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

NCT ID: NCT07281183

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2025-07-19

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).

Detailed Description

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.

Conditions

Low Back Pain; Pilates Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manual Techniques Group ( MTG )

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.

Group Type: ACTIVE_COMPARATOR

Manual and Physiotherapy Techniques

Intervention Type: 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.

MTRPG ( Manual Techniques and Reformer Pilates Group )

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.

Group Type: EXPERIMENTAL

Manual and Physiotherapy Techniques and Reformer Pilates Group

Intervention Type: 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.

Interventions

Manual and Physiotherapy Techniques

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.

Intervention Type: OTHER

Manual and Physiotherapy Techniques and Reformer Pilates Group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Öğr. Üyesi Muhammed Fatih Kavak

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammed Fatih Kavak, Assistant Professor

Role: STUDY_DIRECTOR

Uskudar University

Locations

Uskudar University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

61351342/020-977

Identifier Type: -

Identifier Source: org_study_id