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Manual Therapy
Supportive Care for Osteoarthritis
Phase < 1
Waitlist Available
Led By James Brantingham, D.C., Ph.D.
Research Sponsored by Cleveland Chiropractic College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
Purpose of this study is to examine the effect of chiropractic adjusting (manipulative therapy) and rehabilitation on hip osteoarthritis (hip OA) in older adults.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601100%
Anemia
70%
Blood bicarbonate decreased
70%
Hypophosphatemia
60%
Alanine aminotransferase increased
60%
Aspartate aminotransferase increased
60%
Fever
50%
Hypokalemia
50%
Platelet count decreased
50%
Blood bilirubin increased
50%
Hypocalcemia
50%
Hyperphosphatemia
40%
Hypernatremia
40%
Creatinine increased
30%
Hyponatremia
30%
Respiratory, thoracic and mediastinal disorders - Other, specify:Hypercapnia
30%
Hypercalcemia
30%
Hypoalbuminemia
30%
White blood cell decreased
20%
Hypoxia
20%
Constipation
20%
Lymphocyte count decreased
20%
Anxiety
20%
Hyperkalemia
20%
Headache
10%
Delirium
10%
Cardiac arrest
10%
Anorexia
10%
Rash maculo-papular
10%
Fall
10%
Diarrhea
10%
Depression
10%
Abdominal pain
10%
CPK increased
10%
Cardiac troponin I increased
10%
Hypermagnesemia
10%
Nausea
10%
Neutrophil count decreased
10%
Seizure
10%
INR increased
10%
Eosinophilia
10%
Febrile neutropenia
10%
Hypertension
10%
Hypotension
10%
Lung infection
10%
Urinary tract infection
10%
Ileus
10%
Sepsis
10%
Skin and subcutaneous tissue disorders - Other, specify:rash - unspecified
10%
Confusion
10%
Activated partial thromboplastin time prolonged
10%
Fatigue
10%
Epistaxis
10%
Multi-organ failure
10%
Rectal hemorrhage
10%
Pneumothorax
10%
Acute kidney injury
10%
Peripheral sensory neuropathy
10%
Hypothermia
10%
Fungemia
10%
Hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesenchymal Stromal Cells (MSCs)
Control Group
Safety Run In
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Supportive CareExperimental Treatment1 Intervention
Supportive Care 3) Groups A and B will receive supportive care after the 9th visit consisting of (up to a maximum of) 6 visits, PRN or as needed, until the 9 month follow up. This is to see if peak gains may be maintained (as noted in the previous trial) throughout the follow up period.
Enrolled subjects will commonly receive 2 treatments per week (occasionally, less or more than 1 to 2 treatments per week due to (College or University) semester breaks, exams, clinic closures and so forth) until 9 treatments are completed.
Group II: Group AActive Control1 Intervention
1) Group A will receive 9 manipulative therapy treatments (adjustments) to one area: the hip with pre-manipulative static and post active-assisted stretch of tight hip muscles. After the last (or 9th) treatment these patients will receive general advice and recommendations on managing HOA and how to gently and safely increase general exercise.
• Based on a previous trial, Group A treatment appears superior than placebo. There will be a 3, 6 and 9 month follow up.
Group III: Group BActive Control1 Intervention
2) Group B will receive 9 treatments with manipulative therapy treatments (adjustments) to the entire kinetic chain (five areas): the lumbosacral, sacroiliac, hip, knee, ankle and foot joints with pre-manipulative static and post active-assisted stretch of tight hip muscles. There will be a 3, 6 and 9 month follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supportive Care
2013
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Durban University of TechnologyOTHER
4 Previous Clinical Trials
1,044 Total Patients Enrolled
1 Trials studying Osteoarthritis
144 Patients Enrolled for Osteoarthritis
Cleveland Chiropractic CollegeLead Sponsor
7 Previous Clinical Trials
361 Total Patients Enrolled
1 Trials studying Osteoarthritis
144 Patients Enrolled for Osteoarthritis
Macquarie University, AustraliaOTHER
22 Previous Clinical Trials
26,515 Total Patients Enrolled
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