The Effect of Spinal Stabilization Training in Women With Dysmenorrhea

NCT07563426 | Completed

• 1 other identifier: Trabzon University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study, designed as a randomized controlled experimental trial, was conducted at Tonya Vocational School. Institutional approval was obtained to carry out the study at Tonya Vocational School (Appendix-). Participants who met the inclusion and exclusion criteria and voluntarily agreed to participate were required to sign an informed consent form prior to the initiation of the study. Following the acquisition of informed consent, 50 women with dysmenorrhea, identified based on the WaLIDD score, were randomly allocated into two groups using a simple randomization method (sealed envelope): 25 participants in the experimental group and 25 in the control group.Baseline assessments were performed by the same researcher within the first week immediately following the most recent menstrual period, prior to the commencement of the intervention. Participants' demographic characteristics and menstrual cycle information were recorded using a data collection form before the exercise intervention. Pain intensity was evaluated using the Visual Analog Scale (VAS); menstrual symptom severity using the Menstrual Symptom Scale; body awareness using the Body Awareness Questionnaire; muscle endurance using the McGill trunk endurance tests; lumbopelvic mobility using the Modified Schober test; activities of daily living using the Lawton-Brody Instrumental Activities of Daily Living Scale; problem-solving skills using the Problem Solving Inventory; decision-making styles using the Melbourne Decision Making Questionnaire; quality of life using the SF-12 questionnaire; and physical activity levels using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). All measurements were conducted within the first week immediately following the most recent menstrual period, both before (baseline assessment) and after (post-intervention assessment) the exercise program.

Conditions

Dysmenorrhea; Spinal Stabilization; Menstrual Symptoms; Exercise Training

Keywords

Menstrual symptom; Menstrual pain; spinal stabilization; Quality of life; Lumbopelvic mobility; endurance

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS):

  Pain intensity was assessed using the VAS. Participants indicated the severity of pain by marking an "x" on a 10-cm line, with each centimeter representing one unit. A score of "0" indicated no pain, while a score of "10" represented the most severe pain.

  "Baseline and Week 8

• Menstruation Symptom Scale

  This scale was used to evaluate menstrual symptoms. The questionnaire consists of 22 items, including 19 items assessing symptoms (emotional, physical, and pain-related) and 3 items evaluating coping strategies for symptoms. Higher total scores indicate more severe menstrual symptoms. The Turkish validity and reliability study of the scale was conducted by Gülten Güvenç.Minimum score: 22, Maximum score:110.

  "Baseline and Week 8

• McGill Trunk Endurance Tests:

  Lumbopelvic muscle endurance was assessed using the McGill trunk endurance tests , which include trunk flexion, extension, and lateral flexion (right and left) endurance assessments. The testing positions were demonstrated and explained to participants in advance. Participants were then asked to repeat each position once to familiarize themselves with the assessment postures. Participants were encouraged to maintain each isometric position for as long as possible for each test. The duration for which individuals were able to maintain the correct posture was recorded in seconds . The McGill trunk endurance tests were terminated when the test position deteriorated or when participants indicated that they could no longer continue the test.

  Baseline and Week 8

• Modified Schober Test:

  This test was used to assess lumbopelvic mobility. It is a method that measures lumbar spinal mobility during flexion and extension movements . For the measurement, the line between both posterior superior iliac spines was first marked, and points 10 cm above and 5 cm below this mark were identified. Participants were then asked to bend forward. The difference between the initial and final measurements was recorded in centimeters. In this test, a 0-5 cm difference indicates reduced flexion flexibility, a difference greater than 10 cm indicates increased flexibility, and values between 5-10 cm are considered normal.

