Comparison Study of Two Chiropractic Treatment Protocols for Knee Pain Due to Patellofemoral Pain Syndrome
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chiropractic manipulative therapy
knee exercises
Graston Instrument Soft Tissue Mobilization (GISTM)
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring patellofemoral pain syndrome, chiropractic, knee pain, chiropractic manipulation, Graston Instrument Soft Tissue Mobilization(GISTM)
Eligibility Criteria
Inclusion Criteria:
- anterior, peri or retropatellar knee pain >3 months from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping or overuse activities. Pain is relieved by rest.
- insidious onset of symptoms unrelated to a traumatic incident; and
- presence of pain on palpation of the patellar facets, on step down from a 25-cm step, or during a double-legged squat
- other disorders such as OA, instability or medial meniscus injury must be ruled out
- X-ray or MRI findings not required. There is no clear correlation between severity of complaints and arthroscopic or radiologic findings
- A VAS-Worst pain of ≥ 5.0; a AKPS of ≥ 50.This reflects the current probability that less PFPS patients with less severity currently consult chiropractors for this disorder
Exclusion Criteria:
- Patellar subluxation/dislocation
- meniscal injuries
- intra-articular pathology (ACL injury, etc)
- ligament laxity
- Osgood-Schlatters
- Sinding-Larsen-Johanson syndrome
- knee joint effusion
- previous surgery on patellofemoral joint
- illiteracy/inability to understand and answer questionnaires
- inability to attend all treatment sessions
- true locking of knee joint
- a neurological disorder that influences gait
- if taking medication, amount will be diarized - otherwise not allowed
- foot orthotics allowed if already worn
- arthritidies
- bursitis
- patellar tendonitis
- older subjects > 45 years of age
- subjects < 18 years of age
- those that begin marked ↑ in physical activity during the course of the trial
Sites / Locations
- Cleveland Chirpractic College Los Angeles
Outcomes
Primary Outcome Measures
Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up
Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up
Secondary Outcome Measures
a functional measure (step-ups, step-downs and squats) before treatment, after last treatment and at 2 month follow up
Patient Satisfaction Scale at 2 month follow up only
Full Information
NCT ID
NCT00401050
First Posted
November 16, 2006
Last Updated
April 16, 2010
Sponsor
Cleveland Chiropractic College
1. Study Identification
Unique Protocol Identification Number
NCT00401050
Brief Title
Comparison Study of Two Chiropractic Treatment Protocols for Knee Pain Due to Patellofemoral Pain Syndrome
Official Title
A Randomized Clinical Trial Comparing Two Chiropractic Protocols for Patellofemoral Pain Syndrome: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cleveland Chiropractic College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare outcomes of combined chiropractic care in anterior knee pain patients with patellofemoral pain syndrome.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
patellofemoral pain syndrome, chiropractic, knee pain, chiropractic manipulation, Graston Instrument Soft Tissue Mobilization(GISTM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
chiropractic manipulative therapy
Intervention Type
Procedure
Intervention Name(s)
knee exercises
Intervention Type
Procedure
Intervention Name(s)
Graston Instrument Soft Tissue Mobilization (GISTM)
Primary Outcome Measure Information:
Title
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
Title
Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up
Time Frame
Baseline, 6th Treatment, 2 Month Follow-Up
Secondary Outcome Measure Information:
Title
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
Title
Patient Satisfaction Scale at 2 month follow up only
Time Frame
Baseline, 6th Treatment, 2 Month Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
anterior, peri or retropatellar knee pain >3 months from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping or overuse activities. Pain is relieved by rest.
insidious onset of symptoms unrelated to a traumatic incident; and
presence of pain on palpation of the patellar facets, on step down from a 25-cm step, or during a double-legged squat
other disorders such as OA, instability or medial meniscus injury must be ruled out
X-ray or MRI findings not required. There is no clear correlation between severity of complaints and arthroscopic or radiologic findings
A VAS-Worst pain of ≥ 5.0; a AKPS of ≥ 50.This reflects the current probability that less PFPS patients with less severity currently consult chiropractors for this disorder
Exclusion Criteria:
Patellar subluxation/dislocation
meniscal injuries
intra-articular pathology (ACL injury, etc)
ligament laxity
Osgood-Schlatters
Sinding-Larsen-Johanson syndrome
knee joint effusion
previous surgery on patellofemoral joint
illiteracy/inability to understand and answer questionnaires
inability to attend all treatment sessions
true locking of knee joint
a neurological disorder that influences gait
if taking medication, amount will be diarized - otherwise not allowed
foot orthotics allowed if already worn
arthritidies
bursitis
patellar tendonitis
older subjects > 45 years of age
subjects < 18 years of age
those that begin marked ↑ in physical activity during the course of the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James W. Brantingham, D.C., PhD.
Organizational Affiliation
Cleveland Chiropractic College Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Chirpractic College Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90004
Country
United States
12. IPD Sharing Statement
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Comparison Study of Two Chiropractic Treatment Protocols for Knee Pain Due to Patellofemoral Pain Syndrome
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