Mindfulness Practice vs Strength Training on Pain, Kinesiophobia and Function Among Sprinters

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Effects of Mindfulness Practice With Strength Training on Pain, Kinesiophobia and Function Among Sprinters With Patellofemoral Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06240962
• Other study ID #: REC/RCR&AHS/23/0434
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: January 2024
• Source: Riphah International University
• Contact: Malia Younas, MS DPT
• Phone: 0325-8292286
• Email: maliayounas62[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A & B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive the strength training only. Group B will receive the mindfulness-exercise in addition to the strength training protocol.

Description:

The objective of the study is to determine the effects of mindfulness practice with strength training on pain, kinesiophobia and function among sprinters with patellofemoral syndrome. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A & B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive the strength training only. Group B will receive the mindfulness-exercise in addition to the strength training protocol. Usual pain, pain during stepping, and pain during running will be assessed using visual analog scales. Functional limitations of the knee will be assessed using the Knee Outcome Survey. Fear of movement, pain catastrophizing, and coping strategies will be measured via the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, and the Coping Strategies Questionnaire, respectively. For strength training we will use Muscle-strengthening Exercise Questionnaire Short Form (MSEQ). These outcomes will be assessed at baseline and after 6 weeks

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Males and Female between the ages of 18 and 40 years, Report running =2 times per week for >45 minutes or a minimum weekly running distance of 10 km, Present a history of insidious onset of signs and symptoms of PFP in 1 or both knees that was unrelated to trauma for at least 3 months before assessment, score <85/100 on the Activities of Daily Living Scale and Sports related of the Knee Outcome Survey (KOS-ADLS)

Exclusion Criteria:

• Intra-articular condition, Coexisting lower limb injury, History of patellar dislocation or knee surgery, Osgood-Schlatter or Sinding- Larsen-Johansson syndrome

Related Conditions & MeSH terms

• Kinesiophobia
• Patellofemoral Pain Syndrome
• Resistance Training
• Syndrome

Intervention

Other:
• Strength Training
They will receive the strength training only (6 weeks, 3 sessions/week) that feature training modifications to help control injury-related symptoms.
• Mindfulness Exercise
They will receive mindfulness-exercise for 6-week mindfulness intervention in addition to the strength training protocol.

Locations

Country	Name	City	State
Pakistan	Pakistan sports board	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Domenech J, Sanchis-Alfonso V, Espejo B. Changes in catastrophizing and kinesiophobia are predictive of changes in disability and pain after treatment in patients with anterior knee pain. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2295-300. doi: 10.1007/s00167-014-2968-7. Epub 2014 Apr 2. — View Citation

Domenech J, Sanchis-Alfonso V, Lopez L, Espejo B. Influence of kinesiophobia and catastrophizing on pain and disability in anterior knee pain patients. Knee Surg Sports Traumatol Arthrosc. 2013 Jul;21(7):1562-8. doi: 10.1007/s00167-012-2238-5. Epub 2012 Oct 19. — View Citation

Lopes AD, Hespanhol Junior LC, Yeung SS, Costa LO. What are the main running-related musculoskeletal injuries? A Systematic Review. Sports Med. 2012 Oct 1;42(10):891-905. doi: 10.1007/BF03262301. — View Citation

Mansfield CB, Selhorst M. The effects of fear-avoidance beliefs on anterior knee pain and physical therapy visit count for young individuals: A retrospective study. Phys Ther Sport. 2018 Nov;34:187-191. doi: 10.1016/j.ptsp.2018.10.008. Epub 2018 Oct 18. — View Citation

Piva SR, Fitzgerald GK, Wisniewski S, Delitto A. Predictors of pain and function outcome after rehabilitation in patients with patellofemoral pain syndrome. J Rehabil Med. 2009 Jul;41(8):604-12. doi: 10.2340/16501977-0372. — View Citation

Rathleff MS, Rasmussen S, Olesen JL. [Unsatisfactory long-term prognosis of conservative treatment of patellofemoral pain syndrome]. Ugeskr Laeger. 2012 Apr 9;174(15):1008-13. Danish. — View Citation

Smith BE, Moffatt F, Hendrick P, Bateman M, Rathleff MS, Selfe J, Smith TO, Logan P. The experience of living with patellofemoral pain-loss, confusion and fear-avoidance: a UK qualitative study. BMJ Open. 2018 Jan 23;8(1):e018624. doi: 10.1136/bmjopen-2017-018624. — View Citation

Witvrouw E, Callaghan MJ, Stefanik JJ, Noehren B, Bazett-Jones DM, Willson JD, Earl-Boehm JE, Davis IS, Powers CM, McConnell J, Crossley KM. Patellofemoral pain: consensus statement from the 3rd International Patellofemoral Pain Research Retreat held in Vancouver, September 2013. Br J Sports Med. 2014 Mar;48(6):411-4. doi: 10.1136/bjsports-2014-093450. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Pain	Usual pain, pain during stepping and running will be assessed using visual analog scales.	pre and 6 weeks post interventional
Primary	Kinesiophobia	Tampa Scale will be used to assess kinesiophobia.	pre and 6 weeks post interventional
Primary	Physical Function	Functional limitations of the knee will be assessed using the Knee Outcome Survey.	pre and 6 weeks post interventional