Keywords
Patellofemoral Pain Syndrome, Pain, Function, Mindfulness Training, Recreational Long-Distance Runners, Integrative Approach, Sports Physiotherapy, Rehabilitation.
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Vikhe CS and Ramteke SU. Effect of mindfulness training in adjunct to conventional physiotherapy on pain, function, and mindfulness attention awareness score in recreational long distance runners with patellofemoral pain syndrome: A randomized controlled trial protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:626 (https://doi.org/10.12688/f1000research.151306.1)
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Study Protocol
Effect of mindfulness training in adjunct to conventional physiotherapy on pain, function, and mindfulness attention awareness score in recreational long distance runners with patellofemoral pain syndrome: A randomized controlled trial protocol
[version 1; peer review: awaiting peer review]
PUBLISHED 12 Jun 2024
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Abstract
Corresponding author:
Chaitali S. Vikhe
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2024 Vikhe CS and Ramteke SU.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Vikhe CS and Ramteke SU. Effect of mindfulness training in adjunct to conventional physiotherapy on pain, function, and mindfulness attention awareness score in recreational long distance runners with patellofemoral pain syndrome: A randomized controlled trial protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:626 (https://doi.org/10.12688/f1000research.151306.1)
First published: 12 Jun 2024, 13:626 (https://doi.org/10.12688/f1000research.151306.1)
Latest published: 12 Jun 2024, 13:626 (https://doi.org/10.12688/f1000research.151306.1)
Introduction
Globally running has become a popular and easily accessible sports activity that is accepted and enjoyed by most people worldwide. Because running is minimally expensive and can be participated by a wide range of individuals with minimal equipment, making it more feasible, most runners and running events have increased significantly over the past several decades. Runing-related Musculoskeletal injuries (RRMIs) are frequent in runners. The application of relatively tiny loads over numerous repeating cycles is typically the cause of these RRMIs. Several investigations have explored the frequency of injuries among runners, with occurrence rates spanning from 3.2% to 84.9%.1 An injury related to running is characterized by musculoskeletal discomfort in the lower limbs, which hampers or prevents running activities such as distance, speed, duration, or training. Running-related injuries (RRI) predominantly impact the distal region of the lower limb, with approximately 70% of cases occurring at or below the knee.
The most prevalent RRIs were found to be plantar fasciitis, iliotibial band syndrome, patellofemoral pain, and Achilles tendonitis after a comprehensive review of nine publications. RRI has an impact on event planning and is linked to financial hardship, psychological discomfort, and a decrease in the desire to resume running.2
The most frequent disorder causing knee discomfort is patellofemoral syndrome (runner’s knee). PFPS denotes pain experienced around or beneath the patella. This condition arises from a range of factors, including overuse, trauma, muscular imbalances, and misalignment of the patella. Additionally, a small number of studies have demonstrated that psychosocial elements like mental health, anxiety, sadness, and fear may exacerbate pain in PFPS.3 Clinical management of PFPS poses significant challenges, marked by high recurrence rates ranging from 70% to 90%, and it remains a considerable concern for recreational long-distance runners globally.4
The predominant indication is pain, which impairs proprioception and disrupts sensory motor integrity, leading to abnormalities in muscle stiffness, motor control, strength, and sensory-motor efficiency.5 Proprioception, the sensorimotor system’s ability to acquire stimuli from conscious and unconscious processes, has emerged as a critical factor in preventing chronic injuries and degenerative joint diseases. Disruptions to position sense receptors due to various knee injuries, including PFPS, have been shown to impact knee joint proprioception. The role of proprioceptive impairment in PFPS is further complicated by the involvement of injured neuro proprioceptive components.6
The International Association for the Study of Pain states that nociception’s physical-chemical components are not the only characteristics of pain perception. In addition, sociocultural, emotional, and cognitive variables may exacerbate pain and dysfunction. Additional treatments targeting psychological variables, including cognitive behavioral therapy, recurrent rate, and graded exposure to activity, have been proposed to improve rehabilitation outcomes, including pain and function, in PFP patients. Helping people manage chronic pain, tension, and anxiety is the aim of mindfulness-based interventions (MBI). The adoption of this evidence-based therapy for numerous musculoskeletal issues has been expanding.7
The Mindful Attention Awareness Scale is widely used for assessing mindfulness, particularly focusing on present-moment awareness, also known as dispositional mindfulness. It generates a single score indicative of mindfulness. Comprising 15 items, the MAAS is designed to measure an individual’s receptive awareness of their attention toward current experiences of FormRobust psychometric properties demonstrated by the validated scale.8–10
In the context of runners, PFPS is intricately linked to both the physical and psychological domains, particularly in long-distance runners exposed to repetitive high-impact loading. Existing treatment approaches for PFPS, including conventional physiotherapy, show limited success rates and a high recurrence rate. The study aims to address the lack of comprehensive exploration of adjunctive interventions, focusing specifically on the physical and psychological domains, especially in long-distance runners exposed to repetitive high-impact loading.
