Intervertebral Disc DisplacementNCT05804357
The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients
A study testing Manual Therapy and Exercise in people with Intervertebral Disc Displacement and Lumbar Disc Herniation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, there are studies examining the relationship between low back pain and anxiety depression, quality of life and LDH in patients with lumbar disc herniation. There are many studies on the clinical use of manual therapy methods in LDH. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervertebral Disc Displacement, Lumbar Disc Herniation, Psychological
- What is being tested?
- Manual Therapy and Exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 25 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- It was determined as being diagnosed with LDH by MR by a physical therapy physician
- Having pain of at least 3 levels or more according to the Visual Analogue Scale
- Being between the ages of 18-65.
Who cannot join
- History of spinal surgery
- History of autoimmune disease (ankylosing spondylitis, rheumatoid arthritis or other)
- Spondylolysis and spondylolisthesis
- Spinal fracture
- Heart pathology
- History of stroke,
Show all 9Show fewer
- Cauda equina syndrome
- Continuous use of pain medication
- Spinal inflammation,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients: A Single Blind Randomized Clinical Study
When the literature is examined, there are studies examining the relationship between low back pain and anxiety depression, quality of life and LDH in patients with lumbar disc herniation. There are many studies on the clinical use of manual therapy methods in LDH. Most of these studies examine the effect of manual therapy on pain and functional level. However, there are hardly any studies examining the effect of manual therapy on quality of life and psychological factors in LDH patients.
The aim of our study is to examine the effect of mobilization, which is a manual therapy application, on psychological factors (kinesiophobia, pain catastrophic thought, anxiety and depression) and quality of life in LDH patients.
Read the detailed description
There are various treatment options that can be applied to patients with lumbar disc herniation (LDH). These are basically divided into 2 categories: surgical and conservative treatment. Conservative treatment methods in the treatment of LDH aim to prevent the disease from transitioning to interventional methods and / or surgical treatment and to improve the complaints that negatively affect the quality of life. Conservative treatment; It includes informing the patient, bed rest, drug treatments, exercise, thermotherapy, electrotherapy, traction, orthoses, back school and manual therapy applications. Manual therapy; It is used to reduce pain, provide joint and tissue mobility, inhibit sympathetic reflex activity, normalize muscle tone and dissolve adhesions. Manual therapy is the manual treatment of the spine with two different applications such as manipulation and mobilization.
The clinical effects of manual therapy in LDH patients were examined. The aim of this study was to investigate the effect of manual therapy on psychological factors and quality of life in patients with lumbar disc herniation.
- Being tested
- Manual Therapy, Exercise
- Keywords
- Lumbar disc herniation, Manual therapy, Kinesiophobia, Anxiety and depression, Pain catastrophe
- Medical subject headings
- Intervertebral Disc Displacement, Kinesiophobia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyBehavioural
Also called Lumbal Spinal Mobilization
Mobilization applications are passive movements that do not involve pushing or stimuli, applied within the range of motion or up to the physiological range of motion
ExerciseBehavioural
Also called Stabilization Exercise
It is an approach that is combined with diaphragmatic breathing, activating the passive-active musculoskeletal and neural systems. In this approach, transversus abdominis and multifudus muscles are activated as deep core muscles.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | In our study, stabilization exercises were applied to the patients in the exercise group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Stabilization exercises: It is an approach that is combined with diaphragmatic breathing and activates the passive. The stabilization exercise program was applied in three phases and was progressed in line with the developments in the patients Receives: Behavioral: Exercise |
| Manual Therapy Group | Experimental | In our study, stabilization exercises and spinal mobilization practices were performed to the patients in the manual therapy group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Mobilization applications were applied at Maitland IV degree as standard.Three mobilization methods were applied Anterior-Posterior Lumbal Spinal Mobilization Lumbal Spinal Rotational Mobilization Joint Mobilization in Lumbal Flexion Position Receives: Behavioral: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
McGill-Melzack Pain Questionnaire :It is a questionnaire applied to determine the location, characteristics, relationship with time and severity of low back pain. The total score is obtained by summing the points corresponding to the answer given according to each category. While the maximum score was 78, the minimum score was set to 0. The higher the pain, the higher the score.
Measured: The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Secondary outcomes (4)
Anxiety and Depression Assessment
Hospital Anxiety and Depression Scale :It is a self-assessment scale applied to determine the risk of anxiety and depression in the patient, to measure its level and change in severity. It contains a total of 14 questions, seven of which measure anxiety and the other seven measure depression.
Measured: The change of anxiety and depression assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Kinesiophobia Assessment
Tampa Kinesiophobia Scale :Consisting of 17 questions, the scale measures individuals' fear of re-injury with movement. The questions in the scale are calculated with the Likert scoring type consisting of 4 points. Patients are given a minimum score of 17 and a maximum score of 68. The high score obtained as a result of the scale indicates the high degree of kinesiophobia. In studies, 37 points and above are defined as high kinesiophobia.
Measured: The change of anxiety and depression assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Pain Catastrophizing Assessment
Pain Catastrophizing Scale: It reliably assesses certain variables, such as fears, feelings or thoughts, severe pain, disability, and emotional disturbances associated with individuals' past pain experiences. The scale consists of 13 questions scored between 0-4 (0=Never, 1=A little. 2=Moderately, 3=Seriously, 4=Always). An increase in the scale score indicates a high fear of experiencing pain.
Measured: The change of pain catastrophe assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Quality of Life Assessment
Nottingham Health Profile (NHP): It is a valid-reliable quality of life scale used to evaluate the physical, emotional and social effects of diseases on individuals. It consists of six sections, including pain, physical activity, energy, sleep, social isolation and emotional reaction, and a total of 38 questions.
