMaster Universities Index (WOMAC) (Ordinal) and atrophy and swelling with tape measure (centimeter).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109231675N9
Registration date: 2011-10-31, 1390/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-31, 1390/08/09
Registrant information
Name
Asghar Akbari
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1322 8445
Email address
akbaria@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Zahedan University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Action Potential Simulation and Low Level LASER in Reducing Pain and Improving Function of the Knee: A Randomized Controlled Trial of Women with Knee Osteoarthrosis
Public title
The effect of Action Potential Simulation and Low Level LASER in Reducing Pain and Improving Function of the Knee: A Randomized Controlled Trial of Women with Knee Osteoarthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 14 and 40; Having knee pain according to Altman’s classification; Lack of regular exercise (non-professional or professional) over the past 10 years; Not regular or irregular (5 times per week) of analgesics and steroidal and nonsteroidal anti-inflammatory drugs within 2 months prior to study entry. Exclusion criteria: Insufficient treatment; Using other therapeutic modalities during the study; Trauma; Doing surgery during the study; Exacerbation of symptoms following the intervention; Patients who have had a history of knee surgery; Intra-articular injections in the past 6 months; and Lower extremity fracture in last 3 months.
Age
From 40 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
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

1

Registry name
No registration
Secondary trial Id
No trial id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of University of Sistan and Baluchestan
Street address
Daneshgah Blvd., University of Sistan and Baluchestan
City
Zahedan
Postal code
987-98155
Approval date
2011-10-22, 1390/07/30
Ethics committee reference number
902.2.231

Health conditions studied

1

Description of health condition studied
Knee Osteoarthrosis
ICD-10 code
M17.0, M17
ICD-10 code description
Primary gonarthrosis, bilateral and Other primary gonarthrosis

Primary outcomes

1

Description
Knee pain
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
Visual Analogue Scale

2

Description
Knee function
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
Knee and Osteoarthritis Outcome Score (KOOS)

3

Description
Range of knee flexion
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
Goniometer

4

Description
Stiffness, pain and physical function
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
Western Ontario and McMaster Universities Index (WOMAC)

5

Description
Atrophy
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
Tape measure

6

Description
Swelling
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
Tape measure

Secondary outcomes

empty

Intervention groups

1

Description
LASER Group: A low-level Ga-As LASER was applied with 5 KHz frequency, a 100 mW point probe (average power), wavelength 905 nm, pulse duration 200 ns, 9 J/cm2 dosages per minute, for 6 minutes per session. In addition, this group received hot pack and exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles. A 16 session's treatment program which lasted 4 weeks and 4 sessions per week was performed.
Category
Rehabilitation

2

Description
Action Potential Simulation Group: We applied Action Potential Simulation with intensity of 1mA, 150 Hz frequency, for 16 minutes per session. This group received hot pack and exercises including strengthening of quadriceps, adductors of the hip, and stretching of iliotibial band, buttock, calf and hamstring muscles. A 16 session's treatment program which lasted 4 weeks and 4 sessions per week was performed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razmejo-Moghadam Physiotherapy Clinic
Full name of responsible person
Dr. Asghar Akbari
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmoudzadeh Sagheb
Street address
Deputy 0f Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq., Zahedan.
City
Zahedan
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 Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Asghar Akbari
Position
Ph.D in Physiotherapy, Head of Dept. of Physiotherapy.
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1325 8445
Fax
+98 54 1325 8445
Email
akbari_as@yahoo.com; akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Head of Dept. of Physiotherapy, Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1322 8445
Email
akbari_as@yahoo.com; akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Ph.D in Physiotherapy, Head of Dept. of Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1322 8445
Email
akbari_as@yahoo.com; akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

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...