Low Back PainNCT05992766
The Effect of Traditional Mat Exercises Versus Reformer Pilates and Hammock Yoga on Chronic Back Pain
A study testing Reformer Pilates, Hammock Yoga and Traditional mat exercises in people with Low Back Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Reformer Pilates, Hammock Yoga and Traditional mat exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2022to 11 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being within the 25-60 age range
- Having low back pain in the last 6 months .
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, None Selected, 27144
About this study
Official title: The Effect of Traditional Mat Exercises Versus Reformer Pilates and Hammock Yoga on Pain, Endurance, Balance, Disability, and Quality of Life in Individuals Who Had Chronic Back Pain
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.
Read the detailed description
Low back pain is among the leading musculoskeletal problems worldwide causing serious health expenditures. It can affect people of all ages in the community, but it is common in individuals between the fourth and fifth decades of life. Low back pain is divided into 3 subclasses according to the duration of the symptoms as Acute (lasting only a few weeks), Subacute (lasting about 6 to 12 weeks), and Chronic (lasting more than 12 weeks).Traditional exercise approaches are frequently used modalities in the treatment of Chronic Back Pain as an extremely valuable approach to preventing movement limitation, controlling existing pain, and regaining motor functions. Pilates exercises are very valuable for the treatment of low back pain because they provide stabilization. Pilates activates the lumbopelvic muscles and supports functional movement as an effective factor in reducing pain. Yoga is also a mind-body exercise discipline that includes both physical and mental aspects of pain with core strengthening, flexibility, relaxation, and breathing modalities.When the literature was reviewed, no study was detected examining the effectiveness of Hammock Yoga and Reformer Pilates in people who have Chronic Back Pain and compares it with traditional mat exercises.
- Conditions
- Low Back Pain
- Being tested
- Reformer Pilates, Hammock Yoga, Traditional mat exercises
- Keywords
- Chronic Back Pain, Reformer Pilates, Hammock Yoga, Physical Fitness, Quality of Life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformer PilatesOther
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.
Hammock YogaOther
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.
Traditional mat exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Traditional mat exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (4)
Core Muscle Endurance Test
The forward plank test was used to measure the control and endurance of the back/core stabilizing muscles.The aim of this test was to hold an elevated position for as long as possible. Start with the upper body supported off the ground by the elbows and forearms, and the legs straight with the weight taken by the toes. The hip was lifted off the floor creating a straight line from head to toe. As soon as the subject was in the correct position, the stopwatch was started and time was recorded
Measured: 4 weeks
Static Balance Test
The static balance was evaluated with single leg stance test. The participants were asked to pull their knees towards the abdomen and maintain this position while keeping their hands on their waists without disturbing the neutral pelvis (22). The time that passed until the position was broken was calculated and this test was repeated three times in total for both the right and left legs, and the maximum time was recorded in seconds.
Measured: 4 weeks
Hip Muscle Endurance Test
The Single Leg Bridge Test was used to measure hip muscles endurance;The participants were asked to go to the bridge position with their supine hands-free at their sides and hips in the air, and while they were in this position, they were asked to keep the hip and knee flexion of the tested side and take the other leg into the air with the sole on the ground, and maintain the neutral position of the pelvis. When the test position was taken, the stopwatch was started and recorded the time until the participant broke the pelvis position.
Measured: 4 weeks
Dynamic Balance Test
The dynamic balance was evaluated with the Star Excursion Balance Test. A total of 8 lines (anterolateral, anterior, anteromedial, medial, posteromedial, posterior, posterolateral, and lateral) of 1m length were drawn on a flat surface at 45 degree their centers converging. The individuals were then asked to reach the farthest point possible in each line with the tip of the other foot and the foot to be tested in the middle of the star. A resting period of 5 seconds was given after each stretch. If the balance was disturbed while reaching, the participants could not touch the lines, or gave full weight with their feet, the attempt was rejected and repeated. The distances that the individuals could reach and touch were recorded, and the test was repeated 3 times to record the maximum score.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start13 Apr 2022
- Primary completion5 Dec 2022
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into 3 groups with closed envelope randomization method.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992766
- Sponsor's protocol ID
- 2022/037
- Status last verified
- Oct 2024
- First submitted
- 5 Aug 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19468897Sherman 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.
PubMed 22025101Rydeard 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.
PubMed 16881464Zhu 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.
PubMed 32870936Lim 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.
PubMed 20972339Pereira 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.
PubMed 21856719
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Traditional Mat Exercises Versus Reformer Pilates and Hammock Yoga on Pain, Endurance, Balance, Disability, and Quality of Life in Individuals Who Had Chronic Back Pain
- ClinicalTrials.gov ID
- NCT05992766
- Acronym / sponsor ID
- 2022/037
- Conditions
- Low Back Pain
- Keywords
- Chronic Back Pain, Reformer Pilates, Hammock Yoga, Physical Fitness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low back pain is among the leading musculoskeletal problems worldwide causing serious health expenditures. It can affect people of all ages in the community, but it is common in individuals between the fourth and fifth decades of life. Low back pain is divided into 3 subclasses according to the duration of the symptoms as Acute (lasting only a few weeks), Subacute (lasting about 6 to 12 weeks), and Chronic (lasting more than 12 weeks).Traditional exercise approaches are frequently used modalities in the treatment of Chronic Back Pain as an extremely valuable approach to preventing movement limitation, controlling existing pain, and regaining motor functions. Pilates exercises are very valuable for the treatment of low back pain because they provide stabilization. Pilates activates the lumbopelvic muscles and supports functional movement as an effective factor in reducing pain. Yoga is also a mind-body exercise discipline that includes both physical and mental aspects of pain with core strengthening, flexibility, relaxation, and breathing modalities.When the literature was reviewed, no study was detected examining the effectiveness of Hammock Yoga and Reformer Pilates in people who have Chronic Back Pain and compares it with traditional mat exercises.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The participants were divided into 3 groups with closed envelope randomization method.
| Arm | Type | Receives |
|---|---|---|
| Reformer Pilates | Experimental | Other: Reformer PilatesReformer 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. |
| Hammach Yoga | Experimental | Other: Hammock YogaHammock 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. |
| Mat | Active comparator | Other: Traditional mat exercisesTraditional 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being within the 25-60 age range
- Having low back pain in the last 6 months .
Key exclusion criteria (6 listed)
- The history of surgery in the lumbar region in the last 1 year,
- Diagnosed radiculopathy,
- Systemic diseases
- Malignancy,
- Performed regular physical activity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reformer PilatesReformer 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. | Other | Reformer Pilates |
| Hammock YogaHammock 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. | Other | Hammach Yoga |
| Traditional mat exercisesThe 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. | Other | Mat |
Primary outcome
Pain characteristics
Time frame: 4 weeks
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.
Disability
Time frame: 4 weeks
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
Quality of Life
Time frame: 4 weeks
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.
Pain intensity
Time frame: 4 weeks
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 secondary outcomes
Core Muscle Endurance Test
Time frame: 4 weeks
Static Balance Test
Time frame: 4 weeks
Hip Muscle Endurance Test
Time frame: 4 weeks
Dynamic Balance Test
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 19468897Sorosky 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.
- Background: PubMed 22025101Sherman 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.
- Background: PubMed 16881464Rydeard 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.
- Background: PubMed 32870936Zhu 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.
- Background: PubMed 20972339Lim 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.
- Background: PubMed 21856719Pereira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reformer Pilates, Hammock Yoga and Traditional mat exercises in people with Low Back Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain characteristics (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992766, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.