NCT05992766

Brief Summary

The purpose of the present study was to examine the effects of traditional mat exercises, Reformer Pilates and Hammock Yoga approaches on pain, endurance, balance, disability, and quality of life of individuals who had Chronic Back Pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

August 5, 2023

Last Update Submit

October 3, 2024

Conditions

Keywords

Chronic Back PainReformer PilatesHammock YogaPhysical FitnessQuality of Life

Outcome Measures

Primary Outcomes (4)

  • Pain characteristics

    McGill Short Form was used at the beginning and end of the study to evaluate the qualitative characteristics of pain. The scale helps to learn about the sensory, emotional, and intensity component of pain. Fifteen items in the scale help define pain (11 sensory descriptors and 4 emotional descriptors). The participants were asked to rate their pain as 0=none, 1=less, 2=moderate, and 3=extreme, according to the intensity level. The total score was obtained by summing the scores given.

    4 weeks

  • Disability

    Disability (e.g., walking, sitting, standing, pain intensity, and sleeping) were evaluated with the Oswestry Disability Index, which consisted of 10 sections. A total score was obtained by scoring a Likert-type design ( 0-5 in each section). An increase in the score indicated an increased disability

    4 weeks

  • Quality of Life

    The World Health Organization Quality of Life-Bref (WHOQOL-Bref) Questionnaire was used to evaluate the quality of life. The questionnaire has 5 sections (Psychological Health, Physical Health, General Health, Social Relations, and Environmental Health).An increase in the score indicated an increased Quality of Life.

    4 weeks

  • Pain intensity

    A Visual Analog Scale was used to evaluate pain intensity. This scale is a straight horizontal line of fixed length, usually 100 mm. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    4 weeks

Secondary Outcomes (4)

  • Core Muscle Endurance Test

    4 weeks

  • Static Balance Test

    4 weeks

  • Hip Muscle Endurance Test

    4 weeks

  • Dynamic Balance Test

    4 weeks

Study Arms (3)

Reformer Pilates

EXPERIMENTAL

Reformer Pilates were performed, 2 days a week, for 4 weeks, in a total of 8 sessions (45 minutes each). The exercises of the Reformer Pilates were given as individual sessions by the physiotherapist. Reformer Exercises were explained by the physiotherapist in detail to understand the movement and starting position correctly, and the participants were then asked to perform the movements.

Other: Reformer Pilates

Hammach Yoga

EXPERIMENTAL

Hammock Yoga were performed, 2 days a week, for 4 weeks, in a total of 8 sessions (45 minutes each). Hammock Yoga were given as individual sessions by the physiotherapist.

Other: Hammock Yoga

Mat

ACTIVE COMPARATOR

Traditional mat exercises were performed, 2 days a week, for 4 weeks, in a total of 8 sessions (45 minutes each). The mat exercises were applied as a home program. The exercises were visually given with detailed explanations on a piece of paper, and they were checked by telephone every week.

Other: Traditional mat exercises

Interventions

Reformer Pilates exercises activates the lumbopelvic muscles and supports functional movement. Activated muscles support the spine and reduce the load on the spine by correcting the posture, helping the core muscles such as the abdomen and spine stay healthier by attaching them to a neutral pelvis Pilates consists of a sliding platform working with the help of a pulley system specific to the use, allowing the individual to apply certain resistances, and providing the opportunity to exercise sitting, standing, or lying down.

Reformer Pilates

Hammock Yoga is performed with a silk hammock, which is an auxiliary equipment. The most distinctive characteristic that makes Hammock Yoga different from other exercises is the spine traction provided by the upside-down posture, and the smooth and shiny silk hammock allows strengthening exercises. The Hammock Yoga aims to reduce the load on the spine by upside-down postures that defy the laws of physics.

Hammach Yoga

The mat exercises help build core strength, stamina, and motor control of the abdominal and lumbar trunk musculature. The exercises focus on the re-education of a precise co-contraction pattern of local muscles of the spine. Also mat exercise increases the level of endorphins and the stimulation of mechanoreceptors, causing biomechanical stress to support healing in tissues.

Mat

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being within the 25-60 age range
  • Having low back pain in the last 6 months .

You may not qualify if:

  • The history of surgery in the lumbar region in the last 1 year,
  • Diagnosed radiculopathy,
  • Systemic diseases
  • Malignancy,
  • Performed regular physical activity,
  • Using steroids and anti-inflammatory drugs in the physiotherapy program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, None Selected, 27144, Turkey (Türkiye)

Location

Related Publications (6)

  • Sorosky S, Stilp S, Akuthota V. Yoga and pilates in the management of low back pain. Curr Rev Musculoskelet Med. 2008 Mar;1(1):39-47. doi: 10.1007/s12178-007-9004-1.

    PMID: 19468897BACKGROUND
  • Sherman KJ, Cherkin DC, Wellman RD, Cook AJ, Hawkes RJ, Delaney K, Deyo RA. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med. 2011 Dec 12;171(22):2019-26. doi: 10.1001/archinternmed.2011.524. Epub 2011 Oct 24.

    PMID: 22025101BACKGROUND
  • Rydeard R, Leger A, Smith D. Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial. J Orthop Sports Phys Ther. 2006 Jul;36(7):472-84. doi: 10.2519/jospt.2006.2144.

    PMID: 16881464BACKGROUND
  • Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.

    PMID: 32870936BACKGROUND
  • Lim EC, Poh RL, Low AY, Wong WP. Effects of Pilates-based exercises on pain and disability in individuals with persistent nonspecific low back pain: a systematic review with meta-analysis. J Orthop Sports Phys Ther. 2011 Feb;41(2):70-80. doi: 10.2519/jospt.2011.3393. Epub 2010 Oct 22.

    PMID: 20972339BACKGROUND
  • Pereira LM, Obara K, Dias JM, Menacho MO, Guariglia DA, Schiavoni D, Pereira HM, Cardoso JR. Comparing the Pilates method with no exercise or lumbar stabilization for pain and functionality in patients with chronic low back pain: systematic review and meta-analysis. Clin Rehabil. 2012 Jan;26(1):10-20. doi: 10.1177/0269215511411113. Epub 2011 Aug 19.

    PMID: 21856719BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The participants were divided into 3 groups with closed envelope randomization method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass Prof

Study Record Dates

First Submitted

August 5, 2023

First Posted

August 15, 2023

Study Start

April 13, 2022

Primary Completion

December 5, 2022

Study Completion

January 11, 2023

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations