Osteoarthritis, KneeNCT01188837
Comparing Manipulation, Rehabilitation and Combination of the Two in the Treatment of Knee Osteoarthritis
A study testing Full Kinetic Chain Manipulative Therapy, Full Kinetic Chain Rehabilitation and Full Kinetic Chain Manipulative Therapy with Rehabilitation in people with Osteoarthritis, Knee, run by Cleveland Chiropractic College at 2 sites in 2 countries.
Trial summary
Common medical therapies for knee osteoarthritis are patient education, drug and physical therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery carry significant risk. Manipulative therapy for KOA gives pain relief and increased function. Read more about this study
- Who is it for?
- Ages 38 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Full Kinetic Chain Manipulative Therapy, Full Kinetic Chain Rehabilitation and Full Kinetic Chain Manipulative Therapy with Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain and crepitus with active motion and morning stiffness ≤ 30 min ages ≥ 38 and ≤ 80
- Knee pain and crepitus with active motion and morning stiffness >30 minutes and boney enlargement ages ≥ 38 and ≤ 80
- Knee pain and no crepitus and boney enlargement ages ≥ 38 and ≤ 80 Note: knee x-rays taken in each case to determine grades (0-4) Kellgren Lawrence x-ray scale - but not required for diagnosis - (and if needed lumbosacral/pelvic, hip, ankle or foot x-rays obtained) see exclusions below)
- Knee pain (mild to moderate) of 1 year duration and age ≥ 38 and ≤ 80 years of age and able to stand and walk (see informed consent)
- Diagnosis of concurrent subluxation/joint dysfunction (S/JD) complex a) Diagnosis of S/JD will be supported throughout using the PART(S) system 6).A patient must have a score of ≥720 mm on the WOMAC to be included (≥30%) 7).Additionally, KOA patients, who are + for the Berg Balance Scale (BBS) will be monitored as a subgroup (with OLST and BBS) at all clinic assessments.
Who cannot join
- Rule out: General and internal medical disorders such as significant visual disorders, severe vestibular disorders (i.e., Meniere's), neurological (including Alzheimer's and other degenerative brain and mental disorders, disease and dysfunction) peripheral sensory disorders (severe insulin dependent diabetes), knee and hip joint replacement on side of knee that is treated (case by case otherwise), RA, instability, fracture/ and severe osteoporosis, frank avascular necrosis with or without moderate or severe deformity, lumbar herniated disc and injury, severe balance and proprioception problems (i.e., inability to stand with and/or without marked spinal, knee or hip deformity) etc. Symptoms (moderate to severe) in both knees or hips (case by case), etc. Recent history of meniscal or other knee surgery (not less than 6 months). Severe/constant self reported knee crepitus. Severe loss of knee or hip ROM and or severe deformity (in valgus, varus etc) particularly with instability. Severe depression per Beck Depression Index. Marked or severe fear of chiropractic adjustments/manipulative and or exercise procedures. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Cleveland Chiropractic College Health Center
Los Angeles, California, 90004
About this study
Official title: The Relative Effectiveness of Three Full Kinetic Chain Treatment Protocols for Osteoarthritis of the Knee: Manual Therapy, Rehabilitation and a Combination Thereof
Common medical therapies for knee osteoarthritis are patient education, drug and physical therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery carry significant risk. Manipulative therapy for KOA gives pain relief and increased function. However, research suggests addition of manipulative and soft tissue therapy (to the entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may give a better outcome. Exercise therapy is considered an effective and standard care for KOA.
Read the detailed description
Patients seek treatment from chiropractors for osteoarthritis (OA) and Knee OA (KOA). Significant KOA impacts 10 % of individuals aged ≥63 particularly with radiographic changes; and by age 65, 80% have these x-ray changes. KOA may be the largest cause of decreased mobility, function, disability and pain in people aged ≥ 50 in the US. KOA causes 30% > age 60 to experience decreased social activities of daily living, increased cardiovascular risk, increased fall risk and secondary depression. Overall KOA prevalence is 4% in young adults, 85% in those > 75. Beyond great personal suffering - in the US, annual financial costs associated with OA were $60 billion per year in 2000 and, for all OA and rheumatic disease $128 billion in 2003. Estimates in 2005 were 27 million people suffer significantly due to OA and by 2020 in the US and other developed nations > 12 million will suffer serious, and 19 million minor to moderate work or activity related disability from OA and KOA, with the highest prevalence expected in women.