Aim of the study
This study aims to find out the effect of mindfulness training in adjunct to conventional physiotherapy on pain, function, and mindfulness attention awareness score in recreational long distance runners with patellofemoral pain syndrome.
Objectives of the study
Primary objective
1. To evaluate the effects of the mindfulness training plus conventional physiotherapy and conventional physiotherapy interventions alone on functional outcomes, including improvements in pain (numeric pain rating scale), function (knee injury and osteoarthritis outcome score), psychological well-being (mindfulness attention awareness scale), and overall physical function.
2. To compare the effect of mindfulness training plus conventional physiotherapy vs. Conventional physiotherapy alone in recreational long-distance runners with patellofemoral pain syndrome.
Secondary objective
Protocol
This protocol has been registered with CTRI: CTRI/2024/03/064876.
Name of the registry: CTRI (Clinical Trials Registry)
Institutional Ethical Committee approval number: DMIHER (DU)/IEC/2024/183
IEC approval date: 30/01/2024
No. CTRI/2024/03/064876
Registration Date: 28/03/24
URL: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=102972&EncHid=23891.22918&modid=1&compid=19
Trial design
It is a Two-arm parallel, Single-center, Equal allocation superiority, Randomized control trial.
This study will be conducted after obtaining informed consent from participants. Participants will be recruited from the Department of Sports Physiotherapy outdoor patient section at Ravi Nair College of Physiotherapy in Sawangi, Meghe, Wardha, Maharashtra. Eligible participants will undergo screening based on predefined criteria, and individuals meeting the inclusion criteria will be enrolled. Allocation for both groups will be carried out via simple random selection to ensure fairness. This will be facilitated by a computer-generated random number system, utilizing the Sequentially Numbered Opaque Sealed Envelope Method for sample allocation. This study will be supervised by the Head of the Sports Physiotherapy Department, the Principal of Ravi Nair Physiotherapy College (RNPC), and a member of the Research Guidance Cell. Patients will receive regular treatment sessions to adhere to recommended treatments, and if necessary, they will be reminded of therapy sessions via telephone contact. Outcome measures will be evaluated both pre- and post-analysis. The Numeric Pain Rating Scale is utilized to measure pain, the Mindfulness Attention Awareness Scale is employed for assessing emotional and psychological domains, the Knee Injury and Osteoarthritis Outcome Score is used to evaluate a function, and knee joint position sense is assessed using a goniometer to measure proprioception in the runner groups. Group A will receive Mindfulness Training along with Conventional Physiotherapy for 4 weeks, while Group B will undergo Conventional Physiotherapy alone for the same duration.
Eligibility criteria
Inclusion criteria:
(1) Females Between the ages of 21-30 years.
(2) History of recurrent patellofemoral pain.
(3) Long-distance running for more than six months and experiencing pain for a duration exceeding one month.
(4) Retro patellar, peripatellar, or anterior knee pain on the following activity stair climbing, squatting, and running.
(5) Patient with non-traumatic pain over the knee.
(6) Patient exhibiting functional genu valgus.
Exclusion criteria:
(1) Pain associated with acute trauma around knee.
(2) Laxity of articular ligaments or meniscal injury of the knee.
(3) A medical history of either patellar dislocation or a recent fracture involving the knee joint.
(4) Effusion in the knee joint.
(5) Chondromalacia patella.
(6) Osteoporosis deficits.
