← Back to Search

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 2 years
Awards & highlights

Study 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 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Collect and compare protocol outcome data. measure will be: a 6 point Likert scale.
Establish protocols for long-term surveillance of OAH in chiropractic patients.
Recruit a pool of HOA patients from senior centers, the local community, medical and chiropractic clinics, and through advertising in collaboration with other Universities/Colleges or Schools.
+1 more

Side effects data

From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601
83%
Anemia
67%
Lymphocyte count decreased
58%
Alanine aminotransferase increased
58%
Platelet count decreased
50%
Hypokalemia
42%
Hyponatremia
42%
Fever
33%
Aspartate aminotransferase increased
33%
Blood bicarbonate decreased
33%
Hypoalbuminemia
33%
Diarrhea
33%
Hypocalcemia
33%
Lung infection
33%
Creatinine increased
25%
Atrial fibrillation
25%
Hyperkalemia
25%
Hypermagnesemia
25%
Hypophosphatemia
25%
Hematuria
25%
Hypotension
25%
Hypertriglyceridemia
25%
Proteinuria
17%
Anorexia
17%
Hematoma
17%
Vascular disorders - Other, specify:DVT
17%
Vomiting
17%
Hypernatremia
17%
Urinary tract infection
17%
Glucosuria
17%
Anxiety
17%
Dizziness
17%
Hyperphosphatemia
17%
Hypercalcemia
17%
Pneumothorax
17%
Hypoxia
8%
Hyperuricemia
8%
White blood cell decreased
8%
Acute kidney injury
8%
Folliculitis
8%
Acidosis
8%
Asystole
8%
Bacteremia
8%
Hypoglycemia
8%
Sepsis
8%
Pleural effusion
8%
Thromboembolic event
8%
Lipase increased
8%
Constipation
8%
Multi-organ failure
8%
Blood lactate dehydrogenase increased
8%
Hypertension
8%
Rash maculo-papular
8%
Sinus tachycardia
8%
Blood bilirubin increased
8%
Cardiac troponin I increased
8%
Urinary retention
8%
Dyspepsia
8%
Cytomegalovirus infection reactivation
8%
Syncope
8%
Ileus
8%
Respiratory failure
8%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Safety Run In
Mesenchymal Stromal Cells (MSCs)

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
19 Previous Clinical Trials
25,935 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis
2007. "Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00523172.
All > Osteoarthritis > Oa
~7 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top