Chronic Low-back PainNCT05057091

Immediate Effects of Two Spinal Manipulative Techniques

A study testing Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation and Group 2- Side-Lying Lumbar Spinal Manipulation in people with Chronic Low-back Pain, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to investigate the instant effects of direct vertabral manipulation and indirect vertebral manipulation techniques on muscles mechanical properties, pressure-pain threshold and joint range of motion in individuals with chronic low back pain. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Low-back Pain
What is being tested?: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation and Group 2- Side-Lying Lumbar Spinal Manipulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 19 Sep 2021to 30 Nov 2021
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-65 ages
Individuals with non-specific chronic low back pain who have continued pain for at least 3 months
According to VAS, individuals with pain of at least 3 severity

Who cannot join

Pregnancy situation or suspicion
Spinal Stenosis
Vertebral fracture
Cancer
Osteoporosis
Individuals with BMI over 30 kg/m2
Those with neurological disease that leads to November loss of muscle strength or spasticity-rigidity

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Alanyaaku
Antalya, Alanya

Other trials in Turkey (Türkiye)

About this study

Official title: Immediate Effects of Two Spinal Manipulative Techniques on Clinical Outcomes and Muscle Mechanical Properties in Chronic Low Back Pain: An Assessor Blinded, Randomized Controlled Trial

Read the detailed description

Resolving chronic low back pain is a costly obstacle. There is a wide spectrum of treatment for chronic low back pain, such as exercise training, pain training and spinal manipulation.It is the recommended spinal manipulation in the short and long term in chronic low back pain. Clinical Spinal manipulation is one of the most preferred methods of reducing pain and disability.

Conditions: Chronic Low-back Pain
Being tested: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation, Group 2- Side-Lying Lumbar Spinal Manipulation
Keywords: Acute Manipulation, Chronic manipulation, Low back pain, muscles mechanical treshold, physiotherapy
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.

Group 1 - Maitland's Posterior-Anterior Central Vertebral ManipulationOther
For the posterior-anterior unilateral vertebral manipulation, the therapist positioned both thumbs on top of each other on the spinous process of the vertebra and applied an average of 4 kg of discrete pressure
Group 2- Side-Lying Lumbar Spinal ManipulationOther
The therapist stood in front of the patient, who was instructed to lie on their side with the painful side facing upward.the therapist utilized their arm and body to apply the manipulation. A high-speed, low-amplitude thrust force was applied in opposite directions: anteriorly to the pelvis and posteriorly to the shoulder.

Study groups in NCT05057091
Study group	Role	What they receive
Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation	Experimental	The posterior-anterior unilateral vertebral manipulation. Receives: Other: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; Other: Group 2- Side-Lying Lumbar Spinal Manipulation
Group 2- Side-Lying Lumbar Spinal Manipulation	Experimental	A high-speed, low-amplitude thrust force was applied in opposite directions: anteriorly to the pelvis and posteriorly to the shoulder Receives: Other: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; Other: Group 2- Side-Lying Lumbar Spinal Manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Mechanical properties measurements
A MyotonPro was used to measure the mechanical properties of selected muscles. the measurements of the medial gastrocnemius and biceps femoris muscles were performed while individuals were in prone position the knees at full extension, and the ankle at neural position. The measurements of medial gastrocnemius were performed on plumped portion of the muscle at a point 70% of the lower leg length in line with the popliteal crease to the lateral malleolus. For biceps femoris muscle, measurements were performed at the middle points between tuberosity of the ischium and the head of the fibula.the mechanical properties of lumbar extensor muscle were performed while the individuals were prone position the hip and knee at full extension. For lumbar extensor muscle, the measurements were performed at the point 3 cm from the midpoint of the L3/L4 intervertebral space. The average of three consecutive measurements was recorded.
Measured: through study completion, an average of 1 hour

Secondary outcomes (4)

Oswestry low back pain scale
it measures a total of 10 different aspects, severity of pain, personal care, lifting, walking, sitting, standing, sleeping, degree of pain change, social life, travel to assess the effect of low back pain on daily life activities in the patient.
Measured: Through study completion, an average of 1 hour
Roland morris disability scale
This questionnaire is a 24-point questionnaire designed to assess the degree of functional limitation in patients with low back pain. In the survey, the answers vary from yes to no yes: 1 point, no: 0 points, and high scores indicate severe obstacle status
Measured: Through study completion, an average of 1 hour
Visual analog scale
VAS was used to measure the severity of the patient's pain. It is usually 10 cm long, horizontal or vertical; it is a line that begins with "no pain" and ends with "unbearable pain". This line can only be a straight line, or divided into equal December, or in pain definition, the definition placed on the line can be found in words. The patient indicates the severity of his pain with a sign where he sees fit on this line. "Cm" was measured and recorded between the point marked with the onset of decontamination. "0 'means no pain,' 5 'means moderate pain,' 10" means the most severe pain encountered in life.
Measured: Through study completion, an average of 1 hour
Fear Avoidance Beliefs Questionnare
Fear avoidance beliefs questionnare has 16 questions and two sub-scales, physical activity and work. The physical activity section consists of 5 questions, and the work section consists of 11 questions. The survey was a Likert-type scale of 7. In the answers given to the survey, the expression I disagree with at all is given 0 points and the expression I fully agree with is given 6 points.
Measured: Through study completion, an average of 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 202130 Nov 2021