(7) Presence of progressive neurological conditions or impairments.
Participants timeline
Both groups will be receiving intervention for three sessions per week for a duration of four weeks. Pre and post-intervention assessments will be taken, The CONSORT Flow chart, outlining participant flow from enrollment to analysis, is detailed in Figure 1. The CONSORT flow chart is shown in Figure 1 provides a visual representation of participant progression through the various stages of the study, from enrollment to the final analysis. It includes details on the number of participants assessed for eligibility, excluded, randomized, allocated to interventions, received interventions, followed up, and analyzed.
Figure 1. The CONSORT flow chart.
Interventions
Both Group A and Group B will undergo a four-week intervention, consisting of three sessions per week. Standard physiotherapy treatment will be administered to both groups. Group A will additionally receive mindfulness training alongside conventional physiotherapy, while Group B will undergo conventional physiotherapy.
Experimental Group-A: Mindfulness Training In Adjunct To Conventional Physiotherapy
Group A participants will receive a comprehensive mindfulness training program alongside their standard physiotherapy treatment. Over four weeks, participants will engage in structured mindfulness sessions three times per week, gradually progressing from introductory techniques to more advanced practices. Each week focuses on specific aspects of mindfulness, including body awareness, mindful breathing, coping with challenges, and cultivating self-compassion. By integrating mindfulness training with conventional physiotherapy, this intervention aims to enhance participants’ overall well-being and potentially improve treatment outcomes by addressing both physical and psychological aspects of their condition (Table 1).
Table 1. Mindfulness training.
Control Group-B: Conventional treatment
Group B participants will undergo conventional physiotherapy treatment without any additional mindfulness training. The treatment protocol spans four weeks and consists of various exercises targeting muscle strengthening, closed kinetic chain exercises, passive stretching, functional proprioceptive exercises, and patellar taping techniques (Table 2).
Table 2. Conventional treatment.
| Group B: Conventional treatment | |||
|---|---|---|---|
| Weeks | Exercise | Dosage | Frequency |
| 1-4 | Strengthening: | 10 repetitions × 3 sets11 | 3 days/week |
| 1-4 | Closed Kinetic Chain Exercise:
| 10 repetitions ×3 sets13 | 3 days/week |
| 1-4 | Passive Stretching:
| 3 repetitions ×10 sets with 30-sec hold | 3 days/week |
| 1-4 | Functional proprioceptive exercises by using a wobble board:
| 10 min16 | 3 days/week |
| 1-4 | McConnell Patellar taping Steps:
Sitting with the knees bent to around 30 degrees17 | 1 sessions | 1 day/week |
Outcome measure
Primary outcome
1. Numeric Pain Rating Scale (NPRS):
A unidimensional tool used to evaluate pain intensity, providing individuals with a means to assess their level of discomfort. Scores range from 0 (no pain) to 10 (severe pain) on a ten-point numerical scale. It demonstrates high test-retest reliability and validity across literate and illiterate patient populations, with reliability typically reported at 0.96 and validity ranging from 0.86 to 0.95.18
2. Mindfulness Attention Awareness Scale (MAAS):
The Mindful Attention Awareness Scale is a questionnaire used to assess an individual’s tendency to be mindful and aware of their thoughts and emotions without being overly reactive or overwhelmed by them. It aims to gauge one’s overall level of mindfulness and ability to remain present in the moment.
Higher scores on the MAAS indicate a stronger capacity for mindfulness and present-moment attention. The MAAS normally consists of 15 items. Psychological research frequently uses this scale to examine the connections between different dimensions of mental health and well-being and mindfulness.
The test-retest reliability of MAAS is 0.87, and its Cronbach’s coefficient was 0.89.19
Secondary outcome:
1. Knee Injury and Osteoarthritis Outcome Score (KOOS):
A questionnaire is use to gauge the impact on patients’ well-being following any knee injury, considering both immediate and lasting effects.
The self-administered KOOS measures five outcomes, The knee injury course and treatment outcome can be assessed using the KOOS, which satisfies the fundamental requirements for outcome measures. This is a patient-administered questionnaire designed for follow-up assessments of different types of knee injuries. Its self-administered nature makes it convenient for patients to use, and its straightforward structure ensures ease of completion. Typically, it takes around 10 minutes for patients to complete the KOOS questionnaire.