  Baseline and Week 8

Secondary Outcomes (6)

• Problem Solving Inventory:

  Baseline and Week 8

• Melbourne Decision Making Questionnaire:

  Baseline and Week 8

• Short Form Health Survey (SF-12):

  Baseline and Week 8

• Body Awareness Questionnaire:

  Baseline and Week 8

• Lawton-Brody Instrumental Activities of Daily Living Scale

  Baseline and Week 8

Study Arms (2)

Active Comparator: Standard Group

ACTIVE COMPARATOR

The control group will be provided with relaxation exercises and lifestyle recommendations. After the relaxation exercises are explained by a physiotherapist, lifestyle recommendations for participants will include avoidance of exposure to environmental tobacco smoke; reduction or cessation of smoking and alcohol consumption; limitation of caffeine, sugar, cold foods and beverages, and foods with high salt content; use of loose and cotton clothing; warm standing showers; and adequate and good-quality sleep (at least 6-8 hours) (9,10). To facilitate adherence and support the follow-up of relaxation training, a brochure was prepared and provided to the participants. Participants will perform relaxation exercises once per week for 8 weeks, with each session lasting 30 minutes (1).

Other: Standard

Experimental: Spinal Stabilization Exercise Group

EXPERIMENTAL

In addition to relaxation exercises and lifestyle recommendations, the experimental group received spinal stabilization training . Under the supervision of a physiotherapist, spinal stabilization exercises were performed twice weekly for eight weeks, with session durations of 30 minutes in the initial weeks and 45-55 minutes in the subsequent weeks. Each session consisted of a 5-minute warm-up (walking and stretching exercises), 30-40 minutes of spinal stabilization exercises in the early weeks and 45-55 minutes in the later weeks, and a 5-minute cool-down period (stretching exercises) (12).The progression of the exercises was individualized according to each patient's ability, fatigue level, and pain response. The level of exertion was determined using the Borg Scale (6-20), and the exercise intensity was increased when participants reached a Borg score of 11-14 (13).

Other: Experimental Group

Interventions

Experimental Group OTHER

In addition to relaxation exercises and lifestyle recommendations, the experimental group received spinal stabilization training . Under the supervision of a physiotherapist, spinal stabilization exercises were performed twice weekly for eight weeks, with session durations of 30 minutes in the initial weeks and 45-55 minutes in the subsequent weeks. Each session consisted of a 5-minute warm-up (walking and stretching exercises), 30-40 minutes of spinal stabilization exercises in the early weeks and 45-55 minutes in the later weeks, and a 5-minute cool-down period (stretching exercises) (12).The progression of the exercises was individualized according to each patient's ability, fatigue level, and pain response. The level of exertion was determined using the Borg Scale (6-20), and the exercise intensity was increased when participants reached a Borg score of 11-14 (13).

Experimental: Spinal Stabilization Exercise Group

Standard OTHER

The control group will be provided with relaxation exercises and lifestyle recommendations. After the relaxation exercises are explained by a physiotherapist, lifestyle recommendations for participants will include avoidance of exposure to environmental tobacco smoke; reduction or cessation of smoking and alcohol consumption; limitation of caffeine, sugar, cold foods and beverages, and foods with high salt content; use of loose and cotton clothing; warm standing showers; and adequate and good-quality sleep (at least 6-8 hours) (9,10). To facilitate adherence and support the follow-up of relaxation training, a brochure was prepared and provided to the participants. Participants will perform relaxation exercises once per week for 8 weeks, with each session lasting 30 minutes (1).

Active Comparator: Standard Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 18 and 30 years of age
• Having no history of childbirth
• Being cooperative and oriented
• Having a regular menstrual cycle (28 ± 7 days)
• Scoring \>1 on the WaLIDD scale
• Reporting a menstrual pain score greater than 4 out of 10 on the Visual 7)Analog Scale (VAS)
• )Volunteering to participate in the study

You may not qualify if:

• Using hormonal contraceptive medications or an intrauterine device (IUD)
• Having any mental, cardiovascular, pulmonary, or orthopedic condition that could limit exercise participation
• Being pregnant

Sponsors & Collaborators

• Sevtap Günay: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)