Medical care commonly prescribed for KOA is lifestyle accommodation (decreased activity, a cane, high chairs and toilet seats, etc), non-steroidal anti-inflammatory drugs (NSAIDS), anti-arthritics, steroids, various and sundry prescription and non-prescription oral and topical medications and exercise. Randomized controlled trials (RCTS) support exercise for KOA treatment, proven superior to placebo. At least 50% (and periodically up to 90 percent) of KOA patients regularly use NSAIDs. Frequent minor but intermittently serious gastrointestinal and cardiovascular adverse reactions to chronic use of NSAIDS occur, and there is evidence that using exercise/rehabilitation with or without manipulative (MAN) therapy may give safer, similar or equivalent relief. Supported by earlier RCTs, MAN therapy with and without soft tissue and exercise therapy for KOA appears superior to placebo and equal or superior to exercise. Although Chiropractic has conducted and published two RCTs of manipulative therapy for KOA, the profession has not yet conducted an RCT with combined full kinetic chain MAN therapy, soft tissue and rehabilitation versus standard care (rehabilitation or exercise therapy) nor studied optimum dose for various patients. 1). in effect only 1 study of such combined care (MAN therapy, soft tissue and rehabilitation or exercise therapy) exists; 2) more studies of MAN therapy combined with rehabilitation are needed to establish: a). equivalent or b). superior treatment efficacy with full kinetic chain therapy and to c). use 'dose time to response' techniques to study the optimum number of treatments for various patients and (to help determine who will respond and will not respond and why) and d)collect data to develop future cost effective research.
Significant morbidity and occasional mortality from NSAID and drug-related complications and surgery; difficulty in obtaining compliance with prolonged exercise protocols; apparent similar, equivalent or superior outcomes (manipulative therapy with and without, but possibly superior with, combined rehabilitation) in pain relief, mobility and function; the possibility of decreasing falls with their appalling sequela in morbidity, mortality and expense; justifies further research into multimodal manipulative therapy for treatment of KOA. Data suggests such full kinetic chain MAN therapy with rehabilitation may give earlier, effective, less costly outcomes and reflects a common clinical chiropractic approach to KOA. In addition to the knee joint, KOA disability has been demonstrated to be significantly worsened by hip joint dysfunction, for example restricted hip flexion increases KOA pain and dysfunction; and there are similar associations throughout the full kinetic chain for example lumbosacral spine joint dysfunction may increase knee pain and dysfunction. Manipulative therapy applied appropriately to the full, kinetic chain (to the full axial and appendicular skeleton -the spine and extremities) combined with rehabilitation may be a superior treatment for knee OA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Full Kinetic Chain Manipulative Therapy, Full Kinetic Chain Rehabilitation, Full Kinetic Chain Manipulative Therapy with Rehabilitation
- Keywords
- Osteoarthritis, Knee, Manipulation Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Kinetic Chain Manipulative TherapyOther
Treatment will focus on restoring knee flexion and extension by lesser grades of mobilization and patellar mobilization along with careful high velocity low amplitude axial elongation of the knee joint.
Additionally, manipulative therapy will be applied where needed to the full kinetic chain using diversified techniques, such as HVLA manipulation or mobilization.
This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email.
Full Kinetic Chain RehabilitationOther
Rehabilitative therapy includes exercises, focused soft tissue treatment and stretch to the knee and the full kinetic chain where needed based upon functional assessment. Also included; patient advice, education and home exercise recommendations for managing their KOA.
This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email.
The rehabilitative therapy group will be required to attend the initial treatment/training, the 4th visit and 1 week follow-up. Treatments 2, 3, 5 and 6 are considered optional; they may be done at home
Full Kinetic Chain Manipulative Therapy with RehabilitationOther
This arm is a combination of the manipulative therapy arm and the rehabilitative therapy arm.
This group receives 6 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.
| Study group | Role | What they receive |
|---|---|---|
| Full Kinetic Chain Manipulative Therapy | Active comparator | Not described Receives: Other: Full Kinetic Chain Manipulative Therapy |
| Full Kinetic Chain Rehabilitation | Active comparator | Not described Receives: Other: Full Kinetic Chain Rehabilitation |
| Full Kinetic Chain Manipulative Therapy with Rehabilitation | Active comparator | Not described Receives: Other: Full Kinetic Chain Manipulative Therapy with Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
McMaster Overall Therapy Effectiveness Tool
Measured: 15 months
Western Ontario and McMaster Universities Osteoarthritis index
Measured: 15 months
Secondary outcomes (2)
Range of Motion
Range of motion of the knee
Measured: 15 months
One Leg Standing Test
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Durban University of Technology, Murdoch University
- Responsible party
- Sponsor
- Investigators
- James W Brantingham, DC, PhD, Principal investigator, Cleveland Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188837
- Sponsor's protocol ID
- IRB-CCC08132010
- Status last verified
- Aug 2012
- First submitted
- 24 Aug 2010
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.
PubMed 16305269Pollard H, Ward G, Hoskins W, Hardy K. The effect of a manual therapy knee protocol on osteoarthritic knee pain: a randomised controlled trial. J Can Chiropr Assoc. 2008 Dec;52(4):229-42.
PubMed 19066697Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.