KOOS scoring:
Pain: Consists of 9 items related to the patient’s experience of pain in the knee.
Symptoms: Includes 7 items assessing various symptoms related to knee injury or osteoarthritis.
Activity of daily living function: Comprises 17 items focusing on the patient’s capacity to carry out everyday tasks that involve the knee.
Sport and recreation function: Consists of 7 items evaluating the patient’s capability to participate.
Quality of life: Involves 4 items evaluating the influence of knee injury on a patient’s overall quality of life.
Scores obtained from the KOOS questionnaire are transformed into a scale where 0 indicates significant knee issues or problems, while a score of 100 signifies the absence of any knee-related problems.
Validity: The Cronbach’s alpha coefficients ranging from .72 to .95 indicate moderate to high internal consistency across different dimensions of KOOS.
Reliability: The ICC ranging from 0.84 to 0.89 indicates good to excellent test-retest reliability for KOOS dimensions.20
2. Knee joint position sense by using a goniometer
The knee joint position sense assessment, employing a goniometer, serves as a vital measure of participants’ proprioceptive acuity without visual cues. Participants are comfortably positioned, their knee bent at a specific angle and then instructed to mentally retain this position. Subsequently, participants are prompted to replicate the remembered angle without visual input. Using a goniometer, the actual angle of the knee joint is measured when participants believe they have returned to the memorized position. This recorded angle is then compared to the target angle, with the difference serving as an indicator of proprioceptive ability. A smaller discrepancy between the target and measured angles suggests superior proprioception, while a larger difference may signify deficits in joint position sense. The goniometer showed excellent reliability, with high agreement among different users and consistent measurements over time. Additionally, it demonstrated good validity, with a minimum significant difference of 10°, indicating its accuracy in measuring knee angles.
Inter-rater reliability was high, with an ICC exceeding 0.99. Similarly, intra-rater reliability showed a high level, with an ICC greater than 0.98.21
Sample size calculation
To determine the sample size, we conducted a power analysis to achieve 80% power and a Type 1 error rate of 5%. The primary variable of interest is the Numerical Pain Rating Scale (NPRS) score, focusing on the difference in mean scores before and after treatment compared to baseline to end visits. We obtained the effect size difference in percentage from a previously conducted randomized controlled trial (RCT) as the reference for our study.
(Estimated)
Considering large effect size difference = 0.8 (Large effect size)
Sample size
at 5% level of significance = 1.96
at 80% Power = 0.84
Ratio allocation (Group2/Group1) = 1
Sample size = 28 per group.
Considering 20 % dropout total = 4
A total of 16 samples are required per group.
Total samples required = 32
Methods
DATA COLLECTION METHODS: Participants meeting the inclusion criteria will be enrolled in the study. Baseline data will be collected before the intervention begins. Post-intervention data will be collected after the completion of the four-week intervention period.
Analysis
The full analysis data set will include all the study participants with no missing values for all the parameters in the data set. The Study subjects will be those meeting the inclusion and exclusion criteria.
Outcome variables: Primary outcomes
Secondary variables:
1. Knee injury and osteoarthritis outcome score
2. Knee joint position sense assessment by using a goniometer
All data will be summarized with baseline characteristics for demographic variables described by frequency and percentage for categorical data, and by mean and standard deviation for continuous data. Outcome variables will be analyzed with continuous variables summarized by minimum, maximum, mean, standard deviation, standard error, and 95% confidence interval (CI) for parametric data. The normality of continuous outcome variables will be assessed using the Kolmogorov-Smirnov test at a 5% level of significance (P ≤ 0.05). If the normality test is not rejected, the data will be considered normally distributed and analyzed using a T-test to determine significant differences between groups at a 5% significance level (P ≤ 0.05). If the normality test is rejected, indicating a non-normal distribution, non-parametric tests will be used to find significance. (P≤0.05) for comparative groups 1) Mindfulness Training in adjunct to conventional physiotherapy 2) conventional physiotherapy
Effect size at different visits of assessment between the two groups for the variable Numerical pain rating scale and Mindfulness attention awareness scale.
