Clinical trial NCT06130696: Clamshell Exercise in Patellofemoral Syndrome.
Official title: Effects of Clamshell Exercises on Pain, Range of Motion and Functions in Athletes With Patellofemoral Pain Syndrome.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Clamshell exercises.
Pain
Patellofemoral pain syndrome
Function
Athelete
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 38
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patellofemoral pain syndrome (PFPS), also known as runner's knee, is a common knee condition characterized by pain and discomfort in the front of the knee, specifically around the patella (kneecap) and the surrounding area.

The causes for anterior knee pain are multifactorial like overuse, muscle imbalances abnormal tracking of the patella, biomechanical issues, and improper alignment of the lower limbs. Activities that involve repetitive knee motion, such as running, jumping, squatting, or climbing stairs, can exacerbate the condition . The PFPS may cause aching pain around the front of the knee , especially when sitting for long periods, squatting, or climbing stairs, Pain worsens with activities that involve bending the knee, popping or grinding sensation in the knee and swelling or inflammation around the knee in some cases.

Detailed description: Patellofemoral pain syndrome (PFPS) leads to pain and restricted activities in athletes. There are many remedies used to tackle this problem like Physical therapy, Orthotics or shoe inserts, Patellar taping or bracing, RICE therapy, Nonsteroidal anti-inflammatory drugs (NSAIDs) and in some cases, corticosteroid injections are administered to reduce pain and inflammation. A randomized control trial will be conducted at Pakistan Sports Board Lahore through nonprobability convenience sampling technique on 38 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will receive treatment with Clamshell exercises and group B will receive simple exercises for a period of six weeks. Side-lying clam exercises include lying down on one side on an exercise mat placing the head on arm and top leg/foot on lower leg/foot. Then lift the top leg towards ceiling and lower it again upto 10 to 20 times. Change sides and do 3 sets. Outcome measures such as range of motion will be measured by goniometer and pain by NPRS Scale, Visual analogue Scale and Kujala Patellofemoral pain score and the functional status will be measured with functional mobility test and physical performance testing. Patellar grind test for knee pain will also be performed at start and end to see the effectiveness of Clamshell exercise in athletes.

Data will be analyzed using SPSS software version 21. After assessing normality of data, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Effectiveness of clamshell exercises will be analyzed by comparison in individuals with PFPS.The significance of this study lies in evaluating the effectiveness of clamshell exercises of hip muscles on PFP. The clamshell exercise can be beneficial for individuals with PFPS as part of a comprehensive rehabilitation program as it primarily targets the hip abductor muscles and indirectly contributes to improving knee stability and addressing muscle imbalances that can affect PFPS.

Based on the above stated literature review focusing on PFPS, its effects and remedies, we can conclude that athletes with PFPS shows signs of improvement when re-engaged in training activities. Also Clamshell exercises have wide impact to address muscles and knee problems, so there is a dire need to fill a research gap and study the impact of these exercises on PFPS with special focus on athletes facing the pain.

Eligibility criteria: Inclusion Criteria:

* Patients have at least three months history of peri- or retropatellar pain with worst pain intensity during previous week of VAS 3 or more.
* Players with complain of knee pain.
* Individual having pain during compression of the patella, palpation of the patellar facets

Exclusion Criteria:

* Any degenerative changes of the knee or hip.
* History of patellar dislocation.
* Evidence of edema, Osgood-Schlatter disease or Sinding-Larsen-Johanssen syndrome, patellar -tendinopathy, chondral injury, osteoarthritis.

Joint or muscle injuries in the hip, lumbar pain, sacroiliac pain.

-Patients who previously received surgical treatment in the knee or hip joints, and bilateral complaint of anterior knee pain

Primary outcomes:
measure: Kujala patellar scale. (Pain )
timeFrame: 4th day
measure: Goniometer. (ROM)
timeFrame: 4th day
measure: Functional mobility test ( physical activity / function)
timeFrame: 4th day
Secondary outcomes:
measure: Manual muscle testing.
timeFrame: 4th week
measure: Numeric pain rating scale.
timeFrame: 4th week
measure: Visual analogue scale
timeFrame: 4th week.
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Sports Board
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
citation: Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
citation: Pereira PM, Baptista JS, Conceicao F, Duarte J, Ferraz J, Costa JT. Patellofemoral Pain Syndrome Risk Associated with Squats: A Systematic Review. Int J Environ Res Public Health. 2022 Jul 28;19(15):9241. doi: 10.3390/ijerph19159241.
citation: Fang B, Kim YH, Choi MY. Effects of High-Intensity Aquatic or Bicycling Training in Athletes with Unilateral Patellofemoral Pain Syndrome. Int J Environ Res Public Health. 2022 Apr 13;19(8):4675. doi: 10.3390/ijerph19084675.
citation: Al-Hakim W, Jaiswal PK, Khan W, Johnstone D. The non-operative treatment of anterior knee pain. Open Orthop J. 2012;6:320-6. doi: 10.2174/1874325001206010320. Epub 2012 Jul 27.
citation: Campbell SA, Valier AR. The Effect of Kinesio Taping on Anterior Knee Pain Consistent With Patellofemoral Pain Syndrome: A Critically Appraised Topic. J Sport Rehabil. 2016 Aug;25(3):288-93. doi: 10.1123/jsr.2014-0278. Epub 2015 May 6.