Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322244
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2006-05-03
Brief Title:
Massage Therapy for Osteoarthritis of the Knee
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Massage Therapy for Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
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:
The study is a randomized controlled clinical trial that investigates the efficacy ogf massage therapy for 66 patients with pain secondary to osteoarthritis of the knee It is a wait-list design where subjects and randomly assigned to either Group A or Group B Group A receives two months of massage while Group B is wait-listed receives two months of usual care At the conclusion of the wait period Group B receives two months of massage In all cases subjects continue to receive conventional medical care for their OA symptoms
Outcome measures include a WOMAC questionnaire a visual analog pain scale time to walk fifty feet and range of motion of the knee using a goniometer A research assistant competent in appropriate subject assessment obtains the outcome measures Change in medication use is tracked by the use of patient diaries Assessments of subjects occurs at baseline and week 8 and 16 in both the intervention and control groups
Outcome measures include a WOMAC questionnaire a visual analog pain scale time to walk fifty feet and range of motion of the knee using a goniometer A research assistant competent in appropriate subject assessment obtains the outcome measures Change in medication use is tracked by the use of patient diaries Assessments of subjects occurs at baseline and week 8 and 16 in both the intervention and control groups
Detailed Description:
The Yale-Griffin Prevention Research Center has received funding from the Centers for Disease Control and Prevention to conduct the Complementary and Alternative Medicine CAM Outcomes Research Project CORP CORP includes a systematic review of the CAM literature and the development of pilot studies assessing selected CAM interventions The first year efforts of the CORP research team have culminated in the selection of pilot studies involving three public health priority conditions attention deficit hyperactivity disorder asthma and osteoarthritis and common CAM interventions A pilot study investigating the effects of a massage therapy intervention for osteoarthritis is detailed in this application
Osteoarthritis OA the most common form of arthritis is a slowly progressive degenerative disease of joint cartilage that afflicts 30 million Americans Praemer A Furner S Rice D Musculoskeletal Conditions in the United States p 40 American Academy of Orthopaedic Surgeons 1992 It becomes more prevalent with advancing age Peyron JG Osteoarthritis The Epidemiologic ViewPoint Clin Orthop 21313-19 1986 Nearly half of Americas elderly suffer from osteoarthritis and arthritis is the most frequently reported chronic condition in the elderly Praemer A Furner S Rice D Musculoskeletal Conditions in the United States p 36 American Academy of Orthopaedic Surgeons 1992
Osteoarthritis affects approximately 3 out of every 100 Americans below age 45 and more than a quarter of Americans between the ages of 45 and 64 suffer from this disabling disease National Center for Health Statistics Current Estimates from the National Health Interview Survey 1988 Vital and Health Statistics Series 10 No 173 DHHS Pub No PHS 89-1501 Public Health Service Hyattsville MD Oct 1989 Kelsey JL Hochberg MC Epidemiology of Chronic Musculoskeletal Disorders Am Rev Public Health 91379-401 1988
Osteoarthritis of the hip or knee is particularly disabling because it limits ambulation but the affliction also strikes the hands the spine and the feet with the same destructive joint process Felson DT Epidemiology of Osteoarthritis Prevalence and Risk Factors Osteoarthritis Disorders American Academy of Orthopaedic Surgeons 1995 The endpoint of the OA disease process is total loss of joint cartilage in the affected area and the need for joint replacement
The high prevalence of arthritis in the population is reflected in the economic burden engendered to treat those afflicted The total cost of conventional treatments for arthritis in 1988 for example was estimated at 546 billion dollars Lazenby HC Letsch SW National Health Expenditures 1989 Health Care Financing Review 1221-26 1990 Conventional treatments for OA include pain medication NSAIDS and cox-2 inhibitors exercises hotcold therapy steroid injections and eventually surgery to repair the joint Felson DT Epidemiology of Osteoarthritis Prevalence and Risk Factors Osteoarthritis Disorders American Academy of Orthopaedic Surgeons 1995 Despite conventional treatment OA is a progressive disease that frequently leads to chronic pain and disability
Massage therapy is proposed as an effective treatment for diminishing the symptoms and improving the disease course of osteoarthritis Massage therapy can accomplish these goals by increasing local circulation to the affected joint improving the tone of supportive musculature enhancing joint flexibility and relieving pain J Spinal Cord Med 2001 Spring 241 54-62
Massage therapy has been evaluated and found to have effectiveness as an adjunct treatment for pain secondary to cancer Effects of massage on pain intensity analgesics and quality of life in patients with cancer pain A pilot study of a randomized clinical trial conducted within hospice care delivery Wilkie DJ et al as well as low back pain syndrome Preyde M Effectiveness of massage therapy for subacute low-back pain Journal Burn Care Rehab 2000 213 189-193 It also has been shown to be beneficial for patients with chronic pain following spinal cord injury Nayak S Matheis RJ Agostinelli S Shiflett SC The use of complementary and alternative therapies for chronic pain following spinal cord injury a pilot survey CMAJ 2000 16213 1815-1820 In a randomized open clinical trial a series of classical Swedish massage therapy sessions was found to be as effective as conventional analgesic therapy for chronic rheumatic pain Ernst E Complementary and alternative medicine for pain management in rheumatic disease Current Opinion in Rheum 2002 1458-62 However to date no study has specifically evaluated the effectiveness of massage therapy for osteoarthritis
The proposed study is a randomized controlled clinical trial to investigate the efficacy of massage therapy for patients with pain secondary to osteoarthritis of the knee It is a wait-list design where subjects will be randomly assigned to either Group A or Group B Group A will receive two months of massage while Group B is wait-listed receiving two months of usual care At the conclusion of the wait period Group B will receive two months of massage In all cases subjects will continue to receive conventional medical care for their OA symptoms
Outcome measures will include a WOMAC questionnaire see Appendix A a visual analog pain scale see Appendix B time to walk fifty feet and range of motion of the knee using a goniometer An athletic trainer competent in appropriate subject assessment will obtain the outcome measures see Appendix C for data collection form Change in medication use will be tracked by the use of patient diaries see Appendix D Assessment of subjects will occur at baseline and weeks 8 and 16 in both the intervention and control groups
The intervention will consist of one-hour massage therapy sessions as follows
Weeks one through four twice weekly Weeks five through eight weekly
Initial treatments are given with greater frequency to build a loading dose of massage treatments effecting a greater impact at the onset of treatment The preponderance of published studies built in twice-weekly massage for four to five weeks at the onset of treatment Field T et al Bulimic adolescents benefit from massage therapy Adolescence 1997 33 131 Leivadi S et al Massage therapy and relaxation effects on university dance students Journal of Dance Medicine Science 1999 3 108-112
Nationally certified and licensed massage therapists who have graduated from an accredited school of massage therapy will give the massage therapy intervention The therapists will follow standard Swedish full-body therapeutic massage technique In order to minimize practitioner variability of treatment a standardized protocol incorporating a sequence of strokes effleurage petrissage tapotement has been developed see Appendix E Subjects will remain supine or prone for the full hour of treatment turning over roughly at the halfway point
The second group will begin receiving the identical intervention after the first group has completed its treatment Weekly phone calls to encourage the second group will be made to minimize attrition The first group will be followed via phone interviews with follow-up data collected until the conclusion of the study
Subjects will be men and women with an established diagnosis of OA meeting ACR criteria 35 years of age or greater with a score of 4-9 on a visual analogue scale Subjects will not be excluded based on gender or race
Osteoarthritis OA the most common form of arthritis is a slowly progressive degenerative disease of joint cartilage that afflicts 30 million Americans Praemer A Furner S Rice D Musculoskeletal Conditions in the United States p 40 American Academy of Orthopaedic Surgeons 1992 It becomes more prevalent with advancing age Peyron JG Osteoarthritis The Epidemiologic ViewPoint Clin Orthop 21313-19 1986 Nearly half of Americas elderly suffer from osteoarthritis and arthritis is the most frequently reported chronic condition in the elderly Praemer A Furner S Rice D Musculoskeletal Conditions in the United States p 36 American Academy of Orthopaedic Surgeons 1992
Osteoarthritis affects approximately 3 out of every 100 Americans below age 45 and more than a quarter of Americans between the ages of 45 and 64 suffer from this disabling disease National Center for Health Statistics Current Estimates from the National Health Interview Survey 1988 Vital and Health Statistics Series 10 No 173 DHHS Pub No PHS 89-1501 Public Health Service Hyattsville MD Oct 1989 Kelsey JL Hochberg MC Epidemiology of Chronic Musculoskeletal Disorders Am Rev Public Health 91379-401 1988
Osteoarthritis of the hip or knee is particularly disabling because it limits ambulation but the affliction also strikes the hands the spine and the feet with the same destructive joint process Felson DT Epidemiology of Osteoarthritis Prevalence and Risk Factors Osteoarthritis Disorders American Academy of Orthopaedic Surgeons 1995 The endpoint of the OA disease process is total loss of joint cartilage in the affected area and the need for joint replacement