Non-normal data will be described by mean, median, lower, and upper quartiles for using a nonparametric test. This will be used for testing significance using the Mann-Whitney test.
Categorical variables will be summarised by frequency (N) and percentage value (%). Efficacy over the categorial variable will be analysed by chi square analysis to find efficacy.
Methods: Monitoring
DATA MONITORING: The data monitoring for this study will be overseen by the Data Monitoring Committee at Ravi Nair Physiotherapy College.
HARMS
Any occurrence of adverse events will be promptly reported to both the Ethical Committee and the clinician responsible for assessing and managing any solicited or spontaneous adverse events, as well as other unintended effects related to the trial interventions or trial conduct.
Ethics and dissemination
CONSENT AND ASSENT: Participants enrolled in the study will be fully informed about the study, and their informed consent and assent will be obtained from each individual.
CONFIDENTIALITY: All information related to the study participants will be kept confidential. Patient-related data will only be utilized with explicit permission from the subjects.
ACCESS TO DATA: The Principal Investigator (PI) will oversee the storage and maintenance of all data gathered throughout or after the study. The PI will retain access to the ultimate trial dataset, which will be shared in a de-identified format upon formal request, specifically for research and publication purposes only.
ANCILLARY AND POST-TRIAL CARE: In the event of any occurrences resulting in harm from trial participation, care will be provided to the study subjects by the Principal Investigator (PI) following the policies outlined by Ravi Nair Physiotherapy College and DMIHER.
DISSEMINATION POLICY: Data collected during or after the study will only be utilized for academic and research-related purposes culminating in a publication in a reputedjournal.
Discussion
Patellofemoral pain syndrome (PFPS) is indeed a prevalent musculoskeletal condition that frequently impacts individuals engaged in physical activities like running, jumping, and stair climbing. While conventional physiotherapy approaches have been widely utilized in the Intervention of PFPS, there is still a demand for innovative interventions to address this condition to optimize treatment outcomes, to reduced recurrence rates, and enhance patient satisfaction. Our study protocol introduces the integration of mindfulness training as an adjunct to conventional physiotherapy, aiming to address the multifaceted nature of PFPS by targeting both physical symptoms and psychological factors.
Previous research has highlighted the challenges associated with PFPS management, including high recurrence rates and limited efficacy of traditional treatment.22 PFPS presents a multifaceted challenge in sports medicine, involving both physiological and psychological factors.3,23 By incorporating mindfulness-based interventions into the treatment paradigm, we aim to address the psychological aspects of pain perception and functional limitations often experienced by individuals with PFPS. Mindfulness training has shown promise in enhancing pain acceptance, coping strategies, and overall quality of life in various musculoskeletal conditions.24
The rationale for exploring mindfulness training in PFPS is further supported by its potential to improve proprioceptive awareness and motor control25 which are critical in mitigating symptoms and preventing injury recurrence in individuals with PFPS. By promoting present-moment awareness and acceptance of bodily sensations, mindfulness training may help individuals with PFPS develop more adaptive responses to pain and movement, thereby facilitating rehabilitation and improving functional outcomes.
Our study protocol aims to evaluate the efficacy of mindfulness training as an adjunct to conventional physiotherapy in improving pain, function, and mindfulness awareness in individuals with PFPS. By employing rigorous methodology, including randomization and outcome measures such as the Numeric Pain Rating Scale (NPRS), Mindfulness Attention Awareness Scale (MAAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Knee joint position sense assessment by using a goniometer.
Ethical considerations
Ethical approval was received from the Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha on January 30th 2024 institutional ethics committee Ref No. DMIHER (DU)/IEC/2024/183.
Institutional Ethical Committee approval number: DMIHER (DU)/IEC/2024/183.
IEC approval date: 30/01/2024
CONSENT AND ASSENT: Participants enrolled in the study will be fully informed about the study, and their written informed consent and assent will be obtained from each individual.
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how to cite this article
Vikhe CS and Ramteke SU. Effect of mindfulness training in adjunct to conventional physiotherapy on pain, function, and mindfulness attention awareness score in recreational long distance runners with patellofemoral pain syndrome: A randomized controlled trial protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:626 (https://doi.org/10.12688/f1000research.151306.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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