NCT07022132

Brief Summary

The aim of this study was to compare the effects of conservative treatment with diaphragmatic myofascial release (DMR) and abdominal hypopressive exercise (AHE) technique added to conservative treatment in chronic low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

January 2, 2026

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

May 28, 2025

Last Update Submit

December 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity (Visual Analogue Scale)

    The Visual Analogue Scale (VAS) will be used to assess the level of pain at rest and during movement. The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 100 millimetres long, with two verbal descriptors indicating pain status at the extremes. The patient is asked to indicate where on this line his/her condition fits by drawing a line, putting a dot or pointing.

    6 weeks

Secondary Outcomes (3)

  • Hamstring flexibility (The Active Knee Extension Test)

    6 weeks

  • Chest wall mobility (a tape measure)

    6 weeks

  • Pelvic floor muscle activity

    6 weeks

Study Arms (2)

Diaphragmatic myofascial release (DMR) group

ACTIVE COMPARATOR

This group will receive DMR in addition to conservative treatment consisting of stretching and strengthening exercises.

Other: Diaphragmatic myofascial release (DMR)Other: Conservative treatment

Abdominal hypopressive exercise (AHE) group

ACTIVE COMPARATOR

This group will receive AHE in addition to conservative treatment consisting of stretching and strengthening exercises.

Other: Abdominal hypopressive exercise (AHE)Other: Conservative treatment

Interventions

The physiotherapist, positioned on the head side of the supine patient, makes bilateral contact with the pisiform, hypothenar region and the underside of the 7th-10th costal cartilages with the last three fingers. During the inspiration phase, he/she pulls the contact points cephalically and slightly laterally with both hands, accompanying the elevation of the costae. During expiration, it deepens the contact towards the inner costal margin, maintaining resistance. In subsequent breathing cycles, it gradually increases the depth of contact inside the costal margin. The application is performed in 2 sets of 10 deep breaths with 1 minute between them.

Diaphragmatic myofascial release (DMR) group

Each session consists of 6 hypopressive abdominal exercises with a 2-minute recovery period in between, and each exercise is repeated 3 times. This manoeuvre consists of expelling all air until the reserve volume is reached, then holding the breath (expiratory apnoea) and pulling the abdominal wall inwards and cranially by opening the costae without allowing air to enter. Exercises are performed in 6 different positions.

Abdominal hypopressive exercise (AHE) group

It consists of lumbar flexion and extension, stretching and strengthening exercises for the waist, back and abdominal region.

Abdominal hypopressive exercise (AHE) groupDiaphragmatic myofascial release (DMR) group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing low back pain for at least 12 weeks
  • To be between the ages of 18-65

You may not qualify if:

  • Pregnancy
  • Severe osteoporosis
  • Less than 1 year history of abdominal and/or thoracic surgery
  • Having an additional disease such as severe coronary artery disease, uncontrolled hypertension, COPD that prevents exercise,
  • Difficulty in co-operation
  • History of malignancy
  • History of lumbar spinal surgery
  • Spondylolisthesis, scoliosis, other spinal deformities and congenital malformations
  • Radiculopathy
  • Systemic inflammatory diseases
  • Corticosteroid injection in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Hatice Hümeyra Akıl

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 15, 2025

Study Start

August 10, 2024

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

January 2, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations