Comparison Study of Two Chiropractic Treatment Protocols for Knee Pain Due to Patellofemoral Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT00401050|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : April 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Pain Syndrome||Procedure: chiropractic manipulative therapy Procedure: knee exercises Procedure: Graston Instrument Soft Tissue Mobilization (GISTM)||Not Applicable|
Exercise is standard of care for PFPS but gives limited pain reduction and functional improvement. Previous manipulative therapy for PFPS (with and without exercise) has been limited to the patellofemoral joint alone. However, literature suggests additional manipulative therapy with exercise and soft-tissue treatment may give a better outcome. Further research is needed.
Therefore, this project is a pilot study to inform a future randomized controlled trial to determine if chiropractic adjusting of the full lower extremity (lumbosacral through foot) combined with exercise and soft tissue treatment (Protocol and group A) is superior to chiropractic adjusting of the knee (alone) combined with exercise and soft tissue treatment (Protocol and group B) in the treatment of patellofemoral pain syndrome. We will use the Anterior Knee Pain Scale (AKPS) and Visual Analogue Scale (VAS) as valid and reliable primary outcome measures, a functional measure (step-ups, step-downs and squats) and a Patient Satisfaction Scale (PSS - discharge or refer) as secondary outcome measures. This study will help establish the feasibility of conducting quality research at Cleveland Chiropractic College Los Angeles.
In this pilot study there will be two groups of 10 subjects each
- Group A will receive CMT to the knee only, exercise and soft tissue treatment (Graston Instrument Soft Tissue Mobilization hereafter GISTM)
- Group B will receive CMT to the lumbosacral, sacroiliac and (all) lower extremity joints, exercise and soft tissue treatment (GISTM).
Enrolled subjects will receive a total of 6 treatments. The primary endpoint will be a 2 month follow-up after the 6th treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial Comparing Two Chiropractic Protocols for Patellofemoral Pain Syndrome: a Pilot Study|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]
- Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]
- a functional measure (step-ups, step-downs and squats) before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]
- Patient Satisfaction Scale at 2 month follow up only [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401050
|United States, California|
|Cleveland Chirpractic College Los Angeles|
|Los Angeles, California, United States, 90004|
|Principal Investigator:||James W. Brantingham, D.C., PhD.||Cleveland Chiropractic College Los Angeles|