Disc HerniationNCT06846892
Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy in Lumbar Disc Herniation
A study testing Exercise in people with Disc Herniation, run by Yasemin Şahbaz at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Disc Herniation
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2024to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Disc Herniation
- Being tested
- Exercise
- Keywords
- Reformer Pilates, Conventional Physiotherapy, Lumbar Disc Herniation, Pain Management, Fatigue
- Medical subject headings
- Intervertebral Disc Displacement, Agnosia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Reformer Pilates Group | Experimental | 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. Receives: Procedure: Exercise |
| Conventional Physiotherapy Group | Active comparator | 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. Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire
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.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Tampa Scale of Kinesiophobia
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.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
SF-36 Quality of Life Scale
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.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Beck Anxiety Inventory
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.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Pittsburgh Sleep Quality Index
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.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Fatigue Severity Scale
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.
Measured: Baseline (pre-treatment) and 6 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start8 Jan 2024
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Factorial Assignment randomized controlled trial 2 groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasemin Şahbaz
- Sponsor type
- University, hospital or other
- Collaborators
- Amasya University, Okan University
- Responsible party
- Sponsor-investigator, Yasemin Şahbaz, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846892
- Sponsor's protocol ID
- UBEYKENT-13
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17106618BECK 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.
PubMed 13688369Buysse 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.
PubMed 19110886Armutlu 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.
PubMed 17293726
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Reformer Pilates and Conventional Physiotherapy Rehabilitation Practices in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06846892
- Acronym / sponsor ID
- UBEYKENT-13
- Conditions
- Disc Herniation
- Keywords
- Reformer Pilates, Conventional Physiotherapy, Lumbar Disc Herniation, Pain Management, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yasemin ŞahbazUniversity, hospital or other
- Collaborators
- Amasya University, Okan University
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Factorial Assignment randomized controlled trial 2 groups
| Arm | Type | Receives |
|---|---|---|
| Reformer Pilates Group | Experimental | Procedure: ExerciseThe 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. |
| Conventional Physiotherapy Group | Active comparator | Procedure: ExerciseThe 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseBoth 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. | Procedure or surgery | Conventional Physiotherapy Group, Reformer Pilates Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 17106618Yakut 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.
- Background: PubMed 13688369BECK 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.
- Background: PubMed 19110886Buysse 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.
- Background: PubMed 17293726Armutlu 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.
- Individual participant dataSharing planned: No
Related trials for Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Disc Herniation, run by Yasemin Şahbaz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Pain Questionnaire (time frame: Baseline (pre-treatment) and 6 weeks (post-treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846892, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.