NCT05148013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

December 11, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

November 29, 2021

Last Update Submit

December 6, 2022

Conditions

Keywords

CLBPPilates exerciseProprioceptive Neuromuscular FacilitationPyschological functionsPhysical functions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Visual Analogue Scale (VAS) will ve used to measure the pain severity. It is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values but is difficult to measure directly. On a 100 mm straight horizontal line, the participants will be asked to rate the intensity of their pain at rest and during exercise separately. The score was calculated using a ruler to measure the distance (mm) between the "no pain" anchor and the patient's mark on a 10-cm line, yielding a range of 0-100. A higher score indicates greater pain severity.

    4 weeks

Secondary Outcomes (5)

  • Body Image Scale

    4 weeks

  • Fear Avoidance Beliefs Questionnaire

    4 weeks

  • Trunk Stability Test

    4 weeks

  • Oswestry Disability Index

    4 weeks

  • Fullerton Advanced Balance

    4 weeks

Study Arms (2)

Pilates exercise group

EXPERIMENTAL

Pilates exercise group will receive a total of 20 sessions of 30 minute Pilates exercises 5 days a week which will be performed under the supervision of a physiotherapist.

Other: Pilates exercise

PNF exercise group

EXPERIMENTAL

A total of 20 sessions of PNF exercises for 30 minutes, 5 days a week, will be performed individually with a physiotherapist.

Other: PNF exercise

Interventions

All participants will be given a basic introduction to the Pilates-based exercises and will be taught how to activate the core muscles, which entails isometric contraction of the transverses abdominis, pelvic floor, and multifidus muscles while exhaling during diaphragmatic breathing, before beginning the exercise program. The Pilates exercise program will consist of floor exercises on a mat, including the following exercises: one-leg kick, single leg stretch, shoulder bridge, the hundred, one leg circle, and swimming. All exercises progressed at three degrees of difficulty: basic, intermediate, and advanced. Depending on the patient's tolerance, each exercise will be done for 8-10 repetitions. The treatment plan included a five-minute warm-up, twenty minutes of exercise, and a five-minute cool-down.

Pilates exercise group

The PNF techniques utilized in the PNF exercise group will include a combination of isotonics, rhythmic stabilization, and repeated stretch. The exercises which will be performed are; (1) Trunk rotation in sitting position (1a) Chopping to the left and right and (1b) Lifting to the left and right, (2) Rolling activity (2a) Resistance to pelvic anterior patterns 2(b) Resistance to posterior patterns, 2(c) Combination of scapula and pelvis, 2(d) Combination of scapula and pelvis (i.e. asymmetrical exercise for trunk extension: the scapula moves in posterior elevation, the pelvis in posterior depression) and (3) Bridging activity (3a) Stabilize the pelvis in its neutral position, 3(b) Bridging lower trunk rotation and, 3(c) Bridging on two legs in the supine position.

PNF exercise group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, North Cyprus Via Mersin 10 Turkey, 99450, Cyprus

Location

Related Publications (6)

  • 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.

    PMID: 16813479BACKGROUND
  • 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.

    PMID: 27260764BACKGROUND
  • 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.

    PMID: 24435105BACKGROUND
  • 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.

    PMID: 26922845BACKGROUND
  • 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.

    PMID: 30361077BACKGROUND
  • 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.

    PMID: 27791345BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Movement TechniquesMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gozde Iyigun, PhD

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 7, 2021

Study Start

December 11, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations