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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00401050
Other study ID # 06-15-06
Secondary ID
Status Completed
Phase N/A
First received November 16, 2006
Last updated April 16, 2010
Start date June 2006
Est. completion date December 2007

Study information

Verified date April 2010
Source Cleveland Chiropractic College
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare outcomes of combined chiropractic care in anterior knee pain patients with patellofemoral pain syndrome.


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

1. Group A will receive CMT to the knee only, exercise and soft tissue treatment (Graston Instrument Soft Tissue Mobilization hereafter GISTM)

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
chiropractic manipulative therapy

knee exercises

Graston Instrument Soft Tissue Mobilization (GISTM)


Locations

Country Name City State
United States Cleveland Chirpractic College Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cleveland Chiropractic College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up Baseline, 6th Treatment, 2 Month Follow-Up No
Primary Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up Baseline, 6th Treatment, 2 Month Follow-Up No
Secondary a functional measure (step-ups, step-downs and squats) before treatment, after last treatment and at 2 month follow up Baseline, 6th Treatment, 2 Month Follow-Up No
Secondary Patient Satisfaction Scale at 2 month follow up only Baseline, 6th Treatment, 2 Month Follow-Up No
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