- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06762951
Pilates Mat Versus Segmental Control Exercises in Patients with Chronic Non-Specific Low Back Pain
January 2, 2025 updated by: Alyaa Mohamed Ahmed Mohamed Elgendy, Cairo University
Pilates Mat Versus Segmental Control Exercises on Spinopelvic Angles in Patients with Chronic Non-Specific Low Back Pain
This study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Low back pain (LBP) is the most common musculoskeletal condition and constitutes a global public health problem.
The majority of patients (up to 90%) are categorized as having nonspecific low back pain, which is described as symptoms lack of clear particular reasons, i.e., beginning of low back pain is not known.
Many clinical guidelines and systematic reviews have recommended exercise therapy as one of the preferred treatments at decreasing pain and improving function in NSLBP.
In the last decade, the Pilates method has become one of the most popular exercise programmes incorporated in clinical practice.
Therapeutic exercises, specifically Segmental control exercises, decrease pain, reduce disability, improve quality of life, increase muscular endurance and strength, improve segmental stability, and reduce risk of injury.
Studies have shown that both segmental control exercises and Pilate's exercises are effective in the management of pain and disability in individuals with Chronic LBP.
However, it appears there is dearth of empirical data establishing which is more effective between the segmental control exercises and Pilates exercises on individuals with non-specific chronic low back pain.
Thus, there exist certain gaps involving the two therapeutic techniques.
Therefore, this study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain.
Study Type
Interventional
Enrollment (Estimated)
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 Contact
- Name: Alyaa MAM Elgendy, Master
- Phone Number: +201111447459
- Email: dr.alyaaelgendy55@gmail.com
Study Locations
-
-
-
Egypt, Egypt
- CAIRO UNIVERCITY
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age group: 18 to 65 years. (Yentür et al., 2021)
- Both male and female gender will be included in the study. (Akhtar et al., 2017)
- Nonspecific, non-radicular (axial) chronic LBP diagnosis with hyperlordosis (LBP for at least three months). (Kızıltaş et al., 2022)
- Visual Analog Scale (VAS) score of 3 or higher. (Mannion et al., 2009)
Exclusion Criteria:
- Patients with acute attacks of LBP. (Caglayan et al.,2014)
- Pain referred from the lumbar to the lower extremities.
- Serious spinal disorder including malignancy, osteoporosis, ankylosing spondylitis, cauda equina compression, and infection.
- Fracture of vertebrae, and administered epidural injection. (Sarker et al., 2020)
- Pregnancy and feeding
- Structural abnormalities in the lumbar region
- Surgical history in the lumbar spine area
- Heart disease. (Kızıltaş et al., 2022)
- History of Vestibular dysfunction
- Regular Pilates/any other specific exercise program in the last 3 months. (Mehta et al.,2022)
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group (A)
Group (A): Twenty patients will receive Pilates mat exercise which consists of (single leg stretch + Pelvic press + Swimming + Opposite arm and leg reach + Side to side), 3 sets of 10 repetitions.
And conventional physiotherapy treatment which consists of traditional physical therapy eg.
(Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks.
|
Pilates mat exercise which consists of (single leg stretch + Pelvic press + Swimming + Opposite arm and leg reach + Side to side), 3 sets of 10 repetitions.
Traditional physical therapy eg.
(Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS)
|
|
Experimental: Group (B)
Group B: Twenty patients will receive Segmental control exercise which consists of (Segmental control over primary stabilizers, Exercises in closed chain, and Exercises in open chain) and conventional physiotherapy treatment which consists of traditional physical therapy eg.
(Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks
|
Traditional physical therapy eg.
(Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS)
Segmental control exercise which consists of (Segmental control over primary stabilizers, Exercises in closed chain, and Exercises in open chain)
|
|
Active Comparator: Group (C)
Group C: Twenty patients will receive conventional physiotherapy treatment only which consists of traditional physical therapy eg.
(Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks.
|
Traditional physical therapy eg.
(Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinopelvic angels
Time Frame: 6 weeks
|
Spinopelvic angles consists of (Sacral slope, lumber lordosis, pelvic incidence, and pelvic tilt) from the X-ray picture of the lateral view of the lumbosacral region by using CorelDraw graphic suits X7 software program.
(Bhosale et al.2020)
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 6 weeks
|
Pain intensity by using a Visual analogue scale (VAS).
(Begum, and Hossain 2019)
|
6 weeks
|
|
Functional disability
Time Frame: 6 weeks
|
Functional disability by using the Oswestry disability questionnaire.
(Koivunen et al., 2024)
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Dimitrijevic V, Scepanovic T, Milankov V, Milankov M, Drid P. Effects of Corrective Exercises on Lumbar Lordotic Angle Correction: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Apr 18;19(8):4906. doi: 10.3390/ijerph19084906.
- Tamartash H, Bahrpeyma F. Evaluation of Lumbar Myofascial Release Effects on Lumbar Flexion Angle and Pelvic Inclination Angle in Patients with Non-Specific Low Back Pain. Int J Ther Massage Bodywork. 2022 Mar 2;15(1):15-22. doi: 10.3822/ijtmb.v15i1.709. eCollection 2022 Mar.
- Koivunen K, Widbom-Kolhanen S, Pernaa K, Arokoski J, Saltychev M. Reliability and validity of Oswestry Disability Index among patients undergoing lumbar spinal surgery. BMC Surg. 2024 Jan 3;24(1):13. doi: 10.1186/s12893-023-02307-w.
- Bhosale S, Pinto D, Srivastava S, Purohit S, Gautham S, Marathe N. Measurement of spinopelvic parameters in healthy adults of Indian origin - A cross sectional study. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):883-888. doi: 10.1016/j.jcot.2019.07.013. Epub 2019 Jul 23.
- Huang C, Hsieh YL, Chou LW, Wang JL, Chien A. Effects of pilates exercises on radiographic lumbo-pelvic alignment and range of motion in non-specific low back pain patients. J Bodyw Mov Ther. 2024 Apr;38:339-345. doi: 10.1016/j.jbmt.2023.10.004. Epub 2024 Feb 5.
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 (Estimated)
February 1, 2025
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
January 2, 2025
First Submitted That Met QC Criteria
January 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 2, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spinopelvic Angels In CNSLBP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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