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

NCT07281183 | Completed

• 1 other identifier: 61351342/020-977
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Low Back Pain; Pilates Exercise

Keywords

pain; low back; pilates; exercise

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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).

  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.

  4 months

Study Arms (2)

Manual Techniques Group ( MTG )

ACTIVE COMPARATOR

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

MTRPG ( Manual Techniques and Reformer Pilates Group )

EXPERIMENTAL

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

Interventions

Manual and Physiotherapy Techniques OTHER

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 Techniques Group ( MTG )

Manual and Physiotherapy Techniques and Reformer Pilates Group OTHER

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.

MTRPG ( Manual Techniques and Reformer Pilates Group )

Eligibility Criteria

• Age: 25 Years - 55 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 25 and 55 years
• Female gender
• Voluntary participation in the study
• History of low back pain lasting longer than 12 weeks and diagnosis of mechanical low back pain (chronic low back pain)
• No contraindications to exercise
• No physical or mental condition preventing participation in the study

You may not qualify if:

• Age below 5 years or above 55 years
• Low back pain lasting less than 12 weeks
• Presence of chronic comorbid disease (e.g., hypertension, diabetes, or other systemic conditions)
• Regular use of medication
• Presence of a neurological pathology
• Any contraindication to exercise
• Inability to establish verbal or visual communication
• Pregnancy

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Pain; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Muhammed Fatih Kavak, Assistant Professor

  Uskudar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: December 15, 2025
• Study Start: March 28, 2025
• Primary Completion: July 19, 2025
• Study Completion: July 19, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)