Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy in Lumbar Disc Herniation

Not Applicable

Completed

• Conditions: Disc Herniation

• Registration Number: NCT06846892
• Lead Sponsor: Yasemin Şahbaz

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.

Study Timeline

• Study Start: 2024-01-08
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Tampa Scale of Kinesiophobia	Baseline (pre-treatment) and 6 weeks (post-treatment)	This scale is a 17-item tool that evaluates activity-related injury, injury recurrence, fear, and avoidance. It is used in musculoskeletal disorders (such as low back pain, fibromyalgia). Scores range from 17 to 68, with higher scores indicating a higher level of kinesiophobia.
McGill Pain Questionnaire	Baseline (pre-treatment) and 6 weeks (post-treatment)	The McGill Pain Questionnaire is a reliable tool used to assess pain in a multifaceted way. It addresses the sensory (11 words), emotional (5 words), and general intensity dimensions of pain. Patients select appropriate words that describe their pain to create a total pain score. Pain intensity is measured using a 6-point Likert scale (0 = no pain, 5 = unbearable) and a 10 cm Visual Analog Scale (VAS). This questionnaire is an effective method for evaluating both the intensity and qualitative dimensions of pain.
SF-36 Quality of Life Scale	Baseline (pre-treatment) and 6 weeks (post-treatment)	The SF-36 is an internationally standardized questionnaire used to assess health status and satisfaction, with a structure suitable for different patient groups. The questionnaire analyzes an individual's functional status under eight main categories: social functioning, cognitive health, physical functioning, pain, emotional resilience, energy/vitality, general health perception, and physical health. Each subscale has a different scoring system, and higher scores indicate better health and improved quality of life.
Beck Anxiety Inventory	Baseline (pre-treatment) and 6 weeks (post-treatment)	The BAI is a 21-item Likert-type scale developed by Beck in 1961 to assess depressive symptoms. Each item is scored between 0 and 3, and the total score ranges from 0 to 63. Higher scores indicate more severe levels of depression.
Pittsburgh Sleep Quality Index	Baseline (pre-treatment) and 6 weeks (post-treatment)	The PSQI is a 19-item scale used to assess sleep quality over the past month. It was developed by Buysse and colleagues in 1989. The scale is divided into 7 subcomponents, each scored between 0 and 3. The total score ranges from 0 to 21, with scores above 5 indicating poor sleep quality.
Fatigue Severity Scale	Baseline (pre-treatment) and 6 weeks (post-treatment)	The FSS is a 9-item scale used to assess fatigue. Items are rated on a scale from 1 to 7, and the total score is divided by 9 to calculate the average score. An average score of \<4 indicates no fatigue, while a score of ≥4 indicates the presence of fatigue.

Trial Locations

Locations (1)

Yasemin Şahbaz; 🇹🇷 Beyli̇kdüzü, İstanbul, Turkey