Clinical trial NCT06846892: Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy in Lumbar Disc Herniation
Official title: Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy Rehabilitation Practices in Patients With Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Herniation
Keywords: Reformer Pilates
Conventional Physiotherapy
Lumbar Disc Herniation
Pain Management
Fatigue
Lead sponsor: University of Beykent
Sponsor class: OTHER
Collaborators: name: Amasya University
name: Okan University
First posted: 2025-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Factorial Assignment randomized controlled trial 2 groups
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effects of Reformer Pilates on patient-reported outcomes such as pain level, fatigue, sleep quality, anxiety, kinesiophobia, and quality of life in individuals with lumbar disc herniation (LDH) and to compare its effectiveness with conventional physiotherapy protocols.

Detailed description: All participants underwent a rehabilitation program for six weeks. Pre- and post-treatment assessments were conducted, and the results of the groups were compared. The Reformer Pilates group participated in a 12-session Pilates exercise program, performed twice a week for 45-50 minutes per session, while the Conventional Physiotherapy group underwent a 30-session conventional physiotherapy program, performed five days a week for 45-50 minutes per session.

Assessment tools included the McGill-Melzack Pain Questionnaire, Fatigue Severity Scale, Pittsburgh Sleep Quality Index, Beck Anxiety Inventory, Tampa Scale of Kinesiophobia, and SF-36 Quality of Life Scale. Measurements were taken twice: before and after treatment.

In post-treatment group comparisons, a significant difference was found in pain levels in the Reformer Pilates group and fatigue levels in the Conventional Physiotherapy group. Within-group analyses showed significant improvements in pain, fatigue, kinesiophobia, and physical function subdomains in the Reformer Pilates group, while the Conventional Physiotherapy group showed significant improvements in fatigue, anxiety, and kinesiophobia scores.

In conclusion, Reformer Pilates was found to be an effective method for pain management, whereas Conventional Physiotherapy provided more notable benefits for fatigue management. Both methods were effective in managing kinesiophobia and fatigue, highlighting the importance of tailoring treatment plans to meet the individual needs of patients.

Eligibility criteria: Inclusion Criteria:

* Aged between 21 and 50 years
* Complaints of low back pain for at least three months
* Diagnosed with lumbar disc herniation
* No spinal surgery in the last six months
* Regular participation in the program
* Ability to communicate
* Exclusion Criteria:
* Presence of systemic diseases affecting pain, such as fibromyalgia
* Presence of neurological or orthopedic disorders
* Receiving physical therapy in the past eight weeks
* Presence of spinal stenosis, spondylolysis, spondylolisthesis, or other lumbar -degenerative diseases
* Pregnancy status

Primary outcomes:
measure: McGill Pain Questionnaire
timeFrame: Baseline (pre-treatment) and 6 weeks (post-treatment)
measure: Tampa Scale of Kinesiophobia
timeFrame: Baseline (pre-treatment) and 6 weeks (post-treatment)
measure: SF-36 Quality of Life Scale
timeFrame: Baseline (pre-treatment) and 6 weeks (post-treatment)
measure: Beck Anxiety Inventory
timeFrame: Baseline (pre-treatment) and 6 weeks (post-treatment)
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline (pre-treatment) and 6 weeks (post-treatment)
measure: Fatigue Severity Scale
timeFrame: Baseline (pre-treatment) and 6 weeks (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Beyli̇kdüzü
country: Turkey
facility: Yasemin Şahbaz
state: İstanbul
Study officials:
References:
citation: Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.
citation: BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
citation: Buysse DJ, Hall ML, Strollo PJ, Kamarck TW, Owens J, Lee L, Reis SE, Matthews KA. Relationships between the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and clinical/polysomnographic measures in a community sample. J Clin Sleep Med. 2008 Dec 15;4(6):563-71.
citation: Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.