Measured: The change of quality of life assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Jan 2021
- Primary completion25 Apr 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc DisplacementStudies 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 study was designed as a double-blind randomized controlled clinical trial. In order to carry out the prospectively designed study, ethics committee approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Muş Alparslan University with the decision numbered 21 taken at the meeting dated 29.12.2020 and numbered 15. Informed consent was obtained from all patients included in the study before the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burhan Taşkaya, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804357
- Sponsor's protocol ID
- E-10879717-016.18.22
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taskaya B, Taskent I, Cakilli M, Yilmaz O. The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbar Disc Herniation Patients: A Single Blinded Randomized Clinical Trial. Int J Environ Res Public Health. 2024 Sep 18;21(9):1234. doi: 10.3390/ijerph21091234.
PubMed 39338117
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients: A Single Blind Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05804357
- Acronym / sponsor ID
- E-10879717-016.18.22
- Keywords
- Lumbar disc herniation, Manual therapy, Kinesiophobia, Anxiety and depression, Pain catastrophe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 7 Apr 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.
When the literature is examined, there are studies examining the relationship between low back pain and anxiety depression, quality of life and LDH in patients with lumbar disc herniation. There are many studies on the clinical use of manual therapy methods in LDH. Most of these studies examine the effect of manual therapy on pain and functional level. However, there are hardly any studies examining the effect of manual therapy on quality of life and psychological factors in LDH patients.
The aim of our study is to examine the effect of mobilization, which is a manual therapy application, on psychological factors (kinesiophobia, pain catastrophic thought, anxiety and depression) and quality of life in LDH patients.
Detailed description
There are various treatment options that can be applied to patients with lumbar disc herniation (LDH). These are basically divided into 2 categories: surgical and conservative treatment. Conservative treatment methods in the treatment of LDH aim to prevent the disease from transitioning to interventional methods and / or surgical treatment and to improve the complaints that negatively affect the quality of life. Conservative treatment; It includes informing the patient, bed rest, drug treatments, exercise, thermotherapy, electrotherapy, traction, orthoses, back school and manual therapy applications. Manual therapy; It is used to reduce pain, provide joint and tissue mobility, inhibit sympathetic reflex activity, normalize muscle tone and dissolve adhesions. Manual therapy is the manual treatment of the spine with two different applications such as manipulation and mobilization.
The clinical effects of manual therapy in LDH patients were examined. The aim of this study was to investigate the effect of manual therapy on psychological factors and quality of life in patients with lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was designed as a double-blind randomized controlled clinical trial. In order to carry out the prospectively designed study, ethics committee approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Muş Alparslan University with the decision numbered 21 taken at the meeting dated 29.12.2020 and numbered 15. Informed consent was obtained from all patients included in the study before the study.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Behavioral: ExerciseIn our study, stabilization exercises were applied to the patients in the exercise group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Stabilization exercises: It is an approach that is combined with diaphragmatic breathing and activates the passive. The stabilization exercise program was applied in three phases and was progressed in line with the developments in the patients |
| Manual Therapy Group | Experimental | Behavioral: Manual TherapyIn our study, stabilization exercises and spinal mobilization practices were performed to the patients in the manual therapy group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Mobilization applications were applied at Maitland IV degree as standard.Three mobilization methods were applied Anterior-Posterior Lumbal Spinal Mobilization Lumbal Spinal Rotational Mobilization Joint Mobilization in Lumbal Flexion Position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- It was determined as being diagnosed with LDH by MR by a physical therapy physician
- Having pain of at least 3 levels or more according to the Visual Analogue Scale
- Being between the ages of 18-65.
Key exclusion criteria (9 listed)
- History of spinal surgery
- History of autoimmune disease (ankylosing spondylitis, rheumatoid arthritis or other)
- Spondylolysis and spondylolisthesis
- Spinal fracture
- Heart pathology
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 |
|---|---|---|
| Manual TherapyAlso: Lumbal Spinal MobilizationMobilization applications are passive movements that do not involve pushing or stimuli, applied within the range of motion or up to the physiological range of motion | Behavioural | Manual Therapy Group |
| ExerciseAlso: Stabilization ExerciseIt is an approach that is combined with diaphragmatic breathing, activating the passive-active musculoskeletal and neural systems. In this approach, transversus abdominis and multifudus muscles are activated as deep core muscles. | Behavioural | Exercise Group |
Primary outcome
Pain Assessment
Time frame: The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
McGill-Melzack Pain Questionnaire :It is a questionnaire applied to determine the location, characteristics, relationship with time and severity of low back pain. The total score is obtained by summing the points corresponding to the answer given according to each category. While the maximum score was 78, the minimum score was set to 0. The higher the pain, the higher the score.
4 secondary outcomes
Anxiety and Depression Assessment
Time frame: The change of anxiety and depression assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Kinesiophobia Assessment
Time frame: The change of anxiety and depression assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Pain Catastrophizing Assessment
Time frame: The change of pain catastrophe assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Quality of Life Assessment
Time frame: The change of quality of life assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
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 Apr 2023.
- Derived from this study: PubMed 39338117Taskaya B, Taskent I, Cakilli M, Yilmaz O. The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbar Disc Herniation Patients: A Single Blinded Randomized Clinical Trial. Int J Environ Res Public Health. 2024 Sep 18;21(9):1234. doi: 10.3390/ijerph21091234.
- 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.
Burhan Taşkaya principal investigator
Muş Alparslan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise in people with Intervertebral Disc Displacement and Lumbar Disc Herniation, run by Muş Alparslan 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 3 inclusion and 9 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 Apr 2023. 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 Assessment (time frame: The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment). 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 NCT05804357, which also lists 1 linked publication.
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 Apr 2023.