- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06658327
Comparative Effects Of Dynamic And Static Stretching In Postmenopausal Females With Knee Osteoarthritis
October 24, 2024 updated by: Riphah International University
Comparative Effects Of Dynamic And Static Stretching On Pain, Lower Extremity Function And Knee Range Of Motion In Postmenopausal Females With Knee Osteoarthritis
As the aging population continues to grow, there is a pressing need to explore effective interventions to alleviate the symptoms of osteoarthritis, particularly in postmenopausal women who may experience unique challenges.
Osteoarthritis (OA) is progressive joint disease characterized by joint inflammation and a reparative bone response and is one of the top five most disabling conditions that affects more than one-third of persons >65 years of age, commonly affecting hands, feet, spine, hips, and knees.
Among the various therapeutic modalities, stretching exercises, both dynamic and static, have gained attention for their potential to enhance joint flexibility, reduce pain, and improve functional outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will be a randomized clinical trial and will be conducted in Jinnah Hospital, Mafaza-Tul-Hayat Hospital Lahore and Mayo Hospital Lahore.
This study will be completed in time duration of 7 months after the approval of synopsis.
Non-probability convenience sampling technique will be used and 58 participants will be recruited in study after randomization.
The subjects will be divided into two groups.
Group A will receive dynamic stretching of hamstrings and quadriceps with static stretching and Group B will receive dynamic stretching without static stretching after warm up as baseline treatment.
The tools that will be used are Osteoarthritis outcome scale Goniometer Lower extremity function scale, Strength, MMT, NPRS, after data collection data will be analyzed by using SPSS version 21
Study Type
Interventional
Enrollment (Estimated)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adeela Arif, Mphil
- Phone Number: 03320845723
- Email: adeela.arif@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Recruiting
- Mafaza-Tul-Hayat Hospital
-
Contact:
- Adeela Arif, Mphil
- Phone Number: 03320845723
- Email: adeela.arif@riphah.edu.pk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 50 to 65
- Diagnosed patients of OA with grade 3
- Multiparous (5 children)
- Fertile females
- Pain greater than 6 on NPRS
Exclusion Criteria:
- BMI > 30
- Early menarche ≤10 or 11 years.
- Cancer i.e breast cancer ,Ovrian cancer
- Any bone deformity before menopause i.e limb length discrepancy, angulation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Dynamic stretching
|
Group A will receive 2*10 repetitions of dynamic stretching of hamstrings and calf muscles in standing position after application of hot pack (standard size which had been stored in a hydro collator tank of 74.5-80°C for 30 minutes) with 6-8 layers of towel was applied on lower extremity for 10 minutes The subjects will be asked to stand upright with their feet parallel and facing forward with hands holding onto something.
Each treatment session will last for 30 minutes.
The protocol will be repeated every day for 5 days from the first day of treatment.
|
|
Experimental: Group B
Static Stretching
|
Group B will receive 2*10 repetitions of static stretching of hamstrings and quads in standing position after application of hot pack (standard size which had been stored in a hydro collator tank of 74.5-80°C for 30 minutes) with 6-8 layers of towel was applied on lower extremity for 10 minutes.
The subjects will be asked to stand upright with their feet parallel and facing forward with hands holding onto something.
Each treatment session will last for 30 minutes.
The protocol will be repeated every day for 5 days from the first day of treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GONIOMETER
Time Frame: 6 Weeks
|
Goniometer is a device used to measure joint ranges.
Goniometric measurement of ROM is an important part of clinical examination in osteoarthritis knee and can give information about available knee joint motion, guide about pattern of management, and prognosis.
|
6 Weeks
|
|
LOWER EXTREMITY FUNCTION SCALE
Time Frame: 6 Weeks
|
The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99) and demonstrated the expected relationships with measures assessing similar constructs.
|
6 Weeks
|
|
STRENGTH MMT
Time Frame: 6 Weeks
|
MMT is the most commonly used method for documenting impairments in muscle strength.
Manual muscle testing is used in rehabilitation and recovery to evaluate contractile units, including muscles and tendons, and their ability to generate forces.
|
6 Weeks
|
|
Numerical Pain Rating Scale
Time Frame: 6 Weeks
|
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale.
The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain.
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tanzeela Majeed, MS, Ripah International university, Lahore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
- Jung JH, Bang CH, Song GG, Kim C, Kim JH, Choi SJ. Knee osteoarthritis and menopausal hormone therapy in postmenopausal women: a nationwide cross-sectional study. Menopause. 2018 Dec 21;26(6):598-602. doi: 10.1097/GME.0000000000001280.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2024
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
October 24, 2024
First Submitted That Met QC Criteria
October 24, 2024
First Posted (Actual)
October 26, 2024
Study Record Updates
Last Update Posted (Actual)
October 26, 2024
Last Update Submitted That Met QC Criteria
October 24, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tanzeela Majeed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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