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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01290705
Other study ID # 17790
Secondary ID
Status Completed
Phase N/A
First received February 4, 2011
Last updated February 17, 2016
Start date November 2007
Est. completion date December 2010

Study information

Verified date February 2016
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).


Description:

Exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome (PFPS), but there is still no consensus on recommending any specific rehabilitation program.

This study evaluates two different therapeutic exercise regimens in patients with PFPS and their effect on pain at rest and function.

Supervised exercise therapy will be applied in both groups three times a week over a 3-month period with individually tailored and graded exercise programs, differing between groups in terms of number of exercises, number of repetitions and sets, and time spent on performing aerobic exercises.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 50 Years
Eligibility Inclusion Criteria: Presence of at least 3 symptoms of the following:

Pain when

- Walking stairs

- Squatting

- Running

- Cycling

- Sitting with knees flexed for a prolonged period of time

- Grinding of the patella

- Other positive physical tests (Clarke`s test, patellar crepitus, tenderness upon palpation of the posterior surface of the patella, patellar facets or surrounding structures)

Exclusion Criteria:

- Knee osteoarthrosis/ arthritis

- previous knee injury or knee operations

- patellar tendinopathy

- Osgood- Schlatter`s disease

- Other defined pathological conditions of the knee

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Behavioral:
High exercise therapy

Low exercise therapy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

References & Publications (2)

Østerås B, Østerås H, Torstensen TA, Vasseljen O. Dose-response effects of medical exercise therapy in patients with patellofemoral pain syndrome: a randomised controlled clinical trial. Physiotherapy. 2013 Jun;99(2):126-31. doi: 10.1016/j.physio.2012.05. — View Citation

Østerås B, Østerås H, Torstensen TA. Long-term effects of medical exercise therapy in patients with patellofemoral pain syndrome: results from a single-blinded randomized controlled trial with 12 months follow-up. Physiotherapy. 2013 Dec;99(4):311-6. doi: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain measured by a Visual analogue scale (VAS). This scale was illustrated with a 100 mm horizontal line with descriptors "no pain" at the 0 mm mark and "worst pain imaginable" anchoring the 100 mm. Participants were required to place a vertical mark on the horizontal line, representing their average level of pain experienced during the last 24 hours. This was done at rest and provided an illustration of the perceived pain severity, rated in millimetres. Pre-test, post-test (after completed intervention at 3 months) and one year follow-up. No
Secondary Function measured by a Step-down test and by a modified Functional Index Questionnaire (FIQ). Pre-test, post-test (at 3 months after completed intervention) and at one year follow-up. No
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