Reformer Pilates and Manual Therapy in Women With Chronic Low Back Pain

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 25 to 55 years
• Women only
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: The Effects Of Reformer Pilates And Manual Therapy On Pain, Kinesiophobia, Range Of Motion, Quality Of Life, Muscle Strength, Muscle Flexibility And Muscle Shortness In Women With Chronic Low Back Pain

Conditions

Low Back Pain, Pilates Exercise

Being tested

Manual and Physiotherapy Techniques, Manual and Physiotherapy Techniques and Reformer Pilates Group

Keywords

pain, low back, pilates, exercise

Medical subject headings

Low Back Pain, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Manual and Physiotherapy TechniquesOther

  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.

• Manual and Physiotherapy Techniques and Reformer Pilates GroupOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 4 months

2. 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.

   Measured: 4 months

3. 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.

   Measured: 4 months

4. 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.

   Measured: 4 months

5. 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).

   Measured: 4 months

6. 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.

   Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Dec 2025
2. Study start28 Mar 2025
3. Primary completion19 Jul 2025
4. Study completion19 Jul 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Low Back PainStudies 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.