NCT03937518

Brief Summary

The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups: Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08. Inclusion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 2, 2019

Last Update Submit

May 3, 2020

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • change of pain from base line

    VAS pain is a uni-dimensional tool used to measure pain intensity. It is a 10 cm horizontal line marked every 1 cm. Pain intensity ranges from 0 (no pain, the left end of the line) to 10 (worst possible pain, the right end of the line). The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

    immediately before intervention,3 monthes after intervention,6 monthes after intervention

Secondary Outcomes (2)

  • change of function from base line

    immediately before intervention,3 monthes after intervention,6 monthes after intervention

  • change of MRI findings from base line

    immediately before intervention and 6 monthes after intervention

Study Arms (2)

strontium ranelate

OTHER

included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years,

Drug: Strontium RanelateOther: physiotherapy

physiotherapy

OTHER

included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years

Other: physiotherapy

Interventions

Strontium RanelateDRUG

Patients received strontium ranelate 2gm (one sachet daily with 50 ml water at bedtime at least 2 h after food), as the compliance of patient assessed by counting number of sachet that patient returns at every visit and safety is assessed by recording adverse effects as blood pressure and heart rate every visit and patients received physiotherapy program in the form of (US therapeutic acoustic radiation and exercise program) 3 times per week for 6 months. Ultra sound (US): Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (

strontium ranelate
physiotherapyOTHER

Ultra sound (US): Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (Medserve, England) (Huang et al., 2001). Patients were positioned in a supine position with the affected knee flexed at 90° and the sound head was held stationary over the tibiofemoral joint medial to the patellar tendon to enhance energy penetration into the joint space (White et al., 2007). Exercise program: The subjects were treated with a group-exercise program composed of a range of motion of all lower limb and 45 min strengthening exercises with 5 min stretching exercises of lower limb muscles 3 times per week under the supervision of the same physiatrist (Fitzgerald and Oatis

physiotherapystrontium ranelate

Eligibility Criteria

Age50 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged ≥ 40 years with symptoms of knee osteoarthritis

You may not qualify if:

  • rheumatoid arthritis, spondyloarthropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Uninersity Faculty of Medicine

Al Mansurah, Dakahlia Provence, 050, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

strontium ranelatePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

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

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 3, 2019

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

May 5, 2020

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)