Clinical trial NCT05148013: PNF vs Pilates Exercises in Patients With CLBP
Official title: PNF Versus Pilates Exercises on Pain, Body Image, Fear-Avoidance Beliefs, Core Stability, Disability and Balance Functions in Patients With CLBP: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: CLBP
Pilates exercise
Proprioceptive Neuromuscular Facilitation
Pyschological functions
Physical functions
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: Low back pain (LBP) is a common health problem that affects people all over the world and is a leading cause of disability, affecting work performance and overall health. In patients with low back pain, spinal movements are restricted, endurance decreases, flexor, and extensor muscle strength weaken, and aerobic capacity is impaired. Exercise is an essential component in the therapy of many musculoskeletal issues and chronic disorders. In the literature, studies using Pilates exercises and PNF exercises in patients with CLBP have demonstrated that both treatments have some beneficial effects in terms of reducing pain and disability, as well as improving the functional level and quality of life. Studies in the literature showed that both methods are among the treatment methods frequently used in the clinic, but it is difficult to provide sufficient information about which method is more effective. Therefore, the aim of this study is to examine the effects of PNF and Pilates exercises on pain, body image, fear-avoidance beliefs, core stability, disability, and balance functions in individuals with CLBP.

Detailed description: Low back pain (LBP) is a common health problem that affects people all over the world and is a leading cause of disability, affecting work performance and overall health. Chronic LBP (CLBP) is defined as a problem that develops due to mechanical or non-mechanical causes and is characterized by pain, movement, and antalgic posture in the gluteal region and spine, limiting physical activity. In patients with low back pain, spinal movements are restricted, endurance decreases, flexor, and extensor muscle strength weaken, and aerobic capacity is impaired. It has been found that in patients with CLBP, pain creates fear of movement and avoidance belief, leading to inadequacy in physical functionality and a decrease in quality of life. Exercise is an essential component in the therapy of many musculoskeletal issues and chronic disorders. Exercise therapy addresses aims such as pain relief, relaxing, strengthening weak muscles, extending shortened muscles, minimizing mechanical stress on spinal structures, correcting posture, enhancing endurance, and quickly returning to work.

The Pilates Method is a mind-body approach to therapeutic exercises that promotes movement stability and control. Pilates focuses on body posture alignment, which includes proper head, shoulder, and pelvic girdle adjustment in a neutral position while preserving spine curvatures, as well as the axial position of the lower limbs and symmetrical weight-bearing of the feet in standing position. Back pain inhibits various motions of the lumbar spine and pelvis, and this condition weakens the stabilizer muscles, which can lead to CLBP. In the rehabilitation of patients with back pain, the stabilizer muscles are emphasized in order to decrease pain and improve muscular endurance and strength. The Pilates method utilizes principles of various accepted rehabilitation methods that have scientific support for LBP, including core strengthening. This is important since core weakness has been increasingly recognized as a biomechanical deficit in patients with LBP. The systematic review study by Wells et al (2014) indicates that Pilates exercise results in statistically significant improvements in pain and functional ability in the short term compared to usual care and physical activity in people with CLBP. Another recent systematic review by Barros et al. (2020), on the other hand, shows that the Pilates exercise program in moderate-to-high quality RCTs for the treatment of lower back pain is still insufficient.

Proprioceptive neuromuscular facilitation (PNF) is based on facilitating the responses of neuromuscular mechanisms by stimulating proprioceptors which aim to increase muscle strength, improve active movement ability, increase muscle endurance, and improve stabilization at the point where the technique is applied within the movement pattern. A systematic review and meta-analysis by Tong et al. (2014), identified that compared to controls, patients with low back pain have poorer lumbar proprioception. Furthermore, Meier et al. (2019) stated that back pain-induced disturbed or diminished proprioceptive signaling likely plays a key role in causing long-term alterations in the top-down regulation of the motor system via motor and sensory cortex remodeling. Individuals with chronic LBP showed lower acuity for detecting changes in trunk position and demonstrated significantly higher trunk repositioning errors during flexion of the back compared with pain-free individuals. Nijs et al. (2012), suggested that the presence of increased proprioceptive prediction errors might originate from reduced/disrupted proprioceptive input, probably triggered by nociceptive input. Therefore, the underlying physiological mechanisms of the PNF techniques such as autogenic inhibition, reciprocal inhibition, stress relaxation, and the gate control theory may influence the competition between the proprioceptive and nociceptive inputs, resulting in pain reduction and improved joint control. Furthermore, it has been found that PNF training can increase trunk muscular flexibility, strength, and endurance, providing support for the application of PNF training in functional improvement. Pourahmadi et al. (2020) stated in their systematic review and meta-analysis study that there was a low quality of evidence and a weak level of recommendation that PNF training had good benefits on back pain and disability in LBP patients and suggested further high-quality randomized clinical trials regarding long-term effects of PNF training.

