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

February 20, 2025 updated by: Yasemin Şahbaz

Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy Rehabilitation Practices in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Beyli̇kdüzü, İstanbul, Turkey
        • Yasemin Şahbaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reformer Pilates Group
The study group participated in a 12-session Reformer Pilates exercise program, performed twice a week, with each session lasting 45-50 minutes. The treatment duration for this group was set to 6 weeks, and the effects of the program on pain management, functional recovery, fatigue, and kinesiophobia were evaluated.
Procedure: Exercise
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.
Active Comparator: Conventional Physiotherapy Group
The control group, on the other hand, underwent a conventional physiotherapy protocol, with a total of 30 sessions, performed five days a week, and each session lasting 45-50 minutes. This protocol likely included manual therapy, electrotherapy, and exercises. The effects of conventional physiotherapy on pain, fatigue, anxiety, and kinesiophobia were examined. Both groups were assessed before and after treatment using the McGill-Melzack Pain Questionnaire, Fatigue Severity Scale, Pittsburgh Sleep Quality Index, Beck Anxiety Inventory, Tampa Scale of Kinesiophobia, and the SF-36 Quality of Life Scale.
Procedure: Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-treatment) and 6 weeks (post-treatment)
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.
Baseline (pre-treatment) and 6 weeks (post-treatment)
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.
Baseline (pre-treatment) and 6 weeks (post-treatment)
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.
Baseline (pre-treatment) and 6 weeks (post-treatment)
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.
Baseline (pre-treatment) and 6 weeks (post-treatment)
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.
Baseline (pre-treatment) and 6 weeks (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasemin Şahbaz

Collaborators

Okan University
Amasya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

November 29, 2024

Study Completion (Actual)

November 29, 2024

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBEYKENT-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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