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Completed

NCT Number: NCT06846892

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

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.

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Key information

Conditions

Disc Herniation Agnosia Bone Diseases Fatigue Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Spinal Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yasemin Şahbaz

Beyli̇kdüzü, Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Procedure

Both groups were given a total of 12 sessions of Williams exercises, two days a week, in 20-minute sessions, accompanied by a physiotherapist. Williams back exercises are an exercise method that aims to increase lumbar flexion and strengthen the abdominal and gluteal muscles. The exercise program included pelvic tilts, single and double knee pulls, partial crunches, hamstring stretches, hip flexor stretches and squats. In addition, the patients continued their Williams exercises at home three days a week.

Primary outcomes

  1. McGill Pain Questionnaire

    Time frame: 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.

  2. Tampa Scale of Kinesiophobia

    Time frame: 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.

  3. SF-36 Quality of Life Scale

    Time frame: 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.

  4. Beck Anxiety Inventory

    Time frame: 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.

  5. Pittsburgh Sleep Quality Index

    Time frame: 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.

  6. Fatigue Severity Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yasemin Şahbaz

Other

Collaborators

  • Amasya University
  • Okan University

Registry information

Official study title

Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy Rehabilitation Practices in Patients With Lumbar Disc Herniation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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