NCT06658327

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

PainPostmenopausalknee OsteoarthritisDynamic StretchingStatic Stretching

Outcome Measures

Primary Outcomes (4)

  • GONIOMETER

    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

    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

    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

    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

Study Arms (2)

Group A

EXPERIMENTAL

Dynamic stretching

Other: Dynamic stretching

Group B

EXPERIMENTAL

Static Stretching

Other: Static stretching

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 to 65
  • Diagnosed patients of OA with grade 3
  • Multiparous (5 children)
  • Fertile females
  • Pain greater than 6 on NPRS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mafaza-Tul-Hayat Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (2)

  • Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

    PMID: 24024017BACKGROUND
  • 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.

    PMID: 30586007BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tanzeela Majeed, MS

    Ripah International university, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeela Arif, Mphil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

April 24, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations