Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523172
Status:
UNKNOWN
Last Update Posted:
2010-07-19
First Post:
2007-08-29
Brief Title:
Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis
Sponsor:
Cleveland Chiropractic College
Organization:
Cleveland Chiropractic College
Study Overview
Official Title:
A Randomized Clinical Trial Comparing Two Manipulative Protocols to Assess Changes in Pain ROM Quality of Life Cost and Risk for Falls in Subjects With Hip Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients seek treatment from chiropractors for OA OA is the fifth most reported and treated disorder in medical practice Osteoarthritis of the hip OAH a subset affects 12 million American adults and leads to pain loss of mobility decreased function strength activities of daily living quality of life and is a significant risk factor for falls Medical care prescribed for OAH is lifestyle accommodation a cane high chairs and toilet seats etc non-steroidal anti-inflammatory drugs NSAIDS anti-arthritics steroids various and sundry prescription and non-prescription medications and exercise Randomized controlled trials RCTS support exercise for knee OA KOA treatment proven superior to placebo less so for OAH Ninety-two percent of patients with OAH use NSAIDS Frequent minor and intermittently serious adverse reactions to chronic use of NSAIDS and evidence that manipulativemanual therapy MAN and exerciserehabilitation therapy may give equivalent relief suggests NSAIDS should be infrequently used Supported by an earlier RCT that demonstrated manual soft tissue and exercise therapy for KOA superior to placebo later this protocol was found superior to exercise A similar multimodal multimodal MAN with 2 or more combined treatments 2004 RCT compared exercise protocol versus MAN combined with passive and active stretch for OAH Early superior relief and function was achieved with multimodal MAN This suggests multimodal MAN manipulative therapy may be a superior treatment
In studies that followed multimodal MAN over a year without minimal later PRN or supportive treatment given all treatment benefits begin to decrease toward a similar mean One feature frequently inherent in previous trial design has no availability of additional brief treatment rounds subsequent to a short course of interventional therapy Researchers typically design interventions in search of evaluating short-term interventional strategies where sustained improvements in symptom relief function and QoL quality of life will be achieved The current investigators question the utility of such an approach Frequently patients experience minor setbacks in their improvement secondary to minor injuries or diminution in compliance over time with exercise programs Combining the practical awareness of patient experience during the follow-up interval with the reality of the typically ongoing nature of OA activity has stimulated the need for some reasonable level of and access to follow-up care after the initial treatment course A patient who has responded to the initial brief intervention course but who subsequently requires an occasional office visit for physical re-evaluation review of exercise and a visit or two of manual methods is not inherently synonymous with a failed interventional approach any more that repeat doses of pharmaceuticals are required for other chronic conditions whether it be NSAIDs for OA or insulin for diabetes
Significant morbidity and occasional mortality from NSAID and drug-related complications and surgery difficulty in obtaining compliance with prolonged exercise protocols apparent equivalent manipulative outcomes in pain relief mobility and function falls with appalling sequela in morbidity mortality and expense justifies further research into multimodal manipulative therapy for treatment of OAH Data suggests such therapy may give earlier effective less costly outcomes and reflects a common clinical chiropractic approach to OAH In addition to the hip joint OAH disability is significantly worsened by restricted knee flexion and in a similar vein KOA is made worse by hip joint stiffness and dysfunction Manipulative therapy to a fuller or the full kinetic chain lumbosacral through foot appears superior for Knee and hip OA The 2nd new protocol protocol 2 will be compared to the 1st or Hoeksma et al like protocol 1 Additional PRN treatment for both protocols is added to maintain or restore peak levels of improvement see above and below
Specific Aim 1 Recruit a pool of HOA patients from senior centers the local community medical and chiropractic clinics and through advertising in collaboration with other UniversitiesColleges or Schools
