The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis

NCT ID: NCT04958213

Last Updated: 2021-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-06-20

Brief Summary

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Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some biochemical and morphological changes in the synovial membrane and joint capsule. It is the most common joint disease that causes serious morbidity and its prevalence increases with age. It is known that there is a decrease in the muscle strength around the knee in knee osteoarthritis, which creates difficulties in daily living activities.

Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.

In this study, it is aimed to investigate the effect of dextrose prolotherapy application in and around the knee on pain, range of motion and knee flexor/extensor muscle strength.

Detailed Description

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Conditions

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Knee Osteoarthritis Dextrose Prolotherapy Injection Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional physical therapy

Conventional physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises) will be applied to this group for 4 weeks (20 sessions).

Group Type OTHER

conventional physical therapy

Intervention Type COMBINATION_PRODUCT

4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).

Dextrose prolotherapy treatment

This group will be treated with 15% dextrose prolotherapy around and inside the knee, 2 times with a two-week interval, and home exercise program (isometric and isotonic exercises).

Group Type ACTIVE_COMPARATOR

Dextrose prolotherapy injection

Intervention Type DRUG

15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.

Interventions

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Dextrose prolotherapy injection

15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.

Intervention Type DRUG

conventional physical therapy

4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Women aged 50-75 years
* 2-3 knee osteoarthritis by Kellgren Lawrence stage
* Knee pain and functional limitation

Exclusion Criteria

* Past knee surgery
* Intra articular knee injections in the last six months
* Symptomatic heart and lung disease
* Joint contracture
* History of malignant disease
* Bleeding disorder
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Kamil Mursit Yildiz

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Halil Ogut, Dr.

Role: STUDY_DIRECTOR

Hatay Mustafa Kemal University Faculty of Medicine

Locations

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Hatay Mustafa Kemal University Faculty of Medicine

Hatay, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.

Reference Type RESULT
PMID: 29403602 (View on PubMed)

Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.

Reference Type RESULT
PMID: 23690322 (View on PubMed)

Other Identifiers

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MustafaKU-KOA-Prolo

Identifier Type: -

Identifier Source: org_study_id

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