The high prevalence of arthritis in the population is reflected in the economic burden engendered to treat those afflicted The total cost of conventional treatments for arthritis in 1988 for example was estimated at 546 billion dollars Lazenby HC Letsch SW National Health Expenditures 1989 Health Care Financing Review 1221-26 1990 Conventional treatments for OA include pain medication NSAIDS and cox-2 inhibitors exercises hotcold therapy steroid injections and eventually surgery to repair the joint Felson DT Epidemiology of Osteoarthritis Prevalence and Risk Factors Osteoarthritis Disorders American Academy of Orthopaedic Surgeons 1995 Despite conventional treatment OA is a progressive disease that frequently leads to chronic pain and disability
Massage therapy is proposed as an effective treatment for diminishing the symptoms and improving the disease course of osteoarthritis Massage therapy can accomplish these goals by increasing local circulation to the affected joint improving the tone of supportive musculature enhancing joint flexibility and relieving pain J Spinal Cord Med 2001 Spring 241 54-62
Massage therapy has been evaluated and found to have effectiveness as an adjunct treatment for pain secondary to cancer Effects of massage on pain intensity analgesics and quality of life in patients with cancer pain A pilot study of a randomized clinical trial conducted within hospice care delivery Wilkie DJ et al as well as low back pain syndrome Preyde M Effectiveness of massage therapy for subacute low-back pain Journal Burn Care Rehab 2000 213 189-193 It also has been shown to be beneficial for patients with chronic pain following spinal cord injury Nayak S Matheis RJ Agostinelli S Shiflett SC The use of complementary and alternative therapies for chronic pain following spinal cord injury a pilot survey CMAJ 2000 16213 1815-1820 In a randomized open clinical trial a series of classical Swedish massage therapy sessions was found to be as effective as conventional analgesic therapy for chronic rheumatic pain Ernst E Complementary and alternative medicine for pain management in rheumatic disease Current Opinion in Rheum 2002 1458-62 However to date no study has specifically evaluated the effectiveness of massage therapy for osteoarthritis
The proposed study is a randomized controlled clinical trial to investigate the efficacy of massage therapy for patients with pain secondary to osteoarthritis of the knee It is a wait-list design where subjects will be randomly assigned to either Group A or Group B Group A will receive two months of massage while Group B is wait-listed receiving two months of usual care At the conclusion of the wait period Group B will receive two months of massage In all cases subjects will continue to receive conventional medical care for their OA symptoms
Outcome measures will include a WOMAC questionnaire see Appendix A a visual analog pain scale see Appendix B time to walk fifty feet and range of motion of the knee using a goniometer An athletic trainer competent in appropriate subject assessment will obtain the outcome measures see Appendix C for data collection form Change in medication use will be tracked by the use of patient diaries see Appendix D Assessment of subjects will occur at baseline and weeks 8 and 16 in both the intervention and control groups
The intervention will consist of one-hour massage therapy sessions as follows
Weeks one through four twice weekly Weeks five through eight weekly
Initial treatments are given with greater frequency to build a loading dose of massage treatments effecting a greater impact at the onset of treatment The preponderance of published studies built in twice-weekly massage for four to five weeks at the onset of treatment Field T et al Bulimic adolescents benefit from massage therapy Adolescence 1997 33 131 Leivadi S et al Massage therapy and relaxation effects on university dance students Journal of Dance Medicine Science 1999 3 108-112
Nationally certified and licensed massage therapists who have graduated from an accredited school of massage therapy will give the massage therapy intervention The therapists will follow standard Swedish full-body therapeutic massage technique In order to minimize practitioner variability of treatment a standardized protocol incorporating a sequence of strokes effleurage petrissage tapotement has been developed see Appendix E Subjects will remain supine or prone for the full hour of treatment turning over roughly at the halfway point
The second group will begin receiving the identical intervention after the first group has completed its treatment Weekly phone calls to encourage the second group will be made to minimize attrition The first group will be followed via phone interviews with follow-up data collected until the conclusion of the study
Subjects will be men and women with an established diagnosis of OA meeting ACR criteria 35 years of age or greater with a score of 4-9 on a visual analogue scale Subjects will not be excluded based on gender or race
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CORPRC U48-CCU115802 | None | None | None |