Specific Aim 2 Establish protocols for long-term surveillance of OAH in chiropractic patients This study will take 2 years Recruitment will be during the first 9 months Core measurements and data will be collected at baseline blind measurements after the 9th treatment and 3 6 and a 9 month follow up After the end of the 9th treatmentper protocol 2 additional PRN treatment 1-3 visits every 1-3 months up to 6 months not to exceed 6 additional visits before 9 months after beginning care
Specific Aim 3 integrate a clinical research program with a teaching clinic system
Specific Aim 4 Analysis collect and compare outcome data comparing protocols Primary outcome measure The McMaster Overall Therapy Effectiveness the OTE Tool for determining general improvement satisfaction and the importance of changes to and experienced by the patient Secondary outcome measures WOMAC Harris Hip Scale Goniometry the One Legged Standing test and Berg Balance Scale
Specific Aim 5 Cost Includes tracking time procedures and costs at each visit by CPT codes CPT data will be analyzed by various means after completion of the trial
a Minimum outcome measure Appropriate CPT codes marked at all visits
In studies that followed multimodal MAN over a year without minimal later PRN or supportive treatment given all treatment benefits begin to decrease toward a similar mean One feature frequently inherent in previous trial design has no availability of additional brief treatment rounds subsequent to a short course of interventional therapy Researchers typically design interventions in search of evaluating short-term interventional strategies where sustained improvements in symptom relief function and QoL quality of life will be achieved The current investigators question the utility of such an approach Frequently patients experience minor setbacks in their improvement secondary to minor injuries or diminution in compliance over time with exercise programs Combining the practical awareness of patient experience during the follow-up interval with the reality of the typically ongoing nature of OA activity has stimulated the need for some reasonable level of and access to follow-up care after the initial treatment course A patient who has responded to the initial brief intervention course but who subsequently requires an occasional office visit for physical re-evaluation review of exercise and a visit or two of manual methods is not inherently synonymous with a failed interventional approach any more that repeat doses of pharmaceuticals are required for other chronic conditions whether it be NSAIDs for OA or insulin for diabetes
Significant morbidity and occasional mortality from NSAID and drug-related complications and surgery difficulty in obtaining compliance with prolonged exercise protocols apparent equivalent manipulative outcomes in pain relief mobility and function falls with appalling sequela in morbidity mortality and expense justifies further research into multimodal manipulative therapy for treatment of OAH Data suggests such therapy may give earlier effective less costly outcomes and reflects a common clinical chiropractic approach to OAH In addition to the hip joint OAH disability is significantly worsened by restricted knee flexion and in a similar vein KOA is made worse by hip joint stiffness and dysfunction Manipulative therapy to a fuller or the full kinetic chain lumbosacral through foot appears superior for Knee and hip OA The 2nd new protocol protocol 2 will be compared to the 1st or Hoeksma et al like protocol 1 Additional PRN treatment for both protocols is added to maintain or restore peak levels of improvement see above and below
Specific Aim 1 Recruit a pool of HOA patients from senior centers the local community medical and chiropractic clinics and through advertising in collaboration with other UniversitiesColleges or Schools
Specific Aim 2 Establish protocols for long-term surveillance of OAH in chiropractic patients This study will take 2 years Recruitment will be during the first 9 months Core measurements and data will be collected at baseline blind measurements after the 9th treatment and 3 6 and a 9 month follow up After the end of the 9th treatmentper protocol 2 additional PRN treatment 1-3 visits every 1-3 months up to 6 months not to exceed 6 additional visits before 9 months after beginning care
Specific Aim 3 integrate a clinical research program with a teaching clinic system
Specific Aim 4 Analysis collect and compare outcome data comparing protocols Primary outcome measure The McMaster Overall Therapy Effectiveness the OTE Tool for determining general improvement satisfaction and the importance of changes to and experienced by the patient Secondary outcome measures WOMAC Harris Hip Scale Goniometry the One Legged Standing test and Berg Balance Scale
Specific Aim 5 Cost Includes tracking time procedures and costs at each visit by CPT codes CPT data will be analyzed by various means after completion of the trial
a Minimum outcome measure Appropriate CPT codes marked at all visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None