An interventional study of Manual and Physiotherapy Techniques and Manual and Physiotherapy Techniques and Reformer Pilates Group in Low Back Pain and Pilates Exercise, sponsored by Uskudar University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Uskudar University · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effects of manual therapy alone and manual therapy combined with Reformer Pilates exercises in women with chronic low back pain (CLBP).
The aim of this study was to compare the effects of manual techniques alone and manual techniques combined with Reformer Pilates exercises in women with chronic low back pain (CLBP), focusing on pain, kinesiophobia, range of motion (ROM), muscle strength, trunk endurance, functional level, and quality of life.
A total of 40 women with CLBP who applied to the Kayroterapi Exercise Center were included. Participants were randomized by odd and even numbers into two groups. The control group (MTG) received a manual techniques protocol once a week for 50 minutes over 8 weeks, while the experimental group (MTRPG) received the same protocol in addition to two 50-minute Reformer Pilates sessions per week. Sociodemographic data were collected through a questionnaire specifically designed for the study. Pain was assessed using the Visual Analog Scale (VAS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), and functional disability with the Functional Low Back Pain Scale and the Oswestry Disability Index. Muscle strength was evaluated using manual muscle testing, ROM with a goniometer, and trunk endurance with the sit-and-reach test.
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Exclusion Criteria:
Within the scope of MTG's treatment program; during the first 20 minutes of the session, Transcutaneous Electrical Nerve Stimulation (TENS) was applied to the lumbar region with three channels and a total of six electrodes, while infrared therapy was simultaneously combined and applied to the same region. Soft tissue and mobilization techniques were applied to the lumbar region and surrounding tissues for 15 minutes. Cupping massage and cupping therapy were performed for 5 minutes. Soft tissue mobilization with the Graston technique was applied for 5 minutes, and during the last 5 minutes of the session, a portable percussion massage device was used.
Other: Manual and Physiotherapy Techniques
In the treatment program of the MTRPG group, in addition to the treatment protocol applied in the MTG group, a reformer Pilates exercise program was implemented. Within this program, the session began with the Footwork series as a 5-10 minute warm-up. Subsequently, the exercises included the running exercise, frog exercise, leg circle series (up-down, circle, one leg side stretch), arm circle exercise series, pelvic lift, elephant exercise, and side stretch mermaid exercise, each performed for 10-15 repetitions. The final 5 minutes of the 50-minute reformer Pilates session consisted of child's pose and spinal stretching series.
Other: Manual and Physiotherapy Techniques and Reformer Pilates Group
Within the scope of MTG's treatment program, during the first 20 minutes of the session, Transcutaneous Electrical Nerve Stimulation (TENS) was applied to the lumbar region with three channels and a total of six electrodes, simultaneously combined with infrared therapy applied to the same area. Soft tissue and mobilization techniques were applied to the lumbar region and surrounding tissues for 15 minutes. Cupping massage and cupping therapy were performed for 5 minutes. The Graston technique was applied for 5 minutes to achieve soft tissue mobilization, and the final 5 minutes of the session were carried out using a portable percussion massage device.
n the treatment program of the MTRPG group, in addition to the treatment protocol applied in the MTG group, a reformer Pilates exercise program was implemented. Within this program, the session began with the Footwork series as a 5-10 minute warm-up. Subsequently, the exercises included the running exercise, frog exercise, leg circle series (up-down, circle, one leg side stretch), arm circle exercise series, pelvic lift, elephant exercise, and side stretch mermaid exercise, each performed for 10-15 repetitions. The final 5 minutes of the 50-minute reformer Pilates session consisted of child's pose and spinal stretching series.
Change in Pain Intensity (Visual Analog Scale)
The Visual Analog Scale (VAS), used to assess pain intensity, is a simple, reliable, and easily applicable method. This scale consists of a standard 10 cm vertical or horizontal straight line, with one end indicating "no pain" (0) and the other end indicating "the most severe pain" (10). The patient is asked to mark a point on the line that best represents their current level of pain. The score is then determined based on the location of the mark. Studies have reported that the VAS is a reliable tool for measuring pain intensity.
Time frame: 4 months
Oswestry Disability Index: ODI
This scale, which is widely used to assess the level of functional disability in individuals with low back pain, evaluates daily living activities. It consists of a total of 10 subcategories: pain intensity, degree of pain variation, personal care, lifting, sitting, standing, sleeping, social life, traveling, and sexual activity. Each section contains six statements scored from 0 to 5. The individual is asked to choose the statement that best describes their current condition. The total score ranges from 0 to 50. The interpretation of scores is as follows: 1-10 points: Mild functional disability 11-30 points: Moderate functional disability 31-50 points: Severe functional disability The Turkish validity and reliability study of the scale was conducted by Yakut et al.
Time frame: 4 months
Back Pain Functional Scale : FBAS
This scale is used to assess the extent to which individuals' functional levels are affected by low back pain. The functional areas included in the scale are as follows: work, school, home activities, hobbies, forward bending, putting on shoes or socks, lifting objects from the floor, sleeping, sitting, standing, walking, climbing stairs, and driving. For individuals who do not drive, the last item is answered as "traveling." Each item is scored between 0 and 5. According to the scoring system: (0): Unable to perform the activity 1. : Extremely difficult 2. : Very difficult 3. : Moderately difficult 4. : Slightly difficult 5. : Not difficult The total score ranges from 0 to 60. A score of 60 indicates that the individual can perform all activities without any difficulty.
Time frame: 4 months
Sit and Reach Test : SRT
It is a simple and widely used physical assessment test designed to evaluate an individual's level of flexibility. During the test, the individual sits on the floor with both legs extended straight and the soles of the feet placed against a box. A 26 cm ruler is placed on top of the box prepared for the measurement. The participant is asked to reach forward as far as possible without bending the knees. The farthest point reached is held for approximately 2 seconds, and the distance is recorded. The best result from two trials is taken and recorded in centimeters.
Time frame: 4 months
Range of Motion : ROM
Goniometric measurement is an objective method used in clinical settings to assess normal joint range of motion. During the measurement, the patient is positioned comfortably and appropriately for the joint being evaluated. Before beginning the assessment, the procedure is explained to the patient. All joints are aligned according to the anatomical position, and measurements are taken based on the zero starting position. Joint movements are generally assessed within a range of motion from 0° to 180°. Normal range of motion values for the upper and lower extremities and the vertebral column may vary depending on the reference source. In clinical practice, the most commonly used reference standards are those published by Kendall and the American Academy of Orthopaedic Surgeons (AAOS).
Time frame: 4 months
Manual Muscle Testing : MMT
It is a clinical method used to assess muscle strength. The basis of these tests was developed by Dr. Robert W. Lovett, Professor of Orthopedics at Harvard Medical School, and was first applied in 1912. The evaluation is scored between 0 and 5 based on the muscle's performance against gravity. The interpretation of these scores may vary depending on the specific muscle being tested. 5 (Normal): The muscle completes full range of motion against gravity and maximal external resistance. 4 (Good): The muscle completes full range of motion against gravity but with less than maximal resistance. 3 (Fair): The muscle completes full range of motion against gravity but without any added resistance. 2 (Poor): The muscle completes full range of motion in a gravity-eliminated position. 1 (Trace): Muscle contraction is palpable, but no joint movement occurs. 0 (Zero): No muscle contraction is felt or observed.
Time frame: 4 months
Plan to share: Yes — Study Design
Supporting information: Study protocol
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