Lumbar Disc HerniationNCT05288634
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
A study testing Progressive relaxation exercise in people with Lumbar Disc Herniation, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to assess the influence of progressive muscle relaxation exercise on kinesiophobia and pain during after lumbar disc surgery using the Visual Analog Scale (VAS) and the Tampa Kinesiophobia Scale in a prospective, randomized fashion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 29 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • The patients included in the study had lumbar microdiscectomy surgery,
- Patients aged 18 and over
- Patients should not have any problems that would prevent them from expressing their pain level correctly and from understanding the information given,
- The patients do not have any psychological disorders,
- The patients do not have any other acute disease that will cause pain.
Who cannot join
- • Being diagnosed with a psychiatric disorder,
- A complication (bleeding, hospital infection, etc.) developed in the patients before, during and after the operation within three days,
- Not knowing Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aksaray University
Aksaray, None Selected, 68100
About this study
We aimed to assess the influence of progressive muscle relaxation exercise on kinesiophobia and pain during after lumbar disc surgery using the Visual Analog Scale (VAS) and the Tampa Kinesiophobia Scale in a prospective, randomized fashion.
Read the detailed description
Lumbar disc herniation (LDH) is a common disease that is common in the society and limits the activities of individuals in daily life. Pain, which is an undesirable but expected result of surgical interventions, which are used in the treatment of diseases and play an important role in increasing the health level of people, is one of the most common postoperative complaints. The pain is sometimes severe enough to impede movement and causes paravertebral muscle spasm. Pain can also cause kinesiophobia, which is a factor that limits the person's physical activities. This study was conducted to determine the effect of progressive muscle relaxation exercises on kinesiophobia, which can be seen in parallel with pain in the postoperative period, on the pain level of patients after LDH surgery and on the kinesiophobia experienced in parallel.
The following hypotheses (H) were tested in this study:
H1. Progressive muscle relaxation exercise has an effect on reducing pain after LDH surgery.
H2. Progressive muscle relaxation exercise has an effect on reducing kinesiophobia after LDH surgery.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Progressive relaxation exercise
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exerciseOther
Progressive relaxation exercise is a type of exercise that involves voluntary stretching and relaxation of major muscle groups in the human body, from the hands to the feet.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Routine maintenance and Progressive relaxation exercise practice Receives: Other: Progressive relaxation exercise |
| Control | No intervention | Routine maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale
: It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Measured: the day before the surgery
Visual Analogue Scale
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
Measured: the day before the surgery
Secondary outcomes (2)
Tampa Kinesiophobia Scale
It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Measured: third day after surgery
Visual Analogue Scale
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
Measured: third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start14 Mar 2022
- Primary completion20 Oct 2022
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Cetinkaya, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288634
- Sponsor's protocol ID
- 2020/01-25
- Status last verified
- Jul 2023
- First submitted
- 11 Mar 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT05288634
- Acronym / sponsor ID
- 2020/01-25
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 21 Mar 2022 (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.
We aimed to assess the influence of progressive muscle relaxation exercise on kinesiophobia and pain during after lumbar disc surgery using the Visual Analog Scale (VAS) and the Tampa Kinesiophobia Scale in a prospective, randomized fashion.
Detailed description
Lumbar disc herniation (LDH) is a common disease that is common in the society and limits the activities of individuals in daily life. Pain, which is an undesirable but expected result of surgical interventions, which are used in the treatment of diseases and play an important role in increasing the health level of people, is one of the most common postoperative complaints. The pain is sometimes severe enough to impede movement and causes paravertebral muscle spasm. Pain can also cause kinesiophobia, which is a factor that limits the person's physical activities. This study was conducted to determine the effect of progressive muscle relaxation exercises on kinesiophobia, which can be seen in parallel with pain in the postoperative period, on the pain level of patients after LDH surgery and on the kinesiophobia experienced in parallel.
The following hypotheses (H) were tested in this study:
H1. Progressive muscle relaxation exercise has an effect on reducing pain after LDH surgery.
H2. Progressive muscle relaxation exercise has an effect on reducing kinesiophobia after LDH surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Progressive relaxation exerciseRoutine maintenance and Progressive relaxation exercise practice |
| Control | No intervention | –Routine maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • The patients included in the study had lumbar microdiscectomy surgery,
Key exclusion criteria (3 listed)
- • Being diagnosed with a psychiatric disorder,
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 |
|---|---|---|
| Progressive relaxation exerciseProgressive relaxation exercise is a type of exercise that involves voluntary stretching and relaxation of major muscle groups in the human body, from the hands to the feet. | Other | Experimental |
Primary outcome
Tampa Kinesiophobia Scale
Time frame: the day before the surgery
: It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Visual Analogue Scale
Time frame: the day before the surgery
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
2 secondary outcomes
Tampa Kinesiophobia Scale
Time frame: third day after surgery
Visual Analogue Scale
Time frame: third day after surgery
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 Jul 2023.
- 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 Progressive relaxation exercise in people with Lumbar Disc Herniation, run by Aksaray 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 5 inclusion and 3 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 Jul 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?
Tampa Kinesiophobia Scale (time frame: the day before the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2023.