In the literature, studies using Pilates exercises and PNF exercises in patients with CLBP have demonstrated that both treatments have some beneficial effects in terms of reducing pain and disability, as well as improving the functional level and quality of life. Studies in the literature showed that both methods are among the treatment methods frequently used in the clinic, but it is difficult to provide sufficient information about which method is more effective. Therefore, the aim of this study is to examine the effects of PNF and Pilates exercises on pain, body image, fear-avoidance beliefs, core stability, disability, and balance functions in individuals with CLBP.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 30-65
* Complained of CLBP for more than 3 months without any neurological impairment
* Characterize their pain as \>3 on the Visual Analogue Scale (VAS)
* Non-obese (BMI 30 kg/m2)

Exclusion Criteria:

* Different areas of back pain (for example, neck pain and upper back pain)
* Previous spinal surgery, structural deformities, spinal cord compression, pregnancy, severe cardiovascular or metabolic disease, and acute infection
* Who received any physiotherapy approach or exercise therapy in the previous three months

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Body Image Scale
timeFrame: 4 weeks
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: 4 weeks
measure: Trunk Stability Test
timeFrame: 4 weeks
measure: Oswestry Disability Index
timeFrame: 4 weeks
measure: Fullerton Advanced Balance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
state: North Cyprus Via Mersin 10 Turkey
Study officials:
affiliation: Eastern Mediterranean University
name: Gozde Iyigun, PhD
role: STUDY_DIRECTOR
References:
citation: Kofotolis N, Kellis E. Effects of two 4-week proprioceptive neuromuscular facilitation programs on muscle endurance, flexibility, and functional performance in women with chronic low back pain. Phys Ther. 2006 Jul;86(7):1001-12.
citation: Valenza MC, Rodriguez-Torres J, Cabrera-Martos I, Diaz-Pelegrina A, Aguilar-Ferrandiz ME, Castellote-Caballero Y. Results of a Pilates exercise program in patients with chronic non-specific low back pain: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):753-760. doi: 10.1177/0269215516651978. Epub 2016 Jun 3.
citation: da Luz MA Jr, Costa LO, Fuhro FF, Manzoni AC, Oliveira NT, Cabral CM. Effectiveness of mat Pilates or equipment-based Pilates exercises in patients with chronic nonspecific low back pain: a randomized controlled trial. Phys Ther. 2014 May;94(5):623-31. doi: 10.2522/ptj.20130277. Epub 2014 Jan 16.
citation: Kofotolis N, Kellis E, Vlachopoulos SP, Gouitas I, Theodorakis Y. Effects of Pilates and trunk strengthening exercises on health-related quality of life in women with chronic low back pain. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):649-659. doi: 10.3233/BMR-160665.
citation: Areeudomwong P, Buttagat V. Proprioceptive neuromuscular facilitation training improves pain-related and balance outcomes in working-age patients with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2019 Sep-Oct;23(5):428-436. doi: 10.1016/j.bjpt.2018.10.005. Epub 2018 Oct 17.
citation: Areeudomwong P, Wongrat W, Neammesri N, Thongsakul T. A randomized controlled trial on the long-term effects of proprioceptive neuromuscular facilitation training, on pain-related outcomes and back muscle activity, in patients with chronic low back pain. Musculoskeletal Care. 2017 Sep;15(3):218-229. doi: 10.1002/msc.1165. Epub 2016 Oct 28.