First posted27 Sep 2021
Study start19 Sep 2021
Primary completion20 Sep 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This research is planned as a double blind randomized controlled trials
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05057091
Sponsor's protocol ID: 10354421-2021/03-14
Status last verified: Jan 2025
First submitted: 6 Sep 2021
Last updated: 7 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
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Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
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All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate Effects of Two Spinal Manipulative Techniques on Clinical Outcomes and Muscle Mechanical Properties in Chronic Low Back Pain: An Assessor Blinded, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05057091
Acronym / sponsor ID: 10354421-2021/03-14
Conditions: Chronic Low-back Pain
Keywords: Acute Manipulation, Chronic manipulation, Low back pain, muscles mechanical treshold, physiotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
Study start: 19 Sep 2021 (actual)
Primary completion: 20 Sep 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 27 Sep 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This research is planned as a double blind randomized controlled trials

Arm	Type	Receives
Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation	Experimental	Other: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation, Other: Group 2- Side-Lying Lumbar Spinal ManipulationThe posterior-anterior unilateral vertebral manipulation.
Group 2- Side-Lying Lumbar Spinal Manipulation	Experimental	Other: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation, Other: Group 2- Side-Lying Lumbar Spinal ManipulationA high-speed, low-amplitude thrust force was applied in opposite directions: anteriorly to the pelvis and posteriorly to the shoulder

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18-65 ages
Individuals with non-specific chronic low back pain who have continued pain for at least 3 months
According to VAS, individuals with pain of at least 3 severity

Key exclusion criteria (7 listed)

Pregnancy situation or suspicion
Spinal Stenosis
Vertebral fracture
Cancer
Osteoporosis

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
Group 1 - Maitland's Posterior-Anterior Central Vertebral ManipulationFor the posterior-anterior unilateral vertebral manipulation, the therapist positioned both thumbs on top of each other on the spinous process of the vertebra and applied an average of 4 kg of discrete pressure	Other	Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation, Group 2- Side-Lying Lumbar Spinal Manipulation
Group 2- Side-Lying Lumbar Spinal ManipulationThe therapist stood in front of the patient, who was instructed to lie on their side with the painful side facing upward.the therapist utilized their arm and body to apply the manipulation. A high-speed, low-amplitude thrust force was applied in opposite directions: anteriorly to the pelvis and posteriorly to the shoulder.	Other	Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation, Group 2- Side-Lying Lumbar Spinal Manipulation

Primary outcome

Mechanical properties measurements
Time frame: through study completion, an average of 1 hour
A MyotonPro was used to measure the mechanical properties of selected muscles. the measurements of the medial gastrocnemius and biceps femoris muscles were performed while individuals were in prone position the knees at full extension, and the ankle at neural position. The measurements of medial gastrocnemius were performed on plumped portion of the muscle at a point 70% of the lower leg length in line with the popliteal crease to the lateral malleolus. For biceps femoris muscle, measurements were performed at the middle points between tuberosity of the ischium and the head of the fibula.the mechanical properties of lumbar extensor muscle were performed while the individuals were prone position the hip and knee at full extension. For lumbar extensor muscle, the measurements were performed at the point 3 cm from the midpoint of the L3/L4 intervertebral space. The average of three consecutive measurements was recorded.

4 secondary outcomes

Oswestry low back pain scale
Time frame: Through study completion, an average of 1 hour
Roland morris disability scale
Time frame: Through study completion, an average of 1 hour
Visual analog scale
Time frame: Through study completion, an average of 1 hour
Fear Avoidance Beliefs Questionnare
Time frame: Through study completion, an average of 1 hour

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 7 Jan 2025.

Related trials for Chronic Low-back Pain

Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain

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.

Emine KURT, Assc. Prof. principal investigator

Alanya Alaaddin Keykubat University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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 7 Jan 2025. 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?

Mechanical properties measurements (time frame: through study completion, an average of 1 hour). 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 NCT05057091.

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 7 Jan 2025.