Patellofemoral Pain SyndromeNCT06130696
Clamshell Exercise in Patellofemoral Syndrome.
A study testing Clamshell exercises and Isometric and muscle strengthen exercise in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Clamshell exercises and Isometric and muscle strengthen exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Sports Board
Lahore, Punjab Province, 6666
Misbah Ghous, MS-NMPT, 0333-7636752, misbah.ghous@riphah.edu.pk
Abdul Wasay, MS- NMPT
About this study
Official title: Effects of Clamshell Exercises on Pain, Range of Motion and Functions in Athletes With Patellofemoral Pain Syndrome.
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Clamshell exercises, Isometric and muscle strengthen exercise
- Keywords
- Clamshell exercises., Pain, Patellofemoral pain syndrome, Function, Athelete
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamshell exercisesOther
Group A will receive treatment with Clamshell exercises Change sides and do 3 sets. Total of 6 session were given.
Isometric and muscle strengthen exerciseOther
group B will receive simple exercises also with clamshell 10 to 20 times. Change sides and do 3 sets.
Total 6 session were given
| Study group | Role | What they receive |
|---|---|---|
| Clamshell exercise | Experimental | Clamshell exercise Receives: Other: Clamshell exercises |
| strengthening exercises with clamshell exercise | Active comparator | Isometric and muscle strengthening exercises with clamshell exercise. Receives: Other: Isometric and muscle strengthen exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala patellar scale. (Pain )
diagnostic tool that aims to assess the severity of symptoms and physical limitations in patients with patellofemoral pain syndrome (PFPS). 13-item self-questionnaire that assesses to limitation physical activities and symptoms that are known to correlate with anterior knee pain syndrome.
This scle consist 0 - 100 score. Less than 90 shows physcial limitation or pain at patellar site. While 98 or 100 shows good knee with no pain or limitation.
Measured: 4th day
Goniometer. (ROM)
Goniometer is used to measure the range of motion of joint. For knee joint, flexion ranges between 0-135º and extension ranges between 135-0º.
Measured: 4th day
Functional mobility test ( physical activity / function)
Functional mobility test: Functional movement screen (FMS) is an evaluation tool for whom movement is a key part of exercise. FMS consists of 7 movement pattern and 3 three clearing tests assess pain for shoulder rotation motions, trunk extension, and trunk flexion. The FMS is scored on an ordinal scale, with 4 possible scores ranging from 0 to 3. 'Zero' refers if the individual has pain during any part of the movement. '1' represents that the person is unable to complete the movement pattern, '2' represents the ability to complete the movement with compensation and '3' refers that the person completes the movement without compensation
Measured: 4th day
Secondary outcomes (3)
Manual muscle testing.
Manual muscle testing is an assessment of muscle strength .The score of '0' represents no activity. '1' represents trace contractile activity but no resulting movement. '2' represents full ROM only in horizontal plane. '3' represents full ROM against the effect of gravity. '4' represents full ROM against gravity and test position is held under minimum resistance. '5' represents full ROM against gravity and test position is held under maximum resistance.
Grade 5 shows good muscle power.
Measured: 4th week
Numeric pain rating scale.
Numeric pain rating scale is 11-point scale ranges from "0" no pain to "10' worst imaginable pain.
Measured: 4th week
Visual analogue scale
Visual analogue scale measures pain that ranges across a continuum from none to an extreme amount of pain. VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient mark
Measured: 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130696
- Sponsor's protocol ID
- 42663 Anosh Malik
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19765240Robinson 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.
PubMed 17549951Pereira 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.
PubMed 35954598Fang 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.
PubMed 35457543Al-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.
PubMed 22896779Campbell 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.
PubMed 25946512
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clamshell Exercises on Pain, Range of Motion and Functions in Athletes With Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT06130696
- Acronym / sponsor ID
- 42663 Anosh Malik
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Clamshell exercises., Pain, Patellofemoral pain syndrome, Function, Athelete
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clamshell exercise | Experimental | Other: Clamshell exercisesClamshell exercise |
| strengthening exercises with clamshell exercise | Active comparator | Other: Isometric and muscle strengthen exerciseIsometric and muscle strengthening exercises with clamshell exercise. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clamshell exercisesGroup A will receive treatment with Clamshell exercises Change sides and do 3 sets. Total of 6 session were given. | Other | Clamshell exercise |
| Isometric and muscle strengthen exercisegroup B will receive simple exercises also with clamshell 10 to 20 times. Change sides and do 3 sets. Total 6 session were given | Other | strengthening exercises with clamshell exercise |
Primary outcome
Kujala patellar scale. (Pain )
Time frame: 4th day
diagnostic tool that aims to assess the severity of symptoms and physical limitations in patients with patellofemoral pain syndrome (PFPS). 13-item self-questionnaire that assesses to limitation physical activities and symptoms that are known to correlate with anterior knee pain syndrome. This scle consist 0 - 100 score. Less than 90 shows physcial limitation or pain at patellar site. While 98 or 100 shows good knee with no pain or limitation.
Goniometer. (ROM)
Time frame: 4th day
Goniometer is used to measure the range of motion of joint. For knee joint, flexion ranges between 0-135º and extension ranges between 135-0º.
Functional mobility test ( physical activity / function)
Time frame: 4th day
Functional mobility test: Functional movement screen (FMS) is an evaluation tool for whom movement is a key part of exercise. FMS consists of 7 movement pattern and 3 three clearing tests assess pain for shoulder rotation motions, trunk extension, and trunk flexion. The FMS is scored on an ordinal scale, with 4 possible scores ranging from 0 to 3. 'Zero' refers if the individual has pain during any part of the movement. '1' represents that the person is unable to complete the movement pattern, '2' represents the ability to complete the movement with compensation and '3' refers that the person completes the movement without compensation
3 secondary outcomes
Manual muscle testing.
Time frame: 4th week
Numeric pain rating scale.
Time frame: 4th week
Visual analogue scale
Time frame: 4th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 19765240Boling 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.
- Background: PubMed 17549951Robinson 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.
- Background: PubMed 35954598Pereira 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.
- Background: PubMed 35457543Fang 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.
- Background: PubMed 22896779Al-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.
- Background: PubMed 25946512Campbell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamshell exercises and Isometric and muscle strengthen exercise in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anosh Malik, MS-SPT. (03027427342, anoshmalik7864@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kujala patellar scale. (Pain ) (time frame: 4th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130696, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.