1. Home
  2. Approved trials
  3. » فارسی

Comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis

Protocol summary

Study aim
The basic purpose of this research is to compare the effects of Proprioceptive exercises and topical glucosamine sulfate on knee osteoarthritis.
Design
The randomized clinical trial, single-blinded study.
Settings and conduct
conducted at Muhammad physical therapy clinic and rehabilitation centre, Multan and Faiz Hospital, Multan, Pakistan,
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 45-70 years, bilateral knee OA(grade 1,2 and 3), both genders (male and female), cartilage degeneration, local biomechanical factors (e.g., joint deformity, muscle weakness), nutritional factors, postmenopausal women, and exclusion criteria: grade 4, neurological disorders (e.g. Alzheimer’s disease, Parkinson’s disease), knee replacement, rheumatoid arthritis, steroidal injection in the past 2 months, neuropathy, tumor, knee fractures, knee ligament or meniscus injury, a congenital disorder of knee, diabetes mellitus > 10 years, metal implants in the knee.
Intervention groups
treatment group-A and treatment group-B. Group-A was treated with topical glucosamine sulfate while group-B was treated with proprioceptive exercises.
Main outcome variables
In the management of OA proprioceptive exercises and topical glucosamine sulfate are both effective but it is expected that the effects of proprioceptive exercises in reducing the pain and functional disability in knee osteoarthritis are more as compared to topical glucosamine sulfate.

General information

Reason for update
Acronym
GS,OA
IRCT registration information
IRCT registration number: IRCT20220115053712N1
Registration date: 2022-02-02, 1400/11/13
Registration timing: retrospective

Last update: 2022-02-02, 1400/11/13
Update count: 0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Hifza Arif
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan Pakistan
Country
Pakistan
Phone
+92 309 7697428
Email address
drhizaarif@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-15, 1400/08/24
Expected recruitment end date
2021-12-15, 1400/09/24
Actual recruitment start date
2021-11-15, 1400/08/24
Actual recruitment end date
2021-12-20, 1400/09/29
Trial completion date
2022-02-02, 1400/11/13
Scientific title
Comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis
Public title
Comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
bilateral knee OA with grade 1,2 and 3 Age 45-70 years Both genders (male and female) Cartilage degeneration Local biomechanical factors (e.g., obesity, joint deformity, muscle weakness) Nutritional factors Postmenopausal women
Exclusion criteria:
Rheumatoid arthritis Neurological disorders (e.g., Alzheimer’s disease, Parkinson’s disease) Knee replacement Steroidal injection in the past 2 months Neuropathy Tumor Knee fractures Knee OA with grade 4
Age
From 45 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
Sample size
Target sample size: 38
More than 1 sample in each individual
Number of samples in each individual: 19
19 Individuals in both groups
Actual sample size reached: 30
More than 1 sample in each individual
Actual sample size in each individual: 15
15 individuals in both groups
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes. Each participant will randomly choose the sealed envelope and open this sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In a single-blinded study, participants will be blinded. Participants will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial. subjects will choose between two samples. both the samples are in the same packing. In one sample, glucosamine sulfate gel with conventional exercises i.e., ankle pumps, quadriceps isometrics, and calf stretch. In another sample, an aqueous gel with no effects for the satisfaction of subjects and proprioceptive exercises will be given. Subjects will be completely unaware of the type and effects of both interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Patients were assessed by radiological finding (x-ray) and by physical assessment

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan st
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
60700
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
2020/IRB/2/physio/02

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis with grade 1, 2 and 3
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
pain and functional disability
Timepoint
before and after treatment (6 weeks)
Method of measurement
Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Secondary outcomes

1

Description
To reduce stiffness, muscle tone strength increases and joint receptor function raised.
Timepoint
before and after treatment(6 weeks)
Method of measurement
Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Intervention groups

1

Description
intervention group 2; group-B will be treated with proprioceptive exercises. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand [Akron, OH]), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of treatment is 6 weeks. The frequency of treatment is 3 times per week exercise sessions lasted 30 minutes.
Category
Treatment - Other

2

Description
Intervention group: Group-A will be treated with topical glucosamine sulfate, ankle pumps, quads strengthening, and calf stretching. The drug will purchase from stand pharmaceuticals. The duration of treatment is 6 weeks. Glucosamine sulfate will apply topically twice daily, 3 times per week. The dosage of glucosamine sulfate gel will be 250mg two times a day. Subjects will be instructed to clean the skin adjacent to their throbbing knee and apply the cream
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad physical therapy clinic and rehabilitation center, Multan
Full name of responsible person
Noshaba Kanwal
Street address
HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
60700
Phone
+92 309 7697428
Email
hifzaa630@gmail.com
Web page address
http://www.mimas.edu.pk/

2

Recruitment center
Name of recruitment center
Faiz Hospital, Multan.
Full name of responsible person
Nimra Arif
Street address
HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
60700
Phone
+92 333 3877032
Email
angelnimra95@gmail.com
Web page address
http://www.mimas.edu.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Zahid Manzoor
Street address
HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
60650
Phone
+92 309 7697428
Email
hifzaa630@gmail.com
Web page address
http://www.mimas.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan
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
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Dr.Zahid Manzoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
HBL street, near Sabzazar metro station, Bosan road Multan, Pakistan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 309 7697428
Email
drhifzaarif@mimas.edu.pk
Web page address
http://www.mimas.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Nimra Arif
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, sbzazar station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 333 3877032
Email
angelnimra95@gmail.com
Web page address
http://www.mimas.edu.pk/

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Noshaba Kanwal
Position
professor, Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, Sabzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 309 9709093
Email
zuhahadeed786@gmail.com
Web page address
http://www.mimas.edu.pk/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Title of my study comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis. The basic purpose of this research is to compare the effects of Proprioceptive exercises and glucosamine sulfate on knee osteoarthritis. The expected outcome of this study is proprioceptive exercises may be more effective than glucosamine sulfate. Proprioceptive exercise may improve ADLs and reduce pain. A randomized clinical trial was conducted at Muhammad physical therapy clinic and rehabilitation center, Multan and Faiz Hospital, Multan. 30 patients were selected who met the inclusion criteria will be randomized into two groups; treatment group (A) and treatment group (B). patients were recruited by using the lottery method. Group (B) will be treated with proprioceptive exercises and group (A) will be treated with glucosamine sulfate.
When the data will become available and for how long
This is expected that this study or data will be available at the end of this year 2022. No exact date can be expected.
To whom data/document is available
Nimra Arif
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
researchgate.net https://scholar.google.com/ hifzaa630@gmail.com
What processes are involved for a request to access data/document
open access
Comments
I want randomized clinical trial registration. please provide me as soon as possible. so that I can continue my study
Loading...