PubMed 15478147Fish D, Kretzmann H, Brantingham JW, Globe G, Korporaal C, Moen J. A Randomized Clinical Trial to Determine the Effect of Combining a Topical Capsaicin Cream and Knee-Joint Mobilization in the Treatment of Osteoarthritis of the Knee. Journal of the American Chiropractic Association 8-23, August 2008.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Effectiveness of Three Full Kinetic Chain Treatment Protocols for Osteoarthritis of the Knee: Manual Therapy, Rehabilitation and a Combination Thereof
- ClinicalTrials.gov ID
- NCT01188837
- Acronym / sponsor ID
- IRB-CCC08132010
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Manipulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Cleveland Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Durban University of Technology, Murdoch University
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Common medical therapies for knee osteoarthritis are patient education, drug and physical therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery carry significant risk. Manipulative therapy for KOA gives pain relief and increased function. However, research suggests addition of manipulative and soft tissue therapy (to the entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may give a better outcome. Exercise therapy is considered an effective and standard care for KOA.
Detailed description
Patients seek treatment from chiropractors for osteoarthritis (OA) and Knee OA (KOA). Significant KOA impacts 10 % of individuals aged ≥63 particularly with radiographic changes; and by age 65, 80% have these x-ray changes. KOA may be the largest cause of decreased mobility, function, disability and pain in people aged ≥ 50 in the US. KOA causes 30% > age 60 to experience decreased social activities of daily living, increased cardiovascular risk, increased fall risk and secondary depression. Overall KOA prevalence is 4% in young adults, 85% in those > 75. Beyond great personal suffering - in the US, annual financial costs associated with OA were $60 billion per year in 2000 and, for all OA and rheumatic disease $128 billion in 2003. Estimates in 2005 were 27 million people suffer significantly due to OA and by 2020 in the US and other developed nations > 12 million will suffer serious, and 19 million minor to moderate work or activity related disability from OA and KOA, with the highest prevalence expected in women.
Medical care commonly prescribed for KOA is lifestyle accommodation (decreased activity, a cane, high chairs and toilet seats, etc), non-steroidal anti-inflammatory drugs (NSAIDS), anti-arthritics, steroids, various and sundry prescription and non-prescription oral and topical medications and exercise. Randomized controlled trials (RCTS) support exercise for KOA treatment, proven superior to placebo. At least 50% (and periodically up to 90 percent) of KOA patients regularly use NSAIDs. Frequent minor but intermittently serious gastrointestinal and cardiovascular adverse reactions to chronic use of NSAIDS occur, and there is evidence that using exercise/rehabilitation with or without manipulative (MAN) therapy may give safer, similar or equivalent relief. Supported by earlier RCTs, MAN therapy with and without soft tissue and exercise therapy for KOA appears superior to placebo and equal or superior to exercise. Although Chiropractic has conducted and published two RCTs of manipulative therapy for KOA, the profession has not yet conducted an RCT with combined full kinetic chain MAN therapy, soft tissue and rehabilitation versus standard care (rehabilitation or exercise therapy) nor studied optimum dose for various patients. 1). in effect only 1 study of such combined care (MAN therapy, soft tissue and rehabilitation or exercise therapy) exists; 2) more studies of MAN therapy combined with rehabilitation are needed to establish: a). equivalent or b). superior treatment efficacy with full kinetic chain therapy and to c). use 'dose time to response' techniques to study the optimum number of treatments for various patients and (to help determine who will respond and will not respond and why) and d)collect data to develop future cost effective research.
Significant morbidity and occasional mortality from NSAID and drug-related complications and surgery; difficulty in obtaining compliance with prolonged exercise protocols; apparent similar, equivalent or superior outcomes (manipulative therapy with and without, but possibly superior with, combined rehabilitation) in pain relief, mobility and function; the possibility of decreasing falls with their appalling sequela in morbidity, mortality and expense; justifies further research into multimodal manipulative therapy for treatment of KOA. Data suggests such full kinetic chain MAN therapy with rehabilitation may give earlier, effective, less costly outcomes and reflects a common clinical chiropractic approach to KOA. In addition to the knee joint, KOA disability has been demonstrated to be significantly worsened by hip joint dysfunction, for example restricted hip flexion increases KOA pain and dysfunction; and there are similar associations throughout the full kinetic chain for example lumbosacral spine joint dysfunction may increase knee pain and dysfunction. Manipulative therapy applied appropriately to the full, kinetic chain (to the full axial and appendicular skeleton -the spine and extremities) combined with rehabilitation may be a superior treatment for knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Kinetic Chain Manipulative Therapy | Active comparator | Other: Full Kinetic Chain Manipulative Therapy |
| Full Kinetic Chain Rehabilitation | Active comparator | Other: Full Kinetic Chain Rehabilitation |
| Full Kinetic Chain Manipulative Therapy with Rehabilitation | Active comparator | Other: Full Kinetic Chain Manipulative Therapy with Rehabilitation |
Who may qualify
- Ages
- 38 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Knee pain and crepitus with active motion and morning stiffness ≤ 30 min ages ≥ 38 and ≤ 80
- Knee pain and crepitus with active motion and morning stiffness >30 minutes and boney enlargement ages ≥ 38 and ≤ 80
- Knee pain and no crepitus and boney enlargement ages ≥ 38 and ≤ 80 Note: knee x-rays taken in each case to determine grades (0-4) Kellgren Lawrence x-ray scale - but not required for diagnosis - (and if needed lumbosacral/pelvic, hip, ankle or foot x-rays obtained) see exclusions below)
- Knee pain (mild to moderate) of 1 year duration and age ≥ 38 and ≤ 80 years of age and able to stand and walk (see informed consent)
- Diagnosis of concurrent subluxation/joint dysfunction (S/JD) complex a) Diagnosis of S/JD will be supported throughout using the PART(S) system 6).A patient must have a score of ≥720 mm on the WOMAC to be included (≥30%) 7).Additionally, KOA patients, who are + for the Berg Balance Scale (BBS) will be monitored as a subgroup (with OLST and BBS) at all clinic assessments.
Key exclusion criteria (2 listed)
- Rule out: General and internal medical disorders such as significant visual disorders, severe vestibular disorders (i.e., Meniere's), neurological (including Alzheimer's and other degenerative brain and mental disorders, disease and dysfunction) peripheral sensory disorders (severe insulin dependent diabetes), knee and hip joint replacement on side of knee that is treated (case by case otherwise), RA, instability, fracture/ and severe osteoporosis, frank avascular necrosis with or without moderate or severe deformity, lumbar herniated disc and injury, severe balance and proprioception problems (i.e., inability to stand with and/or without marked spinal, knee or hip deformity) etc. Symptoms (moderate to severe) in both knees or hips (case by case), etc. Recent history of meniscal or other knee surgery (not less than 6 months). Severe/constant self reported knee crepitus. Severe loss of knee or hip ROM and or severe deformity (in valgus, varus etc) particularly with instability. Severe depression per Beck Depression Index. Marked or severe fear of chiropractic adjustments/manipulative and or exercise procedures. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Kinetic Chain Manipulative TherapyTreatment will focus on restoring knee flexion and extension by lesser grades of mobilization and patellar mobilization along with careful high velocity low amplitude axial elongation of the knee joint. Additionally, manipulative therapy will be applied where needed to the full kinetic chain using diversified techniques, such as HVLA manipulation or mobilization. This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email. | Other | Full Kinetic Chain Manipulative Therapy |
| Full Kinetic Chain RehabilitationRehabilitative therapy includes exercises, focused soft tissue treatment and stretch to the knee and the full kinetic chain where needed based upon functional assessment. Also included; patient advice, education and home exercise recommendations for managing their KOA. This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email. The rehabilitative therapy group will be required to attend the initial treatment/training, the 4th visit and 1 week follow-up. Treatments 2, 3, 5 and 6 are considered optional; they may be done at home | Other | Full Kinetic Chain Rehabilitation |
| Full Kinetic Chain Manipulative Therapy with RehabilitationThis arm is a combination of the manipulative therapy arm and the rehabilitative therapy arm. This group receives 6 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email. | Other | Full Kinetic Chain Manipulative Therapy with Rehabilitation |
Primary outcome
McMaster Overall Therapy Effectiveness Tool
Time frame: 15 months
Western Ontario and McMaster Universities Osteoarthritis index
Time frame: 15 months
2 secondary outcomes
Range of Motion
Time frame: 15 months
One Leg Standing Test
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
- Results publication: PubMed 16305269Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.
- Results publication: PubMed 19066697Pollard H, Ward G, Hoskins W, Hardy K. The effect of a manual therapy knee protocol on osteoarthritic knee pain: a randomised controlled trial. J Can Chiropr Assoc. 2008 Dec;52(4):229-42.
- Results publication: PubMed 15478147Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.
- Results publicationFish D, Kretzmann H, Brantingham JW, Globe G, Korporaal C, Moen J. A Randomized Clinical Trial to Determine the Effect of Combining a Topical Capsaicin Cream and Knee-Joint Mobilization in the Treatment of Osteoarthritis of the Knee. Journal of the American Chiropractic Association 8-23, August 2008.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James W Brantingham, DC, PhD principal investigator
Cleveland Chiropractic College
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Kinetic Chain Manipulative Therapy, Full Kinetic Chain Rehabilitation and Full Kinetic Chain Manipulative Therapy with Rehabilitation in people with Osteoarthritis, Knee, run by Cleveland Chiropractic College at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McMaster Overall Therapy Effectiveness Tool (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188837, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012.